CMC Writer

at Incyte Corporation in Wilmington, Delaware, United States

Job Description

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.

Our Global Pharmaceutical Development group is looking for a motivated CMC CMC (Chemistry, Manufacturing, and Controls) Writer This position writes, reviews, and edits cGMP documents, product specifications, Standard Operating Procedures, engineering related documents, and CMC sections of regulatory documents.

Essential Functions of the Job (Key responsibilities)

Write and edit CMC sections of Regulatory documents that are submitted to Regulatory Agencies worldwide.

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.

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.

Work closely with the Technical Operations team to ensure alignment and established priorities to meet and exceed site and corporate goals.

Work collaboratively and transparently with Quality Assurance and Regulatory Affairs to ensure a high quality level of cGMP produced documentation excellence.

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

BS in Chemistry, Pharmaceutical sciences, Regulatory Affairs or other relevant field.

3-5 years of experience in authoring CMC sections of regulatory filings.

Experience working closely with other departments such Process Chemistry, Analytical, Large Molecule Development, and/or Regulatory Affairs.

Demonstrate competency in clear and concise technical writing ability.

Understand CMC manufacturing documentation requirements for both small and large molecule manufactured products.

Demonstrate 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, and 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.

Demonstrate excellent understanding of cGMP manufacturing execution.

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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We appreciate, celebrate, and thrive on one another’s differences and strengths and are proud to be an Equal Opportunity Employer. By valuing diversity of backgrounds and perspectives and prohibiting all forms of harassment, we are able to promote a collaborative and innovative work environment in which everybody can contribute to their fullest potential.        



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Job Posting: 881002

Posted On: Dec 05, 2021

Updated On: Jan 04, 2022