Manager Analytical Development

Job Responsibilities:

Design and execute protocols to develop assays that will be utilized to support process development, characterization, and release of microbially generated products from manufacturing operations. Troubleshoot, analyze, and summarize experimental findings. Generate validated final summary reports. Provide inputs for standard operating procedures (SOPs) and validation consistent with FDA and European Union regulations. Ensure effective, high-quality, timely and appropriate documentation in physical or electronic laboratory notebooks. Maintain diligent and organized records. Effectively maintain good communication and collaborate with cross-functional colleagues and external partners for successful execution/completion of projects. Collaborate and coordinate with upstream process engineering, downstream process engineering, and management teams, as and when necessary. Participate in the tech transfer and scale-up of developed processes to pilot and/or GMP manufacturing. Clearly communicate results and recommendations to colleagues, managers, and senior management, assisting in project decision-making Work on problems of diverse scope (bridging upstream and downstream processes, manufacturing anomalies and analytical science), provide guidance to junior scientists. Additional responsibilities not listed may be assigned as needed by leadership.

Expected qualification:

Minimum M.Sc. in Microbiology, Biotechnology, Biology, Biochemistry, or related field.

6-9 years of relevant hands on experience in biotechnology/pharmaceutical manufacturing practices, guidelines, management practices, cGMP knowledge, and production, QA/ QC operations. Experience with handling and analysis of nucleic acids, specifically plasmid DNA (Plasmid preparation from E. coli, Agarose gel electrophoresis, Restriction digests, Sanger sequencing) HPLC/UPLC experience including software knowledge (e. g. Empower, Unicorn) Experience with plate reader, ELISA, electrophoresis equipment, capillary gel electrophoresis, RT-PCR, ddPCR, and aseptic techniques.

Experience with next generation sequencing is a plus.

Working knowledge of upstream and downstream production techniques.

Relevant industry experience in GMP environment. Must be self-motivating, organized, and proactive. Strong technical aptitude including demonstrated experience in applying scientific reasoning to solve complex problems. Strong knowledge of computer systems including base of computer systems including base of MS word, MS excel, MS PowerPoint, and MS projects in addition to familiarity with statistical software and planning with inventory systems. Ability to work hours necessary to support production and/ or product transfer activities.