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city

state

<h3>Job Description</h3>
Job DescriptionSalary: 
ABOUT EPSILON
Epsilon Associates, Inc. is a leading engineering and environmental consulting firm with extensive experience in assisting clients with historic preservation planning, regulatory compliance and state and federal historic rehabilitation tax credits.
 
POSITION SUMMARY
Epsilon is seeking a full-time Preservation Planner/Architectural Historian to work with our expanding historic preservation group. Key responsibilities include preparation of documents and reports for submission to local, state, and federal government review agencies; including National Register eligibility evaluations and nominations, Project Notification Forms, historic property surveys, design review applications, archival photographic documentation, and state and federal historic rehabilitation tax credit applications.
 
PREFERRED QUALIFICATIONS AND REQUIREMENTS
The successful candidate will have a minimum BA/BS degree in Architectural History, Historic Preservation Planning, or closely related discipline (MA/MS is preferred) and will have 4-6 years of professional experience and must meet the Secretary of the Interiors professional qualifications.
 
Excellent research, writing, editing, and photographic abilities are required. Experience with building research, knowledge of architectural styles and forms, and periods of development and architectural history of New England as well as knowledge and experience with application of the Secretary of the Interiors Standards for the Treatment of Historic Properties is a must. Documented experience with the preparation of historic rehabilitation tax credit applications and National Register nominations is essential.
 
Fluency in reading architectural drawings and the ability to use computer hardware, software, and other related information technologies (Microsoft Word, Excel, PowerPoint, Adobe Acrobat, etc.) is required. Personal vehicle and a willingness to travel, primarily within Massachusetts and New England, also required.
 
Experience with federal and state cultural resource management with a working command of federal and state cultural resource and historic preservation statutes and regulations, including Section 106 and National Register criteria; knowledge of relevant Massachusetts regulations (Chapter 254 and MEPA) is a plus.
 
The ideal candidate will be detail oriented, have a professional demeanor and strong organizational skills, and possess the ability to manage priorities, meet deadlines, and multitask in a fast-paced environment. The candidate should be able to work in a team environment with a variety of project members and manage tasks as delegated by project lead. The candidate must possess strong communication skills including writing skills and the ability to work closely with clients. 
PHYSICAL REQUIREMENTS FOR THE JOB
The Candidate must:
<ul>
<li>be able to work on a computer for extended periods of time; and</li>
<li>be able to travel via car for an extended period of time.</li>
</ul>
 
SALARY RANGE
Epsilon offers competitive salaries commensurate with individual qualifications and experience and a full package of benefits. We seek motivated self-starters who are willing to work hard, communicate well, and have fun in a professional setting.
 
WORKING CONDITIONS IN WHICH THE DUTIES ARE PERFORMED
Epsilon maintains a professional office located in a historic mill in Maynard, MA. Office space is recently renovated, clean, quiet, and friendly. Company employees are currently working on a hybrid basis, which is well supported by company technology and infrastructure. Employees should plan to be in the Maynard office a minimum of 1-2 days per week with additional in-office time as needed for staff events, client meetings, and/or workload requirements.
Our team members enjoy regular opportunities for professional growth, a relaxed and flexible work environment, a competitive base salary, a 401k plan with a generous company match, profit sharing, an annual performance bonus program, and a full benefits package.
 
Epsilon is an equal opportunity employer that recognizes the value of a diverse workforce. We ensure a workplace that supports and encourages creativity, professional growth and a company culture that promotes diversity, inclusion and overall employee health and well-being. All qualified individuals will receive consideration for employment without regard to race, color, age, religion, gender, national origin, sexual orientation, gender identity, disability and/or protected veteran status in accordance with governing laws.
Epsilon Associates, Inc. is an EEO/Disability/Vets Employer
Applicants must have all necessary paperwork to work in the USA.

