MSAT Technical Lead - Drug Substance
Job Description
Location Requirement: This position may be based near Raleigh, NC or Boston, MA. The role requires periodic travel between both locations to support cross-site collaboration and business needs. 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. 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
Qualifications
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
- 5+ 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
- Scientific and technical background in CMC development and manufacturing of drug substances, small molecules
- 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
Personal Attributes
- Fulfillment of all of Sobi's values
- Ability to act independently and take initiative
- Good communication skills, oral/written, and listening
- Strong team player
Additional Information Compensation and Total Rewards at Sobi At Sobi, we are dedicated to providing our employees with a comprehensive and industry-competitive total rewards package. Our compensation philosophy is designed to recognize and reward talent, ensuring that your contributions are valued and reflected in your overall rewards. Your total compensation at Sobi goes beyond just your base salary and annual bonus. It also includes a robust suite of benefits, such as:
- 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.
The base salary range for this role is $153,000-$211,000. Each individual offer will be determined based on several factors, including your experience, qualifications, and location. Additionally, this role is eligible for both short-term and long-term bonuses, as outlined in the plan details. All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease.