MSAT Technical Lead – Drug Substance

Company Description

Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!

At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.

Our mission and culture at Sobi North America get us excited to come to work every day, but here are a few more reasons to join our team:

• 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

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