Job Description
Job Description
In this vital role you will be developing, qualifying and transferring innovative and fit-for-purpose quantitative assays for the measurement of DNA, proteins and other biological analyzes for manufacturing process development. The Senior Associate in Process Development is instrumental in designing, developing, and optimizing manufacturing processes. They are involved in conducting experiments, analyzing results, and implementing process improvements to enhance efficiency and product quality.
Responsibilities:
- Routine testing support for PD DS process related impurity analysis
- Preparation of lab buffers and reagents
- Lab reagent and materials inventory
- Maintenance of critical reagents stocks
- General lab upkeep and equipment maintenance support
- Provides critical evaluation of analytical data and results to support product development analytical testing activities.
- Documentation of assays and laboratory activities in electronic notebook documentation system
- Generating, analyzing, and interpreting analytical data
- Supporting analytical projects involving method development, qualification, and transfer
- Analyzing routine samples by qPCR and ELISA, data interpretation and reporting,
- Documentation of results and peer review of electronic notebooks.
- Preparation of lab buffers and reagents, maintenance of critical reagents stocks
- Sample, reagent and materials inventory tracking and re-stocking
- General lab upkeep and equipment maintenance support
- To perform experiments, organize data and analyze results under minimal supervision. With minimal supervision, plans, conducts or monitors experiments, records and organizes data, analyses results, generates robust and reliable data and/or Ensures that contracted studies are conducted in compliance with the respective protocol and applicable guidelines and regulations.
Requirements / Qualifications:
- Associate’s degree in Biology, Chemistry, Biochemistry, Analytical Chemistry, or a related field and 2 years of Scientific experience OR
- Bachelor’s degree in Biology, Chemistry, Biochemistry, Analytical Chemistry, or a related field
- Experience and expertise with protein assays, especially immunoassays, ELISAs or qPCR.
- Experience in GMP lab setting.
- Experience and expertise with Microsoft Office software: Word, PowerPoint and Excel.
- Enjoys participating in a cohesive, high performing team, establishes effective and adaptable relationships with colleagues, while contributing as an effective independent contributor.
- Communication – establishes and maintains effective communication mechanisms to keep colleagues appropriately advised; bridges communication between individuals, team and other organizational units as necessary.
- Social skills – communicates optimally, using appropriate tact and sensitivity; makes others feel respected, valued and understood.
- ELISA, immunoassays and qPCR technologies
- Familiarity with electronic laboratory notebook/record keeping system(s)
- Familiarity with working in a GMP/GxP environment
- Strong Communication skills
- Team player
Company DescriptionThe Steely Group is a national preclinical, clinical, and commercial staffing firm and certified women’s business enterprise. We partner with small, growing biotech, pharma, and gene therapy companies to help bring treatments to patients by providing flexible talent acquisition solutions including Contingent Search (Direct Hire & Contract Consultants) and Retained Executive Search.
Company Description
The Steely Group is a national preclinical, clinical, and commercial staffing firm and certified women’s business enterprise. We partner with small, growing biotech, pharma, and gene therapy companies to help bring treatments to patients by providing flexible talent acquisition solutions including Contingent Search (Direct Hire & Contract Consultants) and Retained Executive Search.