Preservation Planner

<h3>Job Description</h3>
Job DescriptionSalary: $121,073-$146,643+DOE 
Orum Therapeutics is seeking a highly motivated and accomplished scientist to lead the Bioanalytical and PK/PD function. The successful candidate will have extensive experience in bioanalytical and PK/PD method development and validation, quantitative and qualitative sample analysis, and data interpretation with a particular focus on small molecules and biologics. In this role, you will oversee technical monitoring throughout the bioanalytical method development, validation, and sample analysis processes, whether performed in-house or through external vendors. You will be responsible for managing method transfers between CROs, reviewing validation reports, and ensuring adherence to GLP/GCP regulations. Additionally, you will be accountable for analyzing pharmacokinetic (PK) data and generating PK/PD predictions to support the progression of our projects.
Principal Duties and Responsibilities
<ul>
<li>Oversee all bioanalytical needs, whether in-house or through external vendors, to support DMPK and PK/PD studies.</li>
</ul>
<ul>
<li>Advise on analytical methods for measuring and quantifying small molecule transformations. Manage metabolism, drug-drug interaction (DDI), and transporter studies at CROs.</li>
</ul>
<ul>
<li>Conduct site visits, inspections, and SOP reviews to ensure compliance with regulatory standards and internal protocols.</li>
</ul>
<ul>
<li>Review and approve validation reports, experimental bioanalytical documentation, and archive relevant study documents in consultation with the clinical team.</li>
</ul>
<ul>
<li>Integrate drug metabolism and pharmacokinetics (DMPK) predictions into bioanalytical workflows to support early-phase drug development and optimization. </li>
</ul>
<ul>
<li>Utilize modeling and simulation tools for human PK/PD predictions, enabling dose projection or safety evaluation. </li>
</ul>
<ul>
<li>Collaborate with and support other disciplines across the R&amp;D organization and support regulatory document preparation as needed. </li>
</ul>
<ul>
<li>Maintain up-to-date knowledge of relevant scientific literature, regulatory guidance, and best practices.</li>
</ul>
Skills, Abilities &amp; Competencies
<ul>
<li>Extensive experience with pharmacokinetic and biodistribution studies of antibody-drug conjugates and relevant analytical methods including LC-MS/MS for small molecule quantitation and MSD for ELISA and LBA-based assays.</li>
</ul>
<ul>
<li>Proven experience in developing and validating assays for antibody-drug conjugate modalities including total antibody, total and free payload, ADA, and NAb assays for ADC clinical PK samples.</li>
</ul>
<ul>
<li>Strong expertise in non-compartmental analysis of PK data, with demonstrated experience in PK-PD modeling and simulation, population PK, and meta-analysis (preferred).</li>
</ul>
<ul>
<li>Deep understanding of ADME processes and screening strategies from feasibility to candidate nomination. </li>
</ul>
<ul>
<li>Experience with pharmacokinetic analysis software and understanding of PK and PK/PD principles for interpreting results (preferred). </li>
</ul>
<ul>
<li>Good understanding of GLP/GCP regulations and their application in bioanalytical contexts.</li>
</ul>
<ul>
<li>Demonstrated ability to work independently in a fast-paced biotech environment while thriving in a collaborative, and global multidisciplinary team setting.</li>
</ul>
<ul>
<li>Excellent oral and written communication and time-management skills, and the ability to handle multiple projects simultaneously.</li>
</ul>
<ul>
<li>Strong work ethic and ability to work independently with minimal supervision.</li>
</ul>
Education- Ph.D. or equivalent degree in Analytical chemistry or a related field with minimum 5 years' experience. Level will be commensurate with experience and accomplishments.
*U.S. citizens and those authorized to work in the U.S. (green card) are encouraged to apply. We are unable to sponsor at this time.
*Candidate must be able to pass a background investigation.
*Unable to work with 3rd party candidates or agencies.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above. Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the positions essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
 
Orum Therapeutics is an Equal Opportunity Employer (EOE).

Bioanalytical, Scientist

<h3>Job Description</h3>
Job DescriptionSalary: 
JOB SUMMARY
The Microbiologist I conducts quantitative and qualitative analysis of pharmaceutical products according to FDA, cGMP and Boston Analytical, Inc. Standard Operating Procedures. Duties will include analysis of pharmaceutical products through compendial methods and client specific test protocols.
 
PRIMARY DUTIES AND RESPONSIBILITIES
<ul>
<li>Prepares and analyzes samples to determine microbiological quality through the following analyses: Microbial enumeration methods, absence of specified microorganisms, viable titer.</li>
<li>Performs genetic analysis of microbial growth to determine Genus/Species of unknown isolates.</li>
<li>Performs gram stains.</li>
<li>Performs investigative studies for microbiome clients.</li>
<li>Documents work in a clear and organized manner.</li>
<li>Revises procedures and ELNs under close supervision.</li>
<li>Follows all safety rules and regulations and conducts periodic safety audits.</li>
<li>Follows all cGMP rules and regulations.</li>
<li>Under close supervision confers with Microbiologists and other client personnel regarding research, procedures performed, related results and prepares reports.</li>
<li>Under close supervision will be trained to become proficient at assigned tasks in order to become subject matter experts.</li>
<li>Performs routine data generation and problem solving with a minimal rework.</li>
<li>Works under close supervision to ensure all work performed is executed in compliance with standard operating procedures, good manufacturing practices, and the regulations of the Food and Drug Administration.</li>
<li>Ensures all work performed strictly adheres to Company, client and Pharmacopeial methodologies.</li>
<li>Performs system maintenance and calibrations to ensure equipment is operating with specified requirements. Proper handling of hazardous waste in compliance with the Company and DES hazardous waste rules.</li>
</ul>
REQUIREMENTS &amp; QUALIFICATIONS
Qualifications include a BA or BS degree in Microbiology or related science discipline with 0-2 years of related experience is required. Knowledge of cGMP and related compliance regulations and guidance is preferred.
 
