Manager, CMC Writer

Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.

The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.

Job Summary (Primary function)
The Manager, CMC (Chemistry, Manufacturing, and Controls) Writer writes, reviews, and edits documents, product specifications, Standard Operating Procedures, engineering related documents, and CMC sections of regulatory documents.

Essential Functions of the Job (Key responsibilities)

• Work collaboratively and transparently with Quality Assurance and Regulatory Affairs to ensure a high quality level documentation excellence.
• Work closely with the Technical Operations team to ensure alignment and established priorities to meet and exceed site and corporate goals.
• May assist with technical publishing. 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. Work with initiators to rewrite, clarify or reconstruct controlled documents.
• Provide guidance and expertise on assigned CMC documents/projects. Ensure that the quality and content of CMC documentation is complete and complies with applicable regulations and guidelines set forth by regulatory agencies.
• Research and collaborate 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.
• Write and edit CMC sections of Regulatory documents that are submitted to Regulatory Agencies worldwide.
• Manage and oversee the CMC technical writing and assembly of CMC dossiers.

Qualifications (Minimal acceptable level of education, work experience, and competency)

• Sound technical knowledge of process chemistry, analytical methods, and drug product.
• Good decision making with strong judgment through collaboration and consideration of diverse perspectives.
• Strong communication skills (e.g., clear and concise), team player, and proven negotiation skills.
• Demonstrate a proven ability to lead effectively, including organizing and prioritizing workloads.
• Understand CMC manufacturing documentation requirements for both small and large molecule manufactured products.
• Demonstrate competency in clear and concise technical writing ability.
• Experience working closely with other departments such Process Chemistry, Analytical, Large Molecule Development, and/or Regulatory Affairs.
• Several years of experience in authoring CMC sections of regulatory filings, or equivalent relevant experience.
• A degree (such as Bachelors or Masters) in Chemistry, Pharmaceutical Sciences, Regulatory Affairs or related field, or equivalent experience.
• Demonstrate excellent understanding of cGMP manufacturing execution.
• Must have experience in the biotech manufacturing industry or a related field.
• Must be well organized, adaptable, and able to communicate effectively within CMC functions and Regulatory Affairs.

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.

Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.

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