The Director will partner with late-stage product development teams in order to ensure the robustness of analytical methodology in a commercial setting and will take a leadership role in its implementation at contract manufacturing facilities. The Director is expected to lead continuous improvement opportunities throughout method life-cycle and have a solid understanding of the regulatory and business impact of making changes to existing analytical technology in order to help define the appropriate regulatory and validation strategies to support post-approval changes. The Director will lead high-impact cross-functional initiatives, the resolution of complex analytical / manufacturing issues and provide strategic input to the commercialization of new products and the direction of the Technical Operations - Analytical group. 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.
Key Responsibilities:
• Represent Technical Operations in cross-functional CMC
subteams to influence late stage product development, regulatory submissions and minimize commercialization risks while building strong relationships with key stakeholders.
• Partner with Pharmaceutical Development, Supply Chain, Quality
and Regulatory on activities 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-Analytical group
• Mentor and develop junior staff within Technical Operations – Analytical
Minimum Qualifications:
BS/MS and 12+ years or PhD with 8+ 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)
- Experience with both drug substance and drug product (especially oral solid dosage forms) development
- 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
Preferred Qualifications:
- 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