Senior Director of Process Chemistry- Manufacturing, Science & Technology-(MS&T)

Company: Phlow Corp.
Location: Richmond
Posted on: March 20, 2023

Job Description:

The---purpose of this role is to---manage partner Contract Development Manufacturing Organizations (CDMOs) to ensure excellent Active Pharmaceutical Ingredients (API)---manufacturing process development, technical transfer, validation and commercial manufacture of Phlow's target APIs, and to drive continuous improvement, when appropriate. The candidate will be a partner-facing---leader who personifies Phlow's shared values and culture, both internally and externally.---This role's scope---spans---from process design and development through manufacturing and regulatory submission.---The candidate---will work with the highest standards of integrity, transparency, and ethics to create win-win scenarios for patients, customers, partners, and colleagues.--- -Responsibilities:------ -

• Manage R&D development partners to ensure a scalable, cost-competitive manufacturing process is developed on time, on budget and ready for technology transfer to manufacturing partners -
• Manage manufacturing partners to ensure that manufacturing processes are successfully validated and product manufactured on time and on budget -
• Review, author and approve manufacturing process documentation such as process development protocols and reports, batch records, validation protocols and reports, specifications, etc. - -
• Contribute to the timely and accurate preparation of regulatory submissions - -
  • Supervise the ongoing continuous improvements in manufacturing processes resulting in improving product quality, robustness, and cost -
  • Manage multiple projects/workstreams and make sound and timely decisions based on business priorities -
  • Assist as a process chemistry SME for CRO/CDMO/CMO audits -
  • Collaborate with Project Management, Analytical Chemistry, Quality Assurance, Regulatory Affairs, and Engineering to ensure strong working relationships with all partners and Phlow employees------ -Qualifications:------ -
    • Minimum of---10 years working in related roles in the pharmaceutical industry demonstrating increasing---responsibility------ -
    • Strong track record of success---including process development, technology transfer, and continuous improvement------ -
    • Strong interpersonal and communication skills--------- ----Preferred Qualifications:------ -
      • PhD (or equivalent based upon work experience) in Organic Chemistry, Pharmaceutical Sciences or a related scientific field -
      • Significant process chemistry and API manufacturing experience on multi-kilogram scale -
      • Experience with generic API development, technology transfer and manufacture -
      • Knowledge of ICH and cGMP requirements -
        • Experience managing third-party vendors (CROs/CMOs/CDMOs) -
        • Experience with technical and operational risk assessments (e.g., process robustness, mutagenic impurities, nitrosamines, etc.) -
        • Experience with design of experiments (DOE) and related multivariate experimentation approaches -
        • Experience with the development and implementation of continuous flow manufacturing processes is a plus -
        • Experience authoring or contributing to regulatory submissions (NDAs/ANDAs/DMFs) -About Phlow: - Phlow Corp. ("Phlow") is a public benefit essential medicine manufacturing company dedicated to reliably supplying affordable, high-quality, essential medicines through U.S. based advanced manufacturing processes. The company manufactures precursor chemical ingredients, active pharmaceutical ingredients (API), and finished pharmaceutical products, domestically for essential medicines critical to the Nation's healthcare. To help ensure the quality, safety, and affordability of pharmaceutical products of strategic importance to the United States, Phlow utilizes advanced manufacturing platforms, including continuous manufacturing, to provide essential medicines to its customers, health systems, and government partners. - - - - -Phlow's commitment to diversity includes recognition that our mission is best advanced by the leadership and contributions of colleagues of diverse backgrounds, beliefs, and culture. Recruiting and mentoring staff to create an inclusive organization that reflects our shared values is a priority. - -Corporate Social Responsibility: At Phlow, we recognize and put great value in our responsibility to all of our stakeholders. This is why Phlow pays attention to the triple bottom line, which considers social, environmental, and financial sustainability. Team members are expected to understand these concepts and consider the triple bottom line in daily decision making. - - -EEO Statement: - - Phlow provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability or genetics. In addition to federal law requirements Phlow complies with applicable state and local laws governing nondiscrimination in employment in every location in which the organization has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. - - -At Phlow, we are committed to our people. We strive to create a best workplace in the world through providing world class benefits and creating a culture around our shared values. We are proud to be a certified Great Place to Work. Find out more about what makes Phlow a great place to work - -Powered by JazzHR

Keywords: Phlow Corp., Richmond , Senior Director of Process Chemistry- Manufacturing, Science & Technology-(MS&T), IT / Software / Systems , Richmond, Virginia