Senior Scientist

2 months ago

Lansdale, United States Insight Global Full time

Required Skills and Experience *

-B.S. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field

-6+ years experience within vaccine development

-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)

-Experience with bioreactors (20L or 250 ambr)

-Upstream process experience


Nice to Have Skills and Experience

Experience with Quality by Design (QbD) and Lean Six Sigma principles

Experience supporting/writing regulatory filings (IND, MAA, BLA) and supporting inspections with multiple agencies (FDA, EMA, JNDA, TGA)


Job Description:

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.

  • Senior Fermentation Scientist

    3 weeks ago

    Lansdale, United States Insight Global Full time

    Required Skills & Experience -B.S. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field -6+ years experience within vaccine development -Large molecule process development, or relevant experience including scaling (up and down) and tech transfer of large molecule drug substance...

  • Senior Fermentation Scientist

    4 weeks ago

    Lansdale, United States Insight Global Full time

    Required Skills & Experience -B.S. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field -6+ years experience within vaccine development -Large molecule process development, or relevant experience including scaling (up and down) and tech transfer of large molecule drug substance...

  • Senior Fermentation Scientist

    1 month ago

    Lansdale, United States Insight Global Full time

    Required Skills & Experience-B.S. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field -6+ years experience within vaccine development -Large molecule process development, or relevant experience including scaling (up and down) and tech transfer of large molecule drug substance...

  • Senior Fermentation Scientist

    1 month ago

    Lansdale, United States Insight Global Full time

    Required Skills & Experience-B.S. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field -6+ years experience within vaccine development -Large molecule process development, or relevant experience including scaling (up and down) and tech transfer of large molecule drug substance...

  • Senior Chemist

    2 months ago

    Lansdale, United States NESCO Resource Full time

    Hands-on analytical laboratory experience-e.g., wet chemistry, chromatographyWorking knowledge of laboratory GMP, quality, compliance and data integrity requirements and related recent industry trendsWorking knowledge of troubleshooting analytical techniques (e.g., chromatography, dissolution, spectroscopy, etc).Expertise in Liquid Chromatography (HPLC/UPLC)...

  • Senior Chemist

    1 month ago

    Lansdale, Pennsylvania, United States NESCO Resource Full time

    Hands-on analytical laboratory experience-e.g., wet chemistry, chromatographyWorking knowledge of laboratory GMP, quality, compliance and data integrity requirements and related recent industry trendsWorking knowledge of troubleshooting analytical techniques (e.g., chromatography, dissolution, spectroscopy, etc).Expertise in Liquid Chromatography (HPLC/UPLC)...

  • Chemist - III (Senior)

    2 months ago

    Lansdale, United States On - Board Companies Full time

    HPLC Chromatography and DissolutionWet Chemistry, solution, and sample preparationThe successful candidate will be expected to perform analytical testing of drug products and APIs under the supervision of a senior scientist.Perform data analysis (chromatography/spectroscopy) and present them to the team in a timely manner.Hands-on analytical laboratory...

  • Senior Chemist

    3 weeks ago

    Lansdale, United States Nesco Resource Full time

    Education Minimum: BS or MS or Ph.D. in Analytical Chemistry or related discipline Required Experience and Skills Hands-on analytical laboratory experience-e.g., wet chemistry, chromatography Experience collecting and analyzing raw data, preparing graphs and other visualization tools to help interpret results Familiarity with statistics Demonstrated...

  • Chemist - III (Senior)

    4 weeks ago

    Lansdale, United States ETeam Full time

    BS or MS or Ph. D. in Analytical Chemistry or related disciplineHands-on analytical laboratory experience-e.g., wet chemistry, chromatographyWorking knowledge of laboratory GMP, quality, compliance and data integrity requirements and related recent industry trendsWorking knowledge of troubleshooting analytical techniques (e.g., chromatography, dissolution,...

  • Chemist - III (Senior)

    2 months ago

    Lansdale, Pennsylvania, United States On - Board Companies Full time

    HPLC Chromatography and DissolutionWet Chemistry, solution, and sample preparationThe successful candidate will be expected to perform analytical testing of drug products and APIs under the supervision of a senior scientist.Perform data analysis (chromatography/spectroscopy) and present them to the team in a timely manner.Hands-on analytical laboratory...

  • Chemist - III (Senior)

    4 weeks ago

    Lansdale, Pennsylvania, United States ETeam Full time

    BS or MS or Ph. D. in Analytical Chemistry or related disciplineHands-on analytical laboratory experience-e.g., wet chemistry, chromatographyWorking knowledge of laboratory GMP, quality, compliance and data integrity requirements and related recent industry trendsWorking knowledge of troubleshooting analytical techniques (e.g., chromatography, dissolution,...