Manufacturing Supervisor (Downstream)
Manufacturing Supervisor (Downstream)
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
- Responsible for downstream manufacturing (purification) in compliance with cGMPs and SOPs and supervises a team of Manufacturing Specialists.
- Supervises the shift operation of downstream manufacturing to purify the MAB (Immu-132) and package for shipment for processing into final product.
- Ensures all Manufacturing Specialists under their supervision are fully trained both in cGMPs and their technical responsibilities
- Confirms inventory of raw materials and supplies needed in manufacturing are staged per the schedule.
- Purifies Immu-132 using ion-exchange and affinity column chromatography and virus removal filtration.
- Ensures batch records are completed accurately and in a timely fashion.
- Makes sure required samples are collected and delivered to QC for testing.
- Works with other departments such as Quality Assurance and Compliance, Quality Control, Regulatory Affairs, Process Development, and Cell Culture Production to make the manufacturing process more compliant and more efficient.
- Initiates deviations and conducts investigations as required.
- Maintains and reviews log books for accuracy.
- Writes and revises batch records, buffer sheets, SOPs, and MSSs as needed.
- Confirms that daily and periodic maintenance and calibration of all equipment needed during production is complete.
- Monitors schedule and assures adequate supply of buffers and production aids for manufacturing.
- Carries out direct supervisory responsibilities in accordance with the department-set goals.
Knowledge & Skills
- Must possess excellent communication (oral and written), organizational, and interpersonal skills, with the ability to perform in a team environment.
- Detail oriented with strong bioburden control techniques and understanding.
- The ability to lead technical people and follow SOPs.
- Must be proficient with MS Office applications.
- Familiarity with cGMP regulations and practices.
- Must possess strong leadership skills.
Education & Experience
- A Bachelor's Degree in Biology, Chemistry, or related field, with a minimum of six (6) years of related experience.
- Familiarity working in a bioburden-controlled setting.
- Direct supervisory experience.
- Hands-on experience with protein purification.
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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