Companies you'll love to work for

Job Description

As a key team leader in the Manufacturing Sciences & Technology function, the Associate Director, Analytical Sciences & Technology, Small Molecules- Drug Substance is accountable for all activities and resources associated with the commercialization and management of analytical activities for commercial programs for Vertex’s small molecules portfolio. As a member of the leadership team, the role will contribute to ensuring consistency and compliance with GMPs, managing activities internally and with external partners and partnering with late-stage product development teams to ensure the robustness of analytical methodology in a commercial QC setting. This role will be instrumental in the identification of contract test facilities and implementation of methods during the project transition to the commercial group and for global expansions during the commercial stage. Overseeing the teams across therapeutic areas, the role will ensure consistent conduct and timely execution of Quality testing and is expected to lead continuous improvement opportunities throughout the method life cycle and have an understanding of the regulatory and business impact of making changes to existing analytical technology to help define appropriate regulatory and validation strategies to support post-approval changes. The individual will participate in high-impact cross-functional initiatives, lead the resolution of complex analytical/manufacturing issues, provide strategic input to late-stage product development and commercialization of new products, and maintenance of existing commercial products.

To be successful in this role, the candidate must be an excellent collaborator with proven experience in a cGMP pharmaceutical environment while bringing creativity and energy to teams to promote positive, collaborative, and effective relationships with internal stakeholders and key external suppliers.

Working directly with contract manufacturing organizations and a highly diverse group of scientists at Vertex they will be part of an organization that thrives on innovation and is at the forefront of implementing Quality by Design and Continuous Manufacturing.

Key Responsibilities:

• Represent AS&T on cross-functional CMC teams to influence late-stage product development for commercialization while building strong relationships with key stakeholders.
• Responsible for method transfers, validation, or co-validation to support late-phase and commercial projects to various CMOs or between internal groups
• Own/Review/Approve commercial documents to support new and existing commercial products (methods, SOPs, transfer protocols/reports, lab notebooks, technical reports, specifications, etc.), and their continual improvement/update to ensure compliance and technical content.
• Partner with Development, Supply Chain, Quality, and Regulatory teams to define technical and regulatory strategies that enable process validation, commercial manufacturing, and post-approval maintenance of Vertex products at current and new suppliers for drug substances.
• Analyze data and metrics related to analytical performance, identifying trends, patterns, and potential areas of concern, and develop strategies for continuous improvement
• Author analytical sections in regulatory submissions and post-approval submissions.
• Manage a team of analytical scientists and act as a knowledge resource for junior staff within the team.
• Oversee/own the quality control process at CMOs from inspection and testing to documentation and reporting and Quality events management
• Design/conduct complex troubleshooting activities associated with ongoing commercial manufacturing.
• Continuous method improvement through commercial change control procedures

Knowledge and Skills:

• Knowledge of cGMP’s (e.g. Quality Control), ICH guidelines, and associated CMC regulatory considerations in a pharmaceutical setting
• In-depth knowledge of General Medicine, process chemistry, and associated analytical support.
• Strong leadership skills with the ability to communicate clearly and effectively in a matrix environment.
• Comprehensive knowledge of control strategies such as in-process control strategy, specifications development, and maintenance/ update of global specifications.
• Proficient in the development and validation of chromatographic (HPLC, GC), physical characterization, compendial (KF, elemental impurity, or spectroscopy) and other common analytical techniques used in pharmaceutical analysis
• 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.
• Experience developing, implementing, and troubleshooting analytical methods in the GMP/commercial pharmaceutical industry, supporting new product development and/or commercialization
• 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 in responsibilities or project priorities
• Experience authoring and reviewing Regulatory submissions, investigations, change controls, and corrective/preventative actions (CAPA)
• Experience in developing process maps and implementing sustainable process improvements is desired

Education and Experience:

• Bachelor's, Master's, or PhD in Chemistry, Chemical Engineering, Pharmaceutical Chemistry or other natural science
• Typically requires the following, or the equivalent combination of education and experience: PhD and 7+ years, or Master's and 10+ years, or Bachelor's and 13+ years of relevant work experience.
• Supervisory/management experience is desired.

Company Information