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22 days old

Senior Analytical Development Scientist

Kelly Services
Arcadia, CA 91007
For over 25 years Kelly Science & Clinical has been connecting scientific professionals with industry leading employers. Today we are excited to be hiring a **_Senior Analytical Development Scientist_** for a cell and gene therapy company in Covina, CA. The **_Sr. Analytical Development Scientist_** will assist in developing analytical assays (molecular, bioassays, and immuno-assays inclusive) to support the development of novel modified autologous and allogeneic cell/gene therapies. The Sr. Scientist will be responsible for preclinical and clinical assay development/ optimization/ qualification to support required testing of cell/gene therapies and viral vectors used in the manufacturing process.


**Responsibilities:**


+ Expert in analytical assay development adopting the quality-by-design concept to support testing of all pre-clinical and clinical cell therapy programs.

+ Provide scientific input in all analytical development technical areas

+ Develop, perform troubleshooting and evaluation of analytical methods such as molecular/ biological/ immuno-assays, including ddPCR, qPCR, ELISA, flow cytometry, to support cell and gene therapy programs

+ Assist with test method development and qualification/ validation and establishment of specifications.

+ Execute analytical methods to support analytical development, process development, and quality control

+ Perform equipment/instrumentation evaluation, execution of testing, and data interpretation of results.

+ Author study protocols, development/qualification reports, test methods, relevant sections of regulatory submissions

+ Develop method platforms to support current and new products, increase method throughput, lower cost, and lower operational laboratory complexity.

+ Work strategically to accelerate the development and implementation of novel testing technologies for integration into new and existing drug products.

+ Working closely with other functions such as Research, Regulatory Affairs, Manufacturing, Quality, QC, clients MSAT and others.

+ Prepare and present to management on analytical method development progress, latest data and conclusions, to meet client and companies testing development goals.

+ Draft development reports and SOPs for new methods

+ Ability to adjusts to changing time lines and company needs

+ Builds a strong scientific and technical laboratory team, provides necessary training and ongoing coaching, discipline, and recognition of direct staff, including performing annual performance reviews.

+ Support technology transfer of methods into the QC department, and serve as a key SME with external laboratory organizations and key clients as well as material/component and equipment/instrument vendors.

+ Investigate and resolve problems, identify root cause, and propose laboratory operation improvements through clear communication to senior management.

+ Interact with outside vendors and senior management.

+ Participate in multi-functional project teams, as necessary.

+ Take corrective action to bring about required changes using approved change control procedures


**Requirements:**


+ Masters degree with 8-10 years experience or Ph. D degree with 6-8 years experience in Biochemistry, Cell Biology, Molecular Biology, Virology, Biological Sciences

+ In-depth experience and knowledge in biotherapeutics analytics with emphasis on cell-based potency methods, cellular characterization, viral characterization and infectivity assays, molecular methods, antigenicity methods, and other separation-based methods used for gene/cell therapies

+ Familiar with the FDA regulatory requirements for drug products and IND filing

+ Knowledgeable of cGMP processes and technology transfer

+ Understand requirements for product characterization and release tests

+ Demonstrated ability to design and execute laboratory experiments and evaluate data to provide scientific guidance on assay optimization

+ Demonstrated ability to technically trouble shoot and resolve assay challenges to successfully produce cell therapy products at a high-performance rate.

+ Demonstrated ability to develop, qualify/validate and transfer biologics analytics into manufacturing processes and product testing that meet customer needs is required.

+ Knowledge of method lifecycle management from early to late-phase and throughout commercialization.

+ Knowledge of cGMP in the pharmaceutical industry. Application to cell/gene therapy and viral vector development/manufacturing a plus.

+ Familiar with data analytics software such as JMP, Minitab, and/or GraphPad Prism


**_Apply today to start a conversation on Whats Next for your Career!_**


+ Please feel free to schedule an interview directly with Athena to learn more: https://calendly.com/athp320/interview

+ Additional questions may also be e-mailed to athena.parker@kellyscientific.com.


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **Science & Clinical?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise 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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

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Posted: 2022-09-12 Expires: 2022-10-13

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Senior Analytical Development Scientist

Kelly Services
Arcadia, CA 91007

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