Director, Technical Operations
Director, Technical Operations
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
Director, Technical Operations
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.
Specific Job Responsibilities
The Director, Technical Operations (TechOps) in the Process Development and Manufacturing (PDM) organization at the Morris Plains, New Jersey facility will have sole accountability for Upstream and Downstream TechOps. In this role you will be responsible for both upstream and downstream tech transfers, manufacturing support, and validation activities and for all internal drug substance manufacturing and drive process improvement related to tech transfer, operational support and technical oversight of manufacturing.
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 other support functions, and the ability to interact effectively at all levels.
Essential Duties and Job Functions:
- Leads the TechOps group responsible for both Upstream and Downstream technology transfer, manufacturing support, and validation activities for drug substance manufacturing at the Morris Plains, New Jersey site.
- Oversee and manage process engineering as well as process, equipment, and computer system qualification/validation for the site. Develop and deploy performance management processes including meeting structures and Key Performance Indicators (KPIs) for these functions.
- Responsible for continuous support to manufacturing including technical troubleshooting, root cause analysis, and shopfloor oversight and developing those capabilities within the team.
- Drives business process improvements related to tech transfer, operational support and technical oversight of manufacturing. Ensures clear roles and responsibilities for all related functions involved in these activities.
- Directs activities of the technical operations group including defining, planning and implementing projects related to scale-up, technology transfer, facility fit and/or process validation between sites
- Identify opportunities for improvement in the manufacturing operation - including process robustness and Cost of Goods optimization - and uses sound scientific, engineering and management judgement in prioritizing and execution.
- Participate on the site Continuous Improvement committee and co-develops the Improve Plant program to evaluate new opportunities with a risk-based and unbiased viewpoint.
- Partners with Manufacturing Science & Technology, Quality, Regulatory and other technical functions to ensure project timelines, deliverables, and business operations are aligned and met
- Supports regulatory inspections and authoring of relevant sections of IND, BLA and MAA filings
- Ensures compliance to safety, business policies, laws and regulations applicable to the operations
Knowledge & Skills
- Heavy bias for and experience with safety and especially process safety
- Strong knowledge of biologics unit operations, processing parameters, design levers, etc.
- Knowledge of ASME BPE
- Able to devise a departmental strategy and drive the execution of this strategy
- Knowledge of Situational Self Leadership and other leadership models
- Demonstrated decision-making skills and problem-solving capability.
- Excellent written and verbal communication skills.
- Demonstrated ability to organize, structure and staff the organization in a rapidly changing environment.
- Must understand CIP and SIP principles
- Motivational skills a plus
Required Education & Experience
- A Bachelor's Degree in Engineering with a minimum of twelve (12) years of experience.
- Experience in both stainless steel as well as single-use systems.
- Experience with mammalian and other cell culture-based systems.
- Experience working with common equipment, skids and vessel suppliers in the industry.
- Experience in any of the following is highly preferred: Capital projects, commissioning, validation, automation or utilities.
- Experience working in a GMP, commercial, biologics operation.
Preferred Education & Experience
- A Bachelor's Degree in Chemical Engineering is preferred.
- Alternative degrees considered including Biochemical Engineering, Biotechnology, Chemistry, Biochemistry.
- Lean Six Sigma certification.
- An MBA.
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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