Scientist II (Drug Substance Development and Manufacturing) at Exelixis, Inc. in Alameda, California

Job Description:

Company Description

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.

Job Description

This role will be responsible for supporting Exelixis small molecule development and commercial pipeline for commercial and clinical needs. The successful candidate will be part of a team that leads the efforts at our contract manufacturing organizations (CMOs) to direct all aspects of our Drug Substance (DS) manufacturing including process improvement, verification and scale-up to support larger volume commercial production. This role will contribute to technology transfers, process validation and commercial preparedness for manufacturing at contracted external sites.

Qualifications

ESSENTIAL DUTIES AND RESPONSIBILITIES:
• The successful individual will have proven organic chemistry skills with demonstrated expertise in process optimization, drug development and commercial manufacturing. Experience in working with contract manufacturing organizations (CMOs) in North America, EU and Asia, including raw materials and Drug Substances is also highly desired.
• Work with our CMOs to ensure that the productions of our materials are executed on time, and successfully per our technical, quality and regulatory requirements.
• Review and approve batch documents for drug substance manufacturing ensuring they meet the technical and regulatory requirements.
• Closely track and monitor manufacturing performance including deviations, batch record comments, data trending, and batch yields.
• Work with the DS team to propose process improvements and/or scale up to processes where efficiencies can be introduced.
• Execute tech transfers, process qualification and validation at alternate manufacturing sites in preparation of commercial launch.
• Work with the DS team to develop phase appropriate GMP processes for development products at our CMOs.
• Work closely with other team members within the department and other functional areas/departments, including logistics and planning functions to ensure Drug Substance and Raw Materials production is part of a robust supply chain.
• Contribute to regulatory submissions by writing, reviewing, appropriate sections.
• Assist with expanding the DS team to support commercial manufacturing and tech transfer for Drug Substances at our external manufacturing organizations.
• Act as a technical subject matter expert (SME) internally for troubleshooting and other internal assessments.

SUPERVISORY RESPONSIBILITIES:
• None

EDUCATION/EXPERIENCE/SKILLS:
Education:
• BS/BA degree in related discipline and ten years of related experience; or,
• MS/MA degree in related discipline and eight of related experience; or,
• PhD in related discipline and two to four years of related experience; or,
• Equivalent combination of education and experience.
• May require certification in assigned area.

Experience:
• Experience working with CMOs in a manufacturing role. Track record of working with external contract organizations and thorough understanding of regulatory legislations and quality/compliance in commercial manufacturing.
• Experience in Biotech/Pharmaceutical industry, especially in process engineering, is preferred.
• Experience in performing technology transfer of processes.
• Experience in interacting with external CMOs.
• Experience in process development, process characterization, process validation.

Knowledge/Skills/Abilities:
• Knowledge in P.A.T and Pharmaceutical Quality by Design principles is a plus.
• Knowledge of regulatory and compliance issues as they pertain to the global development and commercialization of Drug Substances.
• Strong process engineering experience is preferred.
• Exposure and understanding of cGMP, quality and regulatory requirements. Preparation and writing of key sections of regulatory documents (such as NDAs, MAAs and INDs) may be required.
• Good technical knowledge in raw materials and drug substance manufacturing.
• Small molecule experience required.
• Strong and effective interpersonal skills, a fast paced company. Team player with high integrity and creativity.
• Ability to communicate clearly and concisely verbally and in writing. Some experience and skills in authoring regulatory submissions is a recommended.

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Additional Information

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.