Drug Substance Engineer, External Operations- Biol


Raleigh, NC


Job Description:

Seeking a Senior Engineer to join the External Operations, Biologics team who will be responsible for external production (clinical & commercial manufacturing) of Drug Substance including optimization, scale-up, technology transfer and validation. The individual will be responsible to manage and lead technical issue resolution relating to biologics production or deliver key technical projects within External Operations with minimal oversight. This could be a remote position.

Key Responsibilities:

  • Ensure operations at our CMOs are conducted to requirements (Compliance, Meeting Orders, Dispute resolution, Production Planning, Materials Management, Technology Issues, Operational Excellence).
  • Ensure externally manufactured products are produced and stored according to the appropriate documentation to obtain the required quality.
  • With CMOs and internal teams, identify and mitigate risks associate with end-to-end supply chain of the externally manufactured product.
  • Review & approve various documents related to GMP activities at CMOs
    • In collaboration with Development and Quality approve instructions relating to external production operations and ensure their strict implementation by the CMOs.
    • In collaboration with Quality coordinate investigations and troubleshooting efforts at CMOs
    • Provide Operations perspective in support of process improvements
  • Contract Liaison
    • Maintain the integrity of the Master Supply Agreement ensuring alignment with Quality agreements and appropriate documents.
    • Ensure contract terms are executed including issuance of purchase orders, forecasts and other deliveries.
    • In collaboration with CMC Teams, Procurement, Legal and Finance, lead contract negotiations and dispute resolution with CMOs
  • Establish and monitor Key Performance Indicators of CMOs, coordinate the reviews for process performance at CMOs. Coordinate preparation of periodic business and operations review meetings
  • Frequently visit and maintain presence at the external partners’ sites and build strong interdependent relationship with the Project Management counterparts to assess the “as-is” state & risks for action-oriented improvement plans.
  • Act as a single point-of-contact to the CMOs to ensure on-time and in-full deliveries. Partner with supply chain, quality, and technology/development on all aspects of the relationships with the CMOs.
  • Act as the company expert in managing the technical, logistical, and operational aspects of assigned projects and/or processes from initiation thorough commercialization.

Required Education and Experience:

  • Bachelor’s Degree in Science, Engineering or similar technical discipline with 8+ years relevant experience in high volume/manufacturing/relevant environment likely to include:
    • Biologics Drug Substance manufacturing
    • Clinical and 3rd party manufacturing

Preferred Qualifications:

Technical Skills

  • Strong understanding of technical/scientific challenges as those apply to the production processes in Drug Substance Manufacture
  • The candidate also needs to have an excellent knowledge of CMC regulations, cGMP, sterility assurance techniques and FDA guidance
  • Demonstrated understanding of the connection between compliance and manufacturing
  • Experience within a CMC team

Other Personal or General Characteristics

  • Ability to foster and promote internal & external collaboration
  • Ability to work and get results through matrixed teams
  • Outstanding attention to detail, critical thinking, and problem-solving skills.
  • Excellent interpersonal and communication skills
  • Speaks clearly and persuasively in positive or negative situations; listens and gets clarification
  • Responds well to questions; Demonstrates group presentation skills; Participates in meetings
  • Balances team and individual responsibilities.

Travel Requirements:

  • Ability to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
  • Position requires up to 25% travel.
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