MSAT Technical Lead – Drug Substance
About The Position
The MSAT Technical Lead – Drug Substance role is part of the Science and Technology (SAT) team within the Global CMC, Science & Technology Department (GCSAT). This department is responsible for the optimization and life-cycle management of Sobi’s clinical and commercial manufacturing and analytical processes across internal and external networks. The SAT team ensures compliant, reliable, cost-effective, and sustainable manufacturing and testing of Sobi's products. They hold the senior scientific and technical knowledge for manufacturing and analytical testing and are responsible for maintaining processes at a validated stage.
Requirements
- University degree in Chemistry, Biology, Biotechnology, Pharmacy, or similar
- +10 years of experience in the development and manufacturing of small-molecule drug substances for clinical and commercial use
- Scientific and technical background in CMC development and manufacturing of Drug Substance, Small Molecules
- Significant NDA experience, preferably as a lead
- Experience with regulatory guidelines, regulatory authorities communication, and file documentation
- Experience overseeing external vendors such as CMOs, CDMOs, etc.
- Demonstrable experience of working in a cross-functional team with the ability to multitask, prioritize, and be an effective decision maker
- Fluent in English
Nice To Haves
- Mandarin proficiency is helpful
- Fulfillment of all of Sobi's values
- Ability to act independently and take initiative
- Good communication skills, oral/written, and listening
- Strong team player
Responsibilities
- Subject matter expert (SME) for Small Molecules Drug Substance Manufacturing.
- Process owner of Small Molecules process validation for Sobi products.
- Lead and execute MSAT projects such as manufacturing process and cost improvement as part of LCM.
- Participate in internal activities related to (external) manufacturing, such as process changes, major/critical deviations, risk assessments, and CAPAs.
- Issue, review, and approve applicable internal and external SOP’s and manufacturing instructions.
- Review and supervise the setup, execution, and documentation of technical studies, qualifications, and validations.
- Write and review applicable sections of the APR/PQR.
- Write and review applicable sections in registration files, variations, and market expansion.
- Support in sourcing evaluation of new Small Molecules contract manufacturers and participation in developing supply and quality agreements.
- Lead the technical part of a product transfer, scale-up activities, validations, and oversee manufacturing of Small Molecules processes at external manufacturers for Sobi projects in the clinical and commercial phase.
- Be aware of external biopharmaceutical manufacturing technology advancements, understand and introduce new technologies, and how they may be applicable to process innovation, cost, or yield improvement.
Benefits
- Competitive compensation
- Generous time off policy
- Opportunity to broaden your horizons by attending popular conferences
- Emphasis on work/life balance
- Collaborative and team-oriented environment
- Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments
- Competitive 401(k) match
- Tuition and wellness reimbursements
- Comprehensive medical, dental, and vision package
- Additional recognition awards
- Eligible for both short-term and long-term bonuses
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What This Job Offers
Job Type
Full-time
Career Level
Senior
