Theravance Biopharma is seeking a talented individual to join the Pharmaceutical Development group. The objectives of this role are to design formulations, make prototype dosage forms, optimize processes, select and work with CMOs, oversee scale-up activities, manufacture clinical trial materials, support clinical studies, write regulatory documents, and contribute to the overall pharmaceutical development activities.
Duties and Responsibilities
- Design and develop robust, scalable formulations, manufacture prototype dosage forms, and conduct drug product process development and process optimization activities in-house.
- Evaluate and select contract service providers (CSPs), conduct tech transfer, plan and oversee scale-up activities, manufacture engineering batches and clinical trial materials, and manage the manufacturing of drug product.
- Prepare and review manufacturing and executed batch records, draft and review formulation and product development reports, and reports from CSPs.
- Support regulatory submissions by drafting and reviewing drug product sections of INDs, NDAs and IMPDs, and ensure compliance with current regulatory requirements.
- Lead CMC team as needed and represent the department at CMC and project meetings and work closely with cross-functional teams to meet project timelines and goals.
- Manage and operate various instruments and carryout preformulation and formulation development activities.
- Travel to the sites of CSPs to oversee the manufacturing activities.
- Keep abreast of latest developments in drug product manufacturing technologies, cGMP requirements, regulatory guidance, and drug delivery approaches to drive new product development and lifecycle management.
- PhD in chemistry, pharmaceutics or related fields with three or more years of drug product development experience or BS/MS degree with extensive industry experience (10 + years).
- Broad understanding of various formulation approaches – especially immediate release and modified release dosage form development, drug delivery methods, and routes of administration.
- Experience in parenteral, pulmonary, ophthalmic, and/or dermatological formulations is considered advantageous.
- Extensive hands-on experience with various formulation equipment.
- Experience with QbD to devise and analyze formulations and process development.
- Experience in selecting and managing CSPs for drug product development and manufacturing.
- Experience in cGMP and drug product IND/NDA/IMPD regulatory filings.
- Demonstrated scientific excellence, technical leadership, and creativity.
- Proven project management skills and productive collaboration with cross-functional teams.
- Ability to deliver under tight timelines and adapt to changing project needs.
- Ability to work on multiple projects at the same time.
- Ability to communicate, organize, and write well.