- 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
-
Director of Manufacturing
2 weeks ago
Pyka Oakland, United StatesJob Description · Job DescriptionPyka is seeking a dynamic and experienced Director of Manufacturing to lead our manufacturing operations and drive operational excellence across production, procurement, inventory management, quality assurance, logistics, and facility operations. ...
-
Director of Manufacturing
3 weeks ago
Pyka Oakland, United StatesPyka is seeking a dynamic and experienced Director of Manufacturing to lead our manufacturing operations and drive operational excellence across production, procurement, inventory management, quality assurance, logistics, and facility operations. Reporting directly to the CEO/CTO ...
-
Director of Manufacturing
4 weeks ago
Pyka Oakland, United StatesPyka is seeking a dynamic and experienced Director of Manufacturing to lead our manufacturing operations and drive operational excellence across production, procurement, inventory management, quality assurance, logistics, and facility operations. · Reporting directly to the CEO/ ...
-
Director, Manufacturing
3 weeks ago
Pendulum San Francisco, United StatesAbout PendulumPendulum is on a mission to help people improve physical and mental health by creating a new category of products that target the microbiome. We are researching, developing and commercializing a novel class of rationally-designed Live SynbioticsTM (probiotics + preb ...
-
Sr. Director, Manufacturing Engineering
2 weeks ago
Tierra Biosciences San Leandro, United StatesJob Description · Job DescriptionTierra Biosciences, a venture capital backed life science company, has pioneered a novel high-throughput protein production platform that produces hundreds of custom proteins on-demand. Our platform can make proteins faster than other technologies ...
-
Director of Manufacturing Engineering
1 week ago
The Mullings Group Menlo Park, United StatesDirector of Manufacturing · Rapid Point-Of-Care IVD Platform · Benchtop Electro-Mechanical Device : Consumables · Menlo Park : Hybrid/Onsite : Estimated 25% Travel · New Product Introduction : Design Transfer : Pilot/Commercial Production · Full Time : Direct Hire : Permanent Pl ...
-
Director, Manufacturing
6 days ago
Pendulum San Francisco, United StatesAbout Pendulum · Pendulum is on a mission to help people improve physical and mental health by creating a new category of products that target the microbiome. We are researching, developing and commercializing a novel class of rationally-designed Live Synbiotics (probiotics + pre ...
-
Manufacturing Program Director
2 weeks ago
訊凱國際 Cooler Master Co., Ltd. Fremont, United StatesAbout Cooler Master · Cooler Master customizes its solutions and services according to each client's individual needs in order to ensure customer satisfaction and to build long-term partnerships. · A career at Cooler Master provides meaningful opportunities to develop profession ...
-
Director, Manufacturing
4 weeks ago
Pendulum San Francisco, United StatesAbout PendulumPendulum is on a mission to help people improve physical and mental health by creating a new category of products that target the microbiome. We are researching, developing and commercializing a novel class of rationally-designed Live SynbioticsTM (probiotics + preb ...
-
Assoc Drug Substance Manufacturing Director
4 weeks ago
Exelixis Alameda, United StatesSUMMARY/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 ...
-
Assoc Drug Substance Manufacturing Director
3 weeks ago
Exelixis Alameda, United StatesSUMMARY/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 ...
-
Director, Manufacturing
3 weeks ago
Pendulum Therapeutics San Francisco, United StatesWill you now, or at any point in the future, require Visa sponsorship? ✱ · Yes · No · Additional information · U.S. Equal Employment Opportunity information · (Completion is voluntary and will not subject you to adverse treatment) · Our company values diversity. To ensure that ...
-
Manufacturing Plant Director
1 day ago
PepsiCo Deutschland GmbH Hayward, United StatesOverview · We are PepsiCo Supply Chain. We are the game changers, innovators, collaborators and history makers. The groundbreakers of the Supply Chain & Logistics space. · We are a diverse group, spread across 200 countries and territories, and united by a shared set of values ...
-
director of manufacturing operations
3 weeks ago
Randstad Burlingame, United Statesdirector of manufacturing operations. · + · burlingame , california · + posted april 12, 2024 · **job details** · summary · + $150,000 - $200,000 per year · + · permanent · + bachelor degree · + category transportation and material moving occupations · + referenceAB_4512913 · j ...
-
Director of manufacturing operations
3 weeks ago
Randstad Burlingame, United StatesThe Director of Manufacturing plays a crucial role in overseeing the entire manufacturing process within an organization. This position requires strong leadership skills, strategic thinking, and a deep understanding of manufacturing operations. The Director of Manufacturing is re ...
-
Autodesk San Francisco, United States Full timePosition Overview · Autodesk has fully reimagined the Design and Manufacturing business for the digital automation age, enabling companies to address the most important challenges they face today while preparing for new ways of working in the future. The Autodesk Product Design ...
-
Sr Director Manufacturing
2 days ago
Cepheid San Francisco, United States PermanentAt Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world's most complex health challenges. Our associates are involved ...
-
Director of Manufacturing
6 days ago
Ondas Networks Inc Sunnyvale, United StatesThe Director of Manufacturing is responsible for activities related to the operation and production of goods while achieving delivery, quality, and cost targets. Is also responsible for developing manufacturing plans that include quantities, costs, and time with the aim of maximi ...
-
Director of Manufacturing
4 weeks ago
Ondas Networks Inc Sunnyvale, United StatesThe Director of Manufacturing is responsible for activities related to the manufacture and production of electronic and electro-mechanical assemblies incorporated in industrial radios, achieving delivery, quality, and cost targets. Responsible for the development of manufacturing ...
-
Associate Director, Drug Substance Manufacturing
3 weeks ago
Sagimet Biosciences San Mateo, United StatesAbout Us · Sagimet is a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors that are designed to target dysfunctional metabolic pathways in diseases resulting from the overproduction of the fatty acid, palmitate. Sagimet's lead drug can ...
Assoc Drug Substance Manufacturing Director - Alameda, 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:
#LI-CW1
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.
