MSAT Technical Lead – Drug Substance
About The Position
Science and Technology (SAT) is part of the Global CMC, Science & Technology Department (GCSAT). GCSAT is responsible for the optimization and life-cycle management of Sobi’s clinical and commercial manufacturing and analytical processes across internal and external networks. SAT ensures compliant, reliable, cost-effective, and sustainable manufacturing and testing of our products now and in the future. The SAT team holds the senior scientific and technical knowledge for the manufacturing and analytical testing of Sobi’s clinical and commercial products and is responsible for maintaining the internal and external manufacturing/analytical 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
- 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 for your work
- 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
- A competitive 401(k) match to support your financial future.
- Tuition and wellness reimbursements to invest in your personal and professional growth.
- A comprehensive medical, dental, and vision package to prioritize your health and well-being.
- Additional recognition awards to celebrate your achievements.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
