Lead Scientist, Stability Coordination Biologics

Catalent Pharma Solutions   •  

Kansas City, MO

Industry: Pharmaceuticals & Biotech

  •  

8 - 10 years

Posted 39 days ago

Job Description

Position Overview:

Catalent is a leading provider of advanced technologies and outsourced services for the pharmaceutical, biotechnology and consumer health industry. Catalent develops, manufactures, packages and distributes pharmaceutical and other products for customers in nearly 100 countries.

Job Title

Lead Scientist, Stability Coordination, Biologics II

Position Summary

The Lead Scientist, Stability Coordination, Biologics II’s main activities will be to provide and report data, as required by project contracts within the Biologics Department. The data may be used for submission in Regulatory packages, release and stability testing of clinical and animal trial dose forms and in support of development projects.

About Catalent Biologics:

Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI., and our market leading biologics analytical services in Kansas City and Research Triangle Park, NC. With the recent acquisition of Redwood Bioscience in Emeryville, CA, we have added the SMARTag Antibody Drug Conjugate technology, providing a next-generation ADC platform to our biologics customers. Leveraging our growing differentiated technology portfolio, world-class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.

Working for Catalent Biologics is an opportunity to join an entrepreneurial team that is building a new business. Catalent is aggressively growing in biologics and is making significant investments in people and capabilities in this area. This is a unique opportunity to join a small, fast-growing business, backed by a global public company. People joining our team will also have significant career development/progression opportunities as our business continues to grow and expand.

The role of the Lead Scientist, Stability Coordination BIO II is critical to the end user which are our patients. This individual will need to strongly drive stability plans, protocols, reports and LIM system builds in addition to communicating with clients. The individual needs to always keep patient safety in mind, executing with efficiency always. Leadership, quality, safety and on-time delivery is a must to be successful in this role!

The Role

  • In support of large molecule therapeutics, work as part of a team of stability Coordinators within the Biologics Department. Serve as a mentor to junior members of the team.
  • Perform activities under cGMP as appropriate.
  • Develop and execute stability work plans/schedules independently, using customer milestones and Division/site performance standards and metrics.
  • Authors and may approve technical documents, such as stability protocols, test reports, certificates of analysis, analytical result forms, and operating procedures.
  • Review technical documents for accuracy, thoroughness and regulatory compliance
  • Ability to interpret and provide a variety of instructions furnished in written, oral, diagram, or schedule form across multiple workgroups
  • Well organized with the ability to handle multiple activities simultaneously
  • Excellent written and verbal communications skills with internal and external customers

The Candidate

  • Degree in life sciences such as chemistry, biochemistry, biology or closely related physical science
  • Bachelor’s Degree: 9-10 years of relevant experiencerequired
  • Master’s Degree: 6-8 years of relevant experiencepreferred
  • Doctorate Degree: 2-4 years of relevant experiencepreferred
  • Strong project management skills are routinely practiced for multiple concurrent projects of moderate complexity
  • Knowledge of large molecule therapeutics, analytical testing, and stability programs

Position Benefits

  • Medical, Dental, Vision and 401K are all offered from day one of employment
  • 19 days of paid time off annually
  • Potential for career growth within an expanding team
  • Defined career path and annual performance review and feedback process

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