Manager, Clinical Manufacturing QA - Small Molecule

Overview:

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, Clinical Manufacturing QA – Small Molecule supports GMP operations and Quality Management Systems related to small molecule clinical development products from early development through validation and the first commercial lot, including Regulatory Starting Materials (RSMs). The Manager, Clinical Manufacturing QA – Small Molecule ensures that manufacturing, testing, and packaging of bulk small molecule products are performed in compliance with GMP requirements, regulatory submissions and Incyte’s procedures.

Essential Functions of the Job (Key responsibilities)

· Act as QA lead and single point of contact for managing small molecule products.

· Manage CMO Quality relationships.

· Develop, implement, perform, and maintain Quality Systems and Incyte procedures.

· Support implementation of Incyte Quality Management Systems and Global Policies.

· Act as a knowledge manager of internal eDMS/eQMS and provide training when needed.

· Perform internal and external cGMP audits.

· Responsible for suppliers GMP oversight per Incyte’s procedures, including supplier qualification.

· Negotiate Quality Agreements with third parties.

· Approve supplier GMP documents including, but not limited to master batch records, specifications, test procedures, validation documents and stability documents.

· Review and disposition of suppliers executed RSM intermediate (when applicable), drug substance and drug product batches intended for use in clinical studies during clinical development stage.

· Review and disposition of suppliers executed stability packaging batches.

· Initiate and maintain Product Specification Files (PSF’s) for new and existing compounds.

· Perform QA duties during management of supplier quality events such as investigations, change controls, CAPAs and complaints related to clinical development projects.

· Review Regulatory documentation, such as NDAs, INDs and IMPD, as well as responses to Health Authority questions as needed.

· Report and maintain Quality Management System metrics associated with assigned responsibilities, as needed.

· Manage and track controlled document distributions to external Contract Manufacturing Organizations (CMOs).

· Perform QA role during management of internal Quality Events records in Veeva such as audits, deviations, CAPAs, and change controls, as needed.

· Provide support and participate in regulatory agency inspections.

· Identify and alert QA Management of internal and external quality system issues.

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

· Degree (such as Bachelor’s) in a scientific discipline such as chemistry, biology, pharmacy, engineering, or related field, or equivalent experience. Advanced degree preferred.

· Experience in Quality Assurance within the pharmaceutical or biotechnology industry, with a focus on GMP for RSM, drug substance, and drug product manufacturing.

· Proven experience with the oversight of early development through validation and commercialization stages.

· In-depth knowledge of global regulatory requirements (FDA, EMA, ICH guidelines).

· Strong experience with process validation, quality systems (CAPA, deviations, change control), and supplier/CMO management.

· Experience in working with diverse, cross-functional teams and managing multiple projects simultaneously in a fast-paced, highly regulated environment. Strong project management and leadership skills.

· Strong communication skills, both verbal and written, are required, with accommodations available for diverse communication needs.

· Willingness to travel up to 15% both domestically and internationally, as needed, with accommodations available for individuals with disabilities.

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.

We Respect Your Privacy

Learn more at:

The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here .

You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.

You can learn more about Incyte’s data protection practices here . By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte’s data protection officer, and your supervisory authority (if applicable).

Please contact [email protected] if you have any questions or concerns or would like to exercise your rights.