24 days old

Associate Director, Analytical Method Development, Santa Monica, CA

Kelly Services
Santa Monica, CA 90407
**Associate Director, Analytical Operations Santa Monica, CA**

Seeking a highly motivated Associate Director, Analytical Operations with method development, method investigations and analytical life cycle management and tech transfer experience to work on innovative T cell therapy for cancer treatment. The Associate Director will work with Process Development, Clinical and Commercial Quality organizations to provide leadership to a team responsible for Manufacturing and Quality investigations related to out of specifications (OOSs), method investigations, optimization and monitoring. The Associate Director will also be responsible to analyze experimental data, perform root cause analysis, and assure careful documentation of resultant information.

**Responsibilities include (but are not limited to):**

+ Develop a team of subject matter experts and technical leads for analytical methods in commercial and clinical phase programs that include method related investigations, optimization and development.

+ Providing leadership relating to support of analytical operations on troubleshooting in QC and long term strategic improvements.

+ Direct technical root-cause investigations for OOS, deviations and CAPAs relating to analytical methods

+ Perform risk assessments, gap assessments for analytical methods and aim to enhance compliance and robustness.

+ Monitor health of methods across the product portfolio to identify common trends or major risks and recommends appropriate technology solutions for implementation

+ Lead communication between Analytical development, Process Design and Quality control (internal and external partners) by communicating requirements and directly participate in the development and implementation of new and optimized methods

+ Ensure standard operating procedures, analytical test methods, analytical sampling plans, batch records, and monitoring, trending and improvement process for all company analytical methods meet the highest industry standard

+ Work with a cross-functional development team to advance development of autologous T cell therapy products

**Position Qualifications:**

+ PhD degree in Biotechnology, Bioengineering or another relevant life-science discipline with a minimum of 4 years of industry experience in analytical development, QC, technology transfers and method lifecycle management.

+ Alternatively, a Masters degree with minimum of 8 years of industry experience or an equivalent combination of education and experience.

+ In depth experience with analytical method development and cGMP requirements and testing in clinical and commercial QC.

+ Experience with gene and cell therapies preferable.

+ Experience with Root Cause Analysis (RCA) methodologies and tools.

+ Proven leadership in analytical, CMC tech- transfer, analytical control strategies and method validation.

+ Knowledge and experience with method related deviations, change controls, CAPAs, investigations, and method performance metrics.

+ Knowledge and understanding of FDA, EMEA and other global regulatory compliance guidelines.

+ Excellent interpersonal, verbal and written communication skills

+ Shown ability to work with both direct reports and senior management

+ Ability to lead a diverse, experienced technical staff team with attention to detail, to think critically and demonstrate troubleshooting and problem solving skills, and work with and lead others.

+ Experience in analytical techniques such as Flow cytometry, qPCR, ddPCR, ELISA and microbiology techniques.

+ Strong knowledge of technical writing for BLA, IND

+ Proficient in MS Word, Excel, Power Point and other applications

+ Ability to function efficiently and independently in a changing environment

+ Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.

+ Self-motivated, detail-oriented, excellent interpersonal and writing skills, and willing to accept temporary responsibilities outside of initial job description.

**Why Kelly** **** **?**

Kelly Science is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at
Posted: 2020-05-08 Expires: 2020-06-08

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Associate Director, Analytical Method Development, Santa Monica, CA

Kelly Services
Santa Monica, CA 90407

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