Manufacturing Specialist, Cell Culture
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POST DATE 8/27/2016
END DATE 11/18/2016
Gilead Sciences, Inc
JOB DESCRIPTIONSPECIFIC RESPONSIBILITIES
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.
Specific Responsibilities and Skills:
Gilead Sciences is currently seeking candidates with strong cell culture manufacturing experience in the biopharmaceutical industry to join our rapidly-growing biologics site in Oceanside, CA.
Qualified candidates for this role will:
Employ and enforce Safety and Compliance at all times.
Execute operations of small- and large- scale bioreactors and centrifuges, and all related equipment / systems to configure, clean, sanitize/sterilize, and maintain equipment.
Work with Manufacturing Technicians under the guidance of a Manufacturing Manager.
Be available for shift and weekend work (Sun-Wed or Wed-Sat).
In-depth knowledge of COP/Glasswashers, autoclaves, filters, pumps, and analytical equipment, to support and monitor mammalian production processes.
Be responsible for planning, execution, and oversight of safe and efficient operation of area processes
Apply Good Documentation Practices, and communicate deviations/incidents/ safety concerns with urgency.
Perform all relevant housekeeping duties to ensure the work areas are kept to a high level of cleanliness and inspection readiness
Lead Batch Record review, approval, CAPA, and deviation and change control
Oversee and close all Out of Specification (OOS), Deviations, and CAPAs within the Mfg department.
In-depth knowledge of quality systems, validation principles, regulatory/ICH guidelines and multi-product controls in a commercial manufacturing environment.
Apply more complex research techniques and methodologies like Six Sigma and Kaizen to improve process/product quality.
Employ advanced statistical techniques to complete projects.
Perform non-routine and project-based tasks to aid in increasing efficiency, reliability, cost savings, and overall department/site improvements.
Departmental representation and the ability to work across functions and in teams, including with Process Development, Quality Assurance and Control, Calibration, Maintenance, Validation, Materials and Logistics and CMC/Regulatory teams.
Interfaces with contract manufacturers to address standard documentation and compliance issues.
Demonstrates the ability to think outside of the process and consider the impact decisions will have on other areas.
Oversight, scheduling, training and execution of all operations associated with:
Generation and proliferation of cell cultures including thaw, expansion and production
Shake flasks through 2750L bioreactor scale
Depth filtration and centrifugation
Clean in Place (CIP) and Steam in Place (SIP) of fixed tanks/vessels/portable equipment and Clean out of Place (COP)/Glasswash of miscellaneous parts/equipment
Proficiency and routine maintenance of analytical equipment including but not limited to: pH/conductivity meters, bioanalyzers, osmometers, benchtop centrifuges, cell counters and microscopes
In-depth understanding of DeltaV Automation Systems
ESSENTIAL DUTIES AND JOB FUNCTIONS
Investigates and reports on variance or deviations from standard procedures.
Plans, executes and tracks a variety of manufacturing projects both internally and in coordination with contract manufacturers.
Contributes to the development of department strategies for obtaining and outsourcing raw materials, intermediates and APIs.
Coordinates cross-functional efforts to resolve manufacturing issues in projects.
May participate in audits to include internal, vendors, contract manufacturers, or APIs.
Coordinates technical transfer efforts internally and with contract manufacturers or raw material suppliers.
May review and approve batch record and processing documentation, including planned or unplanned deviations.
Implements systems for tracking project progress.
KNOWLEDGE, EXPERIENCE AND SKILLS
6+ years of relevant experience and a BS or BA.
4+ years of relevant experience and a MS.
Prior experience in a cGMP related industry is required; within Biopharmaceutical or Pharmaceutical industry required
Proficient knowledge of Good Manufacturing Practices (GMPs)
Audit and Investigation Skills, Report Writing Skills.
Strong verbal, technical writing and interpersonal skills are required.
Proficiency in Microsoft Office applications.
Must possess a strong knowledge of the FDA/IMB and cGMP standards as well as regulatory guidance documents.
Demonstrated investigation and report writing skills.
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. 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, view the EEO is the Law poster at :