Senior Manager, Project Management, Regulatory Affairs CMC

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Sep 11, 2020
Ref
R0014823
Required Education
Bachelors Degree
Position Type
Full time

Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job

Job Description

Kite is seeking a highly motivated individual to join us as a Senior Manager, Project Management, to work in the exciting area of cancer immunotherapy. This position will provide business operations support and project management to the Regulatory CMC team in a dynamic and fast paced organization. The preferred candidate will possess strong interpersonal skills as this position interacts with all levels of employees in Operations Teams, Process Development, Quality, Supply Chain, Manufacturing, and Regulatory Affairs.

Are you interested in helping ensure timely execution of CMC strategy in a cell therapy setting? Come join us in our mission to cure cancer!

RESPONSIBILITIES:

  • Drive cross-functional Regulatory CMC submission project teams (e.g. INDs, process improvements, annual reports) and manage deliverables to meet deadlines
  • Partner with Regulatory CMC, Global Regulatory, Regulatory Operations, and Technical Operations departments at multiple sites to ensure coordinated preparation and delivery of submissions
  • Manage submission documents including file organization, transfer between systems, and traceability from draft through approval and publishing
  • Develop, deploy, and support the optimization of business processes and tools to improve efficiency and advance Regulatory CMC-Technical Operations interactions
  • Provide effective communication and coordination with Regulatory CMC teams and Technical Operations teams and proactively update stakeholders on progress and issues (e.g. project dashboards, reporting)
  • Direct and mentor junior employees for complex projects

 


REQUIREMENTS:

 

 

  • BA/BS in Sciences or Engineering with 8+ years of experience in the biotech or pharmaceutical industry or MA/MS in Sciences or Engineering or MBA with 6+ years of experience in the biotech or pharmaceutical industry
  • Project Management certification or equivalent

 


ADDITIONAL QUALIFICATIONS:

 

 

 

  • Experienced managing multiple complex projects simultaneously and resolving conflicts related to meeting numerous deadlines
  • Knowledgeable with the drug development process, cell therapy industry, and Regulatory CMC practices; Module 3 experience strongly preferred
  • Ability to take initiative and think critically with demonstrated troubleshooting and problem solving skills
  • Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment
  • Comfortable negotiating and influencing in a fast-paced, dynamic, highly fluid, matrixed global organization and able to adjust workload based upon changing priorities
  • Proficient in MS Word, Excel, Power Point, SharePoint and Outlook; MS Project, Documentum, document formatting tools experience a plus

 


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:

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 contactcareers@gilead.comfor assistance.

For more information about equal employment opportunity protections, please view the'EEO is the Law'poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

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 to apply for this job.