1+ months

Sr. Director Analytical Development - Santa Monica, CA

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

Kelly Scientific has a fantastc opening for a **Senior Director of Analytical Operations** for one of our top clients in Santa Monica, CA!

**This is a Direct Hire opportunity with full relocation package!**


The Senior Director will work with Process Development, Research, Translational Medicine and Quality organizations to provide process and analytical development and CMC leadership to a team responsible for analytical characterization of cell therapy products, maturation of research analytical methodology into development and GMP, and analytical method transfer from/ to company contract vendors. The Senior Director will also be responsible to direct laboratory studies, analyze experimental data and assure careful documentation of resultant information.

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

+ Lead Analytical activities in support of engineered T cell products, including oversight of cross functional team

+ Design, develop, execute and document analytical method development and qualification in support of process development, product release and stability, and product characterization of T cell therapies in Process Development

+ Identify, develop and implement appropriate analytical technologies and methods to study and characterize processes for production of T cell therapies, including process improvements and efficiencies

+ Lead and implement quality by design (QbD) and design of experiment (DOE) approaches to method development to quickly identify robust operating regions within phase-appropriate pre-defined acceptance criteria aimed to meet ICH guidelines

+ Lead analytical laboratory staff in the selection, design and implementation of novel analytical methods, including FACS/flow cytometry, with emphasis on automation and high throughput technologies

+ Manage method and analytical technology transfers to/ from contract testing labs and facilities as appropriate

+ Lead the analytical arm of OOS investigations, deviations and CAPAs

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

+ Draft and review of CMC sections and supporting documents for Regulatory filings. Participate in PAI, defend regulatory audits and draft responses

+ Responsible for personnel recruitment, development and retention

+ Ensure a collaborative work environment with key client groups in Research, Quality, Manufacturing and Process Development to support analytical method and process development as well as the characterization of T cell products; e.g. lead maturation of research analytical methodology into Development and GMP, and analytical method technology transfer to and from partners

**Job Requirements:**

+ Ph.D. in Chemistry, Biochemistry, Biology or related discipline with 10+ years of leadership and management experience in the biotech and/or pharmaceutical industry

+ Proven leadership ability in pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products, analytical method development, technology transfer, and method qualification/validation and process development

+ Proven ability to work with both subordinate staff and corporate senior leadership team

+ Excellent interpersonal, verbal and written communication skills

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

+ Expertise with analytical method development and qualification and analysis of cell therapy products

+ Well versed in various analytical techniques such as FACS, ELISAs, PCR, FTIR, UV and Fluorescence spectroscopy, enzyme assays and other applicable methods to the testing of biopharmaceuticals, preferred.

+ Excellent understating of cellular processes and metabolism and experience working with human primary cells, including T cells, and flow cytometry

+ Knowledge of QbD approaches to analytical method development including risk assessment, DOE, and statistical analysis

+ 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

**APPLY TODAY! Questions? Email Kevin at**

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

With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your careerconnect with us today.

**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: 2019-12-16 Expires: 2020-01-20

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Sr. Director Analytical Development - Santa Monica, CA

Kelly Services
Santa Monica, CA 90407

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