Sr Manufacturing Tech

Gilead Sciences Inc.; Oceanside, Escondido (CA, CA); On-site; USD 93,000 - 120,000; Full time

Job summary

Kite Pharma, Oceanside, CA, is hiring for a manufacturing role on the floor collaborating with MSAT, Facilities, Engineering and Quality to ensure safe, compliant production of viral vector products. You will follow cgMP practices, maintain batch records, and drive continuous improvement in a fast-paced environment.

The ideal candidate has 2+ years with a relevant degree, strong communication and problem-solving skills, and willingness to work off-shift.

Qualifications

• Master’s Degree and at least 2 years of experience in manufacturing, engineering in a biotech/pharma industry
• Bachelor’s Degree and at least 4 years of experience in manufacturing, engineering in a biotech/pharma industry
• Associate’s Degree and at least 5 years of experience in manufacturing, engineering in a biotech/pharma industry
• High School Degree and at least 6 years’ experience in manufacturing, engineering in a biotech/pharma industry

Responsibilities

• Lead and execute manufacturing processes on the floor with MSAT, F&E and Quality teams
• Follow batch records, SOPs and cGMP to ensure safety and compliance
• Ensure right-the-first-time performance for process steps and drive safety culture
• Manage MES and EBS inventory transactions and weighing of raw materials
• Troubleshoot and manage moderate issues in buffer prep, purification and filling
• Develop SOPs, MPRs and CAPAs as needed
• Mentor junior staff and support cross-functional meetings
• Lead shift notes and operational tier huddles

Skills

Communication

Collaboration

Team-based work

Flexibility

Education

Master’s degree

Bachelor’s degree

Associate’s degree

High School diploma

Tools

MES

EBS

Single-use systems

Automation platforms

Electronic batch records

Job description

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

Job Description

Key Responsibilities

• 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 buffer preparation, 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.
• 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 at least 2 years of experience in manufacturing, engineering in a biotech/pharma industry OR
• Bachelor’s Degree and at least 4 years of experience in manufacturing, engineering in a biotech/pharma industry OR
• Associate’s Degree and at least 5 years of experience in manufacturing, engineering in a biotech/pharma industry OR
• High School Degree and at least 6 years’ experience in manufacturing, engineering in a biotech/pharma industry

Preferred Qualifications

• At least 6 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 Downstream and filling operations.
• Knowledge and experience with single use systems including chromatography, UFDF, and single use mixers.
• 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: $92,820.00 - $120,120.00. 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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Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex , 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 [e-mail] for assistance.

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Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

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.

Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.