Manufacturing, Science and Technology Drug Product Lead

Sobi • Waltham, MA

8h • Hybrid

About The Position

The Manufacturing, Science and Technology Drug Product Lead is responsible for serving as a subject matter expert (SME) and process owner for Drug Product (DP) manufacturing of a small molecule used in non-sterile dosage forms. This role will oversee all technical drug product manufacturing aspects (fully under GMP) for a small molecule manufactured at an external manufacturer. The lead will also guide technical workstreams for product transfers from development to commercial sites and between commercial sites, scale-up activities, process validations, and oversee the manufacturing of Drug product with a small molecule at external manufacturers for projects in clinical and commercial phases. Additionally, the role involves leading internal activities related to external manufacturing, such as process change assessments, major/critical deviations, risk assessments, and CAPAs. The position requires reviewing and supervising the setup, execution, and documentation of DP-related technical studies (CMC development and commercial operations), as well as process and equipment qualifications and validations. The lead will also be responsible for writing and reviewing applicable sections in registration files, variations, and market expansion documents, and for issuing, reviewing, and approving applicable internal and external SOPs and external manufacturer manufacturing instructions. Contributions are expected in setting up new analytical specifications and stability programs, and reviewing changes thereof. Support in sourcing evaluation of new Drug product small molecules, hard-gelatine capsule based alternative contract manufacturers, and participation in developing supply and quality agreements are also key responsibilities. The role requires staying aware of external manufacturing technology advancements, understanding, and introducing new technologies and their potential applicability to process innovation, cost, or yield improvement. Other job-related tasks may also be assigned.

Requirements

• University education in Chemistry, Pharmacy or similar.
• +10 years of experience of development and manufacturing of oral dosage forms, drug products, with small molecules for clinical and commercial use.
• Recognized expert in Drug product manufacturing of hard-gelatine capsules.
• Scientific and technical background of CMC development and GMP-compliant manufacturing in for small molecule drug products.
• Demonstrable experience of working in cross functional team with ability to lead functional teams, prioritize and be an effective decision maker.
• Experience of working with External manufacturers.
• Experience of regulatory guidelines (FDA & EMA), regulatory authorities communication and filing documentation.
• Fluent in English, intermediate to full proficiency in Chinese is a plus.

Responsibilities

• Subject matter expert (SME) and process owner for Drug Product (DP) manufacturing of a small molecule used in non-sterile dosage forms.
• Oversee all technical drug product manufacturing aspects (fully under GMP) for a small molecule manufactured at an external manufacturer.
• Lead the technical workstreams of product transfers from development to commercial site and between commercial sites, scale-up activities, process validations and oversees manufacturing of Drug product with a small molecule at external manufacturers for projects in clinical and commercial phase.
• Lead internal activities related to external manufacturing such as process change assessments, major/critical deviations, risk assessments and CAPAs.
• Review and supervise set up, execution and documentation of DP related technical studies (CMC development and 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 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 product small molecules, hard-gelatine capsule based alternative contract manufacturers and participation in developing supply and quality agreements.
• Be aware of external manufacturing technology advancements, understand and introduce new technologies and how they may be applicable to process innovation, cost or yield improvement.
• Other job related tasks

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

What This Job Offers

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