- Ensure timely plant readiness to support experimental and clinical activities.
- Ensure timely delivery of clinical material from internal pilot plants or external contract manufacturing organizations (CMOs).
- Manage the overall relationship with internal and external manufacturers, acting as the single point of contact between the organization and each manufacturing site.
- Provide pilot plant input and requirements to Drug Product Development (DPD) and Primary Container Development (PCD).
- Support scale-up and technology transfer activities.
- Source raw materials and components as required, and act as the point of contact for material- and supplier-related issues at the CMO.
- Put in place the relevant manufacturing information and technical capabilities to enable the operations team to produce the drug product (DP) flawlessly, in line with GxP, EHS and business requirements.
- Ensure that manufacturing processes are consistent with agreed platforms and are scalable and transferable to commercial operations.
- Support investigations, CAPAs and change controls according to assigned responsibilities, and perform critical raw data review of key documents.
- Assess new technologies and applications, covering feasibility, business case, conceptual design, installation and implementation.
Profile:
- Degree in Pharmaceutical, Biochemical, Life, Chemical or other relevant Sciences, or comparable experience, with a demonstrated track record of 7+ years in the pharmaceutical industry or a related field; alternatively, a PhD with 3+ years of proven experience.
- Demonstrated proficiency and experience in biologics drug product development within the biopharmaceutical industry is an asset.
- Demonstrated proficiency and experience in biopharmaceutical process design is an asset.
- Solid understanding of, and experience in, technology transfer operations is preferred.
- Solid understanding of, and experience in, fill/finish operations is preferred.
- Experience in clinical or commercial manufacturing is required; prior experience working with a CMO is preferred.
- Proven track record of creativity and problem-solving.
- Ability to collaborate with cross-functional teams is a must.
- Excellent oral and written English skills; German is a plus.
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