Senior Scientist II

SUMMARY/

JOB PURPOSE:

The Senior Scientist II, Process Chemistry supports Exelixis’ small-molecule development programs from early development through commercialization. As part of the team responsible for all aspects of drug substance (DS) development and manufacturing, this role executes process development in Exelixis’ internal laboratory and supports technology transfer, process development, and manufacturing activities at selected contract development and manufacturing organizations (CDMOs).

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Work independently or as part of a project team to evaluate synthetic routes and test alternatives that enable the scale-up of small-molecule drug substances and intermediates.

Develop safe, phase-appropriate processes for development programs in-house or racterize process impurities and establish appropriate impurity control strategies.

Facilitate process scale-up and manufacturing to supply drug substances for preclinical and clinical studies, and provide troubleshooting and problem-solving support for ongoing manufacturing projects.

Prepare technical packages for process transfer to CDMO facilities and serve as the project technical expert on cross-functional teams supporting CDMO manufacturing.

Collaborate with CDMOs to ensure materials are produced on time and in accordance with technical, quality, and regulatory requirements.

Prepare and review drug substance manufacturing batch documents to ensure compliance with technical and regulatory requirements.

Collaborate with team members and cross-functional partners, including logistics and planning, to integrate drug substance and raw material production into a robust supply chain.

Contribute to regulatory submissions by drafting and reviewing relevant sections.

Prepare and author sections of regulatory documents, such as NDAs, MMAs, and INDs, as required.

Serve as an internal technical subject matter expert (SME) for troubleshooting and other technical assessments.

SUPERVISORY RESPONSIBILITIES:

None EDUCATION/EXPERIENCE/KNOWLEDGE &

SKILLS:

Education/

Experience:

Bachelor’s degree in Organic Chemistry, Chemical Engineering, Pharmaceutical Science, or a related field, with at least 9 years of relevant experience in the biotechnology or pharmaceutical industry; or Master’s degree in Organic Chemistry, Chemical Engineering, Pharmaceutical Science, or a related field, with at least 7 years of relevant experience in the biotechnology or pharmaceutical industry; orPhD in Organic Chemistry, Chemical Engineering, Pharmaceutical Science, or a related field, with at least 2 years of relevant experience in the biotechnology or pharmaceutical industry;

orAn equivalent combination of education and experience.

Knowledge/

Skills:

Demonstrated track record of delivering results with integrity, a commitment to quality, and a collaborative approach.

Required knowledge of process chemistry, synthetic organic chemistry, analytical methods—particularly NMR, MS, and HPLC—and physicochemical characterization of compounds.

Experience in the biotechnology or pharmaceutical industry, particularly in process chemistry, is strongly preferred.

Experience developing drug-linker molecules for antibody-drug conjugates (ADCs), peptide-drug conjugates (PDCs), or highly potent compounds is preferred.

Experience in working with contract manufacturing organizations (CMOs) in North America, EU, and Asia, including raw materials and Drug Substances is a plus.

Highly self-motivated and detail-oriented, with a demonstrated ability to work independently.

Ability to communicate clearly and concisely, both verbally and in writing.

Excellent organizational skills and the ability to manage multiple priorities successfully.

Ability to work effectively on cross-functional…