Principal Scientist - Analytical Lead - Biosimilars

Pfizer   •  

Lake Forest, IL

Industry: Pharmaceuticals & Biotech

  •  

5 - 7 years

Posted 114 days ago

ROLE SUMMARY

Join one of the leading Biosimilars Pharmaceutical Sciences organizations in the industry.   As a leader in the biosimilars sector with approved products in the U.S. and Europe and an industry-leading biosimilars pipeline, Pfizer offers an exciting opportunity for strong scientists to join our global biosimilars R&D team.  We currently have an opportunity for an experienced Principal Scientist with a strong technical background in leading analytical development for recombinant protein products to join our global Biosimilars Pharmaceutical Sciences team in Lake Forest, IL.

The Principal Scientist will lead the development of analytical control strategies for assigned projects and define approaches for demonstrating analytical similarity in support of regulatory submissions.  He/she will ensure alignment of these strategies across biologics programs/platforms and with the relevant industry benchmarking and regulatory expectations.

ROLE RESPONSIBILITIES

  • Lead technical execution of defined analytical strategies for biosimilar products, including biosimilarity assessment, CQA assessment, specification development, reference standard establishment and characterization. Lead or participate cross-functional collaborations with process/formulation development or operations to define integrated product control strategies and support drug substance/drug product development/manufacturing.
  • Drive and coordinate analytical method development, optimization, qualification, and validation activities across global analytical sites.
  • Ensure timely completion of high-quality technical reports/protocols and integrated cross-functional reports and/or strategy documents. Primary author and/or reviewer for analytical sections of regulatory submissions and/or briefing documents to support clinical development and marketing authorization.
  • Maintain up-to-date scientific knowledge through regular literature review and participation in conferences. Leverage external data and publications and relevant industry benchmarking information to drive experimental design, data analysis and functional/cross-functional strategy development.  

QUALIFICATIONS

  • B.S. Degree required in Analytical Sciences, Biochemistry or related field, Master or Ph. D preferred.
  • More than 6 years of experience in biotechnology or pharmaceutical industry supporting the development and/or commercialization of therapeutic recombinant proteins is required.
  • Demonstrated scientific and project leadership skills.
  • Extensive expertise in state-of-the-art analytical techniques for biologics product such as HPLC/UPLC and/or Capillary Electrophoresis.
  • Experience with the development and qualification/validation of analytical methods for biologics products.
  • Experience with regulatory filings.
  • Experience defining and implementing analytical control strategies for biologics products.
  • Experience with cross-functional development of recombinant therapeutic proteins for pharmaceutical use, including knowledge of key regulatory and quality/compliance expectations.
  • Excellent verbal/written communication skills and the ability to lead cross functional and/or multi-geography teams.

PHYSICAL/MENTAL REQUIREMENTS

The role will require a combination of activities in office and laboratory environments, which will require sitting and standing for extended periods.  The ability to analyze and evaluate complex and multifaceted data sets is required.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Travel to internal and external customer and partner sites may be required.

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