Formulations R&D Head

Job Description

JOB OVERVIEW: Lead functionally the R&D function. Be the process owner of the Formulation development continuum. Supporting clients for all aspects of drug product formulation development. Guiding and supporting R&D formulations sites globally from a technical perspective. Building & integrating scientific capabilities across formulations sites, design and conduct pre-formulation, formulation development, process selection and scale-up for clinical manufacturing activities , formulation & excipient screening, stability & compatibility studies, bio-analytical characterization, pharmaceutical testing, and formulation transfer to pilot- and GMP production. Involved in process improvement , serve as drug product subject matter expert to teams for programs from early development through registration, leading scale up and tech transfer of manufacturing process. Collaborate with the Business Development and Program Management teams to drive client interactions from a technical perspective.

The formulations R&D teams at sites will report functionally to the position.

RELEVANT EXPERIENCE:

• Minimum 15 years of Formulation and/or Analytical Pharmaceutical Development experience in the pharmaceutical industry
• Experience in working with clients and customers preferred, especially in a CDMO environment
• Experience and demonstrated success in formulation/analytical development and delivery across a range of molecules, and through all stages of development
• Experience and understanding of Design of Experiments (DOE), Quality by Design (QbD), Process Analytical Technology (PAT), scale up, formulation and process technologies

Key Role/responsibilities:

• Process owner of the R&D standards for formulations, from Creation, Roll Out, Sustainability
• Responsible for supporting clients for all aspects of drug product formulation development from lead optimization to clinical development through commercialization and scale up based on Quality by Design (QbD) strategies and application of design of experiments (DOE) .
• Responsible for supporting Forms sites globally from a technical perspective- dev projects, accountable for client interactions from a tech perspective.
• Responsible for leading and guiding site R&D teams for development of NCEs, Generics and Innovative Generics (505B2s).
• Building & integrating scientific capabilities across Formulations sites
• Collaborate with the BD team to drive client acquisition and retention
• Strategic initiatives for long term growth, P&L and budget management
• Scientific deliverables & product launches
• Product development involving Formulations, Analytical development, IP, Regulatory, Quality, Packaging, Clinical and project management
• Development of simple to complex formulations in Oral solids, Liquid orals, ointments and creams
• Design and conduct pre-formulation, formulation development, process selection and scale-up for clinical manufacturing activities as well as process robustness investigations, and process validation of drug products for commercial launch
• Formulation & excipient screening, stability & compatibility studies, bio-analytical characterization, pharmaceutical testing, and formulation transfer to pilot- and GMP production.
• Involved in process improvement through preparation of formulation development protocols, clinical batch manufacturing documents and technology transfer dossier
• Serve as drug product subject matter expert to program teams for programs from early development through registration. Be instrumental in developing improved (efficacious, stable and safe) formulations of drugs using novel drug delivery technologies
• Leading scale up and Tech transfer of manufacturing process
• Provide technical strategic support and documentation for answering questions during regulatory submission reviews.

Key Competencies

• Strong OSD, liquids, creams and ointments experience and sterile fill finish experience preferred
• Strong leadership and management abilities
• Excellent communication, problem-solving and organizational skills; thrives in a cross-functional team environment
• Extensive working knowledge of GxP, regulatory practices
• Extensive knowledge of the scientific literature and of emerging research areas of pharmaceutical science