Gilead Sciences
Associate Director, Process Technologies and Development
Gilead Sciences, San Francisco, California, United States, 94199
Overview
Associate Director, Process Technologies and Development at Gilead Sciences, Inc. Gilead is a research-based biopharmaceutical company focused on delivering life-saving therapies and addressing unmet medical needs. The role involves leading development of processes for small molecule and large molecule (biologics) parenterals, interfacing between formulation scientists and manufacturing operations, and contributing to a cross-functional team with independent critical thinking and scientific curiosity. Specific Job Responsibilities
Apply fundamental engineering principles to the design, development, scale-up, and validation of processes for sterile drug product unit operations (e.g., refrigerated/frozen storage and handling of bulk solutions, dissolution of APIs, pooling and mixing, sterile filtration, filling, pre-filled syringe processing, lyophilization, and vial capping) for both small molecule and large molecule parenterals Support extremely complex technical problems related to sterile processing engineering that advance Gilead portfolio priorities Execute studies and author reports related to container closure system compatibility and manufacturing process development Play a key role in the establishment of a state-of-the-art sterile process engineering lab Evaluate new/novel technologies relevant to parenteral drug product manufacturing Represent sterile processing engineering in cross-functional project teams Author regulatory filings (IND, NDA, BLA) to support global regulatory submissions Serve as a subject matter expert for development and commercial sterile processing operations Share expertise and provide guidance/mentorship to support the growth and development of talented junior team members Knowledge & Skills
Excellent verbal, written, and interpersonal communication skills are required. Must be able to write clear, concise, and error-free documents. Expert knowledge of FDA and cGMP standards and sterile processing. Required Education & Experience
A Bachelor’s Degree in chemical engineering or a related scientific field and a minimum of ten (10) years of relevant industry experience A Master’s Degree and a minimum of eight (8) years of relevant industry experience A Ph.D. Degree and a minimum of two (2) years of relevant industry experience People Leader Accountabilities
Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams. Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose. Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem. Compensation & Benefits
Salary range for this position is $182,070.00 – $235,620.00. The company considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. This position may be eligible for discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans. Equal Opportunity & How to Apply
Gilead is an equal employment opportunity employer. For current employees and contractors, please apply via the Internal Career Opportunities portal in Workday. If you require accommodation in the job application process, contact ApplicantAccommodations@gilead.com.
#J-18808-Ljbffr
Associate Director, Process Technologies and Development at Gilead Sciences, Inc. Gilead is a research-based biopharmaceutical company focused on delivering life-saving therapies and addressing unmet medical needs. The role involves leading development of processes for small molecule and large molecule (biologics) parenterals, interfacing between formulation scientists and manufacturing operations, and contributing to a cross-functional team with independent critical thinking and scientific curiosity. Specific Job Responsibilities
Apply fundamental engineering principles to the design, development, scale-up, and validation of processes for sterile drug product unit operations (e.g., refrigerated/frozen storage and handling of bulk solutions, dissolution of APIs, pooling and mixing, sterile filtration, filling, pre-filled syringe processing, lyophilization, and vial capping) for both small molecule and large molecule parenterals Support extremely complex technical problems related to sterile processing engineering that advance Gilead portfolio priorities Execute studies and author reports related to container closure system compatibility and manufacturing process development Play a key role in the establishment of a state-of-the-art sterile process engineering lab Evaluate new/novel technologies relevant to parenteral drug product manufacturing Represent sterile processing engineering in cross-functional project teams Author regulatory filings (IND, NDA, BLA) to support global regulatory submissions Serve as a subject matter expert for development and commercial sterile processing operations Share expertise and provide guidance/mentorship to support the growth and development of talented junior team members Knowledge & Skills
Excellent verbal, written, and interpersonal communication skills are required. Must be able to write clear, concise, and error-free documents. Expert knowledge of FDA and cGMP standards and sterile processing. Required Education & Experience
A Bachelor’s Degree in chemical engineering or a related scientific field and a minimum of ten (10) years of relevant industry experience A Master’s Degree and a minimum of eight (8) years of relevant industry experience A Ph.D. Degree and a minimum of two (2) years of relevant industry experience People Leader Accountabilities
Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams. Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose. Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem. Compensation & Benefits
Salary range for this position is $182,070.00 – $235,620.00. The company considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. This position may be eligible for discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans. Equal Opportunity & How to Apply
Gilead is an equal employment opportunity employer. For current employees and contractors, please apply via the Internal Career Opportunities portal in Workday. If you require accommodation in the job application process, contact ApplicantAccommodations@gilead.com.
#J-18808-Ljbffr