CMC & Manufacturing, Science and Technology Drug Substance Lead

Sobi • Raleigh, NC

7h • Hybrid

About The Position

The CMC & Manufacturing, Science and Technology Drug Substance Lead will be responsible for serving as an experienced subject matter expert (SME) and process owner for Drug Substance (DS) synthesis of a small molecule used in oral dosage forms. This role will lead the technical workstreams of manufacturing process transfers from development to commercial sites and between commercial sites, scale-up activities, process validations, and oversee the manufacturing of Drug Substance small molecules at external manufacturers for projects in clinical and commercial phases. The position requires experience in collaborating effectively with external manufacturing partners and overseeing all technical drug substance synthesis aspects (GMP and non-GMP steps). The Lead will also manage internal activities related to external manufacturing, such as process change assessments, major/critical deviations, risk assessments, and CAPAs. Additionally, they will review and supervise the design, setup, execution, and documentation of DS-related technical studies (CMC development and commercial operations), as well as process and equipment qualifications and validations. The role involves writing and reviewing applicable sections in registration files, variations, and market expansion documents, and issuing, reviewing, and approving applicable internal and external SOPs, while fully overseeing the correctness and compliance of external manufacturer manufacturing instructions. The Lead will contribute to setting up new analytical specifications and stability programs and review changes thereof, and support sourcing evaluations of new Drug Substance small molecules, alternative contract manufacturers for oral dosage forms, and participate in developing supply and quality agreements. A key aspect of the role is to stay aware of modern synthetic organic chemistry methodologies and advancements, and to understand and introduce new technologies and their applicability to process innovation, cost, or yield improvement.

Requirements

• University education in Chemistry, Pharmacy or similar.
• 10+ years of experience of development and manufacturing of Drug Substance small molecule, non-sterile dosage forms for clinical and commercial use. Ideally for more than 2 molecules.
• Recognized expert in synthetic organic chemistry and process R&D.
• Scientific and technical background of CMC development and GMP-compliant manufacturing in for small molecule drug substance.
• Experience of working with external manufacturers.
• Demonstrable experience of working in cross functional team with ability to lead functional teams, prioritize and be an effective decision maker.
• Experience of regulatory guidelines (FDA & EMA), regulatory authorities communication and filing documentation.
• Fluent in English.
• Strong cross-functional team player with a strong track record to achieve compromise.
• Ability to act independently and show strong ownership.
• High agility to deliver in a changing environment and be able to build strong scenarios approaches.
• Excellent communication skills, oral/written and listening to external and internal partners and stakeholders.

Nice To Haves

• Experience with deuterated molecules is a plus.
• Intermediate to full proficiency in Chinese is a plus.

Responsibilities

• Serve as an experienced subject matter expert (SME) and process owner for Drug Substance (DS) synthesis of a small molecule used in oral dosage forms.
• Lead the technical workstreams of manufacturing process transfers from development to commercial site and between commercial sites, scale-up activities, process validations and oversees manufacturing of Drug Substance small molecules at external manufacturers for projects in clinical and commercial phase.
• Collaborate effectively with external manufacturing partners and oversee all technical drug substance synthesis aspects (GMP and non-GMP steps).
• Lead internal activities related to external manufacturing such as process change assessments, major/critical deviations, risk assessments and CAPAs.
• Review and supervise design, set up, execution and documentation of DS related technical studies (CMC development as well as commercial operations), process and equipment qualifications and validations.
• Write and review applicable sections in registration files, variations and market expansion.
• Issue, review and approve applicable internal and external SOP's and fully oversee correctness and compliance of external manufacturer manufacturing instructions.
• Contribute during set up of new analytical specifications and stability programs and review changes thereof.
• Support in sourcing evaluation of new Drug Substance small molecules, oral dosage forms alternative contract manufacturers and participation in developing supply and quality agreements.
• Be aware of modern synthetic organic chemistry methodologies, 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
• Eligible for both short-term and long-term bonuses
• Competitive benefits package

What This Job Offers

• Job Type: Full-time
• Career Level: Senior