Senior Scientist II

Exelixis Inc; Alameda (CA); Sur place; USD 133 000 - 188 000; Plein temps

Avantages offerts par ce poste

401k plan

Medical/Dental/Vision coverage

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus

Résumé du poste

Exelixis Inc. is seeking a Senior Scientist II, Process Chemistry to advance small-molecule drug substance development from early development through commercialization. You will execute process development in-house and support technology transfer and CDMO manufacturing.

The role requires leading synthetic route evaluation, impurity characterization, and cross-functional collaboration, with responsibility for regulatory documentation and batch transfer packages.

Qualifications

• Bachelor’s, Master’s, or PhD in Organic Chemistry, Chemical Engineering, Pharmaceutical Science, or related field with 9/7/2+ years in biotech/pharma
• Demonstrated track record in process chemistry and scalable drug-substance development
• Experience with analytical methods (NMR, MS, HPLC) and impurity profiling

Responsabilités

• Evaluate synthetic routes and enable scale-up of drug substances and intermediates
• Develop safe, phase-appropriate processes in-house or at CDMOs
• Characterize process impurities and establish impurity control strategies
• Support scale-up and manufacturing for preclinical/clinical studies
• Prepare technical packages for process transfer to CDMO facilities
• Collaborate with CDMOs to meet technical, quality, and regulatory requirements
• Prepare/review drug substance manufacturing batch documents
• Assist regulatory submissions by drafting relevant sections
• Serve as internal SME for troubleshooting and assessments

Connaissances

Process chemistry

Analytical methods

NMR

MS

HPLC

Cross-functional teamwork

CDMO experience

Formation

Bachelor’s degree in Organic Chemistry or related

Master’s degree in Organic Chemistry or related

PhD in Organic Chemistry or related

Outils

CDMO collaboration tools

Description du poste

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

None

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%.

#LI-HG1

Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets.

The base pay range for this positionis $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.

• a 401k plan with generous company contributions
• group medical, dental and vision coverage
• life and disability insurance
• flexible spending accounts
• discretionary annual bonus program
• sales-based incentive plan (if field sales staff)
• opportunity to purchase company stock
• long-term incentives
• 15 accrued vacation days in their first year
• 17 paid holidays including a company-wide winter shutdown in December
• up to 10 sick days throughout the calendar year

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: [e-mail].

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.

Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset.

After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial.

As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we’re seeking to add talented, dedicated employees to power our mission.

Cancer is our cause. Make it yours, too.