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Associate Director, Process Development
- Gilead Sciences, Inc. (Santa Monica, CA)
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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
At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.
We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.
Kite is seeking a strong candidate for the role of Associate Director in life-cycle management team for Kite’s commercialized cell therapy products. This individual will be based within process design and will lead a team that enables process characterization & post-commercialization changes to manufacturing process, through feasibility assessments, characterization studies, support of process validation, regulatory filings, GMP manufacturing,
response to agencies and pre-approval inspections for commercial sites. In addition, this role will also lead business process improvements within life-cycle management as it pertains to implementation of novel process improvements utilizing QbD principles and incorporation of automation using AI machine learning models for process characterization and development. This role is expected to routinely interface and maintain good work relationships with several key stakeholders within the company including but not limited to analytical sciences, manufacturing sciences and technology, commercial manufacturing, quality, and CMC product teams.
As an Associate Director, Process Development, at Gilead you will ...
Key Responsibilities:
+ Work with key stakeholders to support the life-cycle management activities including developing efficient business processes for process characterization and development of integrated control strategies.
+ Provide guidance to team members to enable efficient and timely execution of life-cycle management activities.
+ Act as an SME for design of experiments, execution of studies under protocol, appropriate use of statistical approaches, implementation of QbD principles, authoring of reports / regulatory documents, response to questions from regulatory agencies, process data analysis & trending using JMP, and GMP manufacturing support.
+ Review technical documentation, technical SOPs, manufacturing batch records, technical reports and summary reports.
+ Support equipment qualification, risk assessment, process characterization, parameter classification TT and process validation activities for commercial manufacturing.
+ Support and lead AI initiatives for process development and characterization
Basic Qualifications:
+ PhD Degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology or related discipline with pharmaceutical / biotechnology manufacturing & process development with 5+ years of experience or
+ MS Degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology or related discipline with pharmaceutical / biotechnology manufacturing & process development with 8+ years of experience or
+ BS Degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology or related discipline with pharmaceutical / biotechnology manufacturing & process development with 10+ years of experience or
Additional Qualifications:
+ Candidates with prior experience and demonstrated capability within life-cycle management of cell and gene therapy products will be preferred.
+ Candidates with prior leadership experience managing direct reports or cross-functional project teams will be preferred
+ Practical knowledge of regulations and requirements pertaining to cGMP manufacturing for cell and gene therapy products.
+ Practical knowledge of scientific and engineering principles related to bioprocessing including scale-up / scale-out approaches, and process data analysis including machine learning models for process development
+ Ability to think critically, troubleshoot, and problem solve in a timely manner.
+ Excellent interpersonal, verbal and written communication skills.
+ Ability to work and collaborate in a fast paced, dynamic cross-functional team setting across research, development, and manufacturing departments.
People Leader Accountabilities** **:
•Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
•Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
•Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
The salary range for this position is: $177,905.00 - $230,230.00. 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 .
For 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 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 [email protected] 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.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf)
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.
For Current Kite Pharma Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
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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