- Propose process improvements for scale up to processes where efficiencies can be introduced.
- Develop phase appropriate processes for development products at our CMOs.
- Execute tech transfers, process qualification and validation at manufacturing sites.
- 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 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.
- Preparation and writing of key sections of regulatory documents (such as NDAs, MAAs and INDs) may be required.
- Act as a technical subject matter expert (SME) internally for troubleshooting and other internal assessments.
- No supervisory responsibilities initially.
- Direct work to CMOs, Consultant, and/or 3rd party.
- BS/BA degree in related discipline and a minimum of eleven years of related experience; or,
- MS/MA degree in related discipline and a minimum of nine years of related experience; or,
- PhD in related discipline and and a minimum of five years of related experience; or,
- Equivalent combination of education and experience.
- May require certification in assigned area.
- Proven organic chemistry skills with experience in process optimization, development and commercial manufacturing. Small molecule experience required.
- Experience in Biotech/Pharmaceutical industry, especially in process chemistry, is preferred.
- Experience in performing technology transfer of processes.
- Experience in development of drug linker molecules for ADCs and PDCs is a plus and highly desired.
- Experience in working with contract manufacturing organizations (CMOs) in North America, EU, and Asia, including raw materials and Drug Substances.
- Some process engineering experience is preferred.
- Some experience and skills in authoring regulatory submissions is a recommended.
- Exposure and understanding of cGMP, quality, and regulatory requirements.
- Knowledge of regulatory and compliance issues as they pertain to the global development and commercialization of Drug Substances.
- Good technical knowledge in small molecular drug substance manufacturing.
- Knowledge in P.A.T and Pharmaceutical Quality by Design principles is a plus.
- 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.
- Environment: primarily working indoors in an office/lab environment or meeting with clients
- Travel required - 30% of domestic travel required
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Assoc Drug Substance Manufacturing Director - Alameda, CA, United States - Exelixis
Description
SUMMARY/JOB PURPOSE:
This role is responsible for supporting Exelixis' small molecule development from early-stage development through commercialization. This role is part of a team that leads the efforts at our contract manufacturing organizations (CMOs) to direct all aspects of our Drug Substance (DS) development and manufacturing. Specifically, s/he guides our CMO partners in process development/optimization, process verification and scale-up to support larger volume development and commercial production. This role leads projects, technology transfers, process validation, and commercial preparedness for manufacturing at contracted external sites.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
SUPERVISORY RESPONSIBILITIES:
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
Experience/The Ideal for Successful Entry into Job:
Knowledge/Skills:
WORKING CONDITIONS:
If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us
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 $159,000 - $225,500 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. 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.
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