Job Description

Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description



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.nOversees 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.nWorks 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.nAdapt to changing needs through all hours of the day and weekend to resolve conflicts and maintain manufacturing continuity when unexpected situations arise.nDevelops key performance indicators and daily cadence of operations using a Tier board / visual management approach.nEnsures SOPs and operating records are completed accurately and in a timely manner to minimize deviating from established standards such as dirty hold time.nStock all manufacturing areas with necessary consumables and supplies such as garments.nProperly dispose of process waste and collect and remove all solid waste from the manufacturing areas.nMinimize equipment downtime; establish a close relationship with the maintenance team.nUtilize 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.nOversees employee and contractor hiring and onboarding training for the area.nResponsible for employee assignments and establishes the optimum shift schedule based on business and manufacturing needs.nManages all mechanical equipment and systems in assigned area. Submits and follows up on all maintenance and calibration requests.nRepresent (or delegate) manufacturing support operations on projects related to this area and seeks to continuously improve efficiency and compliance.nResponsible 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.nMaintain orderly storage locations for materials; maintain proper inventory levels for items not being managed by supply chain.nMaintains proper inventories of components, raw materials, and consumables with the supply chain and works with their schedule to ensure stock levels are maintained.nManages and supervises the daily monitoring of process and all employees and contractors.nManage outside contractors and service providers as assigned to ensure the facility is receiving the maximum benefit for the proper expense.nResponsible 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.nResponsible for all cGMP activities in the area/rooms (e.g., logbooks, records, etc)nMaintains assigned manufacturing records and documentation. Revises SOPs as necessary.nSupports other manufacturing areas with internal audits and walkthroughs as well as coaching and training as needed or requested.nEnsures equipment is properly cleaned, stored and within validated state.nDevelop a training program for the area and then oversee the training of operators in order to reduce human error deviations.nIdentify and resolve any safety behaviors or situations. Be a model employee for safety and engage on the shop floor.nMinimal work on weekends and/or holidays may be required. nCarries out direct supervisory responsibilities in accordance with the department-set goals.nLeads assigned projects (large or small) for manufacturing.nCarries 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.nIt is each employees 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 employees responsibility to immediately report observations regarding anything that deviates from established standards to their supervisor and to the Quality function. Qualifiacations:Bachelors 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.nHands 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.nExperience leading a team is required.nMust possess strong communication (oral and written), organizational, and interpersonal skills.nAbility to work well within a team environment and persevere in changing conditions.nAbility to document clearly and accurately as per Good Documentation Practices and also review documentation against GDPs.nBe proficient with Microsoft Office, industry-standard software systems and other means of electronic communications.nAble to lead a workforce with a wide range of skills and capabilities and train new manufacturing specialists as per established SOPs.nMentor and lead by example.nHave an aptitude for troubleshooting and continuous improvement.nFamiliarity working in a bioburden controlled manufacturing setting.nStrong knowledge of applicable cGMP regulations and practices.nBe proactive in identifying, communicating and escalating issues.nAbility to forecast and plan for daily manufacturing activities.nAn aptitude for process troubleshooting and mechanical knowledge of equipment.nAbility to solve complex operational problems with cross-functional team involvementnMust 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:

Please log onto your Internal Career Site to apply for this job.