Senior Scientist, Drug Product Development

Location
Hayward, California
Posted
Oct 12, 2021
Ref
omPzgfwK
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time

Summary


The Senior Scientist will be responsible for pre-formulation and primarily formulation development related activities with focus on; clinical-stage drug product development, representing the drug product group in core team meetings, and providing timely updates to inform the clinical supply chain, and clinical/upper management on drug product development directions.

Responsibilities

  • Conduct pre-formulation and formulation activities to support early development candidate selection, which include PK studies, non-GLP and GLP studies.
  • Work with external manufacturing CMOs to enable tech transfer and implementation of processes
  • Accountable for drug product process development and GMP manufacturing.
  • Lead formulation activities related to scale up
  • Lead formulation development activities, including stability studies
  • Under the guidance of the Director of Drug Product Development, help implement and maintain a state-of-the-art drug product development laboratory.
  • Responsible for technical leadership towards key formulation decision as part of the overall selection process for advancing molecule for development.
  • Develop strategy with other functions to prioritize and meet CMC deliverables.
  • Interact effectively & build successful relationships with members of the drug product group, and with other Arcus stakeholders (Drug Substance, Quality, Analytical Development, Regulatory, Medicinal Chemistry, Clinical Operations & Discovery Biology).
  • Consistently seek out, recognize and assess new technologies, and implement such for efficient, reliable & robust drug product development.

Qualifications

  • Ph.D. in Chemical Engineering or Pharmaceutical Sciences (or related discipline) required
  • 6+ years of relevant industry experience required, e.g., a formulation expert with industrial experiences in solid dosage form (tablets and capsules) and parenteral delivery systems (sterile solution & lyophilized formulation)
  • Experienced in parenteral & oral formulation development, drug product process development, and technology transfer
  • Experienced in High Pressure Liquid Chromatography (HPLC) as analytical tool for evaluating formulation stability
  • Experience with DSC, TGA, XRPD, and other advanced formulation scientific equipment.
  • Thorough understanding of GMPs, ICH guidelines, QbD, and industry best practices.
  • Strong interpersonal skills: ability to communicate effectively both verbally and in written formats are necessary to collaborate effectively with the rest of the Drug Product Development team and well as across other teams
  • Detail oriented, rigorous, and excellent skills in record keeping/documentation
  • Experience in laboratory implementation & management is preferred.
  • Proven ability to think creatively, and to obtain solutions to complex and diverse problems