SHIFT
Tuesday-Friday 2nd shift
 
MINIMUM SKILLS REQUIREMENTS
<ul>
<li>Must have the ability and skill to perform the detailed job requirements noted above competently, safely and proficiently.</li>
<li>A self-starter, motivated person who possesses good interpersonal skills capable of effectively interacting with all departments and client personnel.</li>
<li>Must have excellent organizational, verbal communication and technical documentation skills.</li>
<li>Solid computer skills.</li>
<li>Knowledge of safe laboratory practices, including the proper procedures in handling chemicals and samples.</li>
<li>Must be a team player with integrity and concern for the quality of Company products, services and staff members.</li>
</ul>

Microbiologist I, MB

<h3>Job Description</h3>
Job Description
The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures. 
WORKING AT GENEZEN
Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.
JOB SUMMARY
The QC Microbiology Supervisor will lead, plan, organize, guide, and be responsible for the coordination/performance of the QC Microbiology Laboratory Operations,
This position is located in Lexington, MA and will supervise the 2nd shift which will operate M-F from 1:00-9:30pm. The Supervisor will report to the Manager of Microbiology.
ESSENTIAL JOB FUNCTIONS
<ul>
<li>Oversee the execution of monitoring for controlled environments and utility systems within the Manufacturing Facility. Ensure execution is compliant with appropriate regulatory requirements and guidelines using approved Standard Operating procedures (SOPs). </li>
<li>Serve as an SME and provide guidance and support for critical QC Microbiology assays and methods.</li>
<li>Provide leadership, coaching, mentoring and training of QC Microbiology staff, aiding in employee development and performance. </li>
<li>Ensure QC Microbiology testing is completed, reviewed, and reported in a compliant manner and results are timely delivered to clients.</li>
<li>Maintain all aspects of QC Microbiology day-to-day operations and scheduling to align with all aspects of GXP requirements.</li>
<li>Manage data and trending in support of environmental monitoring and utility monitoring reports.</li>
<li>Represent QC Microbiology at cross-functional meetings and interact with internal customers, clients and external vendors.</li>
<li>Perform QC Microbiology testing as required, including bioburden, endotoxin of in-process, product and utility samples. </li>
<li>Perform EM and utility related monitoring, as necessary. </li>
<li>Identify continuous improvement opportunities. Design, implement and maintain resulting systems.</li>
<li>Ensure a safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies is maintained.</li>
<li>Author and revise SOPs, protocols and technical reports to meet industry standards, as necessary.</li>
<li>Oversee QC sample submission and processing activities, and ensure testing is performed accordingly. </li>
<li>Initiate and collaborate on change controls, deviations, and Out of Specification (OOS), Out of Tolerance (OOT) investigations related to QCM and assist with non-conformance investigations. </li>
<li>Serve a system owner of QC Microbiology controlled temperature units, respond per on-call schedule to CMS alarms, including off-hours and weekends </li>
</ul>
SPECIAL WORK REQUIREMENTS
<ul>
<li>Ability to troubleshoot equipment and microbiological testing methods.</li>
<li>Ability to adapt to schedules and priorities changes based on business needs</li>
<li>Experience creating comprehensive department schedules</li>
<li>Leadership experience within a high functioning team</li>
<li>Other duties, as assigned. </li>
</ul>
KNOWLEDGE, SKILLS AND EXPERIENCE
EDUCATION / CERTIFICATIONS / LICENSES
Essential/Desired
Bachelor's degree in microbiology; other related science will be considered. 
Essential
ON-THE-JOB EXPERIENCE

5-15 years of Microbiology laboratory-based experience in a QC testing capacity within a cGMP setting. 
Required
Prior supervisory experience. 
Desired
SKILLS / ABILITIES

