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 at CDMOs.
- Characterize 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:
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; or
- PhD 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; or
- An 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 teams.
- Ability to travel domestically up to 10%.
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Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $132,500 - $188,000 annually. The base pay range may take into account the candidate’s geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
If you have a disability and need an accommodation in relation to the recruiting process, please email us at: ApplicantAccommodations@exelixis.com.
WORKING CONDITIONS:
Our office is a modern space that fosters collaboration and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.
DISCLAIMER:
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.