Associate Director, Manufacturing Science & Technology

Location:

Philadelphia area preferred/Remote

Founded in 2019, Veradermics, Incorporated (NYSE: MANE) is a well-funded, publicly listed company that offers the opportunity to work in a performance-driven, highly dynamic environment. At Veradermics, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally.

Veradermics is a dermatologist-founded, late clinical-stage biopharmaceutical company focused on developing innovative therapeutics for common aesthetic and dermatological conditions.

Veradermics lead product candidate, VDPHL
01, is as an oral, non-hormonal treatment for men and women with pattern hair loss (PHL). We are currently conducting three Phase 3 clinical trials as we work to deliver potentially transformative solutions and aspire to redefine the standard of care in dermatology. Learn more here.

At Veradermics, we combine scientific rigor with a vision for impactful innovation to make a lasting difference in the lives of patients.

• You Can Be Part of a Meaningful Mission:
  Veradermics aims to become a leader in medical dermatology by bringing pharmaceutical innovation to the treatment of common skin conditions to improve the lives of patients.
• Veradermics is Growing:
  Veradermics is a dynamic and growing company; we are advancing our VDPHL
  01 Phase 3 clinical trials and preparing for commercialization. PHL affects approximately 80 million people in the U.S. alone.
• The Veradermics Culture:
  We are an innovative, collaborative, hard-working and performance-driven company that values the contributions of our employees and keeps our focus on patients
• We have been featured in Forbes, Allure, Marie Claire, Bazaar, Dermatology Times, the Slate, The New York Post, The Hartford Courant, The Kansas City Star, and other multi-media platforms.

The Associate Director, Manufacturing Science and Technology will play a critical role in supporting the successful transfer, scale-up, validation, and ongoing performance of drug product manufacturing processes. This individual will serve as a technical expert who ensures robust, compliant, and efficient manufacturing throughout the product lifecycle, partnering closely with contract manufacturing organizations and internal cross-functional teams.

• Develop and maintain technical and business relationships with respective CMOs.
• Participate in the technology transfer of processes and analytical methods between contract manufacturing organizations for a pre-commercial drug product.
• Evaluate scale-up, equipment capabilities, and process parameters, and design manufacturing research studies to demonstrate equivalent performance.
• Evaluate the impact of raw material changes and design manufacturing research studies to demonstrate equivalent performance.
• Provide product expertise to CMOs during manufacturing campaigns, including assistance with troubleshooting.
• Develop and maintain process documentation, including batch records, control strategies, and technical protocols.
• Support process validation activities (PPQ), continued process verification (CPV), and lifecycle management.
• Provide on-the-floor technical support during manufacturing campaigns and resolve process-related challenges.
• Perform risk assessments, such as FMEA, for manufacturing processes, equipment, raw materials, and suppliers.
• Conduct root cause analysis, support deviations, and implement CAPAs.
• Analyze process data using statistical tools, including DOE, SPC, and multivariate analysis.
• Contribute to regulatory filings, including IND, NDA, and BLA submissions, and support regulatory inspections.
• Collaborate closely with R&D, Quality, Operations, Engineering, and Supply Chain partners.

• MS or PhD in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biochemical Engineering, or related field; BS with relevant industry experience will be considered.
• 5-15+ years of experience in pharmaceutical manufacturing, MS&T, or process development.
• Strong understanding of cGMP, process validation principles, and ICH guidelines, including Q8-Q11.
• Experience with statistical software, such as JMP or Minitab, and data-driven decision-making.
• Solid knowledge of unit operations relevant to Veradermics' product modalities, including OSD, blending, compression, and packaging.
• Experience with domestic and global tech transfers and commercial manufacturing support.
• Familiarity with QbD…