Excellent microbiological skills and technical experience in GXP environment. 
Essential
Thorough understanding of industry and regulatory testing requirements for QC Microbiology.
Essential
Computer literacy (MS Word, Excel, and LIMS)
Essential
Must possess excellent communication and organizational skills.
Essential
Detail-Oriented
Essential
Self-organized
Essential
Work Environment:
<ul>
<li>Regularly sit or stand for long periods of time </li>
<li>Work in a BSL 2 environment</li>
</ul>
Movement:
<ul>
<li>Work in a BSL 2 environment</li>
</ul>
Lifting
<ul>
<li>Frequently lift and/or move up to 25 pounds </li>
</ul>
Vision
<ul>
<li>Frequently utilize close vision and the ability to adjust focus</li>
</ul>
Communication
<ul>
<li>Frequently required to communicate by talking, hearing, using telephone and e-mail</li>
</ul>
GENEZEN'S CURES VALUE-BASED COMPETENCIES
Committed to Science We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.
Urgency in action for the patients We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.
Resilience &amp; Grit in operations We are committed to overcoming challenges, learning from failures, and persistently striving for success. 
Execute with Excellence &amp; Integrity We are dedicated to delivering quality results and upholding ethical principals.
olutions driven for our partners We are committed to being a proactive, collaborative, creative and open-minded partner.
GENEZEN'S BENEFITS
<ul>
<li>Paid vacation days, amount based on tenure</li>
<li>Paid sick time</li>
<li>10 observed holidays + 2 floating holiday + 1 volunteer day</li>
<li>401(k) plan with company match up to 6% of salary, vested immediately</li>
<li>Share Appreciation Rights</li>
<li>Choice of several healthcare plans</li>
<li>FSA and HSA programs</li>
<li>Dental &amp; vision care</li>
<li>Employer-paid basic term life/personal accident insurance</li>
<li>Voluntary disability, universal life/personal accident insurance</li>
<li>Accidental Death &amp; Dismemberment (AD&amp;D) Insurance</li>
</ul>
ADDITIONAL DETAILS
<ul>
<li>Nothing in the job description for this role restricts management's right to assign or reassign duties and responsibilities to this job at any time.</li>
<li>This position requires a criminal background check.</li>
<li>Genezen is an Equal Opportunity Employer.</li>
<li>Genezen participates in EVerify.</li>
<li>Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.</li>
</ul>
Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts. 
Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world's largest children's museum--to name just a few reasons why this area is a great place to live.
Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.

QC Supervisor, Microbiology (2nd Shift, 1pm-9:30pm)

<h3>Job Description</h3>
Job Description
DIVISION: Operations
DEPARTMENT: Laboratory Services
UNION/ GRADE: Unit 9/Grade 18
TO VIEW OUR BENEFITS PLEASE CLICK ON THE LINK! - <a href="https://www.mwra.com/about-mwra/careers" target="_blank">https://www.mwra.com/about-mwra/careers</a>
BASIC PURPOSE:
Performs a variety of moderately complex microbiological, biological, and chemical analyses using prescribed procedures on water, wastewater and air.
SUPERVISION RECEIVED:
Works under the general supervision of a Laboratory Supervisor.
SUPERVISION EXERCISED:
None.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
<ul>
<li>Performs a wide range of moderately complex microbiological, biological, and chemical laboratory analyses and field tests and operates all related equipment, assuring adherence to Standard Operating Procedures (SOPs).</li>
<li>Assists in studies and investigations by performing microbiological analyses and tests as directed.</li>
<li>Provides technical direction to technicians and laboratory support personnel by reviewing and confirming the results of routine laboratory and field tests and providing instruction to assure conformity to SOPs.</li>
<li>Performs set-up, maintenance, calibration and minor troubleshooting duties on a variety of standard instrumentation and oversees technicians in their performance of routine equipment maintenance duties.</li>
<li>Maintains a current knowledge of new analytical procedures and equipment.</li>
<li>Follows SOPs to maintain accurate, reliable data, and to effect the efficient transfer of the data in the LIMS system.</li>
<li>Utilizes standard applications software and prepares accurate statistical and graphics displays, as instructed. May assist in the development or modification of software.</li>
<li>Prepares detailed notes and assists with technical reports. May write assigned portions.</li>
<li>Prepares purchase requisitions to reorder standard supplies and materials, and may lead or perform duties to take inventory of supplies and equipment parts.</li>
<li>Provides instruction to technicians in laboratory safety, assures that safety procedures are followed and maintains clean and safe work areas.</li>
</ul>
SECONDARY DUTIES:
Performs related duties as required.
MINIMUM QUALIFICATIONS:
Education and Experience:
<ul>
<li>A four (4) college degree in microbiology, biology, chemistry or a related field; and</li>
<li>At least (1) year of experience in microbiological/chemical analysis, quality control and statistical techniques; or</li>
<li>Any equivalent combination of education and experience.</li>
</ul>
Necessary Knowledge, Skills and Abilities:
<ul>
<li>Thorough knowledge of state of the art modern microbiological/chemical laboratory methods, procedures, materials and equipment.</li>
<li>Skill in the operation of the listed tools and equipment.</li>
<li>Thorough knowledge and experience in proper sampling techniques and analytical procedures.</li>
</ul>
SPECIAL REQUIREMENTS:
<ul>
<li>A valid Class D Motor Vehicle Operators License.</li>
<li>TOOLS AND EQUIPMENT USED: Laboratory equipment and instruments, telephone, personal computer including word processing and other software, copy and fax machines.</li>
</ul>
PHYSICAL DEMANDS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
While performing the duties of this job, the employee is frequently required to use hands to finger, handle, feel or operate objects, tools, or controls and reach with hands and arms. The employee frequently is required to stand and talk or hear. The employee is occasionally required to walk, sit, climb, balance, stoop, kneel, crouch or crawl.
The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move more than 25 pounds. Specific vision abilities required by this job include close, distance, color, peripheral vision, depth perception and the ability to focus.
WORK ENVIRONMENT:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
While performing the duties of this job, the employee occasionally works in outside weather conditions. The employee is occasionally exposed to wet and/or humid conditions. The employee is occasionally exposed to fumes or airborne particles, toxic or caustic chemicals.
The noise level in the work area is usually loud in field settings, and moderately quiet in a laboratory environment.
Massachusetts Water Resources Authority (MWRA) is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, national or ethnic origin, age, religion, disability, sex or gender, sexual orientation, gender identity or expression, genetics, or veteran status.
 Job Posted by ApplicantPro

