Manufacturing, Science and Technology Lead

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Act as the subject matter expert (SME) and process owner for the manufacturing of Drug Products (DP) involving small molecules utilized in non-sterile dosage forms.

• Manage all technical aspects of drug product manufacturing (fully compliant with GMP) for a small molecule produced at an external facility.

• Lead technical workstreams for product transfers from development to commercial sites, oversee scale-up activities, process validations, and manage the manufacturing of drug products with small molecules at external manufacturers for both clinical and commercial projects.

• Direct internal processes related to external manufacturing, including assessments of process changes, management of major/critical deviations, risk evaluations, and CAPAs.

• Review and oversee the setup, execution, and documentation of technical studies related to DP (CMC development and commercial operations), as well as process and equipment qualifications and validations.

• Write and review relevant sections in registration files, variations, and market expansion documents.

• Issue, review, and approve necessary internal and external SOPs and manufacturing instructions from external manufacturers.

• Contribute to the establishment of new analytical specifications and stability programs while reviewing any related changes.

• Assist in the evaluation of new small molecule drug product sources, alternative contract manufacturers based on hard-gelatine capsules, and take part in developing supply and quality agreements.

• Stay informed about advancements in external manufacturing technologies, understand their applications, and introduce innovations that may enhance processes, reduce costs, or improve yields.

⛳️ Requirements

• A degree in Chemistry, Pharmacy, or a related field.

• Over 10 years of experience in the development and manufacturing of oral dosage forms and drug products featuring small molecules for both clinical and commercial applications.

• A recognized authority in the manufacturing of drug products, particularly hard-gelatine capsules.

• A solid scientific and technical foundation in CMC development and GMP-compliant manufacturing for small molecule drug products.

• Proven experience working in cross-functional teams, with demonstrated leadership abilities, effective prioritization skills, and decision-making capabilities.

• Experience collaborating with external manufacturers.

• Familiarity with regulatory guidelines (FDA & EMA), communication with regulatory authorities, and documentation for filings.

• Fluency in English; intermediate to full proficiency in Chinese is advantageous.

🏝️ Benefits

• Competitive salary for your contributions.

• Generous leave policy.

• Opportunities to expand your knowledge by attending well-known conferences.

• Focus on maintaining a work/life balance.

• A collaborative, team-oriented workplace.

• The chance to make a meaningful difference for patients with ultra-rare diseases in need of life-saving treatments.