Job Type: Analytical Development
Cell Based Potency Scientist / Principal Scientist
Summary
The Cell Based Potency Scientist has the opportunity to drive our state-of-the-art potency assay development that supports the company’s portfolio of our client’s different clinical- stage cell and gene therapy products. We are recruiting a Scientist with experience in the development, optimization, and qualification of potency assays and characterization of cell and gene therapy products. S/he will work with a CBM analytical development team for rapid advancement of cellular therapy candidates from development through commercialization. The role requires a strong understanding of cell biology/immunology/molecular biology and expertise with the design and development of cell-based assays to assess protein function. The ideal candidate will be independent and detail oriented, have experience in design and development of novel functional cell-based assays, have a working knowledge of analytical guidelines and work collaboratively with cross functional teams, viz. discovery groups, process sciences groups, internal analytical functions, as well as with Manufacturing Sciences and the Quality Control organization.
Responsibilities
- Develop, optimize, and qualify potency assays used for development, characterization, qualification of cell and gene therapy products and critical materials.
- Author and review SOPs, technical reports, and assist in the preparation of regulatory submissions.
- Contribute to technical transfer of analytical methods both internally and to external vendors by acting as an SME during the transfer of assays and providing technical troubleshooting support when needed.
- Work with cross-functional groups including Research & Development, QC, and Process Development.
- Participate in various aspects of method development, transfer, characterization, comparability, and investigation.
- Manage routine sample testing including the coordination of testing with Process Development, Research and Development groups, and external vendors.
- Analyze, track, and trend data to monitor analytical assays and ensure consistency in assay performance.
Qualifications
- PhD in Immunology, Biological Science, Biochemical Engineering, or related discipline with 0-2 years of R&D / analytical development experience or bachelor’s or master’s degree with 3-5 years of relevant experience.
- Strong background in cell culture and experience working with cell lines and primary human cells.
- Experience with mechanism of action, functional, or potency assay development.
- Broad experience with molecular biology, cellular, and immunoassay techniques including transfections/transductions, ddPCR/qPCR, ELISA.
- Experience using data analysis software including JMP and PLA software.
- Ability to critically think though experimental challenges and troubleshoot.
- Strong organizational skills and attention to detail.
- Excels at written and verbal communication.
- Knowledge of ICH/USP guidelines and experience with assay qualification/validation preferred.
- Experience with FACS is a plus.
Scientist/Sr. Scientist, Flow Cytometry
Summary
The Center for Breakthrough Medicine is seeking a solid candidate to join our flow cytometry team as a technical lead in our Analytical Development and Testing organization.
Responsibilities
- Demonstrate the highest moral standard and ethical integrity.
- Optimize and qualify assays for characterization and analytical testing of cell therapy products.
- Capable of making decisions independently and troubleshoot/optimize experiments and procedures.
- Flexible to support multiple research projects as the AD organization grows.
- Author and review test method SOPs, method development reports, qualification protocols, risk assessments, and transfers methods to partner functions, and represent the Analytical Flow Cytometry team in cross-functional meetings.
- Able to perform GMP operations, including following detailed SOPs, maintaining training, and following good documentation practices.
- Responsible for operation and maintenance of flow cytometers.
Qualifications
- Ph.D. with 1+ years of directly flow cytometry experience OR MS with 5+ years of directly related experience
- Basic knowledge of immunology preferable adaptive immunity
- Experience in multicolor flow cytometry and mammalian cell culture is required
- Experience with multiple flow cytometry data analysis tools is required
- Prior experience with cell proliferation, cytokine release, or potency assay development is desirable
- Demonstrate ability to maintain lab execution records and perform data analysis.
