Assoc Drug Substance Manufacturing Director - Alameda, CA, United States - Exelixis

Description

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.
Propose process improvements for scale up to processes where efficiencies can be introduced.
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.

PhD in related discipline and and a minimum of five years of related experience; Proven organic chemistry skills with experience in process optimization, development and commercial manufacturing.

Experience in Biotech/Pharmaceutical industry, especially in process chemistry, is preferred.

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

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.
T and Pharmaceutical Quality by Design principles is a plus.
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

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.

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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