Manager QA External Manufacturing

The Senior Manager, Biologics External Manufacturing within Global BioPharmaceutical Development is responsible for managing external manufacturing partners. The person in this role will be the key contact with external partners for cGMP manufacture activities including cell banking, upstream mammalian cell culture, downstream purification, and sterile vial fill finish in collaboration with functional area SMEs and Quality Assurance. The position oversees all activities occurring at CMOs related to manufacturing, which can include but is not limited to, project management, GMP readiness, coordination of internal manufacturing teams, and batch release support.

Essential Functions of the Job (Key responsibilities)

• Responsible for external GMP manufacturing of early clinical material
• Work as cGMP manufacturing SME and report into the program Product Development Team
• Work with internal and external teams to ensure successful technical transfer to Incyte external partner through release of clinical material.
• Oversee detailed project plans to ensure clarity and attainment of milestones and timelines; develop mitigation plans as needed to achieve project deliverables.
• Establish and communicate key project milestones and manage timelines for manufacturing campaigns
• Identify issues and facilitate problem solving, contingency planning, and decision-making.
• Inform key stakeholders of project statuses, issues, problems and propose solutions as appropriate.
• Collaborate with the Project Team Leader of the CMOs to foster effective team dynamics; engage in regular interactions to assess program progress and present findings to team.
• Provide engineering expertise to manufacturing process to improve efficiency, sustain product quality, and reduce cost of goods.
• Review and assess Statement of Work from a technical and management perspective.
• Manage budget for CMO Activities.
• Perform and manage Person-in-Plant (PIP) in manufacturing campaigns as needed.

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

• Degree (such as BS or MS) in Chemistry, Biology, Biochemistry, Chemical Engineering or related Life Sciences field, or equivalent experience.
• Experience in process operations in an automated biotechnology manufacturing facility subject to GMP regulations.
• Strong background leading and managing projects for CMOs is preferred.
• Strong communication skills, both verbal and written, are required, with accommodations available for diverse communication needs.
• Strong interpersonal skills to collaborate effectively with Regulatory, QA, QC, CRO and CMO teams.
• Cooperative, independent, capable of critical thinking and multi-tasking.
• Experience working with international business partners and familiarity with global regulatory guidelines is preferred.
• Travel required, as needed - occasional international travel to partner(s) and CMO facilities.

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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