The Cell Culture and Fermentation Sciences group within our Company's Manufacturing Division focuses on early and late stage process development, technology transfer, and in-line support of Large Molecule product (Vaccines and Biologics). We are seeking individual contributors with strong scientific and technical skills to lead development and commercialization activities supporting multiple vaccine programs in late stage development. These Scientist will need to specialize in fermentation support, BSL 2, & small scale bioreactors -- 20L or Ambr 250mL. This is a one and half year long project, with potential extensions.
In this role, you will be responsible for:
- Leading microbial process development activities to execute large molecule upstream processing including lab-scale process development and process scale-up/scale-down.
- Executing lab scale experiments and authoring associated technical reports and documents.
- Leading assignment execution against accelerated, critical-path timelines in a right-first-time manner.
- Authoring and/or reviewing technical documents to support Process Performance Qualification (PPQ) and licensure.
- Collaborating with commercial manufacturing teams to support facility start-up activities and provide on-the-floor support for drug substance manufacturing, both within our Company's network and at contract manufacturing organizations (CMOs).
- Leading assignment execution against accelerated, critical-path timelines in a right-first-time manner.
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to
HR@insightglobal.com.
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-B.S. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field
-6+ years experience within vaccine development
-Stainless Steel Bioreactor experience (20L or 250 ambr)
-Large molecule process development, or relevant experience including scaling (up and down) and tech transfer of large molecule drug substance processes
-Good understanding of microbial physiology and metabolism and ability to correlation to in-lab or shop floor fermentation events
-Experience with small, lab or pilot-scale microbial large molecule fermentation
-Biosafety Level 2 exposure - BSL2
-Upstream process experience
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.