Sr. Formulation Scientist

Formulation Scientist

This role leads the end-to-end development, optimization, scale-up, and technology transfer of animal health pharmaceutical products across multiple dosage forms, including tablets, liquids, powders, chews, and other oral solid and semi-solid products. You will design and execute formulation and process development studies using Quality by Design (QbD) and Design of Experiments (DOE) principles, generate high-quality technical documentation, and collaborate closely with cross-functional teams to move products from feasibility through commercialization in a regulated GMP environment.

The position combines significant project management and technical writing responsibilities with hands-on work in scale-up and manufacturing suites.

• Lead the development, optimization, and scale-up of pharmaceutical formulations for animal health, including tablets, chews, liquids, powders, and other dosage forms from feasibility batches through commercialization.
• Design and execute formulation and process development studies using QbD and DOE principles, including identification and management of CMAs, CQAs, CPPs, and FMEA-based risk assessments.
• Establish robust manufacturing processes that meet quality, regulatory, and operational requirements for oral solid dose and other dosage forms.
• Prepare, review, and maintain technical documentation such as development reports, manufacturing protocols, master batch records, change controls, deviations, and technology transfer packages.
• Lead and support technology transfer activities from R&D to production, including process validation efforts and preparation of Pharmaceutical Development Reports (PDR) to support CMC documentation and dossier submissions.
• Collaborate cross-functionally with Analytical, Regulatory, Quality, Manufacturing, MSAT, Industrial Operations, and Operations teams to support product development, validation, scale-up, and commercialization.
• Evaluate and interpret stability data to support product development decisions and regulatory submissions, and contribute to responses to regulatory inquiries.
• Ensure compliance with cGMP, GLP, FDA, EMA, and internal quality system requirements throughout formulation and process development activities.
• Provide technical leadership and mentorship to junior scientists and development technicians, fostering scientific excellence, knowledge sharing, and continuous improvement.
• Support laboratory and operational compliance activities, including data integrity initiatives, investigations, deviations, CAPAs, safety programs, and adherence to SOPs.
• Coordinate with production and industrial operations to align formulation and process designs with manufacturing capabilities and constraints.
• Manage projects effectively, balancing multiple development initiatives, timelines, and deliverables in a fast-paced, deadline-driven R&D environment.
• Conduct literature searches and technical reviews to inform formulation strategies, process improvements, and problem solving.
• Participate in large audience meetings and cross-functional forums, presenting technical data, project status, and risk assessments clearly and confidently.
• Contribute to building a collaborative, close-knit team culture among scientists and technicians in a dynamic and evolving R&D group.

• At least 5 years of pharmaceutical formulation and/or process development experience in a regulated GMP environment.
• Hands-on experience developing solid dosage forms, such as tablets and/or chews, in an R&D/GMP setting from feasibility batches through commercialization.
• Demonstrated expertise in formulation development, process scale-up, technology transfer, and pharmaceutical manufacturing of oral solid dose products.
• Strong mastery of QbD and DOE principles, including practical application of CMAs, CQAs, CPPs, and FMEA in process and formulation design.
• Experience with stability programs, including evaluation of stability data to support product development and regulatory submissions.
• Proven ability to prepare and review technical documentation, including development reports, manufacturing protocols, master batch records, change controls, deviations, and technology transfer packages.
• Experience supporting CMC documentation and dossier submissions, including writing Pharmaceutical Development Reports (PDR).
• Strong understanding of cGMP, FDA, EMA, and quality system requirements relevant to pharmaceutical development and manufacturing.
• Excellent written and verbal communication skills for effective collaboration across scientific, quality, regulatory, manufacturing, and operations teams, including international and large audience meetings.
• Demonstrated project management skills, with the ability to manage multiple development projects, timelines, and deliverables in a fast-paced environment.
• Ability to mentor and provide technical guidance to junior scientists and technicians, promoting scientific rigor and continuous improvement.
• Direct industry experience in…