Associate Director, Upstream Technical Services - Biologics Technical Manufacturing & Operations

Location
Foster City, CA
Posted
Aug 28, 2020
Required Education
Bachelors Degree
Position Type
Full time

Associate Director, Upstream Technical Services - Biologics Technical Manufacturing & Operations

 

Associate Director, Upstream Technical Services - Biologics Technical Manufacturing & Operations

 

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.

 

Job Description

 

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.

 

Gilead has an opportunity for an experienced Associate Director of Upstream Technical Services at our Oceanside biologics facility in Southern California. We are seeking motivated, team-oriented individuals with expertise in internal and external technical transfer of recombinant proteins. Reporting to the Director of Upstream Technical Operations, you will have the opportunity to lead Upstream technical transfers, identify process gaps and facility fit issues and help to ensure the success of clinical and commercial manufacturing campaigns.

 

Specific responsibilities and skills for position:

 

• Lead aspects of Gilead's Biologics Upstream Technical Operations to ensure timely and successful technology transfer of upstream manufacturing processes, both internally and to external contract manufacturing organizations (CMOs)

 

• Responsible for defining, planning and implementing activities on one or more complex projects related to scale-up, technology transfer, facility fit and/or process validation between sites to ensure production schedules are met.

 

• Significant experience with Upstream bioprocessing equipment and operations from thaw through harvest. In-depth understanding of cell culture scale-up, engineering principles, and associated equipment - i.e. growth rates, specific consumption/production rates, bioreactor design and geometry, power calculations, gas flow/velocities, shear stress

 

• Lead technical investigations of process deviations and assess their potential impact on product quality as well as leading discussions and influencing stakeholder acceptance of critical process and quality-based decisions.

 

• Ensure that appropriate process data are recorded and analyzed to monitor run-to-run consistency for Upstream operations across internal and CMO production campaigns

 

• Present and document Cell Culture Manufacturing Technology Transfer status/updates and monitoring/trending of historical process performance, and tech transfer/campaign summary reports

 

• In-depth understanding of cGMP requirements for commercial manufacturing, experience with assisting in the generation of relevant regulatory sections of BLA and MAA filings, data capture and management, process monitoring and trending, including control charting and statistical process control, and supporting regulatory and site inspections.

 

• Lead upstream manufacturing technical training internally and at CMO facilities to support process transfer, scale-up, and commercialization.

 

• Lead the investigation and identify process gaps and facility fit issues, implement remediation plans, and generate solutions to ensure successful scale-up and process fit into Oceanside manufacturing and CMO plants

 

• Responsible and accountable for monitoring process performance/process history and assessing process deviations both internally and at CMO sites

 

• Travel routinely to CMOs for meetings focused on upstream technology transfer and person-in-plant support during manufacturing campaigns

 

• Partner with Gilead Biologics Process Development, Quality and Operations teams, and provide routine Technology Transfer progress updates to internal and external technical teams.

 

• Collaborate with Gilead's Biologics Outsourcing group to ensure timelines, deliverables, and business operations are aligned and met. Ensures adherence to budgets, schedules, and performance requirements.

 

• Support regulatory inspections and routine site audits as a process-specific Subject Matter Expert

 

• Comply with safety and environmental rules and regulations applicable to the operations.

 

• Submit environmental, safety, and property damage near miss and incident reports and participate in investigations and corrective action identification.

 

Essential Duties and Job Functions:

 

• May be accountable for both personnel and task management.

 

• Demonstrates a commitment to compliance and a thorough knowledge of current Good Manufacturing Practices (cGMPs)

 

• Works on non-routine to complex problems, projects and assignments where analysis of data, procedures or operations requires evaluation of multiple factors before taking action

 

Specific Education & Experience Requirements:

 

• 10+ years of relevant experience in the pharmaceutical industry and a BS or BA.

 

• 8+ years of relevant experience and a MS.

 

• 7+ years of relevant experience and a PhD in a relevant scientific discipline.

 

• Has extensive experience in biotech or pharmaceuticals industry.

 

Knowledge:

 

• Demonstrates in-depth knowledge of industry best practice and trends

 

• Demonstrates in-depth knowledge of current Good Manufacturing Practices (GMPs).

 

• Demonstrates excellent verbal, technical writing, and interpersonal communication skills.

 

• Has proven analytical and conceptual skills.

 

• Demonstrates ability to effectively manage multiple projects/priorities.

 

• Demonstrates ability to understand key business processes and business areas

 

• Demonstrates the ability to work effectively in cross-functional teams

 

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 mailto: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

 

https://www.dol.gov/sites/dolgov/files/WHD/legacy/files/eppac.pdf

 

YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

 

https://www.dol.gov/sites/dolgov/files/WHD/legacy/files/fmlaen.pdf

 

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

 

https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

 

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.

 

To apply, visit: https://apptrkr.com/1990629

 

To apply, visit https://apptrkr.com/1990629

 

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