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Senior Scientist - Associate Director, Product Development

  • Location: Pleasanton
  • Salary: £155000.00 - £230000.00 per annum per year
  • Job Type:Permanent

Posted 12 days ago

  • Sector: Life Sciences
  • Contact: Summer Martinez
  • Expiry Date: 14 October 2022
  • Job Ref: JN -092022-473718

Senior Scientist - Associate Director, Product Development

The Senior Scientist - Associate Director, Product Development will be responsible for leading formulation and product development activities with emphasis on small molecule oral drug product formulations. The incumbent will apply enabling manufacturing technologies to develop bioavailable immediate release (IR) and modified release (MR) formulations and robust manufacturing processes. Experienced in dissolution enhancing formulations for Biopharmaceutics Classification System (BCS) Class II compounds is desirable, but not required. This individual will be interacting with contract manufacturing organizations and also hands-on in the on-site laboratory, while acting as a subject matter expert leading product development activities from early clinical stage through product registration and commercialization. Familiarity with and experiences working in GMP facility is required. Title will be commensurate with experience.

Responsibilities:

  • Design and develop solid oral drug product formulations and manufacturing processes of small molecule drug candidates to support clinical trials and commercialization
  • Lead the design and manufacture of solid oral dosage formulations in the in-house laboratory (hands-on) and execution of pre-formulation studies, e.g., solubility, stability, and excipient compatibility studies
  • Write and execute study protocols for developing and trouble-shooting drug product formulations
  • Actively support CRO/CMO activities to achieve CMC milestones and project timelines as needed. Ascertain on time delivery of clinical, stability, registration, and validation batches.
  • Develop and propose experimental plans and seek alignment with manager and functional heads
  • Develop project plans with contingency and ascertain timely CTM manufacture and packaging for un-interrupted clinical supply
  • Design and execute stability studies at various stages of product development
  • Support scale-up and technology transfer of manufacturing processes to global contract manufacturing sites
  • Proactively identify potential issues and develop creative solutions or contingencies to achieve project goals
  • Write technical reports to document results of experimentation performed in-house and at contract laboratories
  • Write and/or review development study protocols and technical reports, GMP documents such as batch records, and regulatory documents, e.g., CTD Module 3, to support IND and NDA submissions
  • Adhere to budgets, resources, and timelines to achieve development goals
  • Represent Product Development in various inter-disciplinary team meetings and communicate findings to department managers
  • Travel up to 15%

Qualifications:

  • Ph.D. in Pharmaceutical Sciences, Chemical Engineering, or other relevant discipline with at least 3 years industry experience, but will consider exceptional applicants with less experience
  • Experienced working in a pharma/biotech R&D and cGMP regulated manufacturing environment with proven expertise in formulation development of small molecules and solid oral dosage forms is highly desirable
  • Experienced interacting with and overseeing CMOs/CROs is highly desirable
  • Basic knowledge of quality and regulatory requirements including FDA and ICH guidelines
  • Basic understanding of Design of experiment and Quality by Design principles to formulation and process development is desirable
  • Enthusiastic and energetic personality with ability to work independently as a self-starter in a fast-paced environment
  • Creative problem-solving skills with ability to work in highly collaborating cross-functional teams
  • Exceptional written and oral communication skills

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