- 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
- 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.
- 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.
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Senior Engineer III, Sterile Process Engineering - Foster, CA, United States - Taleo BE
Description
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.
Job Description
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
Qualified candidates will be part of the sterile process engineering group, acting as an interface between formulation scientists and manufacturing operations. The individual will lead the development of processes for both small molecule and large molecule (biologics) parenterals. We are seeking a creative, highly motivated, detail oriented individual to contribute in a cross-functional team setting. The candidate must demonstrate independent critical thinking, have scientific curiosity, be open minded and have an appetite for learning.
Location: Foster City, CA
Specific Job Responsibilities
Knowledge & Skills:
Required Education & Experience
OR
OR
If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community:
About Gilead
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions. The salary range for this position is: $172, $223, Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a 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*.For additional benefits information, visit:
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order 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 who require accommodation in the job application process may contact for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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