Director, MSAT Analytical, Small Molecule

Job Description

General Summary:

The Director Analytical Sciences and Technology (Small Molecule Drug Product) is a leader and subject matter expert who represents the analytical function for multiple product areas in cross-functional and external settings. The director provides technical and strategic leadership across global test sites for analytical process and CMC functions primarily focused on small molecule commercialization and global expansion including SDDs and Formulation-Drug Product. The Director has central responsibility for analytical and testing support for global manufacturing operations overseeing activities of staff and adapting personnel deployment to changing priorities. They take a leadership role in department-wide initiatives and guide the resolution of critical issues impacting manufacturing and analytical operations.

The position reports directly to the Senior Director of Analytical Sciences and Technology.

Key Duties and Responsibilities:

• Responsible for all aspects of the team(s) and manages activities of the team(s) across project boundaries
• Manage support mentor hire and develop scientist within their team
• Represent Analytical Science and Technology on cross-functional CMC sub-teams with minimal guidance to influence late-stage process/product development and minimize subsequent commercialization risk
• Lead and direct the plans and activities of their DP functional area ensuring safe and GMP-compliant operations that adhere to budget and schedule.
• Recognized as subject matter expert and acts as a resource in one or more technical areas
• Provide analytical expertise for global expansion commercial supply and regulatory submissions
• Expertise in analytical strategy and methodologies for DP release stability and characterization testing. Responsible for commercial drug product analytical methods specifications and global impact of product stability and shelf-life.
• Own Drug product analytical method validations analytical method transfers in-country testing and associated activities/documentation
• Actively drive best practices and continuous process improvement for programs & processes on behalf of AS&T
• Support process transfers to new CMOs and analytical support for second-source activities and problem-solving/root cause analysis
• Provide scientific and technical input to assess potential business opportunities new ventures and product development. Identify areas or equipment and capabilities the team should consider for evaluation and commercialization.
• Author review and approve technical quality and regulatory documentation.
• 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 the resolution of quality investigations change controls CAPAs and Quality events
• Ensure positive relationships with key suppliers stakeholders and represent the department on cross-functional teams. 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
• Participate in the scientific community by attending conferences and being on external committees to support the company strategy of being best in class

Knowledge and Skills:

• Excellent interpersonal and collaboration skills
• Knowledge of cGMPs 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
• Proven ability to lead and manage projects of high complexity including the development of and adherence to timelines and budget
• Fosters a team environment of confidence and commitment and models the core values throughout the organization
• Knowledgeable in technical areas outside the main area of expertise
• Proven supervisory experience and track record of enabling career development of staff

Education and Experience:

• Small molecule experience
• Bachelors degree Masters degree or PhD in Analytical Chemistry or related field.
• Ph.D. (or equivalent degree) and 10 years of relevant post-doctoral employment experience or
• Masters Degree (or equivalent degree) and 13 years of relevant employment experience or
• Bachelors Degree (or equivalent degree) and 15 years of relevant employment experience

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertexs 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 persons 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