Manager, CMC Writer

 •  Incyte Wilmington, DE

5 - 7 years experience  •  Biotech/Pharma

Salary depends on experience
Posted on 08/02/17
Wilmington, DE
5 - 7 years experience
Biotech/Pharma
Salary depends on experience
Posted on 08/02/17

Summary:

The CMC Writer is primarily responsible for writing, reviewing, and editing cGMP manufacturing documents, product specifications, Standard Operating Procedures, engineering related documents, and CMC sections of regulatory documents. This person is accountable for the on-time delivery and right first time cGMP compliant technical documents supporting the manufacturing, formulation development, clinical supplies, packaging, labeling, technology transfer and validation of drug product.

Job Requirements:   

  • Writes and edits CMC sections of Regulatory documents that are submitted to Regulatory Agencies worldwide.
  • Researches and collaborates with subject matter experts to write and edit Standard Operating Procedures, Specifications, batch documentation and other manufacturing related controlled technical documents using a uniform style and language for regulatory compliance.
  • May assist from time to time with technical publishing. Also may assist in developing documentation for instructional training, descriptive, reference and/or informational purposes. May coordinate the review, approval and revision of procedures, specifications and forms. Works with initiators to rewrite, clarify or reconstruct controlled documents.
  • Works closely with the Technical Operations leadership team to ensure alignment and established priorities to meet and exceed site and corporate goals.
  • Works collaboratively and transparently with Quality Assurance and Regulatory Affairs to ensure a high quality level of cGMP produced documentation excellence.
  • Strong understanding of CMC manufacturing documentation requirements for both small and large molecule manufactured products

Qualifications:

  • BS or MS in Chemistry, Pharmaceutical sciences, Regulatory Affairs or other relevant field
  • 5 years of experience in authoring CMC sections of regulatory filings. 
  • Experience in work closely with other departments such Process Chemistry, Analytical, Large Molecule Development, Regulatory Affairs
  • Experience in authoring various regulatory filings including IND’s, IMPD’s, NDA’s, CMC Amendments, BLA’s. 
  • Sound technical knowledge of process chemistry, analytical methods, drug product. 
  • Must be well organized, flexible and able to communicate effectively within CMC functions and Regulatory affairs.
  • Must be knowledgeable and worked in biotech manufacturing related industry.
  • Demonstrated excellent understanding of cGMP manufacturing execution.
  • Demonstrated competency in clear and concise technical writing ability.
  • Demonstrated track record of effective leadership including organization and prioritization of work load.
  • Strong communication skills (e.g., clear and concise), team player, and proven negotiation skills.
  • Good decision making with strong judgment through collaboration and consideration of others point-of-view.
  • Sound technical knowledge of process chemistry, analytical methods, drug product. 
  • Must be well organized, flexible and able to communicate effectively within CMC functions and Regulatory affairs.
  • Must be knowledgeable and worked in biotech manufacturing related industry.
  • Demonstrated excellent understanding of cGMP manufacturing execution.
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