Sr. Scientist - Drug Product Development

Location
Hayward, California
Posted
Mar 22, 2021
Ref
195
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time

Summary
We are seeking a motivated candidate to join the Drug Product Development Group at Arcus Biosciences.


The Drug Product Development Group supports programs across various stages of clinical studies and provides technical leadership towards technology transfer, external collaboration efforts & clinical drug product process development. In addition, the drug product group provides technical support for drug product GMP manufacturing.

The candidate will be responsible for some level of pre-formulation and primarily formulation development related activities, with focus on clinical-stage drug product development. The candidate will be a formulation expert with industrial experiences in solid dosage form (tablets and capsules) and parenteral delivery systems (sterile solution & lyophilized formulation).   Additionally, this position will be responsible for representing drug product group in core team meetings and for providing timely updates to inform other important functions such as the clinical supply chain, the clinical and 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.
  • Represent drug product group in core team meeting and 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 assesses new technologies, and implement such for efficient, reliable & robust drug product development.

Requirements

  • Ph.D. in Chemical Engineering or Pharmaceutical Sciences (or related discipline) with 6+ years of relevant industry experience
  • 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.
  • The candidate should have high degrees of both flexibility and organizational skills as well as an eagerness and ability to learn in order to effectively navigates Arcus’ multiple projects and timelines
  • 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