Job Summary (Primary function)
The Sr. Biologics CMC (Chemistry, Manufacturing, and Controls) Writer will be primarily responsible for authoring CMC sections of global regulatory submissions including BLA, IND, IMPD, MAA as well as working with other technical documents (e.g.. Redlining/SOC reports). The position will manage work independently with members of the Biologics Pharmaceutical Development group as well as other functional areas within the organization, including external collaborators, to complete the full package ready for submission.
Essential Functions of the Job (Key responsibilities)
- Contribute to the phase appropriate development strategy for the Biologics portfolio.
- Write and edit CMC sections of Regulatory documents that are submitted to Regulatory Agencies worldwide. Experience with authoring Module 3 CTD sections for IND and BLA is highly desirable.
- Collaborate with subject matter experts to write and edit other manufacturing related controlled technical documents using a uniform style and language for regulatory compliance.
- Coordinate authoring and review activities with the functional areas within Global Biopharmaceutical Development and Quality Assurance to reach alignment and to meet deadlines for Regulatory Submissions.
- Work closely with Regulatory Affairs to establish priorities and ensure successful completion of regulatory submissions to Regulatory Operations.
Qualifications (Minimal acceptable level of education, work experience, and competency)
- Degree (such as BS/MS/PhD) in Engineering or Biological Sciences or equivalent experience and in the biotech related industry.
- Several years of experience in Biologics technical writing as a SME in Analytical, Formulation, or Process Sciences, in authoring CMC sections of global regulatory filings.
- Technical knowledge of and experience in monoclonal antibody development is a plus.
- Experience with working collaboratively with other departments such as technical teams, Quality Assurance and Regulatory Affairs.
- Proven track record on regulatory submissions of biological products.
- Demonstrate competency in clear and concise technical writing ability.
- Must be well organized, flexible, with excellent cross-functional communication skills that encourages inclusion and welcomes diversity of thought among stakeholders.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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