- Strong technical writing and presentation skills
- Experience in cell therapy and GMP environment is strongly desirable
Vice President of Analytical Development, Cell & Gene Therapy
Summary
Reporting to the Senior Vice President of Testing and Analytical Services, the Vice President of Analytical Development will provide leadership for the development and execution of complex analytical assays for Cell and Gene Therapy products. The Vice President will lead the team on technology and assay development, client assay transfers, assay validation, and deliverables related to cell and gene therapy analytical programs. The ideal candidate has experience with team leadership, demonstrated skillset and knowledge of analytical development, with a proven track record in molecular / virology and cell-based methods that support cell and gene therapy products in the areas of the process, characterization, and release testing. The incumbent will also be responsible for driving the strategy and evaluation of new analytical technologies and techniques to serve our clients, bringing cell and gene therapies from bench to bedside.
Responsibilities
- Leads the technical team responsible for the successful design, execution, analysis, and documentation of programs that will be built to develop analytical assays for Cell and Gene Therapy Products
- Provides technical and scientific leadership to the team responsible for the development and validation of analytical essays
- Responsible for evaluating and implementing novel analytical technologies and assays with the
- Testing Business Unit Leadership team
- Trend Technical performance of assays and participate in assay improvements, client investigations, and regulatory support
- Review and approve technical documents including standard operating procedures, test methods, and technical reports
- Provide technical leadership, guidance, and training to the team as defined in the Good Manufacturing Practice (GMP) regulations.
- Develop and maintain systems that ensure the technical and regulatory competency of Scientists and staff.
- Support business with scientific and technical input and participation.
- Ensure all team members are providing the highest level of customer service to clients.
- Monitor requests for additional information (AIs) from regulatory bodies received through Sponsors and ensure test protocols and reports conform to the most current regulatory guidelines and expectations.
- Evaluate risks and opportunities with Sr. Management and drive strategic outcomes for the business.
- Recommends hire/transfer/promotion/discharge and salary changes and acts on employee problems. Conducts employee performance appraisals in a timely and objective manner. Monitors the growth and career development of direct reports.
- Ensure quality and assists Quality Assurance in maintaining all technical and regulatory requirements.
- Lead, coach, and mentor a team of up to 50 scientists
- Continuously reach out to academia, conferences, literature to stay ahead of developments in the space of AD
- Monitor the effective implementation of appropriate EHS and Biosafety procedures and provide for their updating in line with SOPs.
- Where required, and in partnership with QA/Regulatory Affairs, meet with relevant Regulatory Bodies to resolve any compliance issues or help with any new business requirements that potentially impact the accreditation or compliance status.
- Represent the Company to customers, visitors, community organizations, local/state and governmental authorities, unions, industry associations, and regulatory agencies.
- Perform all other related duties as assigned by the SVP of Testing and Analytical Services.
Qualifications
- M.S. degree in cellular biology, virology, molecular biology, analytical or relevant scientific discipline with 15+ years of relevant experience or Ph.D. in relevant field with 8+ years of experience in cellular biology, virology, molecular biology, analytical and experience in leadership or equivalent capacity is preferred.
- Proven track record in assay development, including experimental design, execution, and evaluation
- Experience qualifying and transferring analytical assays to QC GMP lab setting * Knowledge of and experience with Cell and/or Gene Therapy products and/or programs
- Experience with cell-based assays, ELISAs, virology based methods, flow cytometry, and qPCR/ddPCR
- Ability to work in a fast-paced environment, meet deadlines, and prioritize work on multiple projects
- Strong communication skills in technical writing and oral presentation
- Excellent written and verbal communication skills.
- Motivation and ability to solve complex problems.
- A systematic approach to tasks.
- Theoretical and practical knowledge of analytical techniques.
- The ability to develop and validate new methods.
- Numerical and analytical ability.
- Computer literate
Director of Analytical GMP Operations, Cell and Gene Therapy
Summary
The Director of Analytical GMP Operations will be responsible for providing senior leadership over Analytical Chemistry testing services (e.g HPLC, CE, ELISA, UV Nano, Gels, etc) supporting Cell and Gene Therapy Programs at the Center for Breakthrough Medicines (CBM). The Director will be a key member of the Testing Leadership team and will be responsible for leading the transition of developed methods to GMP ready from Analytical Development, cross-functional groups and/or CBM clients. The Director will be responsible for managing a large team of Cell and Gene Therapy scientists that will be directly responsible for delivering results to our customers for complex characterization and product release methods. The Director will also be responsible for driving the strategy and execution of new analytical technologies and techniques to serve our clients, bringing cell and gene therapies from bench to bedside.
