Alexion Pharmaceuticals-posted 8 months ago
$87,000 - $130,000/Yr
Full-time • Mid Level
Cambridge, MA
Chemical Manufacturing

As an Engineer II in Downstream Development for Viral Vector Product Development, you will design and execute experiments focused on downstream AAV (Adeno-Associated Virus) manufacturing processes. You will play a crucial role in the purification team by generating, summarizing, and presenting experimental data to recommend process operating conditions. Your goal will be to develop robust and scalable manufacturing processes. Additionally, you will draft documentation and provide expertise to support scale-up and tech transfer to clinical and commercial manufacturing facilities and regulatory filings.

  • Support the downstream development of AAV manufacturing processes to optimize viral vector purification steps (chromatography, filtration, UF/DF)
  • Independently perform OFAT and DoE-directed experiments to identify key and critical process parameters and recommend acceptable ranges for process scale-up and tech transfer
  • Document experiments, compile analytical data, and summarize findings in lab notebook entries and reports
  • Support tech-transfer of manufacturing processes to external partners, providing person-in-plant (PIP) support when necessary
  • Coordinate with the process analytics and method development team to align sample submission requests and process workflows
  • Support authoring of development reports, tech transfer documents, and other relevant process/regulatory documents for pipeline programs and research collaborations
  • Engage in platform development for the evaluation and implementation of novel technologies to improve purification efficiency and product quality
  • BS or MS degree in Biological Engineering, Chemical Engineering, Biochemistry, or related discipline with 3+ years (BS) or 0 years (MS) experience in the biotech industry, including internships or co-op experience
  • Wet lab experience required
  • Ability to lift/carry 15/30 pounds unassisted/assisted
  • Comfortable working in a controlled environment with biological, infectious, and hazardous materials
  • Ability to gown/degown PPE
  • Proficient in using a computer and engaging in communications via phone, video, and electronic messaging
  • Strong problem-solving and analytical skills
  • Experience with purification techniques (Clarification, NFF, chromatography, UF/DF)
  • Experience authoring technical documents (tech transfer, batch records, IND supporting documents)
  • Proficiency in MS Excel, experience with statistical data analysis and design of experiment (DOE) using software tools such as JMP
  • 401(k) plan
  • Paid vacation and holidays
  • Paid leaves
  • Health benefits including medical, prescription drug, dental, and vision coverage
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