Microbiologist I

<h3>Job Description</h3>
Job DescriptionSalary: 
JOB SUMMARY
The Manager of Microbiology is responsible for the day-to-day and strategic functions of the QC Microbiology and Microbiology- Validation groups in Salem, NH. The Manager is responsible for providing technical support, scheduling and prioritizing work to meet customer expectations, and ensuring all work is performed in compliance with the quality, health, and safety objectives of the company. Provide technical support to Microbiologists and Client Services team members as needed. Responsible for all aspects of staff management including training, hiring, conducting feedback sessions, employee development, retention and engagement, disciplinary actions, and terminations. The Manager has direct responsibility for improving production efficiency and helping to meet the financial goals of the Microbiology department.
The essential duties and responsibilities of this position include the following. Other duties may be assigned as needed.
 
PRIMARY DUTIES AND RESPONISIBITIES
<ul>
<li>Leads the development and implementation of process improvement initiatives that promote increased productivity for the QC Micro and Validation groups.</li>
<li>Coordinates work projects to appropriately prioritize laboratory workload to meet client requirements as related to quality, on-time performance and TAT (Turnaround Time).</li>
<li>Distributes work to staff in order to maximize productivity.</li>
<li>Maintains quality performance metrics, conducts routine metrics review and root cause analysis in collaboration with the microbiologists.</li>
<li>Devises and develops processes and methods for the solution of technical problems.</li>
<li>Trains, mentors and supervises staff on an as needed basis.</li>
<li>Confers with Quality Assurance and Microbiology Director to design and/or improve standard operating procedures and/or training programs.</li>
<li>Responsible for scheduling work in support of maintaining all deadlines.</li>
<li>Ensures that laboratory supplies, consumables, standards are available to perform the analyses within the required project turnaround time.</li>
<li>Communicates project delays, quality and or technical issues to the Microbiology Director, and/or Client Services/Sales Team, as needed.</li>
<li>Reviews lab nonconformance (investigation and deviations) with microbiologists. Conducts root cause analysis and implements solutions in collaboration with the team.</li>
<li>Manages all aspects of office and lab operations as related to operating costs.</li>
<li>Responsible for the interviewing and the hiring of employees.</li>
<li>Provides regular ongoing performance feedback while serving as a coach and mentor.</li>
<li>Responsible for developing and communicating goals to microbiologists.</li>
<li>Ensures all work is performed in compliance with Standard Operating Procedures, Good Manufacturing Practices, Regulations of the Food and Drug Administration, Company, Client and Pharmacopeial Methodologies.</li>
<li>Follows all safety rules and regulations.</li>
<li>Follows all cGMP rules and regulations.</li>
<li>Documents work in a clear and organized manner.</li>
<li>Maintain a clean and orderly laboratory environment.</li>
<li>Proper handling of hazardous waste in compliance with the Company and hazardous waste rules.</li>
</ul>
REQUIREMENTS &amp; QUALIFICATIONS
Qualifications include a Masters and/or Bachelors degree in Microbiology or a related discipline is required. Must have laboratory experience with a minimum of 5 years of related work experience. Knowledge of cGMPs and related compliance regulations and guidances required.
Must have experience with the various products and services the Company offers including LIMS and ELN and Microbiology.
This position requires a self-starting, motivated person who possesses excellent interpersonal skills; who is able to assume a leadership role in the organization; and, who is able to effectively interact with all departments within the company and with client personnel.
 
