Senior Scientist - Associate Director, Formulation Development

5 - 7 years experience  •  Biotech/Pharma

Salary depends on experience
Posted on 10/15/17
Pleasanton, CA
5 - 7 years experience
Biotech/Pharma
Salary depends on experience
Posted on 10/15/17

The Senior Scientist - Associate Director, Formulation Development will be responsible for leading formulation and product development activities with emphasis on small molecule oral drug product formulations. Responsible for designing, executing, and analyzing results from laboratory tests and experimentation to advance formulation and process development. The incumbent will lead formulation development activities focusing on developing dissolution enhancing formulations for Biopharmaceutics Classification System (BCS) Class II compounds. This individual will act as a subject matter expert leading product development activities from preclinical stage through product registration and commercialization. Title will be commensurate with experience.

 

Responsibilities:

  • Develop drug product formulations, dosage forms, and manufacturing processes for small molecule products to support clinical trials and commercialization
  • Develop, optimize, and characterize dissolution enhancing formulations of BSC Class II compounds for oral administration. Requires familiarity with various formulation technologies used to address challenges of BCS-II molecules
  • Design and execute pre-formulation activities such as (pH-dependent) solubility, stability, and excipient compatibility testing, and determine physicochemical properties of NCEs
  • Lead material characterization, e.g. physical and polymorphic forms, particle size distribution, morphology, hygroscopicity, DSC, TGA, and powder flow
  • Work with CRO/CMO to design studies to develop robust, commercially-viable formulations and processes
  • Responsible for the manufacture and timely provision of clinical supplies. Supervise CMO and develop contingency plan to ascertain on-time IMP delivery
  • Design stability studies for various stages of formulation development
  • Responsible for scale-up and technology transfer of manufacturing processes to global contract manufacturing sites 
  • Identify and manage process improvement opportunities
  • Proactively identify potential issues and develop creative solutions to technical problems in order to meet project timelines and goals
  • Lead efforts to write technical reports to document results of experimentation performed by contract laboratories
  • Write regulatory documents, e.g. CMC sections of CTD, development protocols, and other cGMP related documents as needed
  • Adhere to budgets, resources, and timelines to achieve successful project completion
  • Represent the formulation group in various inter-disciplinary meetings and communicate findings to the CMC team
  • Travel: Up to 15%

 

Qualifications:

  • PhD in Pharmaceutical Sciences, Chemical Engineering, or other relevant disciplines
  • Minimum 5 years’experience working in a pharma/biotech cGMP regulated manufacturing environment with proven expertise in formulation development of small molecules and solid oral dosage forms is required
  • Biopharmaceutics Classification System (BCS) Class II experience is strongly preferred
  • Experience with early stage development is required. Experience with late stage process development and technology transfer is a plus
  • Experience collaborating with and overseeing CMOs/CROs is required
  • Experience authoring CMC section for regulatory (IND/NDA) submissions is preferred
  • Proficient with quality and regulatory requirements of small molecule products including ICH guidelines
  • Experienceapplying DoE and QbD principles to develop drug formulations and manufacturing processes
  • Ability to work independently in a fast-paced environment
  • Exceptional written and oral communication,  collaboration, and creative problem-solving skills ensuring alignment with other functions

17-24R

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