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Senior Process Development Scientist in St. Louis, MO at Apex Life Sciences

Date Posted: 12/14/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    St. Louis, MO
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    12/14/2018
  • Job ID:
    914436

Job Description


Sr. Process Development Scientist - MTS

Summary:

This Senior Scientist will be the primary technical support person for manufacturing processes, investigations of the most challenging technical level, and take an integral role in resolving key process developments.

This individual will also lead a team of junior scientists.

Responsibilities:

Perform all functions associated with process support.

Author and perform the technical review of deviations and planned deviations, change controls, perform process monitoring, author campaign summary reports, perform activities for lot release.

Actively drive improvements for practices and procedures.

May provide guidance on process transfer and support activities to junior members of the team.

Assess all major deviations including those that affect product quality as well as post lot release deviations that may affect multiple products.

Identify potential root causes using a systematic approach. Exhibit expertise in use/application of a variety of problem solving tools.

Resolve complex problems and leads teams in developing and implementing solutions.

Author and review process descriptions, definitive formulations, batch records, raw material listings, change controls and the corresponding templates.

Demonstrate ability to identify and create new documents that would help in process transfer or support activities.

Recognize process changes and assess change controls for impact of process/equipment or procedural changes that can affect both process performance and product quality. Support documentation preparation for regulatory purposes.

Requirements:

Education

PhD preferred with a minimum of 8 years of relevant experience.

Master’s degree plus 10 years of relevant experience and Bachelor’s degree plus 12 years of relevant experience will be considered.

Experience

Advanced knowledge of cell biology, cell culture, scale up and technology transfer.

In depth knowledge of large scale manufacturing and current Good Manufacturing Practices.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




914436