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

Job Description

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

• 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).
• Serve as an SME and provide guidance and support for critical QC Microbiology assays and methods.
• Provide leadership, coaching, mentoring and training of QC Microbiology staff, aiding in employee development and performance.
• Ensure QC Microbiology testing is completed, reviewed, and reported in a compliant manner and results are timely delivered to clients.
• Maintain all aspects of QC Microbiology day-to-day operations and scheduling to align with all aspects of GXP requirements.
• Manage data and trending in support of environmental monitoring and utility monitoring reports.
• Represent QC Microbiology at cross-functional meetings and interact with internal customers, clients and external vendors.
• Perform QC Microbiology testing as required, including bioburden, endotoxin of in-process, product and utility samples.
• Perform EM and utility related monitoring, as necessary.
• Identify continuous improvement opportunities. Design, implement and maintain resulting systems.
• Ensure a safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies is maintained.
• Author and revise SOPs, protocols and technical reports to meet industry standards, as necessary.
• Oversee QC sample submission and processing activities, and ensure testing is performed accordingly.
• 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.
• Serve a system owner of QC Microbiology controlled temperature units, respond per on-call schedule to CMS alarms, including off-hours and weekends

SPECIAL WORK REQUIREMENTS

• Ability to troubleshoot equipment and microbiological testing methods.
• Ability to adapt to schedules and priorities changes based on business needs
• Experience creating comprehensive department schedules
• Leadership experience within a high functioning team
• Other duties, as assigned.

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:

• Regularly sit or stand for long periods of time
• Work in a BSL 2 environment

Movement:

• Work in a BSL 2 environment

Lifting

• Frequently lift and/or move up to 25 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail

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 & Grit in operations
We are committed to overcoming challenges, learning from failures, and persistently striving for success.

Execute with Excellence & 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

• Paid vacation days, amount based on tenure
• Paid sick time
• 10 observed holidays + 2 floating holiday + 1 volunteer day
• 401(k) plan with company match up to 6% of salary, vested immediately
• Share Appreciation Rights
• Choice of several healthcare plans
• FSA and HSA programs
• Dental & vision care
• Employer-paid basic term life/personal accident insurance
• Voluntary disability, universal life/personal accident insurance
• Accidental Death & Dismemberment (AD&D) Insurance

ADDITIONAL DETAILS

• 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.
• This position requires a criminal background check.
• Genezen is an Equal Opportunity Employer.
• Genezen participates in EVerify.
• Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.

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.