Salary Range: $125K - $140K/year
Position Summary:
Client is seeking a highly motivated Senior Scientist, Analytical Development, reporting directly to the Head of Process Sciences, to 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.
This role 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. 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.
This position represents a seasoned people leadership skillset, and the energy and boldness to grow an innovative assay development laboratory organization. The successful candidate has demonstrated experience in the cGMP method qualification/validation requirements for phase-appropriate cell-based therapies.
Primary Responsibilities:
Expert in analytical assay development adopting the quality-by-design concept to support testing of all pre-clinical and clinical Client 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 Client 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.
Knowledge, Skills & Abilities:
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.
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. (Note from MaryAnn - not a plus seems to be REQUIRED)
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:
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.
Two to three years managing an analytical science or multi-functional bioanalytical laboratory technical team.
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%
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.
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.
