Patheon General Manager, Biologic Drug Substance Development Operations in Princeton, New Jersey

Job Descriptions:

The General Manager is a visible and critical leadership role that will direct all cGMP biopharmaceutical development activities at our facility. S/he will play an integral role in significantly expanding Patheon’s Biologics business, while fulfilling the global demand for biologic drug substance process development on behalf of our vast customer base. This role will also play a key role in growing and organizing our global footprint within the rapidly expanding Contract Developing and Manufacturing (CDMO) services industry. This individual will deliver results using insights of current trends in Biologics technical development, a deep understanding of our customer’s needs, and will strategically deploy an array of industry leading internal capabilities. S/he will influence change across the network, identifying processes improvement opportunities and delivering solutions to such challenges.

Key Responsibilities:

  • Lead the Princeton site to deliver industry leading Process Development services.

  • Provides, and executes upon, strategies to deliver upon both long-term and short-term goals for the site(s), which also aligns with the strategic business plans of the entire organization.

  • Develop and implement programs to drive operational excellence towards ‘right first time and on-time’ delivery.

  • Ensure alignment of Princeton Site strategy with Business Unit’s strategies.

  • Ensure Process Development labs are properly controlled and all regulatory compliance requirements (i.e. GLP, GMP, OSHA) are met and/or improved. comply with GLP and cGMP where appropriate.

  • Prepare, approve, and control expense, headcount, and capital budgets while ensuring budget targets are met or improved.

  • Support the company’s safety health and environmental program to maximize safety awareness and provide a safe work environment.

  • Develop, drive, and nurture acquisition of new business by actively expanding services to current clients, and introduction of new clients to the Patheon network.

  • Recruit, retain, and develop talent to support the growth of a world class Biologics program.

  • Direct administrative aspects of the group through the preparation of performance plans, job descriptions, and leadership meetings.

Required Experience:

  • Extensive experience managing dynamic and complex manufacturing operations in a highly regulated environment.

  • 15+ years of exceptional (Site Sr Leadership Team level +) operational leadership of process development operations.

  • Demonstrated track record of success, in hiring talent, building teams, obtaining results, and achieving "turnaround".

  • Must have variety of career functional experience within areas such as: Process Development, Analytical Development, Pilot Scale Manufacturing, Quality, Finance, Engineering, EH&S, Business Development and Supply Chain.

  • Must have extensive and successful P&L "owning" experience.

  • Commitment to excellence in deployment of technical and scientific solutions mindful of both safety and compliance.

  • Masters level and above degree highly preferred, as well as a Masters of Business Administration (MBA).

  • Aggressive Growth and Change Management oriented mindset aligned with the aspirations of the company.

Keyword: General Manager, Biologic Drug Substance Development Operations

From: Patheon