Exciting opportunity to lead experimental design and execution within the pilot plant network, driving process and product improvements, supporting technology implementation, and collaborating across departments. Ideal for candidates with strong expertise in process development and manufacturing, and experience in the pharmaceutical or biotechnology sector.
Tasks
- Lead design and execution of experiments to support process and product improvements, technology implementation, process validation, hands-on second-level commercial product support, and process transfer to and from internal manufacturing and contract manufacturing sites.
- Conduct experiments within the pilot plant network, accurately document and analyze data, summarize results in technical documents and oral presentations, and support health authority submissions and inquiries.
- Support or lead inter-departmental process, technology, and business process improvement projects as needed.
- Support the design, implementation, and operational start of the foreseen Pilot Plant, including equipment implementation, establishment of procedures, and all elements necessary for the start of a pilot plant.
- Interface with Technical Development and MSAT teams to design and execute lab-scale experiments within the MSAT laboratory/pilot plant.
- Support Make-Assess-Release (MAR) activities in collaboration with MSAT and manufacturing as needed.
- Participate in the project, implementation, and operation of the Pilot Plant.
- Work on multiple projects, prioritize effectively, and adapt to changes quickly.
- Represent the function on cross-functional project teams, collaborating with leads from other functions on all aspects of project deliverables.
- Stay updated on industry trends and advancements in bioprocess technologies.
- Collaborate with representatives from Development, Manufacturing, Quality, and Regulatory functions as required.
- Review/author sections in regulatory submissions and responses during Health Authority inquiries as required.
- Serve as an ambassador for the function with the ability to influence stakeholders for new technology development and implementation.
- Train and mentor team members to enhance their skills and promote professional growth.
- Provide knowledge and training on complex process and equipment technologies to PT partners as required.
Requirements
- B.S. or M.S. degree in Chemical, Biochemical Engineering, or related discipline with at least three years of experience in the industry, OR a PhD with 0-2 years of relevant experience in the pharmaceutical or biotechnology industry with process development, operations/manufacturing, or related experience.
- Extensive practical and theoretical expertise in process development and manufacturing, with deep understanding of the drug development process.
- Ability to build connections, encourage feedback, and foster a collaborative environment.
- Strong written and verbal communication skills.
- Committed to creating an inclusive environment where team members feel safe, valued, and empowered to perform their best.
- Ability to work independently and challenge the status quo, handle multiple projects, prioritize and delegate effectively, adapt to changes quickly, and work collaboratively on cross-functional teams.
- Less than 5% travel required.
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Über uns
Das Team
As part of Pharma Technical Operations (PT), the Pharma Technical Technology (PTT) team leads industrialization and technical product management, integrating SHE, proactive maintenance, facility fitness, performance optimization, and scalable manufacturing processes and technologies. Within PTT, the global Manufacturing Science and Technology (gMSAT) department is the process and product owner for commercial products, supporting internal and external drug substance and drug product networks, new technology implementation, network standardization, and mitigation of technical risks.