Thepurpose of this role is toprovide process chemistry support to Phlow's Continuous Manufacturing R&D lab. The Manager, Process Chemistry will design, synthesize, purify, and analyze chemical intermediates and target compounds under the direction of the Director, Process Chemistry. The candidate will support the CDMO business to ensure business objectives are met and for the execution of the internal Phlow API development projects. The candidate will ensure the excellence of our process development and technology transfer to Phlow's partners or customers. The candidate will personify Phlow's shared values and culture, both internally and externally. The candidatewill 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 support to Phlow's Continuous Manufacturing R&D lab to ensure the deliverables to customers' projects are met on time and on budget and to ensure a scalable, cost-competitive manufacturing process is developed on time, on budget, and ready for technology transfer to manufacturing partners for internal projects.
- Design, synthesize, purify, and analyze chemical intermediates, target compounds, and impurities.
- Author progress reports and present scientific results to team members.
- Support Phlow's manufacturing partners during product manufacturing and validation campaigns.
- Contribute to the timely and accurate preparation of regulatory submissions.
- 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 of5 years working in related roles in the pharmaceutical industry demonstrating increasingresponsibility.
- Strong track record of successincluding process development, technology transfer, and continuous improvement.
- Strong interpersonal and communication skills.
- PhD (or equivalent based upon work experience) in Organic Chemistry, Pharmaceutical Sciences, or a related scientific field.
- Process chemistry and API manufacturing experience on a multi-kilogram scale.
- Experience with generic API development, technology transfer and manufacture.
- Understanding of the business principles of a CDMO or like environment.
- Knowledge of ICH and cGMP requirements.
- Experience managing third-party vendors (CROs/CMOs/CDMOs) is a plus.
- Experience with technical and operational risk assessments (e.g., process robustness, mutagenic impurities, nitrosamines, etc.) is a plus.
- 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) is a plus.