Manufacturing Tech IV- Downstream
Manufacturing Tech IV- Downstream
United States - California - Oceanside
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
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.
The Manufacturing Tech IV is responsible for day to day planning and execution of all Downstream production operations as well as all related equipment and systems necessary to clean, configure, sanitize/sterilize and maintain equipment in a dynamic and fast-paced team environment. Safety and Compliance are the two primary objectives of manufacturing operations and this position works in conjunction with other manufacturing technicians under the guidance of a Team Lead. Your ability to work independently and in teams, be proactive and self-managing, as well as have a detailed and organized approach are key components to success in this role.
Specific responsibilities and skills for the position include:
- Oversight, planning, training and execution of all operations associated with: Protein Purification by means of column chromatography, Viral Filtration, UFDF, and Buffer Preparation and Clean in Place (CIP) and Steam in Place (SIP) of fixed tanks/vessels and portable equipment and Clean out of Place (COP) of miscellaneous parts and equipment
- Proficiency and routine maintenance of analytical equipment including but not limited to: pH/conductivity meters, filter integrity testers, peristaltic pumps etc.
- Operation and practical knowledge of glasswashers, autoclaves, filters, pumps and analytical equipment to support and monitor the process is required.
- Planning, execution and oversight of safe, compliant and efficient operation of area processes, Good Documentation Practices (GDPs), timely and effective written and oral communication of deviations, incidents, and/or safety concerns, and all relevant housekeeping duties to ensure the work areas are kept to a high level of cleanliness and inspection readiness.
- Acts as a departmental representative / SME (Subject Matter Expert) on cross-functional teams including Process Development, Quality Assurance and Control, Calibration, Maintenance, Validation, Supply Chain, and CMC/Regulatory teams is.
- Follows established Standard Operating Procedures (SOPs), Master Batch Records (MBR's) and cGMPs (current Good Manufacturing Practices)
- Perform troubleshooting as necessary and takes initiative in resolving issues
- Sets up and operates equipment in a classed clean room environment and completes all required paperwork using GDPs in a timely and accurate manner
- Interacts with scientists, engineers, and production staff
- May train junior staff in assigned area, and ensure that work is performed in accordance with quality standards and SOPs
- May support deviation investigations, corrective action implementation and change management initiation
Knowledge, Experience, and Skills:
- HS diploma and minimum 5 years of relevant industry experience, or a Bachelor's degree in engineering or scientific discipline and minimum 3 years of industry experience.
- Previous biotechnology experience supporting Purification manufacturing of monoclonal antibodies in a clinical or commercial environment is required.
- Knowledge of Current Good Manufacturing Practices (cGMPs) is required
- Experience with DeltaV Automation Systems and Unicorn System Control required.
- Aseptic Processing experience required.
- In-depth knowledge of quality systems, validation principles, regulatory/ICH guidelines and multi-product controls required.
- Prior experience initiating, owning and closing out deviations, change control, CAPA's and safety improvement projects required.
- Background or understanding of Lean concepts (Kaizen, 5S, KanBan) is preferred
- Knowledge of Class A and Lean Principles is preferred
- Background in disposable technology and multi-product facility is preferred
- Consistent positive attitude and demonstrated ability to learn new skills is preferred
- Ability to lift equipment up to 25 lbs
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.avature.net/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.
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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 email@example.com 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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