Vertex Pharmaceuticals creates new possibilities in medicine to cure diseases and improve people’s lives. This Senior Director, Technical Operations - Analytical opening is an exciting opportunity to join Vertex’s growing Technical Operations team and play a critical role in the rapid commercialization of new life-changing products. If you are looking for an entrepreneurial, non-hierarchical, science-driven, collaborative environment where you can have a highly visible impact, then this is the perfect position for you!
The Senior Director will lead all analytical activities supporting commercial products, from raw materials through drug substance, intermediates, and drug product. Responsibilities include partnering with late-stage product development teams in order to ensure the robustness of analytical methodology in a commercial setting, leading its implementation internally and at contract manufacturing facilities, and maintaining an in-house GMP lab to provide strategic support for investigations, method changes, tech transfer activities, and selected QC testing. The Senior Director is expected to lead continuous improvement opportunities throughout the method and product life-cycle and to have a robust understanding of the regulatory, quality, and business environment to in order to champion innovative strategies to support initial Market Authorizations, post-approval changes, and global expansion. The Senior Director will lead high-impact cross-functional initiatives, provide strategic input to the commercialization of new products and the direction of the Technical Operations organization, and will play a key role driving ongoing innovation in areas such as Quality-by-Design, predictive stability, continuous manufacturing and PAT.
In order to assure success in this role, the candidate must be an excellent collaborator with proven experience in a cGMP pharmaceutical environment while bringing creativity and energy to all teams in order to promote positive, collaborative, and effective relationships with internal stakeholders and key external suppliers.
- Represent Technical Operations in leadership forums to influence late stage product development and regulatory submission strategies, minimize commercialization risks, and foster effective post-approval and lifecycle management approaches while building strong relationships with key stakeholders.
- Partner with Pharmaceutical Development, Supply Chain, Quality and Regulatory to define technical transfer strategies which enable process validation and commercial manufacturing of Vertex products at new suppliers and new manufacturing sites.
- Design/conduct complex troubleshooting activities associated with ongoing commercial manufacturing.
- Participate in shaping the strategic direction of the Technical Operations department
- Mentor and develop staff within Technical Operations – Analytical
- BS/MS and 16+ years or PhD with 12+ years of relevant work experience
- Proficient in standard analytical technology (chromatography, spectroscopy, compendial methods, etc.)
- Proficient in at least one other area of pharmaceutical development (e.g. solid state analysis, dissolution IVIVC, physical characterization, trace analysis, PAT/chemometrics)
- Experience with small molecule drug development for both drug substance and drug product (especially oral solid dosage forms)
- Advanced knowledge of cGMP’s (e.g. Quality Control) and associated CMC regulatory considerations in a pharmaceutical setting
- Must be a committed team player and collaborator
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
- PhD in Analytical Chemistry
- Experience in applying QbD concepts, methodology and implementation to analytical technology and manufacturing processes
- Strong knowledge of DoE and statistics
- Experience with any or all of the following is a definite plus: cleaning validation, microbial testing, heavy metals testing, experience with regulatory submissions in Emerging Markets, post-approval change management
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