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Sr. Director, Analytical Sciences and Technology - Small Molecule Drug Product

Semma Therapeutics

Semma Therapeutics

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IT, Product
Boston, MA, USA
Posted on Wednesday, January 24, 2024

Job Description

The Analytical Sciences & Technology (AS&T) – Small Molecule Drug Product Senior Director has central responsibility for global commercial operations related to their technical area to ensure successful commercialization and production of Vertex products. The Senior Director models leadership behaviors, builds and organization capable of ensuring future success, develops leaders, and drives efficiency and risk reduction into relevant internal and external processes. The Senior Director is a major contributor to overall AS&T strategy development and to the collective success of Manufacturing Sciences and Technology (MS&T) at Vertex.

This position reports directly to the Head of AS&T.

Key Responsibilities:

The responsibilities of this position may include, but are not limited to, the following:

  • 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/validations 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.
  • Represents Vertex to global regulatory agencies
  • May Represent AS&T on strategic teams such as supplier JDCs/JMCs
  • Integrates AS&T activities with other areas of the company such as Pharm Sci, Quality, Regulatory, Marketing, Commercial Operations, etc.
  • Champions initiatives that foster the company’s core values
  • Provides guidance on the resolution of key quality issues in collaboration with relevant stakeholders
  • Represents AS&T on corporate teams and participates in the long-range planning process
  • Drives critical company-wide initiatives impacting commercial manufacturing operations
  • Cultivates morale and esteem in others
  • May provides support to Business Development in due diligence activities for partnering or out-licensing of compounds
  • Reviews and approves documents with strategic importance to department or organization
  • Is required to supervise staff, with all incumbent supervisory responsibilities
  • Takes full responsibility within scope of the position to work with various stakeholders (such as Quality, Supply Ops, Regulatory, Development, suppliers, etc.) to proactively and collaboratively resolve issues that may negative impact project timelines or deliverables
  • Performs other duties as assigned

Technical and Communication Skills:

  • Exhibits an outstanding record in multiple projects, enabling the success of others
  • Proven ability to develop staff
  • Acumen recruiting quality staff and refining activities to improve productivity across disciplines
  • Advanced understanding of regulatory and supply chain fields that impinge on primary area(s) of responsibility
  • Displays compelling verbal, written and presentation skills in communication with internal and external customers

Education and Experience:

  • Bachelor's degree, with a preference in Chemistry, Chemical Engineering, Pharmaceutical Chemistry or other natural science
  • Ph.D. (or equivalent degree) and 11+ years of relevant post-doctoral employment experience, or
  • Masters Degree (or equivalent degree) and 15+ years of relevant employment experience, or
  • Bachelors Degree (or equivalent degree) and 20+ years of relevant employment experience

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.

This job is no longer accepting applications

See open jobs at Semma Therapeutics.