This role will lead a multi-functional laboratory team developing analytical (molecular, bioassays, and immuno-assays inclusive) assays to support the development of novel modified autologous and allogeneic cell/gene therapies. The role will also 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.
location: Arcadia, California
job type: Permanent
salary: $130,000 - 150,000 per year
work hours: 9 to 5
education: Masters
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 strategic and scientific guidance in all analytical development technical areas; Serve as the analytical development expert on molecular/ biological/ immuno-assays, structure-function relationships, test method development and qualification/ validation, and establishment of specifications, including cell and gene therapy programs.
- Oversee all analytical development personnel and activities, including laboratory. equipment/instrumentation, execution of testing, and data interpretation of results.
- Develop method platforms to support current and new product formats, increased product control, 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.
- Play a key role in project team meetings and decisions working closely with other functions such as Research, Regulatory Affairs, Manufacturing, Quality, Clinical, Finance, Program Management, Business Development, and others.
- Prepare and present to leadership, external clients, and stakeholders on analytical method development strategy, latest data and conclusions, plans and roadmap to meet client and Theragent testing development goals.
- Responsible for method LCM; execute on IND development timelines against operational plans.
- 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 products and processes into the cGMP facility, 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.
qualifications:
- Masters/Ph. D degree in Biochemistry, Cell Biology, Molecular Biology, Virology, Biological Sciences with 5 - 8 years of experience managing a technical laboratory team in the cell therapy biotechnology industry.
- Direct experience with cell and gene therapy process development, IND filing, and supporting clinical products expectations is required.
- 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.
- Two to three years managing an analytical science or multi-functional bioanalytical laboratory technical team.
- Familiar with the FDA regulatory requirements for drug products and IND filing
- Knowledgeable of cGMP processes and technology transfer.
- 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.
skills: Cell Biology, Biology, Chemistry, GLP (Good Laboratory Practice), GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
