Sr. Device Engineer I (Primary Containers)

Location: Foster City, California US

Notice

This position is no longer open.

Job Number: 1878

External Description: Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.

Job Description
Sr. Device Engineer I (Primary Containers)

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 primary container systems incorporated into drug delivery devices (e.g., pre-filled syringes, auto-injectors). We are seeking a detail-oriented, technically strong driver with cross-functional project leadership experience.

Specific Job Responsibilities

  • Serve as material science subject matter expert for glass and polymer primary container systems, providing support for development and commercial activities.
  • Lead primary container development projects in support of drug delivery device development projects.
  • Participate in new formulation evaluation and optimization related to drug delivery primary container systems. Develop and execute technical evaluation plans, conducting experiments on-site and supervising experiments performed at contract sites.
  • Procure laboratory equipment and establish processes essential to evaluating primary container systems on-site.
  • Direct the technology transfer of product manufacturing processes to clinical and commercial manufacturing sites.
  • Author regulatory content pertinent to primary container systems.
  • Position may include managing one or more device engineers.


Knowledge & Skills
  • Able to write clear, concise, and error-free documents.
  • Able to exercise judgment within well-defined and established procedures and policies in order to determine and take appropriate action.
  • 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.
  • Able to effectively communicate ideas, project goals, and results to team members across functions and departments.


Required Education & Experience

  • A Bachelor's Degree in material science, chemical engineering, mechanical engineering, or a related scientific field and a minimum of seven (7) years of relevant industry experience with primary container systems / device development, OR a M.S. in material science, chemical engineering, mechanical engineering or a related scientific field and a minimum of five (5) years of relevant industry experience with primary container systems / device development.
  • Experience with development and commercialization of primary containers for parenteral and biologics formulations (e.g., vials, syringes, cartridges).
  • Experience with medical device design control and quality system regulations (QSRs).
  • Working knowledge of the FDA, cGMP, and GCP standards, as well as regulatory guidance documents such as PAPAC and Annex 13.
  • Strong verbal, written, and interpersonal communication skills.


Preferred Experience
  • Experience working with drug product/medical device contract manufacturing organizations (CMOs).
  • Experience in cross-functional team leadership.


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.avature.net/Gilead

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.


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For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Number: R0014469

Community / Marketing Title: Sr. Device Engineer I (Primary Containers)

Location_formattedLocationLong: Foster City, California US

 

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