MINIMUM SKILLS REQUIREMENT
<ul>
<li>Demonstrated skills in laboratory techniques.</li>
<li>Solid computer skills.</li>
<li>Knowledge of safe laboratory practices, including the proper procedures in handling chemicals and samples.</li>
<li>Must be a team player with integrity and concern for the quality of Company products, services and staff members.</li>
</ul>

Microbiology Manager

<h3>Job Description</h3>
Job DescriptionSalary: 
JOB SUMMARY
The Microbiologist conducts validation and feasibility testing for quantitative and qualitative analysis of pharmaceutical products according to FDA, cGMP and BA, Inc. Standard Operating Procedures. Duties will include analysis of pharmaceutical products through compendial methods and client specific test protocols.
 
PRIMARY DUTIES AND RESPONSIBILITIES
<ul>
<li>Performs validation testing to analyze samples to determine an accurate microbiological procedure for the following analyses: Microbial enumeration methods, absence of specified microorganisms, endotoxin, and water quality analysis (bioburden, TOC, Conductivity).</li>
<li>Performs Disinfectant Efficacy testing for clients facilities utilizing specific disinfectants, surfaces, and organisms determined by the clients.</li>
<li>Perform feasibility work with guidance from USP and BA SOPs. Being able to work independently with little to no guidance to figure out and apply test methods to different products and materials.</li>
<li>Documents work in a clear and organized manner.</li>
<li>Revises procedures and ELNs under close supervision.</li>
<li>Writes validation reports and client protocols for QC Micro to follow for routine testing.</li>
<li>Follows all safety rules and regulations and conducts periodic safety audits.</li>
<li>Follows all cGMP rules and regulations.</li>
<li>Under close supervision confers with Microbiologists and other client personnel regarding research, procedures performed, related results and prepares reports.</li>
<li>Under close supervision will be trained to become proficient at assigned tasks in order to become subject matter experts.</li>
<li>Performs data generation and problem solving with a minimal rework.</li>
<li>Works under close supervision to ensure all work performed is executed in compliance with standard operating procedures, good manufacturing practices, and the regulations of the Food and Drug Administration.</li>
<li>Ensures all work performed strictly adheres to Company, client and Pharmacopeial methodologies.</li>
<li>Performs system maintenance and calibrations to ensure equipment is operating with specified requirements.</li>
<li>Proper handling of hazardous waste in compliance with the Company and DES hazardous waste rules.</li>
</ul>
REQUIREMENTS &amp; QUALIFICATIONS
Qualifications include a BA or BS degree in Microbiology or related science discipline with 0-2 years of related experience is required. Knowledge of cGMP and related compliance regulations and guidances is preferred.
 
SHIFT
WED-SAT 1ST SHIFT

MINIMUM SKILLS REQUIREMENTS
<ul>
<li>Must have the ability and skill to perform the detailed job requirements noted above competently, safely and proficiently.</li>
<li>A self-starter, motivated person who possesses good interpersonal skills capable of effectively interacting with all departments and client personnel.</li>
<li>Must have excellent organizational, verbal communication and technical documentation skills.</li>
<li>Solid computer skills.</li>
<li>Knowledge of safe laboratory practices, including the proper procedures in handling chemicals and samples.</li>
<li>Must be a team player with integrity and concern for the quality of Company products, services and staff members.</li>
</ul>

