Sobi
MSAT Technical Lead – Drug Substance (Sr Manager)
Morristown, NJ, United States · Senior
Sponsorship not specified$140k-$165kDetected 27 days ago
ResearchCommunicationCollaboration
About the role
- If this role excites you but you're unsure if you meet every requirement, we encourage you to apply.
- Your unique perspective and experiences could be exactly what we need.
- Our edge comes from our team of people and our commitment to patients.
Responsibilities
- Support in sourcing evaluation of new Small Molecules contract manufacturers and participation in developing supply and quality agreements.
- This has been our approach since day one, but we know we can't change the world of rare diseases on our own.
- Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain.
- Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.
Requirements
- University degree in Chemistry, Biology, Biotechnology, Pharmacy, or similar
- 6+ years of experience in the development and manufacturing of small-molecule drug substances for clinical and commercial use
- 3+ years of experience in a commercial setting, leading the technical pieces of product transfer, scale-up, and validation
- Experience reviewing applicable sections of the APR/PQR
- Experience with regulatory guidelines, regulatory authorities communication, and file documentation
- Experience overseeing external vendors such as CMOs, CDMOs, etc.
- Demonstrable experience working in a cross-functional team with the ability to multitask, prioritize, and be an effective decision-maker
- Ability to act independently and take initiative
Compensation
- $140k-$165k
Benefits
- We offer a competitive benefits package, to support the health and happiness of our staff.
Company info
- 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
- Lead and execute MSAT projects such as manufacturing process and cost improvement as part of LCM.
- 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.
- Science and Technology (SAT) is part of the Global CMC, Science & Technology Department (GCSAT).
- We are a global company with over 1,900 employees in more than 30 countries and are committed to the societies where we operate.
- We know our employees are our most valuable asset, and our culture conveys that.
- At Sobi, we refuse to accept the status quo.
- As a specialized biopharmaceutical company, we are dedicated to rare diseases.
Equal opportunity
- An Equal Opportunity Employer
- Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.
This listing is sourced directly from Sobi's careers page and normalized into a canonical job model.