Senior Engineer I (Parenteral Container Closure Systems)
United States - California - Foster City
Gilead Sciences, Inc. is a research-based bio-pharmaceutical 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.Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
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to apply for this job.Job DescriptionSenior Engineer I (Parenteral Container Closure Systems)
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 focus on the development of parenteral container closure systems (e.g., vials, elastomeric stoppers, pre-filled syringes), support clinical manufacturing operations for parenteral products, and serve as subject matter expert for commercial parenteral products. We are seeking a motivated, detail oriented individual able to contribute in a cross-functional team setting.Specific Job Responsibilities
Knowledge & Skills:
- Drive selection of parenteral container closure systems for intravenous, injectable, and inhalation development programs.
- Assess compatibility of parenteral CCS with formulations in development.
- Develop and execute technical evaluation plans, conduct experiments on-site, and supervise experiments performed at contract sites.
- Lead extractables and leachables study teams for parenteral products.
- Assist with secondary package development for parenteral products.
- Contribute to regulatory content pertinent to parenteral primary packaging.
- Direct the technology transfer of product manufacturing processes to clinical and commercial manufacturing sites.
- Support investigations and change management activities related to commercial parenteral container closure systems as necessary.
- Effectively communicate ideas, project goals, and results to team members across functions and departments.
- Qualified candidates should be self-motivated and organized, knowledgeable of relevant scientific literature, passionate about scientific inquiry and investigation, proactive in identifying and addressing potential challenges, and collaborative in driving solutions.
Required Education & Experience
- Strong verbal, written, and interpersonal communication skills are required.
- Must be able to write clear, concise, and error-free documents.
- Must be able to exercise judgment within well-defined and established procedures and policies in order to determine and take appropriate action.
- A Bachelor's Degree in chemical engineering, bioengineering, material science, or a related scientific field and a minimum of seven (7) years of relevant industry OR a Master's Degree in in chemical engineering, bioengineering, material science, or a related scientific field and a minimum of five (5) years of relevant industry
- Experience with parenteral pharmaceutical container closure systems.
- Experience with the development and commercialization of parenteral pharmaceutical products.
- Working knowledge of FDA and cGMP standards for parenteral container closure systems.
- Experience working with pharmaceutical contract manufacturing organizations (CMOs) and component suppliers.
- Experience working in cross-functional teams.
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: https://gilead.yello.co/external/form/24a8oU4jF5UL3CKq7lO_CgAbout 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.
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