About The Position

This role is for an External API Expert responsible for overseeing externally manufactured Active Pharmaceutical Ingredients (API). The expert will support supplier selection, transfers, risk assessment, and continuous improvement to maintain a reliable API supply chain, collaborating with internal teams and third-party manufacturers. The successful applicant must possess in-depth practical knowledge and experience in API manufacturing and its associated processes. They will work closely with and support multidisciplinary teams, requiring strong communication skills for open dialogue and collaboration. A solution-oriented approach is essential to meet customer needs, build partner confidence, and keep stakeholders informed.

Requirements

  • Technical understanding and practical problem‑solving skills.
  • Effective project management capabilities and experience coordinating remote or matrixed teams.
  • Manage changing priorities and work productively in uncertain environments.
  • Communication and stakeholder engagement skills, fostering collaboration and inclusion.
  • Willingness and ability to travel as required to support supply priorities.
  • In-depth practical knowledge / experience of API manufacturing and its associated processes.
  • Strong communicator (to encourage open dialogue and collaboration).
  • Completely solution-orientated in your approach (maintain a focus on meeting customer needs, build confidence with partners and keep stakeholders informed).
  • Degree in chemistry or a related scientific/technical/engineering discipline.
  • Relevant (practical) experience in API manufacturing (eg; previously worked in an API manufacturing facility).
  • Experience managing transfers and introducing new products into supply.
  • Familiarity with quality and regulatory expectations for manufacturing operations.
  • Experience working in cross‑functional and virtual teams, with the ability to influence stakeholders at different levels.

Nice To Haves

  • Chemical background (and associated qualifications).

Responsibilities

  • Serve as technical product owner for externally produced materials (guiding technical projects, setting priorities, and tracking progress to completion).
  • Identify opportunities for process improvement with third‑party suppliers (working across functions to scope projects, assess benefits, and support delivery).
  • Provide technical input during supplier selection and sourcing activities, assess supplier capability and risk, and support transfers to new suppliers. Supply technical details needed for regulatory or registration documentation.
  • Manage or support troubleshooting and root cause analysis at supplier sites (coordinate required expertise, track corrective actions, and ensure timely closure).
  • Facilitate risk assessments and help suppliers develop mitigation plans. Review supplier validation exercises and ongoing performance monitoring to support consistent supply quality.
  • Review supplier technical change requests, coordinate cross‑functional review and communication, and support any required regulatory evaluations.
  • Contribute to development and maintenance of business processes that support third‑party supply, including handover and knowledge transfer practices. Help define and monitor supplier performance metrics.
  • Follow environmental, health, and safety procedures applicable to the role. Ensure risk assessments and incident reports are completed and corrective actions closed. Model positive safety behaviour when visiting supplier sites.
  • Build and maintain constructive relationships with internal and external partners across supply, development, procurement, quality, planning, and other relevant teams.

Stand Out From the Crowd

Upload your resume and get instant feedback on how well it matches this job.

Upload and Match Resume

What This Job Offers

Job Type

Full-time

Career Level

Senior

Number of Employees

5,001-10,000 employees

© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service