Manager, Manufacturing

Manager, Manufacturing
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

Overview: Responsible for the operation of manufacturing support, which includes equipment and facilities cleaning and sanitization, as well as media/supplement/buffer preparation in compliance with cGMP regulations. Responsibilities: Oversees a multi-shift, 7-day operation of manufacturing support personnel to ensure equipment and facilities are cleaned and sanitized and that assigned areas are in order and ready for manufacturing. This requires strong leadership and management to establish a zero overdue, zero accident and compliant operation.
Oversees all facets of media/supplement/buffer preparation including safety, quality, compliance, delivery and costs. The Senior Manager/Manager is accountable for all maintenance and execution of batch records, documentation of activities and on-time delivery to manufacturing.
Works closely with the area managers that are services by this department (upstream, downstream, quality control, etc) to understand and be able to deliver on needs, schedules, and required services and to troubleshoot and solve problems for the success of the entire Manufacturing function.
Adapt to changing needs through all hours of the day and weekend to resolve conflicts and maintain manufacturing continuity when unexpected situations arise.
Develops key performance indicators and daily cadence of operations using a Tier board / visual management approach.
Ensures SOPs and operating records are completed accurately and in a timely manner to minimize deviating from established standards such as dirty hold time.
Stock all manufacturing areas with necessary consumables and supplies such as garments.
Properly dispose of process waste and collect and remove all solid waste from the manufacturing areas.
Minimize equipment downtime; establish a close relationship with the maintenance team.
Utilize resources to the maximum benefit of the manufacturing operations and minimize risks. Evaluate when to apply the team to clean and otherwise support areas that are not normally part of standard work.
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 in assigned area. Submits and follows up on all maintenance and calibration requests.
Represent (or delegate) manufacturing support operations on projects related to this area and seeks to continuously improve efficiency and compliance.
Responsible for assigned quality items related to manufacturing support including investigations, deviations, CAPAs and change controls. Makes delegation assignments and ensures on-time completion of actions. Provide coaching and support to other areas in the department.
Maintain orderly storage locations for materials; maintain proper inventory levels for items not being managed by supply chain.
Maintains proper inventories of components, raw materials, and consumables with the supply chain and works with their schedule to ensure stock levels are maintained.
Manages and supervises the daily monitoring of process and all employees and contractors.
Manage outside contractors and service providers as assigned to ensure the facility is receiving the maximum benefit for the proper expense.
Responsible for the area/rooms where manufacturing support operations are performed and ensuring the area is maintained in order, properly cleaned and released properly. Upon request or as the business needs require it, may represent the interests of the other departments during startup and shutdown activities.
Responsible for all cGMP activities in the area/rooms (e.g., logbooks, records, etc)
Maintains assigned manufacturing records and documentation. Revises SOPs as necessary.
Supports other manufacturing areas with internal audits and walkthroughs as well as coaching and training as needed or requested.
Ensures equipment is properly cleaned, stored and within validated state.
Develop a training program for the area and then oversee the training of operators in order to reduce human error deviations.
Identify and resolve any safety behaviors or situations. Be a model employee for safety and engage on the shop floor.
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.
Carries out direct supervisory responsibilities in accordance with the department-set goals. Responsibilities include interviewing potential employees; employee training and development; planning, assigning, and directing work; appraising performance; rewarding and disciplining; corrective action and complaint resolution. Coaching is a major factor in the success of this role.
It is each employee's responsibility to perform their work properly and ensure a product or service meets the current Good Manufacturing Practice (cGMP) requirements for Safety, Identity, Strength, Purity, and Quality. It is each employee's responsibility to immediately report observations regarding anything that deviates from established standards to their supervisor and to the Quality function. Qualifiacations:Bachelor's degree in engineering or biology/chemistry or related scientific discipline with at least 8+ years of related work and leadership experience in the cGMP industry; or equivalent combination of education and experience.
Hands on experience with biologics or pharmaceutical operations preferred specifically working with autoclaves, glasswashers, mixers, vessel, and related systems including facility and equipment cleaning and sanitization.
Experience leading a team is required.
Must possess strong communication (oral and written), organizational, and interpersonal skills.
Ability to work well within a team environment and persevere in changing conditions.
Ability to document clearly and accurately as per Good Documentation Practices and also review documentation against GDPs.
Be proficient with Microsoft Office, industry-standard software systems and other means of electronic communications.
Able to lead a workforce with a wide range of skills and capabilities and train new manufacturing specialists as per established SOPs.
Mentor and lead by example.
Have an aptitude for troubleshooting and continuous improvement.
Familiarity working in a bioburden controlled manufacturing setting.
Strong knowledge of applicable cGMP regulations and practices.
Be proactive in identifying, communicating and escalating issues.
Ability to forecast and plan for daily manufacturing activities.
An aptitude for process troubleshooting and mechanical knowledge of equipment.
Ability to solve complex operational problems with cross-functional team involvement
Must be proficient with MS Office.
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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To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---New-Jersey---Morris-Plains/Manager--Manufacturing_2021-1776-1

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