Senior Scientist, Analytical Development

Position Summary:

Theragent is seeking a highly motivated Senior Scientist, Analytical Development, reporting to the Manager Analytical Development, developing analytical assays (molecular, bioassays, and immuno-assays inclusive) to support the development of novel modified autologous and allogeneic cell/gene therapies.

This role will be responsible for preclinical and clinical assay development/ optimization/ qualification to support required testing of cell/gene therapies used in the manufacturing process. Additionally, some support of testing components and raw materials with contract laboratories may be required.

The successful candidate will have extensive experience with cell/gene therapy analytical assay development, deep expertise on the underlying science and technology of these assays, and a detailed understanding of the CMC testing requirements for IND/NDA filings, and materials qualification.

Primary Responsibilities:

• Expert in analytical assay development adopting the quality-by-design concept to support testing of all pre-clinical and clinical Theragent 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, Process Development, Manufacturing, Quality, QC, MSAT and others.
• Prepare and present to management on analytical method development progress, latest data and conclusions, to meet client and Theragent 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 management.
• Interact with outside vendors and management.
• Participate in multi-functional project teams, as necessary.
• Take corrective action to bring about required changes using approved change control procedures.

Reports to: Manager, Analytical Development

FLSA Status: Exempt

Location: Covina, CA

Knowledge, Skills & Abilities:

• In-depth experience and knowledge in biotherapeutics analytics with emphasis on cell-based potency methods, cellular characterization/immunophenotyping, molecular methods, antigenicity methods, and other 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.
• Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required.
• Strong problem-solving and organizational skills are required.

• Professional Knowledge
• Problem Solving
• Team Player / Building Relationships
• Multi‐tasking
• Customer Focus
• Action and detail oriented
• Active Listening
• Decisive Decision Making

Education & Professional Experience:

• Sen. Scientist: Master`s degree with 8-10 years experience or Ph. D degree with 6-8 years experience in Biochemistry, Cell Biology, Molecular Biology, Immunology, Biological Sciences
• Direct experience with cell and gene therapy assay development, IND filing, and supporting clinical products is required.

Working Conditions:

• Laboratory environment
• Must wear PPE due to safety requirements in designated lab areas
• May be required to work in controlled or clean room environments

Travel: Occasional. Less than 10%

Physical / Mental Demands:

• Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting to 40 lbs.
• Ability to sit, stand, walk, and move within workspace for extended period.
• Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing, and pulling.

Environmental Conditions:

• Primarily office environment but will be required to enter laboratory or GMP process areas donning proper gowning / lab coats or PPE such as safety glasses and shoes.
• Ability to work safely and effectively when working alone or working with others.

* This description outlines the basic responsibilities and requirements for the position noted. This is not a comprehensive listing of all job duties of position. Duties, responsibilities, and activities may change at any time with or without notice

Theragent, Inc. is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status, and veteran status. All qualified applicants will receive consideration for employment.

Theragent, Inc. requires employees to be vaccinated against COVID-19. To the extent permitted by applicable law, candidate must be able to provide proof of full vaccination or receipt of the first dose of a two-dose COVID-19 vaccine, or request an exemption due to a medical reason, a sincerely held religious belief of practice, or pregnancy, as of the first day of work, to be considered for a U.S.-based job.