Supervisor, Manufacturing (Back- End Swing Shift)

Kite Pharma; Frederick (MD); On-site; USD 107,000 - 139,000; Full time

Benefits offered by this job

Health insurance

Stock-based incentives

Paid time off

Annual bonus

Job summary

Kite Pharma in Frederick, MD is seeking a Supervisor, Manufacturing to lead a team of cell therapy manufacturing specialists in a state-of-the-art cGMP facility.

The role focuses on on-the-floor supervision, staff development, training, performance reviews, and ensuring adherence to SOPs and production schedules, with a back-end swing shift from 3:00 PM to 1:30 AM.

Qualifications

• MA / MS in science with 3+ years of cGMP manufacturing/leadership experience.
• BA / BS with 5+ years of cGMP manufacturing/leadership experience.
• Associate degree with 7+ years of cGMP manufacturing/leadership experience.
• High school diploma with 9+ years of cGMP manufacturing/leadership experience.

Responsibilities

• Oversee on-the-floor operations of cell therapy manufacturing in a cGMP environment.
• Build and lead a trained manufacturing team with adherence to CFRs and SOPs.
• Support change control, document review, and procedural updates.
• Schedule production and resources per operational plan.
• Investigate issues, identify root causes, and implement corrective actions.

Skills

Staff supervision

Team leadership

cGMP Manufacturing

Problem solving

Communication skills

Education

MA / MS

BA / BS

Associate

High School Diploma

Tools

Electronic Batch Records

ERP systems

Quality systems

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

We are seeking a highly effective Supervisor, Manufacturing to be responsible for supervising a team of cell therapy manufacturing specialists in our state-of-the-art commercial biotechnology facility in Frederick, MD.

In this role, the Supervisor will supervise the on-the-floor operations of our commercial cell therapy manufacturing facility in a cGMP environment including developing a team, and providing the necessary training and ongoing coaching, performance management and recognition of direct staff, including performing annual performance reviews.

**This position is for Back-end Swing shift (Wednesday to Saturday, from 3:00PM to 01:30 AM)**

Responsibilities of the Supervisor of Cell Therapy Manufacturing include:

• Provide oversight and/or supervision for the on-the-floor operationsof celltherapy manufacturing in a cGMP environment.
• Build a team, provide leadership, guidance, and necessary training to staff in alignment with cGMP requirements.
• Support the review and approval of procedural changes within controlled documentation.
• Clear communication with outgoing and incoming shift supervisors to disseminate all relevant information.
• Support the review and approval of procedural changes within controlled documentation.
• Participate in multi-functional project teams, as necessary.
• Responsible for oversight of on-the-floorexecution of protocol driven production activities withinmanufacturing (APVs, PPQs, Engineering Runs, etc.)
• Execute production and resource schedule against operational plan
• Ensure performance of all processstepsarein compliance withapplicable SOPs, policies, and governing documents.
• Process monitoring, including manipulation of databases,documentsand/or spreadsheets to support business reporting requirements.
• Review of completed manufacturing documentationpercompliance standards and established timelines.
• Investigate and resolve problems, identifyingroot cause, and proposing process improvements through clear communication to senior leadership.
• Take corrective action to bring aboutrequiredchanges using change control procedures.
• Support cross-functionalmeetings to ensure manufacturing representationasneeded.
• Additionalduties as assigned.
• These duties can be delegated to designated deputies ofa satisfactoryqualification level as needed.

Basic Requirements:

MA / MS with 3+ years of cGMP Manufacturing and/or Manufacturing Leadership and/or Operations experience

OR

BA / BS Degree with 5+ years of cGMP Manufacturing and/or Manufacturing Leadership and/or Operations experience

OR

Associate and 7+ years of cGMP Manufacturing and/or Manufacturing Leadership and/or Operations experience

OR

High School Degree with 9+ years of cGMP Manufacturing and/or Manufacturing Leadership and/or Operations experience

Preferred Qualifications:

• 5+ years of experience supervising staff
• 9+ years of experience in manufacturing in a biotech/pharma industry
• Proven capability to build and lead a team as well as train entry-level personnel
• Knowledgeable of the current Code of the Federal Regulations (CFR’s) and Current Good Manufacturing Practices (cGMP’s)
• Sufficient understanding of process, systems and equipment to troubleshoot problems and provide solutions to senior management
• Sufficient knowledge of electronic batch record, ERP and quality systems
• Able to work evening to late mid night hours as well as part of the on-call rotation as needed is required; partial weekend shift
• Excellent interpersonal, verbal and written communication skills are important in this collaborative work environment
• High energy level and a positive outlook coupled with the requisite “can do” attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles
• Willingness to think outside of the box and adapt standard methodologies to our small, but growing environment
• Ability to adapt in a constantly evolving environment
• Self-motivated with a deep sense of ownership in areas of responsibility

The salary range for this position is: $107,185.00 - $138,710.00. 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.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' 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.

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