The purpose of this role is to provide leadership and Subject Matter Expertise (SME) in process chemistry. The Director of Process Chemistry will support Phlow's CDMO business to meet its objectives. This role serves as the technical leader for API development projects and oversees Phlow's partners, ensuring excellence in process development and technical transfer. The candidate will interact with various internal and external departments (EH&S, Operations, Program Management, Quality Assurance, Regulatory Affairs, Commercial, Finance) and embody Phlow's shared values and culture, working with high standards of safety, integrity, transparency, and ethics to create win-win scenarios for patients, customers, partners, and colleagues.Requirements:
Lead process development projects for small molecule APIs, key intermediates, or related materials.Ensure projects meet all deliverables, including budgets and timelines.Support Phlow's US government and commercial businesses effectively.Provide SME support on other Phlow projects.Ensure efficient technology transfers.Evaluate new projects to identify scalable, cost-competitive synthetic routes ready for transfer to manufacturing.Conduct literature searches and laboratory work to identify and develop optimal synthetic routes.Review, author, and approve relevant documentation such as protocols, reports, batch records, validation documents, and specifications.Participate in continuous improvement initiatives to enhance product quality, robustness, and cost-effectiveness.Manage multiple projects and make timely decisions aligned with business priorities.Collaborate with various departments to maintain strong working relationships.Qualifications:
Minimum of 7 years of relevant experience in process chemistry management within the pharmaceutical or CDMO industry.Proven success in process development, technology transfer, and continuous improvement.Understanding of business principles in a CDMO or similar environment.Experience working in multidisciplinary teams.Excellent interpersonal and communication skills.Ability to lead, mentor, influence, and collaborate effectively.Preferred Qualifications:
PhD or equivalent in Organic Chemistry, Pharmaceutical Sciences, or related field.Extensive process chemistry and API manufacturing experience at multi-kilogram scale.Experience with generic API development, technology transfer, and manufacturing.Knowledge of ICH and cGMP regulations.Experience working with CROs, CMOs, or CDMOs, including vendor management.Experience speaking at conferences and publishing in peer-reviewed journals.Knowledge of risk assessments related to process robustness and impurities.Experience with design of experiments (DOE) and multivariate experimentation.Experience contributing to regulatory submissions.Experience with continuous flow manufacturing is a plus.Working Conditions:
Exposure to chemicals and high noise areas.High emphasis on safety for personnel and equipment.Use of PPE such as respirators, gloves, safety glasses, and protective clothing may be required.Physical Requirements:
Ability to work in various positions, including walking, standing, or sitting for prolonged periods.Exposure to indoor and outdoor environments with varying temperatures.#J-18808-Ljbffr
