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Gilead Sciences, Inc. Sr. Manufacturing Associate - Biotech in Oceanside, California

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

Job Description

Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a line between that purpose and our day-to-day work. Join us in our mission! We are seeking a highly effective Sr. Manufacturing Associate at our Oceanside, CA site.

Responsibilities (include but are not limited to):

  • Work as part of a team to execute and lead manufacturing processes on the floor in close collaboration Manufacturing Science and Technology (MSAT), Facilities and Engineering (F&E) and Quality departments.

  • Rigorously follow batch records, standard operating procedures (SOPs) and Current Good Manufacturing Practice (cGMP) regulations to ensure manufacturing operations are safe and compliant.

  • Ensure right-the-first-time performance of all process steps specific to the phase or stage of operation, as well as help drive the safety-first culture at Kite Oceanside.

  • Perform and manage electronic inventory transactions utilizing Manufacturing Execution Systems (MES) and Enterprise Business system (EBS) and weighing of raw materials and cycle count of raw materials.

  • Perform, troubleshoot and manage moderately complex issues during solution prep, cell culture, purification and filling unit operations for the manufacture of viral vector products in a cGMP environment.

  • Manage and implement tasks related to formulation of solutions along with filter integrity testing.

  • Maintain mammalian cell culture in flasks and bioreactors with metabolite and cell count experience.

  • Execution of downstream purification processes

  • Experience escalating floor issues for triage while communicating out status updates and follow ups.

  • Review and sign off in-process cGMP documentation for completeness, accuracy, and compliance.

  • Participate in and manage operational excellence initiatives such as 5S, Kaizen, lean manufacturing and continuous improvement.

  • Development of SOPs, Manufacturing Production Record (MPRs), and other process documents including minor deviations and Corrective Action and Preventive Action (CAPAs) as needed.

  • Act at a delegate for supervisor and managers during cross functional team meetings.

  • Manage and write shift notes for all unit operations.

  • Lead operational tier huddles as needed.

  • Manage and act as back-up qualified trainer for all unit operations.

  • Act as a mentor to junior staff with limited task management responsibility.

  • Excellent communication skills

  • Ability to collaborate across all levels

  • Ability to work effectively in an inclusive, cross-functional, team-based environment.

  • Able to work off shift hours and weekend.

  • Additional duties as assigned. These duties may be delegated to designated deputies of a satisfactory qualification level as needed.

Basic Qualifications:

  • Master’s Degree and 2+ years of experience in manufacturing, engineering in a biotech/pharma industry OR

  • Bachelor’s Degree and 4+ years of experience in manufacturing, engineering in a biotech/pharma industry OR

  • Associate’s Degree and 5+ years of experience in manufacturing, engineering in a biotech/pharma industry OR

  • High School Degree and 6+ years’ experience in manufacturing, engineering in a biotech/pharma industry

Preferred Qualifications:

  • 4+ years of experience with bachelor’s degree in biology or related scientific discipline, or equivalent combination of experience and education.

  • Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.

  • Prior experience with biopharmaceutical, cell or gene therapy manufacturing across Upstream, Downstream and filling operations is a plus.

  • Knowledge and experience with single use systems including chromatography, UFDF, and bioreactors.

  • Experience with automation platforms and electronic batch records.

  • Knowledge of the current Code of the Federal Regulations (CFR's) and Current Good Manufacturing Practices (cGMP's) a plus

  • Excellent skills in Microsoft Word, Excel and data analysis

  • Self-motivated and willing to accept temporary responsibilities outside of initial job description.

  • Excellent interpersonal, verbal and written communication skills

  • Willingness to think outside of the box as well as comfortable in an exciting and constantly evolving environment.

  • Ability to lift 40 lbs. repeatedly and stand for hours at time.

  • Able to work off shift hours and weekends, as well as provide the on-call support as required.

  • Ability to work effectively in an inclusive, cross-functional, team-based environment.

  • Able to work off shift hours and weekend, as well as provide on-call support as needed

The salary range for this position is: $90,695.00 - $117,370.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

  • Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com . Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma .

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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 ApplicantAccommodations@gilead.com for assistance.

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For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

Change The World With Us

Everyone at Kite is grounded by one common goal – curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work.

We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don’t take success for granted.

While we’ve come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.

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