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Job Description

POSITION SUMMARY:

The Director, Analytical Sciences & Technology (AS&T) - Small Molecule has central responsibility for analytical and testing support for global, virtual manufacturing operations, overseeing activities of staff and adapting personnel deployment to

changing priorities. The Director champions continuous improvement of activities and relationships

within and outside Vertex. The Director takes a leadership role in company-wide initiatives and

guides resolution of critical issues impacting manufacturing and analytical operations.

KEY RESPONSIBILITIES:

• Ownership of commercial drug product analytical methods and specifications, expertise on global impact of product stability and shelf-life
• Provide analytical expertise for global expansion and the elements that impact AS&T, including elemental impurities, nitrosamines, water control strategy, microbial testing, packaging and co-packaging
• Drug product analytical method validations, including analytical tech transfers and all associated activities/documentation
• Actively drive best practices and continuous process improvement for processes that impact AS&T
• Method transfers to new CMOs and analytical support for second-source activities
• Supporting new product development and commercialization and problem-solving/root cause analysis
• Authoring, reviewing, and approving technical documentation, including reports, protocols, work instructions, SOPs, etc.
• Understanding of physical characterization method development (XRPD, laser diffraction, vision analysis, powder flow analysis, etc.)
• Understanding of the fundamentals of QbD, the use of DOEs in process development and commercial, and the implications of criticality and thresholds on the commercial functions
• Assist with and lead resolution of quality investigations
• Work with supervisor to develop tools and standards for department functions
• Ensure positive and effective relationships between Vertex and key suppliers of materials, technology, and manufacturing and testing resources
• Independently represent the department on cross-functional CMC sub-teams and select task force teams
• Responsible for overall relationship with contract manufacturing partners; provides leadership for the working team
• Determine project assignments and staffing requirements for projects
• Assist in setting overall strategy for technical area and creation of department goals
• Takes full responsibility within scope of the position to work with groups such as Quality, Supply Chain, Regulatory, Pharmaceutical Development, contract partners, etc. to proactively resolve issues that may negatively impact project timelines or deliverables

TECHNICAL AND COMMUNICATION SKILLS:

• Excellent interpersonal and collaboration skills
• Knowledge of cGMP’s and associated CMC regulatory considerations in a pharmaceutical environment
• Proven ability to interact effectively and give presentations to senior management
• Demonstrated flexibility to accommodate changes in responsibilities or project priorities

In addition to those of Associate Director:

• Expert knowledge of cGMP’s and associated CMC regulatory considerations in a
• pharmaceutical environment
• Proven ability to lead and manage projects of high complexity including development of
• and adherence to timelines and budget
• Fosters a team environment of confidence and commitment and models the core values
• throughout the organization
• Has achieved distinction in resolving important organizational problems using innovative
• approaches
• Knowledgeable in technical areas outside main area of expertise
• Proven supervisory experience and track record of enabling career development of staff

Education and Experience:

• Small molecule experience
• Bachelor's degree, Masters degree or PhD in Analytical Chemistry or related field.
• Ph.D. (or equivalent degree) and 9 years of relevant post-doctoral employment experience, or
• Masters Degree (or equivalent degree) and 12 years of relevant employment experience, or
• Bachelors Degree (or equivalent degree) and 15 years of relevant employment experience

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