Associate Scientist - Bioprocess Drug Substance and Commercialization

Job Description

The Bioprocess Drug Substance and Commercialization (BDSC) group within our Manufacturing Division focuses on late-stage process development, technology transfer, and in-line support of vaccine and biologic products.  We seek a motivated scientist/engineer to work under technical direction of a group leader to support development and licensure of novel candidates and in-line products. In this role, you will be responsible for:

Primary Responsibilities:

• Executing process development in large molecule downstream processing including lab-scale process development and optimization, in-process assay support, and process scale-up/scale-down and model development.

• Leading the hands-on execution of lab-scale experiments and authoring associated technical reports and documents.

• Collaborating with commercial manufacturing teams to support facility start-up activities and provide on-the-floor support for drug substance manufacturing.

• 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.

Education Minimum Requirement:

• Bachelor’s Degree or higher in Chemical Engineering, Chemistry, Biology or comparable discipline.

Required Experience and Skills:

• Academic, internship, co-op, or professional experience in a laboratory setting.

Preferred Experience and Skills:

• Hands-on expertise with downstream unit operations and process development

• Laboratory operations support including study preparation, equipment set up, raw material and supplies ordering, inventory management, task assignment and tracking.

• Experience within or collaboration with analytical teams, pilot-scale, or manufacturing environment.

• Large molecule drug substance process development, scaling (up and down) and tech transfer

• Current Good Manufacturing Practice (cGMP) awareness or experience. 

• Experience authoring technical documentation in support of the following: process performance qualification, risk assessment, control strategy, process comparability reports, and/or regulatory submissions.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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