We are seeking an experienced formulation scientist to support development of new veterinary drug products and reformulation of existing products. The formulation scientist will be responsible for formulation screening, characterization, process development, and nomination of drug product composition. Dosage forms may include sterile injectables (liquid and lyophilized), topicals/transdermals, oral liquids, and others for a variety of animal species. This is an exciting opportunity where the scientist will have full ownership of formulation development and early involvement from discovery through product launch. The scientist will work with interdisciplinary teams and partner groups including discovery, chemistry, clinical, regulatory, marketing, and manufacturing. The scientist may be expected to lead PharmSci and Co-Development subteams and bring forward a drug product, analytical methods, and registration pathway for candidate compounds from early discovery through commercialization.
- Pre-formulation and formulation development, including formulation screening to solve stability, solubility, and absorption challenges.
- Formulation design, characterization, development, and process scale-up including transfer to global manufacturing sites.
- Support discovery team with enabling formulations.
- Generation of experimental supplies for early-stage studies.
- Research and development of drug delivery systems internally and/or through external partners.
- Conduct formulation research in the laboratory and provide PharmSci and Co-Development leadership when appropriate.
- Author regulatory documents for filing and commercial launch.
EDUCATION AND EXPERIENCE
- MS (with 5-15 years’ experience), or PhD (with 0-10 years’ experience) in Pharmacy, Pharmaceutics, Chemistry, Chemical Engineering, or related field.
- Experience in conducting pre-formulation and formulation development studies.
- Experience in authoring supporting documentation for regulatory filings.
- Knowledge in Biopharmaceutics and Pharmacokinetics, Design of Experimentation and Quality by Design aspects for formulation development.
- Extensive knowledge of drug degradation pathways, solubilization, and stabilization techniques.
- Effective and demonstrated communication and leadership skills.
- Solid understanding of statistics and statistical tools.
- Experience with international teams, CROs/CMOs.
OTHER DESIRABLE ATTRIBUTES
- Familiarity of the Animal Health industry with experience of working with Marketing/Commercial colleagues.
- Familiarity with GMP, VICH, Pharmacopoeia, Technical and Regulatory requirements in relation to animal health product development and manufacturing.
- Familiarity with manufacturing process development, scale-up, technology transfer to pilot/commercial scale.
- Use of statistical modeling for shelf life determination and specification setting.
- Experience with writing CMC technical sections and supporting post commercial changes.
- Understanding of packaging considerations for commercial products and primary pack screening and selection activities