Manager/Director, Continuous Manufacturing R&D Laboratory, Manufacturing, Science & Technology (MS&T)
The purpose of this role is to provide Subject Matter Expertise (SME) in the area of process chemistry and to direct process development in Phlow’s Continuous Manufacturing R&D lab. The Director, Process Chemistry will support the CDMO business to ensure business objectives are met and for execution of the internal Phlow API development projects. Serve as the technical leader for the development and scale-up of new processes for the synthesis of active pharmaceutical ingredients. The candidate will plan, organize, and oversee all process chemistry activities in the Phlow Continuous Manufacturing R&D lab to ensure that timelines, specifications, cGMP requirements, in addition to other elements of contracts, are realized. The candidate will ensure excellence of our process development and technical transfer to Phlow’s partners or customers and interact with other internal and external Phlow departments (EH&S, Engineering, Program Management, Quality Assurance, Regulatory Affairs) as required. The candidate will personify Phlow’s shared values and culture, both internally and externally. The candidate will work with the highest standards of safety, integrity, transparency, and ethics to create win-win scenarios for patients, customers, partners, and colleagues.
- Provide process chemistry subject matter expertise to support Phlow’s Continuous Manufacturing CDMO business.
- Ensure the deliverables to customers’ projects are met on time and on budget.
- Work with customers for efficient technology transfers.
- Manage a team of process chemists within the Phlow Continuous Manufacturing R&D lab.
- Screen, interview, and select qualified candidates for open positions within the department.
- Evaluate new projects with the department to identify synthetic routes for process development that deliver scalable, cost-competitive manufacturing processes that are ready for technology transfer to manufacturing partners for internal projects.
- Conduct literature searches and laboratory work to identify potential synthetic routes and propose optimal routes for evaluation and development.
- Review, author and approve documentation such as process development protocols and reports, batch records, validation protocols, and reports, specifications, etc.
- Participate in 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.
- Collaborate with Analytical Chemistry, EH&S, Engineering, Project Management, Quality Assurance, and Regulatory Affairs to ensure strong working relationships with all partners and Phlow employees.
- 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.
- Extensive understanding of the business principles of a CDMO or like environment.
- Excellent interpersonal and communication skills.
- 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 a multi-kilogram scale.
- Significant experience with generic API development, technology transfer, and manufacture.
- Knowledge of ICH and cGMP requirements.
- Experience working for a contract organization (CROs/CMOs/CDMOs)
- Experience managing third-party vendors (CROs/CMOs/CDMOs).
- A track record of speaking at conferences and publishing in peer-reviewed journals.
- 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 authoring or contributing to regulatory submissions (NDAs/ANDAs/DMFs).
- Experience with the development and implementation of continuous flow manufacturing processes is a plus.