Microbiologist I, VD

<h3>Job Description</h3>
Job Description
Principal Biostatistician
Statistics &amp; Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials.
Job Location: AZ/MA/NC
Job Summary
Apply a high level of technical expertise to help guide and develop the more junior biostatistics staff members. Serve as a lead statistician on clinical studies and provide senior level peer review of work being accomplished by other biostatisticians in the department. Maintain the statistical and analytical integrity of clinical trials analyzed by SDC. Actively participate in writing statistical sections of protocols, preparing statistical analysis plans, preparing data deliverables for clinical study reports, interpreting analysis results, writing statistical sections of clinical study reports, and participating in meetings with drug regulatory agencies as required. Support business development and project management with strategic planning, proposals, pricing, and timeline planning.
Primary Responsibilities
• Serve as an internal consultant for biostatistics analysis tools and methods
• Serve as a subject matter expert during client and vendor meetings for biostatistics analysis support
• Actively support business development in capabilities presentations to prospective and current clients
• Effectively manage assigned clinical study budgets for biostatistics analysis support
• Develop, coach and mentor junior biostatistics department personnel
• Act as the lead statistician on clinical research projects and help with SAS programming
• Provide statistical expertise for study design of clinical trial protocols
• Write statistical methods section of the study protocol, as needed
• Write statistical analysis plans ensuring appropriate regulatory requirements and study objectives defined in the study protocol are followed
• Review CRFs to ensure consistency with protocol and statistical analysis plan (SAP)
• Program summary tables, data listings and graphical representations of clinical trials data
• Perform all analyses defined in the statistical analysis plan as well as any post-hoc analyses and relevant exploratory analyses of clinical trial data
• Prepare/review key sections of clinical study reports and various regulatory documents
• Perform statistical QC of all department outputs including analyses and clinical study reports
• Provide statistical support to answer questions from external clients (such as FDA, Investigators)
• Contribute to the development, maintenance, and training of standard operating procedures (SOPs)
• Represent the biostatistics department at regulatory meetings, sponsor meetings, and any other multifunctional meetings, as needed
• Manage biostatistics timelines, budgets, and client expectations
• Adhere to all aspects of the Statistics &amp; Data Corporation’s quality system
• Comply with Statistics &amp; Data Corporation’s data integrity &amp; business ethics requirements
• Perform other related duties incidental to the work described herein
• Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements
The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
Requirements
Required Skills
• Effective leadership, budget forecast and implementation skills
• Excellent analytical skills, with the ability to process scientific and medical data
• Able to work independently and in teams
• Project management abilities including analytical evaluation, organization, delegation, flexible team management, negotiating and resource management skills
• Excellent knowledge of statistical programming
• Expertise in manipulating and analyzing SAS data
• Able to identify data issues, present problems, and implement solutions.
• Capable of communicating technical concepts clearly, concisely, and understandably to non-statistical colleagues and clients
• Excellent organizational and time management skills, with the ability to multi-task
• Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP)
• Strong interpersonal communication and presentation skills
• Able to effectively collaborate across cross-functional teams
• Focus on quality at all times and in all situations
Education or Equivalent Experience
• A Master’s degree in biostatistics, statistics or other related, scientific field and at least eight years of relevant professional experience or a combination of education and experience.
Benefits
Why SDC
SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop great medicines that save lives and cure diseases in the most efficient manner possible. Our global team operates as a value partner to our clients by fulfilling their needs as our own and delivering exceptional results. We are a specialty CRO in that we provide scalable service offerings, focused services area specialists, efficient project timelines, optimal technology solutions, and proven success and experience. Our commitment to our clients is the same commitment to our employees. By offering strong benefits including competitive pay, generous time off, attainable career advances, positive work/life balance and 401k matching (US), we are able to attract some of the most talented people in the industry. 
•We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits. 
•We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment. 
•We strive to provide a place of belonging to our employees with fun and engaging activities from SDC’s culture club.
•We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry. 
•With a proven track record, SDC has been successfully executing client clinical programs since 2005.
Take a look at how you can join our team!
#LI-Hybrid

Principal Biostatistician

<h3>Job Description</h3>
Job DescriptionSalary: 
JOB SUMMARY
The QC Microbiologist conducts quantitative and qualitative analysis of pharmaceutical products according to FDA, cGMP and Boston Analytical, Inc. Standard Operating Procedures. Duties will include analysis of pharmaceutical products through compendial methods and client specific test protocols.
 
PRIMARY DUTIES AND RESPONSIBILITIES
<ul>
<li>Prepares and analyzes samples to determine microbiological quality through the following analyses: Microbial enumeration methods, absence of specified microorganisms, Sterility, endotoxin, and water quality analysis (bioburden, TOC, Conductivity).</li>
<li>Documents work in a clear and organized manner.</li>
<li>Revises procedures and ELNs under close supervision.</li>
<li>Follows all safety rules and regulations and conducts periodic safety audits.</li>
<li>Follows all cGMP rules and regulations.</li>
<li>Under close supervision confers with Microbiologists and other client personnel regarding research, procedures performed, related results and prepares reports.</li>
<li>Under close supervision will be trained to become proficient at assigned tasks in order to become subject matter experts.</li>
<li>Performs routine data generation and problem solving with a minimal rework.</li>
<li>Works under close supervision to ensure all work performed is executed in compliance with standard operating procedures, good manufacturing practices, and the regulations of the Food and Drug Administration.</li>
<li>Ensures all work performed strictly adheres to Company, client and Pharmacopeial methodologies.</li>
<li>Performs system maintenance and calibrations to ensure equipment is operating with specified requirements.</li>
<li>Proper handling of hazardous waste in compliance with the Company and DES hazardous waste rules.</li>
</ul>
REQUIREMENTS &amp; QUALIFICATIONS
Qualifications include a BA or BS degree in Microbiology or related science discipline with 0-2 years of related experience is required. Knowledge of cGMP and related compliance regulations and guidances is preferred.
 