Responsibilities
- Lead a team of highly talented scientists responsible for delivering testing for Cell and Gene Therapy Programs and new modalities
- Provides technical and scientific leadership to the team responsible for validation and GMP Testing of Analytical assays supporting Cell and Gene Therapy Programs
- Responsible for managing a total of 30 – 40 Scientists with plans for future expansion.
- Execute on the cell and gene therapy strategy, in alignment with all CBM operations and support functions
- Establish and monitor performance against established KPIs, internal metrics and trends to ensure the department performance against Safety, Compliance, Technical Trending and Delivery.
- Maintain Operational execution of the department to CBM expectations through regular business reviews and other performance management activities.
- Develops talent strategies and implements hiring, and broader talent issues and provides people-related decisions for a department/multiple teams within Testing and Analytical Services that cultivates innovative culture.
- Actively lead the strategic direction and goals of the department
- Build and foster relationships across the technical operations groups, Analytical Development Departments, contributing to projects and peer review when required
- Responsible for ensuring quality, consistency and best practice within reporting line
- Accountable for scientific development and mentoring of scientists within reporting line
- Fostering a culture of scientific rigor and continuous improvement in line with the Innovation Performance and Trust strategy at The Center for Breakthrough Medicines
- Ensure compliance with The Center for Breakthrough Medicines values and policies
- Evaluate risks and opportunities with Sr. Management and drive strategic outcomes for the business.
- Recommends hire/transfer/promotion/discharge and salary changes and acts on employee problems. Conducts employee performance appraisals in a timely and objective manner. Monitors the growth and career development of direct reports.
- Ensure quality and assists Quality Assurance in maintaining all technical and regulatory requirements.
- Continuously reach out to academia, conferences, literature to stay ahead of developments in the space of Cell and Gene Therapy
- Monitor the effective implementation of appropriate EHS and Biosafety procedures and provide for their updating in line with SOPs.
- Where required, and in partnership with QA/Regulatory Affairs, meet with relevant Regulatory Bodies to resolve any compliance issues or help with any new business requirements that potentially impact the accreditation or compliance status.
- Represent the Company to customers, visitors, community organizations, local/state and governmental authorities, unions, industry associations and regulatory agencies.
- Perform all other related duties as assigned by the Head of Testing Operations.
Qualifications
- Ph.D. in relevant field with 10+ years of experience in molecular laboratory experience or M.S. degree in Molecular or related field with 15+ years of relevant experience is preferred
- Strong background and deep subject-matter expertise in Analytical methodologies
- Experience managing a large team of full-time scientists, including PhD level scientists, supporting multiple projects and fostering a culture of innovation, teamwork, performance and trust, with 5 years (minimally) of People Management experience is required.
- 10 years of biotechnology experience or relative industry experience is required, with experience in Gene Therapy preferred.
- Demonstrated Experience transferring, qualifying and validating to a GMP lab setting (cGMP experience is required).
- Strong management/leadership skills and demonstrated ability to lead a group of scientists to deliver on objectives in defined timelines is required.
- Independent, self-motivated and innovative and the ability to excel in a goal-oriented, multifaceted and fast-moving team environment are required.
- Outstanding communication, organizational and leadership skills, with a successful track record of collaborating with cross-functional scientific teams is required.
