Associate Director, Manufacturing Engineering
Associate Director (Manufacturing Engineering)
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.
- Manages project budgets and organizes resources according to team priorities and customer needs. Contributes to the development of new concepts, techniques, and standards.
- Ensures solutions are consistent with organization objectives.
- Provides leadership and direction to engineers and contractors.
- Provides expert project management skills and experience.
- Manages programs and processes to ensure high quality of operations, equipment maintenance, and compliance with codes, Current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs)
- Interacts with contractors and/or vendors on routine machinery and equipment administration matters.
- May hire, train, evaluate, and review personnel.
- Performance and task management may be required
- Ensures GMP training of all employees.
- Manages department operational areas.
- Manage larger scale engineering projects
- Manages multiple projects of significant complexity and risk. Manages machinery and equipment maintenance and operations functions.
- Evaluates design processes to modify machinery and equipment; approves estimated cost and designs layouts.
- Ensures that team personnel are trained and developed to meet changing company needs.
- Assists in programs and processes to ensure high quality of manufacturing operations,
equipment, instrumentation, facility layout and compliance with of relevant
engineering codes, Current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices
- Doesn't mind rolling up the sleeves (boots on the floor to get things done together with the vendors/Gilead team).
Knowledge & Skills:
- Demonstrates extensive understanding and application of process engineering principles, concepts, and practices, and standards.
- Demonstrates proficiency in current Good Manufacturing Practices (GMPs) and safety regulations.
- Demonstrates excellent verbal, written, and interpersonal communication skills.
- Proficient in Microsoft Office applications.
- Demonstrates expertise in project management
- Understands the compliance expectation for aseptic operation and design principals for aseptic processing equipment
- Demonstrated ability and desire for personnel management
- Responsible for managing the standards, methods and procedures for the design, modifications, and maintenance of manufacturing equipment, facilities and processes.
- Manages external vendor relationships and negotiates contracts.
- Manages budget for engineering related projects and activities.
- Works on moderately complex problems where analysis of situations or
data requires an in-depth evaluation of various factors.
- Exercises judgment within generally defined practices and policies in selecting methods, techniques and evaluation criteria for
- Contributes to the development of new concepts, techniques, and standards.
- Must be able to develop solutions to a range of moderately complex problems, which require the regular use of ingenuity an innovation
- Excellent verbal and written communication skills and interpersonal skills are
required, both within the Engineering group and across functional areas.
Education & Experience:
- A minimum of (10) years of relevant experience and a BS or BA or related fields, OR a minimum of (8) years of relevant experience and a MS, MA or MBA.
- Previous experience in pharmaceuticals industry.
- Previous experience in packaging, isolator technology, and aseptic operation equipment (e.g. filler, isolator, lyophilizer, autoclave, and partswashers).
- Previous experience in managing design/build (e.g. architecture/engineering design) and construction team.
- Previous experience in managing engineering capital projects from design/build to installation/startup.
- Experience in managing junior engineers (contractors or FTEs).
- Automation Experience as it relates to automated equipment.
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
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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