Senior Scientist, Drug Product Development

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