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Frederick, Maryland, United States
Onsite
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.
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 front-end day shift (Sunday - Wednesday, from 6:00am to 4:30pm)**
Responsibilities of the Supervisor of Cell Therapy Manufacturing include:
Provide oversight and/or supervision for the on-the-floor operations of cell therapy 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-floor execution of protocol driven production activities within manufacturing (APVs, PPQs, Engineering Runs, etc.)
Execute production and resource schedule against operational plan
Ensure performance of all process steps are in compliance with applicable SOPs, policies, and governing documents.
Process monitoring, including manipulation of databases, documents and/or spreadsheets to support business reporting requirements.
Review of completed manufacturing documentation per compliance standards and established timelines.
Investigate and resolve problems, identifying root cause, and proposing process improvements through clear communication to senior leadership.
Take corrective action to bring about required changes using change control procedures.
Support cross-functional meetings to ensure manufacturing representation as needed.
Additional duties as assigned.
These duties can be delegated to designated deputies of a satisfactory qualification 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
Does this sound like you? If so, apply today!
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.
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 ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
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.
Please apply via the Internal Career Opportunities portal in Workday.