SHIFT
Sunday-Wednesday, 1st shift.
 
MINIMUM SKILLS REQUIREMENTS
<ul>
<li>Must have the ability and skill to perform the detailed job requirements noted above competently, safely and proficiently.</li>
<li>A self-starter, motivated person who possesses good interpersonal skills capable of effectively interacting with all departments and client personnel.</li>
<li>Must have excellent organizational, verbal communication and technical documentation skills.</li>
<li>Solid computer skills.</li>
<li>Knowledge of safe laboratory practices, including the proper procedures in handling chemicals and samples.</li>
<li>Must be a team player with integrity and concern for the quality of Company products, services and staff members.</li>
</ul>

Microbiologist QC I

<h3>Job Description</h3>
Job Description
Boston Metal is commercializing cutting­­-edge­ extractive metallurgy technology that will revolutionize primary metals production by improving metal quality while decreasing cost and lowering environmental impact. This fast-paced startup company is looking for a Senior Scientist to join the team. 
The Senior Scientist will collaborate with the R&amp;D team on the laboratory-scale research programs as well as with the process, operations, and engineering teams for the development activities of full-scale industrial experiments.
Responsibilities include but are not limited to:
<ul>
<li>Lead the development of electrometallurgical processes for new products using new feedstocks for our Critical Metals program.</li>
</ul>
<ul>
<li>Carry out thermodynamic and electrochemical calculations to support process development.</li>
</ul>
<ul>
<li>Track metrics such as conductivity, voltage, current efficiency, and specific energy consumption. </li>
</ul>
<ul>
<li>Collaborate with process development, engineering, operations, and supply chain to keep a focus on scalability while optimizing process parameters. </li>
</ul>
<ul>
<li>Conduct experiments and analyze data on existing high temperature electrochemical testing setup.</li>
</ul>
<ul>
<li>Regular presentation and communication of results within the technical team, to senior management, and company-wide.</li>
</ul>
Requirements
Strong theoretical background in electrochemistry with proven ability to perform data analysis and first-principles modeling, track record in novel electrochemical research, demonstrated ability to independently plan and implement research programs.
7+ years of experience with electrochemical research or metallurgy in a technical environment. MS/PhD from accredited university or college in one or more of the following areas: Materials Science, Chemical Engineering, Chemistry, process metallurgy or a closely related field. 
<ul>
<li>Demonstrated technical leadership experience</li>
<li>Experience with experimental electrochemical cell setup and characterization</li>
<li>Familiarity with chemical engineering principles (e.g., mass and energy balances, thermodynamics, transport phenomena)</li>
<li>Experience developing a MATLAB or Python based data analysis pipeline, and using graphical plotting software for data analysis and visualization</li>
<li>Experience in research and working with large datasets </li>
<li>Materials or metallurgical research</li>
<li>Experience with high-temperature setup/system</li>
<li>Experience with thermodynamic modeling and calculations (FactSage preferred)</li>
<li>Analysis Scripting in Matlab or Python</li>
<li>Experience using Labview</li>
<li>Materials characterization</li>
<li>Portuguese language experience preferred</li>
<li>Intermittent travel to our Brazil facility </li>
</ul>
Benefits
Additional Information:
We are people first with a comprehensive benefits package that can be customized to fit your needs. Our full benefits package offers health, dental, vision, life and disability insurance, paid vacation, sick &amp; holidays, health savings account with a company contribution, dependent care account plan, paid parental and bonding leave and a 401k with company matching provision.
You will be working in a small team environment where teamwork and good relationships with other team members is critical. We operate pilot plants and labs and many of our staff members are required to wear Personal Protection Equipment (PPE) and you should be prepared to do so as well when necessary.
Boston Metal is an equal opportunity employer who considers all qualified applicants equally for employment. We do not discriminate on the basis of race, color, religion, national origin, age, sex, gender identity, sexual orientation, pregnancy or pregnancy-related condition, disability, ancestry, genetic information, veteran or military status, or any other characteristics protected by applicable federal, state or local law.

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