Group Leader, Analytical Development

at Catalent
Location Madison, WI
Date Posted October 30, 2020
Category BioPharma
Job Type Full-time
Address 726 Heartland Trail

Description

Group Leader- Analytical Development

The Analytical Development team is responsible for developing analytical methods to support cell line, upstream, and downstream development, and performing robustness assessments of the methods prior to transferring them to the QC department. The team is also responsible for characterizing primary and high order structures of manufactured protein biopharmaceutical products. This position will contribute to and support the activities of the Analytical Development Group. The responsibility of the Group Leader, Analytical Development group would be to lead a team of analytical scientists with responsibility for developing robust analytical methods in support of process development and transfer to the quality control organization for validation and application to testing the quality of manufactured biological products.

This is a permanent, full time position. It is a salaried role. The shift is Monday-Friday 8:00am-5:00pm.

Our new, state of the art Madison, WI facility, with expanded mammalian cell line engineering and biomanufacturing capabilities utilizing single-use systems, offers increased flexibility and manufacturing scale to support our customers’ growth. We offer a broad range of integrated formulation and analytical services to solve your most difficult development challenges in Biologics.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

The Role:

  • Manage Madison Analytical Development Group (4-6 direct reports)
  • As a member of the Analytical Development Leadership Team, collaborate with clients and internal customers to deliver world class analytical methods to support process development and generation of robust methods to support GMP testing of biological products
  • Develop and support training of junior Analytical Development scientists to be productive and efficient team members and direct their activities to ensure directives and project milestones are met
  • Enhance value of analytical and protein characterization studies performed in Madison to clients through high-value add activities
  • Develop and support team, department and organizational process and training improvements to enhance operational efficiencies

The Candidate:

Education:

  • Ph.D. in Chemistry or related field with at least 5 years of industry experience with biologics, especially proteins
  • MS in Chemistry, or related field with at least 7 years of industry laboratory experience with biologics, especially proteins
  • B.S/B.A. in Chemistry, or related field with at least 7-10 years of experience in a laboratory environment with biologics, especially proteins
  • Experience:
  • Experience in analytical method development and validation and/or protein characterization analytics for use in support of process development and QC analyses of proteins, not limited to antibodies, required
  • Ability to communicate data and lead analytical discussions through verbal and written communications with clients
  • Thorough understanding of the analytical requirements applied to proteins during the pharmaceutical development process
  • Knowledge and experience in troubleshooting a range of analytical techniques, including HPLC/UPLC (including but not limited to RP-HPLC, SEC and IEX), CE and iCE (cIEF) SDS-PAGE, Western, and ELISA and other general biochemical analyses/methods applied to the analysis of biologic drugs and their quality attributes
  • Experience in experimental design, the statistical analysis and interpretation of analytical data to drive decisions, preferred.
  • Experience (2 or more years) mentoring and training junior staff, including: goal setting, career development, establishing and applying performance metrics and employee evaluation.

 

Applicants can send resumes to [email protected]