2 days ago

Manager Production USP

Incyte

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Manager Production USP

Job Summary (Primary function)

During the construction and facility startup phase, the Production Manager will mainly be responsible for overseeing site readiness activities. This may include tracking progress and writing, reviewing Policies, SOP, Work Instructions, and other USP manufacturing related documentation.

During manufacturing operation, the Production Manager will develop in an operation based role, line managing a group of operators, establishing the training plan, managing the compliance and performance metrics and downstream batch release activities.

Essential Functions of the Job (Key responsibilities)

During the construction phase, you will mainly:
• Author, review and maintain comprehensive USP related Policies, Work Instructions, SOP, etc
• Track and report progress of USP documentation
• Actively participate in the definition and review of the Qualification Master Plan
• Perform SAT, IQ, Commissioning and OQ. Up to 25% European travel required
• Own (develop, document, apply, close) Change Controls and deviations including any corrective actions arising during verifications
• Perform and report PQ activities
• Own training matrix and prepare and deliver training to new members of the team

During operational phase, you will mainly:
• Manage, plan, lead and execute batch related activities – including batch release
• Contribute to and establish training plan for team
• Author, review, approve, maintain life cycle (…etc.) of all required Standard Operating Procedures, Work Instructions, Manufacturing Batch Records, PQ protocols and other quality documents related to areas of responsibility, as well as support other areas as required
• Act as a mentor to more junior team members and lead by example to ensure timely batch execution and release, and proactively propose problem resolution
• Raise, investigate and close events, deviations and non-conformances
• Line manage a group of operators
• Support the tracking of USP performance metrics
• Contribute positively to a strong culture of business integrity and ethics
• Act within compliance and legal requirements as well as within company guidelines
• Delegate to: Associate Director Manufacturing

Qualifications (Minimal acceptable level of education, work experience, and competency)
• Biotechnology or pharmaceutical BSc (e.g. Swiss HES) degree preferred or relevant experience from chemical, food, pharmaceutical or biotech industry
• Must have hands-on experience of equipment commissioning and qualification
• Demonstrated, solid hands on experience of USP manufacturing – typically 7-10 years
• Shift work is expected
• Ability to work in a fast paced – high regulated environment
• French and English (Fluent)
• Team work oriented mindset

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