Getting Hired
Senior Manager, Global External Manufacturing, Biologics
Getting Hired, Foster City, California, United States, 94420
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that improve lives and to ensure access to these therapies worldwide.
Senior Manager, Global External Manufacturing
Support uninterrupted supply of Gilead’s clinical and commercial products through execution of manufacturing campaigns within our global external contract‑manufacturing network, ensuring compliance with cGMP, regulatory requirements, and environmental, health, and safety legislations.
Represent the Manufacturing Operations group within the larger Pharmaceutical Development and Manufacturing organization (PDM).
Lead the manufacture of biologics drug substance – experience in this area is mandatory.
Essential Functions
Execute the network strategy, including tactical manufacturing strategy and supplier performance management.
Lead collaboration with functions within and external to PDM to achieve corporate, cross‑functional, and departmental goals.
Define technical requirements with the Technical Development Organization, partner with Global Supply Chain in selecting CMOs, and influence overall CMO performance to meet key performance indicators.
Coordinate technical transfers and validate new or existing processes/products at CMOs.
Ensure products are manufactured in accordance with registered processes and approved Master Production Records.
Resolve complex manufacturing and compliance issues, including deviations, complaints, investigations, material review board issues, finished product trending, and change control.
Facilitate continuous improvement of production and business processes to reduce cost, improve quality, increase efficiency, and ensure sustainability.
Represent manufacturing on cross‑functional Development or Commercial CMC teams, managing product strategy across the lifecycle from clinical supply to commercial launch and routine supply.
Basic Qualifications
Ph.D. with 2+ years of progressively responsible experience in a pharmaceutical/biotech organization
M.S. with 6+ years of progressively responsible experience in a pharmaceutical/biotech organization
B.S. with 8+ years of progressively responsible experience in a pharmaceutical/biotech organization.
Preferred Qualifications
8+ years of progressively responsible experience in a pharmaceutical/biotech organization
Experience in sterile large‑molecule drug substance or large‑molecule drug product manufacturing and supply chain execution and oversight in the pharmaceutical industry
Experience in supply risk management and knowledge of industry best practices
Understanding and application of manufacturing principles governed by cGMP, including worldwide regulatory requirements and ICH guidance
Knowledge of the contract manufacturing organization (CMO) landscape and CMO capabilities for worldwide bulk drug substance manufacturing
Ability to travel internationally, including overnight up to 10% of the time
Exceptional verbal and written communication skills, including ability to interact effectively with senior management
Demonstrated ability to understand and contribute to resolution of complex situations
People Leader Accountabilities
Create inclusion – model diverse teams and embed diversity value in management practices.
Develop talent – assess skills, aspirations, and potential of employees and coach on current performance and future growth.
Empower teams – align goals and departmental objectives, remove barriers, and connect teams to the broader ecosystem.
Salary and Benefits Salary range: $157,590.00 – $203,940.00. Compensation may also include discretionary annual bonus, discretionary stock‑based long‑term incentives (eligibility may vary), paid time off, and a benefits package. Benefits include company‑sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit: https://www.gilead.com/careers/compensation‑benefits‑and‑wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
Equal Employment Opportunity Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment with diverse perspectives, backgrounds, and experiences. Employment decisions will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information, gender identity and expression, veteran status, or other non‑job related characteristics.
To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants requiring accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the Know Your Rights poster.
Gilead Sciences will not discriminate against employees or applicants who inquire about or discuss pay, except where disclosure is required by law or investigation.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Gilead promotes a work environment free of harassment and prohibited conduct, embracing diversity of thoughts and opinions.
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Senior Manager, Global External Manufacturing
Support uninterrupted supply of Gilead’s clinical and commercial products through execution of manufacturing campaigns within our global external contract‑manufacturing network, ensuring compliance with cGMP, regulatory requirements, and environmental, health, and safety legislations.
Represent the Manufacturing Operations group within the larger Pharmaceutical Development and Manufacturing organization (PDM).
Lead the manufacture of biologics drug substance – experience in this area is mandatory.
Essential Functions
Execute the network strategy, including tactical manufacturing strategy and supplier performance management.
Lead collaboration with functions within and external to PDM to achieve corporate, cross‑functional, and departmental goals.
Define technical requirements with the Technical Development Organization, partner with Global Supply Chain in selecting CMOs, and influence overall CMO performance to meet key performance indicators.
Coordinate technical transfers and validate new or existing processes/products at CMOs.
Ensure products are manufactured in accordance with registered processes and approved Master Production Records.
Resolve complex manufacturing and compliance issues, including deviations, complaints, investigations, material review board issues, finished product trending, and change control.
Facilitate continuous improvement of production and business processes to reduce cost, improve quality, increase efficiency, and ensure sustainability.
Represent manufacturing on cross‑functional Development or Commercial CMC teams, managing product strategy across the lifecycle from clinical supply to commercial launch and routine supply.
Basic Qualifications
Ph.D. with 2+ years of progressively responsible experience in a pharmaceutical/biotech organization
M.S. with 6+ years of progressively responsible experience in a pharmaceutical/biotech organization
B.S. with 8+ years of progressively responsible experience in a pharmaceutical/biotech organization.
Preferred Qualifications
8+ years of progressively responsible experience in a pharmaceutical/biotech organization
Experience in sterile large‑molecule drug substance or large‑molecule drug product manufacturing and supply chain execution and oversight in the pharmaceutical industry
Experience in supply risk management and knowledge of industry best practices
Understanding and application of manufacturing principles governed by cGMP, including worldwide regulatory requirements and ICH guidance
Knowledge of the contract manufacturing organization (CMO) landscape and CMO capabilities for worldwide bulk drug substance manufacturing
Ability to travel internationally, including overnight up to 10% of the time
Exceptional verbal and written communication skills, including ability to interact effectively with senior management
Demonstrated ability to understand and contribute to resolution of complex situations
People Leader Accountabilities
Create inclusion – model diverse teams and embed diversity value in management practices.
Develop talent – assess skills, aspirations, and potential of employees and coach on current performance and future growth.
Empower teams – align goals and departmental objectives, remove barriers, and connect teams to the broader ecosystem.
Salary and Benefits Salary range: $157,590.00 – $203,940.00. Compensation may also include discretionary annual bonus, discretionary stock‑based long‑term incentives (eligibility may vary), paid time off, and a benefits package. Benefits include company‑sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit: https://www.gilead.com/careers/compensation‑benefits‑and‑wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
Equal Employment Opportunity Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment with diverse perspectives, backgrounds, and experiences. Employment decisions will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information, gender identity and expression, veteran status, or other non‑job related characteristics.
To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants requiring accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the Know Your Rights poster.
Gilead Sciences will not discriminate against employees or applicants who inquire about or discuss pay, except where disclosure is required by law or investigation.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Gilead promotes a work environment free of harassment and prohibited conduct, embracing diversity of thoughts and opinions.
#J-18808-Ljbffr