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Director, Analytical Sciences & Technology (Biologics, Cell & Gene Therapy)

Semma Therapeutics

Semma Therapeutics

IT
Boston, MA, USA
Posted on Tuesday, June 25, 2024

Job Description

The Director of Protein Analytics, Reference Standard & Critical Reagent Management is a leadership position within the Analytical Science & Technology team, reporting to the MS&T function. The Director will provide expertise in biological assays and analytical requirements to ensure readiness for commercial submissions, product launches, global expansions, and scalability for the commercial Biologics portfolio. The candidate will lead a team of scientists to manage all commercial analytical activities overseeing the development, validation, transfer, and implementation of an end-to-end analytical strategy for the biologics portfolio products. Additionally, the role involves supporting and maintaining the global management of reference standards and critical reagents used in testing late-stage clinical and commercial products for all Vertex products. The director will partner closely with all departments within Vertex, and with contract testing sites establishing a solid partnership to ensure compliance with cGMP and Quality Management systems for the global network to effectively deliver our medicines to patients.

This position will report directly to the Executive Director, AS&T.

Key Responsibilities:

  • Develop and manage analytical commercial capabilities, robust and compliant analytical methods, and strategies to support the biologic’s products efficiently and independently.

  • Represent AS&T on cross-functional teams to influence product development for commercialization while effectively collaborating with stakeholders to define technical and regulatory strategies that enable process validation, commercial manufacturing, testing, and post-approval maintenance.

  • Lead or provide technical expertise for the development/ optimization, method transfers, validation, or co-validation to support late-phase and commercial projects to various CDMOs or CTLs.

  • Led the development of global business practices, processes, projections, and standards for Reference Standards, Assay Controls, and Critical Reagent supply planning, including qualification, inventory management, logistics, re-qualification, expiry extensions, and storage planning in partnership with AD and QC teams.

  • Act as the main point of contact for reference standards and critical reagent management for commercial programs. Oversee the lifecycle management across the portfolio of products including documents for qualification, data trending, and re-qualification of alternative/replacement reagents

  • Lead/ author/ review regulatory submissions (BLA, PAS, and PMCs), and health authority interactions (briefing books and queries).

  • Own/Review/Approve commercial documents to support new and existing commercial products (methods, SOPs, technical protocols/reports, change controls, etc.), and their continual improvement/update to ensure compliance and technical content.

  • Manage a team of scientists responsible for the molecular and cell-based assay platforms and reference standard management to support the rapid advancement of programs.

  • Responsible for all analytical change management ensuring compliance with global cGMP, and Quality Management systems.

  • Provide analytical oversight for CDMO, and CTLs to support commercial manufacturing and act as the primary contact for regulatory inspections and audits for analytical activities.

  • Analyze regulatory guidance documents in areas relevant to the testing of biological products and advise on actions that could adversely affect the program or represent opportunities to be pursued.

  • Analyze data and metrics related to analytical method performance, identify trends, patterns, and potential areas of concern, and develop strategies for continuous improvement.

Knowledge and Skills:

  • In-depth knowledge of commercial biological assay development, validation, transfer, and troubleshooting compliant with GMP operations, supporting product development and/or commercialization

  • Expertise in 2-tiered biologics reference standard requirements, including qualification, implementation, method performance monitoring, and re-qualification

  • Strong leadership skills with the ability to communicate clearly and effectively in a matrix environment.

  • Comprehensive knowledge of cGMP’s, ICH guidelines, and CMC regulatory considerations in a commercial setting

  • Experience authoring and reviewing Regulatory submissions, responses, investigations, change controls, and corrective/preventative actions (CAPA)

  • Experience contributing to CMC strategy through participation on the project team with the proven ability to build open and collaborative relationships and work effectively as a member of a multidisciplinary team

  • Experience in critical evaluation and interpretation of data, visualization tools, and technical writing skills to generate comprehensive assessments and reports.

  • Extensive knowledge of Benefit-Risk strategies, problem-solving/root cause analysis for analytical-related issues, and decision-making with the ability to influence colleagues.

  • Excellent time management, and organizational skills with an ability to work effectively in a fast-paced, rapidly changing environment.

  • Demonstrated ability to effectively manage project(s), work successfully in a team/matrix environment as well as independently, and flexibility to accommodate changes.

  • Experience managing CTL/CDMO analytical testing is desirable.

  • Demonstrates advanced judgment balancing technical feasibility, opportunity, and impact while showing initiative and ability to capitalize on scientific creativity and insights.

Education and Experience:

  • PhD, Master’s or Bachelor's in Biochemistry, Cell & Molecular Biology, Analytical Chemistry, or related discipline

  • Typically requires the following, or the equivalent combination of education and experience: PhD and 10+ years, or Master's and 13+ years, or Bachelor's and 15+ years of relevant work experience

  • Supervisory/management experience is desired.

Flex Designation:

On-Site Designated

Flex Eligibility Status:

In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

Company Information

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.

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