Vertex Cell and Genetic Therapies (VCGT) is seeking an Associate Director, Analytical Development to join its growing Cell Analytical Development team. The candidate will lead the development and qualification/validation of test methods and analytics supporting the manufacturing and release of our cell-
based products. The candidate will be responsible for both the strategic planning and day-to-day execution of specific projects, in collaboration with various stakeholders. The candidate will manage the scientiﬁc functions and coordinate the activities of one or more functional teams
Key Duties and Responsibilities:
- Lead the design, execution and analysis of studies to develop and qualify and validate test methods, demonstrate technological feasibility and characterize cell- based products, including safety, composition and potency.
- Manage and provide subject matter expertise to a team of scientists to support multiple VCGT cell-based programs
- Lead development of analytical program plans in conjunction with relevant stakeholder and Sr. management as well as oversee their execution to meet strategic objectives
- Monitor and report on project progress, write analytical development protocols and reports, provide recommendations to senior management
- Identify, qualify and manage analytical reagents as per regulatory standards
- Establish design criteria using Design of Experiments (DOE) and other contemporary development tools
- Perform sufficient statistical analysis to establish specificity, sensitivity, linear range, precision and accuracy of test methods.
- Establish reference standard materials as required to support assay validation.
- Assists with developing department goals and ensures linkage to personnel goals in support of the corporate goals
- Constructs draft-budgets and manages execution of approved budgets and hiring for the group(s)
- Oversees effective management of group’s CRO/CDMO contracts and/or external scientiﬁc collaborations
- Communicates company objectives to the group(s) and availability of group(s) resources and methods to project team(s), in a clear and timely manner
- PhD in cell/molecular biology or related discipline with 8+ years of industry experience in assay /analytical development, plus 5 years management experience or MS with 10+ years will be considered
- Previous experience leading a team of scientists
- Deep practical knowledge of analytical development requirements, regulatory guidance
- Good understanding of statistical methods requirements for study design and data analysis
- Proven experience with the culture of multiple mammalian cell lines
- Ability to use literature to design proof of concept experiments for assays
- Demonstrated prior experience developing cell-based and analytical biochemistry assays for the assessment of product composition and potency employing multiple analytical methods (ELISA, PCR, FC, HPLC, etc…)
- Excellent organizational skills, technical writing, record-keeping and ability to manage multiple projects
- Excellent written and verbal communications skills, and the ability to present and defend positions and approaches critical to program progression and success
- Strong knowledge of GMP, GLP, ICH and other regulatory requirements for biological product characterization and release assay qualification.
- Flexible team player excited to collaborate with internal and external partners
- Flexibility in working schedule to accommodate deadlines and weekend work as necessary
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.