Manager, Process Engineering
Manager, Process Engineering
United States - New Jersey - Morris Plains
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. Gileads 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 companys five core values. Thats 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.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
Manager, Process Engineering
This position requires a strong scientific and engineering approach, established expertise in upstream and/or downstream processes, process engineering, process and equipment validation, and technology transfer experience. This position will also require establishing mutual respect, trust, and close collaborations with internal and external organizations, and the ability to interact effectively at all levels.
- Develop and then oversee and manage the process engineering team, including staffing, capabilities, workflow processes, standards, and systems are in place.
- Establish a team-based work environment that shares best practices, standards and lessons learned.
- Institute and deploy a system owner program in which the process engineering department supports the day-to-day production activities and primary responsibilities. The number one objective is to ensure the plant stays up (available) at the maximum level at all times. This includes if necessary 24/7 troubleshooting, root cause analysis, process monitoring, single point lessons, and coordinating/overseeing external resources
- Organize the work based on systems and equipment. Ensure documentation is updated, drawings are updated, and performance feedback is visible and used in making operational decisions.
- Develop and lead an Improve Plant program which includes unbiased assessment and evaluation of problems (opportunities) for business case, risks and importance. Lead the Improve Plant Committee to make informed decisions about which problems to pursue and how to assign resources.
- Lead the development of solutions and options of priority projects using sound operational, scientific, and engineering judgement to seek process robustness and reduced Cost of Goods Manufactured. Successfully transfer the chosen solutions into the next phase of execution.
- As requested, lead nsure scale-up and technology transfer of biologic products or process changes across all areas of Manufacturing.
- Manage equipment/unit operation ownership, deploying existing Process Engineer skillsets across the process to ensure cross-training and ability to support continuous production operations.
- Coach and develop Process Engineers and seek after and provide meaningful opportunities to develop their careers.
- Support regulatory interactions and contribute to content of regulatory documents as needed.
- Collaborates effectively with Manufacturing, Quality Control, Quality Assurance, Supply Chain and Regulatory Affairs.
- Lead or participate in capital projects and CMC development teams, as required.
- Take leadership role in promoting technology development and continuous improvement to streamline biologics development within Gilead.
- Serves as an area representative for CCRB, Deviation Triage, Quality Review Board, and other oversight teams as deemed by Management
Knowledge & Skills
- Excellent management skills - hiring, recruiting, training, performance management, planning, prioritization, objective setting, meeting management and plan execution.
- Demonstrated decision-making and problem-solving capability.
- Excellent written and verbal communication skills.
- Demonstrated ability to organize, structure and staff the organization in a rapidly changing environment.
Education & Experience
- A Bachelor's Degree in Science or Engineering, preferably Biochemical, Biologics, or Chemical engineering or other related technical field and a minimum of seven (7) years of experience.
- Operations or engineering experience in the biologics industry.
- Knowledge of biologics engineering principles for upstream and downstream unit operations, including CIP and SIP.
- Previous team leadership experience.
- Experience with data collection and analysis tools including Excel, Minitab or Tableau/DOMO
- Ability to read, understand and mark up engineering drawings.
- Knowledge of industry standards including ASME BPE and ISPE Baseline Guides.
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_Cg
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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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 firstname.lastname@example.org for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
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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:
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