Manufacturing Supervisor (Buffer and Media Preparation)

Location
Morris Plains, NJ, United States
Posted
Jun 24, 2021
Ref
2277810
Required Education
Bachelors Degree
Position Type
Full time
Manufacturing Supervisor (Buffer and Media Preparation)
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. 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.

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

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Manufacturing Supervisor (Buffer and Media Preparation)

Manufacturing Team Lead

This role will be responsible for the daily and routine operation of the buffer and media preparation activities in support of Upstream and Downstream production processes in compliance with cGMP regulations.

Specific Responsibilities
  • Responsible for providing support to manufacturing to maintain the production environment Oversees the entire operation of the buffer and media preparation activities. This requires strong leadership and management to establish a zero overdue, zero accident and compliant operation.
  • Works in counsel with the Upstream and Downstream teams to share and cross-train resources, to schedule and coordinate work cell activities and to troubleshoot and solve problems for the success of the manufacturing operations.
  • Proactively resolve conflicts between areas and departments to ensure Buffer and Media Prep can consistently deliver the right quality, at the right volume, and at the right time.
  • Develops key performance indicators and daily cadence of operations.
  • Oversees employee and contractor hiring and onboarding training for the area.
  • Responsible for employee assignments and establishes the optimum shift schedule based on business and manufacturing needs.
  • Manages all mechanical equipment and systems used to prepare supplements and media preparation. Submits and follows up on all maintenance and calibration requests.
  • Maintains proper inventories of components with the supply chain and works within their schedule to ensure single-use assemblies and other consumables are always in stock.
  • Manages and supervises the daily monitoring of process and all employees and contractors including GEMBA walks and self-inspections.
  • Responsible for all quality items related to the Buffer and Media Prep including investigations, deviations, CAPAs and change controls. Makes assignments and ensures on-time completion of actions. Provide coaching and support to other areas in the department.
  • Responsible for the area/room where buffers and media are prepared (e.g., Room C212 in the Seed Lab) ensuring the area is maintained in order, properly cleaned and released properly. Upon request, may represent the interests of the entire Seed Lab area during startup and shutdown activities.
  • Responsible for all cGMP activities in the area where buffer and media are prepared (e.g., logbooks).
  • Maintains assigned production batch records and standard operating procedures (SOPs) and documentation for the department. Reviews documented GMP work performed by others.
  • Supports the large-scale cell culture activities with internal audits and walkthroughs as well as coaching and training as needed or requested.
  • Supervises cleaning and storage of equipment.
  • Develop a training program for the area and then oversees the training of operators to use supplement and media prep systems and other supporting equipment in accordance with personnel training procedure and related SOPs.
  • Identify and resolve any safety behaviors or situations. Be a model employee for safety.
  • Minimal work on weekends and/or holidays may be required.
  • Carries out direct supervisory responsibilities in accordance with the department-set goals.
  • Leads assigned projects (large or small) for manufacturing such as establishing an internal buffer preparation capability.
  • Other projects as assigned by manager.


Knowledge & Skills
  • Knowledge of solids handling, dispensing/weighing, mixing, pumping and liquid filtration processes.
  • Knowledge of aseptic processing and facility cleanliness and housekeeping.
  • Skilled at writing GMP work instructions and reviewing work performed to identify errors.
  • Ability to coordinate work activities and timelines across multiple departments with competing priorities.
  • Skilled at proactive communication (oral and written).
  • Ability to troubleshoot processing issues, escalate those issues and develop solutions.
  • Skilled using MS Office and electronic communications tools.


Education & Experience
  • A Bachelor's Degree in Chemistry, Biology, Engineering or related scientific discipline with a minimum of six (6) years of related experience in the cGMP industry, OR a High School Diploma and a minimum of eight (8) years of related work experience in the cGMP industry.
  • Experience preparing buffers and/or media solutions in clinical or commercial GMP manufacturing -or- leading a department that does this. Similar experience in non-GMP industry (weighing, dispensing, mixing, etc.) may be considered.
  • Experience i writing GMP documentation such as batch records and SOPs as well as conducting investigations for deviations, and writing/executing CAPAs and Change Controls.


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

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.
For jobs in the United States:
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 careers@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

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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