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20 days old

Director, Analytical Development

Kelly Services
Philadelphia, PA 19133
**We are Kelly Science and Clinical** **,** the second largest scientific staffing firm in the U.S. serving 90% of Fortune 100 companies. We have partnered with a fast-growing, cutting-edge, innovative biotechnology company utilizing a comprehensive cell therapy platform to develop transformative cell therapies with the potential to overcome many of the challenges inherent to cell therapy and provide a significant advantage over existing and cell therapy technologies.


**Job Title:** **Director, Analytical Development**


**Overview:**


Our client is leveraging their expertise in cellular reprogramming, genetic engineering, and manufacturing to evolve the way patients are treated with cell therapies and positively transform the lives of patients suffering from life-threatening cancers. Immediately seeking a new Director of Analytical Development with an entrepreneurial spirit who can provide strategic leadership, and scientific guidance to the analytical team, responsible for developing the companys quality control and characterization platform and who can really make an impact with the direction of this company. Business culture includes, employees can make immediate contributions, have freedom to explore and try new solutions and forge a path to future success.


**Responsibilities may include (but are not limited to) the following:**


+ Oversee the selection of analytical technologies, establishment of analytical procedures, and the validation and transfer of methods in support of early development programs. This role will interact extensively with internal and external partners to advance pipeline programs through key CMC milestones.

+ Provide strategic, technical, and scientific leadership to the Analytical Development team

+ Function as an analytical lead in early development product teams to deliver on corporate objectives related to the advancement of the companys pipeline programs.

+ Ensure systems, processes, and resources are in place to conduct laboratory activities in compliance with cGMP/GLPs (as needed), SOPs, good documentation practices, and OSHA safety standards.

+ Define the product control strategy for the companys pipeline of genetically-engineered, iPSC-derived cell therapy products.

+ Foster the growth of analytical development capabilities, including the implementation of state-of-the-art, phase-appropriate methods in support of product and process characterization, comparability, and quality control activities.

+ Oversee execution of analytical method development, optimization, transfer, and validation under cGMP in collaboration with Quality Control in order.

+ Author, review, and approve technical documents such as study protocols, methods, validation protocols and reports in collaboration with QC


**Education/Experience Requirements/Qualifications** **:**


+ Legally authorized to work in the job posting Country.

+ Ph.D. in Biochemistry, Cell Biology, Molecular Biology, Biotechnology, Biological Sciences or related discipline

+ At least 12 years relevant experience in biopharmaceutical assay development, with minimum 3 years in a managerial capacity.

+ Extensive experience in leading analytical activities to support IND, Phase I/II, pivotal, and commercial activities in the biotech or pharmaceutical industry.

+ Demonstrated leadership skills, including the ability to manage a scientific team; work effectively within a matrix team; communicate, coach, and mentor employees. **Company Offers a Fabulous Compensation and Benefits Package Including Relocation Assistance EOE, including Disability/Vets #TJP2021_SPEC**


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


Kelly Science & Clinical 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 (plus, did we mention we provide a ton of benefits ?). 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-09-03 Expires: 2021-10-04

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Director, Analytical Development

Kelly Services
Philadelphia, PA 19133

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