- Capable of multi-tasking but with attention to detail, working on multiple projects, while delivering on objectives and budget
Director of Molecular Biology, Cell and Gene Therapy Operations
Summary
The Director of Molecular will be responsible for providing senior leadership over Molecular testing services supporting Cell and Gene Therapy Programs at the Center for Breakthrough Medicines (CBM). The Director will be a key member of the Testing Leadership team and will be responsible for leading the development of a new Molecular laboratory, transitioning and implementing GMP test methods from Analytical Development and other cross-functional groups, and CBM’s clients. The Director will be responsible for managing a large team of Cell and Gene Therapy scientists that will be directly responsible for delivering results to our customers for complex characterization and product release methods. The Director will also be responsible for driving the strategy and execution of new analytical technologies and techniques to serve our clients, bringing cell and gene therapies from bench to bedside.
Responsibilities
- Lead a team of highly talented scientists responsible for delivering testing for Cell and Gene Therapy Programs and new modalities
- Lead development of a new Molecular laboratory at CBM for cell and gene therapy programs that will be supporting GMP work.
- Provides technical and scientific leadership to the team responsible for validation and GMP Testing of Molecular assays supporting Cell and Gene Therapy Programs
- Responsible for managing a total of 30 – 40 Scientists with plans for future expansion.
- Execute on the cell and gene therapy strategy, in alignment with all CBM operations and support functions
- Establish and monitor performance against established KPIs, internal metrics and trends to ensure the department performance against Safety, Compliance, Technical Trending and Delivery.
- Maintain Operational execution of the department to CBM expectations through regular business reviews and other performance management activities.
- Develops talent strategies and implements hiring, and broader talent issues and provides people-related decisions for a department/multiple teams within Testing and Analytical Services that cultivates innovative culture.
- Actively lead the strategic direction and goals of the department
- Build and foster relationships across the technical operations groups, Analytical Development Departments, contributing to projects and peer review when required
- Responsible for ensuring quality, consistency and best practice within reporting line
- Accountable for scientific development and mentoring of scientists within reporting line
- Fostering a culture of scientific rigor and continuous improvement in line with the Innovation Performance and Trust strategy at The Center for Breakthrough Medicines
- Ensure compliance with The Center for Breakthrough Medicines values and policies
- Evaluate risks and opportunities with Sr. Management and drive strategic outcomes for the business.
- Recommends hire/transfer/promotion/discharge and salary changes and acts on employee problems. Conducts employee performance appraisals in a timely and objective manner. Monitors the growth and career development of direct reports.
- Ensure quality and assists Quality Assurance in maintaining all technical and regulatory requirements.
- Continuously reach out to academia, conferences, literature to stay ahead of developments in the space of Cell and Gene Therapy
- Monitor the effective implementation of appropriate EHS and Biosafety procedures and provide for their updating in line with SOPs.
- Where required, and in partnership with QA/Regulatory Affairs, meet with relevant Regulatory Bodies to resolve any compliance issues or help with any new business requirements that potentially impact the accreditation or compliance status.
- Represent the Company to customers, visitors, community organizations, local/state and governmental authorities, unions, industry associations and regulatory agencies.
- Perform all other related duties as assigned by the Head of Testing Operations.
Qualifications
- Ph.D. in relevant field with 10+ years of experience in molecular laboratory experience or M.S. degree in Molecular or related field with 15+ years of relevant experience is preferred
- Strong background and deep subject-matter expertise in Molecular biology
- Experience managing a large team of full-time scientists, including PhD level scientists, supporting multiple projects and fostering a culture of innovation, teamwork, performance and trust, with 5 years (minimally) of People Management experience is required.
- 10 years of biotechnology experience or relative industry experience is required, with experience in Gene Therapy preferred.
- Demonstrated Experience transferring, qualifying and validating to a GMP lab setting (cGMP experience is required).
- Strong management/leadership skills and demonstrated ability to lead a group of scientists to deliver on objectives in defined timelines is required.
- Independent, self-motivated and innovative and the ability to excel in a goal-oriented, multifaceted and fast-moving team environment are required.
- Outstanding communication, organizational and leadership skills, with a successful track record of collaborating with cross-functional scientific teams is required.
- Capable of multi-tasking but with attention to detail, working on multiple projects, while delivering on objectives and budget