Director, Manufacturing
Gilead Sciences, Inc.
**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.
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**
The Director of Manufacturing is an exciting key role at the Oceanside CA site which is responsible for leading and developing a biologics team to successfully establish a high functioning and robust clinical and commercial operations producing viral vectors in a complex single use technology environment. This role will instill a culture that achieves competitive commercial and clinical operational excellence with continuous improvement, operational efficiency, quality, and safety as its foundation.
This is a “hands-on” leadership role. The leader will be able to continue the build of three biologics operational units for upstream, downstream and fill finish/packaging. The leader will collaborate with cross-functional teams of Facilities & Engineering, Supply Chain, MSAT (Manufacture Science & Technology), and Business Operations. The Director of Manufacturing will be knowledgeable and have had demonstrated experience to ensure compliance with Biological Single Use Technologies, Good Manufacturing Practices (cGMP), Standard Operating Procedures (SOPs), product licenses, Pivotal Clinical and Commercial Manufacturing, corporate policies and safety practices.
**Responsibilities (include but are not limited to):**
+ Leads manufacturing team with a focus on consistent and reliable biologics operations with high success rates per batches and no to low deviations per batches
+ Works hands-on to supervise and monitor performance of manufacturing manager and supervisor and the development of overall skills and expertise of the manufacturing team
+ Assures successful transfer of new biologic technologies/platforms and processes
+ Continuous improvements in all operation processes including safety
+ Investigates and resolve problems, identifying root causes, and proposes process improvements through clear communication utilizing expertise coupled with OE tools
+ Ensure operational readiness of team to perform and utilize single use technologies for upstream, downstream and fill finish platforms via training and preparation deliverables
+ Ensures manufacturing areas, team, and equipment meet all cGMP and regulatory specifications
+ Manages manufacturing of products which closely impact budget line of the department
+ Coordinates with Supply Chain on the creation and revision of production schedule based on Capacity Review Management and Operations Council Process.
+ Ensures cGMP training and readiness of Manufacturing Team for compliance audits and day to day compliance
+ Creates operational efficiencies related to materials, labor and overhead
+ Resolves organizational targets and interprets company policies for the department
+ Create an environment where productivity and efficiency are achieved and recognized
+ Establish operational plans, goals and assignments
+ Anticipate, prepare organization, and address inspection issues that impact plant operations.
+ Maintain a high level of compliance through effective monitoring and reporting of operational, key quality and safety metrics while incorporating in 6S systems
+ Ensure timely execution of deviations, CAPA’s, change control support and continuous improvement initiatives
+ Manufacturing leader prepare team members for inspection activities, observation commitments, submission and agency requests for products for assigned manufacturing plant
+ Develop team’s technical capabilities for single use technologies, upstream and downstream manufacturing and fill/finish manufacturable activities for both pivotal clinical and commercial manufacturing
+ Provide necessary training and ongoing coaching, discipline and recognition of direct staff, including performing annual performance reviews
+ Collaborate with cross functional leaders to implement strategy and shared goals
+ Communicate, collaborate and interact with Manufacturing Leadership Team and functional department heads
+ Develop, administer, and execute to budgets, schedules, and goals
+ Independently determine approach and requirements to managing teams and executing operations with meaningful collaborations with peer leaders
+ Other duties as assigned
**Basic Qualifications:**
+ Doctorate and 8+ years of experience managing a cell culture and/or purification manufacturing team in the biotechnology or biologics industry OR
+ Master’s and 10+ years of experience managing a cell culture and/or purification manufacturing team in the biotechnology or biologics industry OR
+ Bachelor’s and 12+ years of experience managing a cell culture manufacturing and/or purification team in the biotechnology or biologics industry
**Preferred Qualifications:**
+ Demonstrated ability to work side by side on the biologic floor or operations environment to develop a team
+ Deep understanding of the business, science, engineering, and technology of biotechnology, processes, equipment and facilities
+ Very knowledgeable of the current regulations, Code of the Federal Regulations (CFR's) and Current Good Manufacturing Practices (cGMP's)
+ Clinical (Pivotal-Phase II/III) and commercial cell culture and/or purification manufacturing experience highly preferred
+ In depth knowledge of process operations related to upstream and downstream equipment and ability to troubleshoot with facilities and the team
+ Expertise or knowledge
+ in how Upstream bioreactors and Downstream TFDF/UFDF, Chromatography and Fill/Finish/Packaging Equipment operates.
+ Expert knowledge of electronic quality systems
+ Excellent interpersonal, verbal and written communication skills are essential 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 best practices to our small, but growing environment
+ Ability to adapt in a constantly evolving environment
+ Always leading with safety area ownership utilizing 6 S and Gemba walks to establish a world class safety culture
+ Self-motivated with a thorough sense of ownership in areas of responsibility
Does this sound like you? If so, apply today!
The salary range for this position is: $191,250.00 - $247,500.00. 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.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) 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.
Gilead 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:**
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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