Supervisor, Manufacturing (Back End Day Shift)

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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 Day shift (Wednesday - Saturday from 06:00 AM to 4:30 PM)**

Responsibilities of the Supervisor of Cell Therapy Manufacturing include:

• Provide oversight and/or supervisionforthe on-the-floor operationsof celltherapy manufacturing in a cGMP environment.

• Build a teamprovide 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 andincoming shiftsupervisors todisseminateall 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 databasesdocumentsand/or spreadsheets to support business reporting requirements.

• Review of completed manufacturing documentationpercompliance standards and established timelines.

• Investigate and resolve problemsidentifyingroot 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 (CFRs) and Current Good Manufacturing Practices (cGMPs)

• 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

Does this sound like you If so apply today!

For additional benefits information visit:

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 systems ability to recognize and kill tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at jobs in the United States:

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 disabilitygenetic 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 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 for assistance.

For more information about equal employment opportunity protections please view theKnow Your Rights poster.

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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 proceeding hearing or action including 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.

For Current Kite Pharma Employees and Contractors:

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