Senior Director, Process Chemistry

The?purpose of this role is to?provide leadership and Subject Matter Expertise (SME) in the area of process chemistry and API development. The Senior Director, Process Chemistry will support Phlow's CDMO businesses to ensure business objectives are met. Serve as the technical leader for the API development projects and oversee and manage Phlow's partners. The candidate will ensure excellence of our process development and technical transfer to Phlow's partners and interact with other internal and external Phlow departments (EH&S, Operations, Program Management, Quality Assurance, Regulatory Affairs, Commercial, Finance) 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.

Requirements

• Provide leadership to Phlow's process development projects for small molecule APIs, key intermediates or related materials
• Ensure that projects meet all deliverables including budgets and timelines
• Provide excellent support to Phlow's US government business
• Provide excellent support to Phlow's commercial business
• Provide process chemistry subject matter expertise on other Phlow projects
• Ensure efficient technology transfers
• Evaluate new projects with the department to identify synthetic routes for process development that deliver scalable, cost-competitive manufacturing process that are ready for internal technology transfer
• 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, Operations, Program Management, Quality Assurance, Regulatory Affairs, Commercial, Finance to ensure strong working relationships with all partners and Phlow employees

Qualifications:?

• Minimum of 10 years of relevant process chemistry management and leadership experience within the Pharmaceutical or Contract Development and Manufacturing industry.
• 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.
• Experience in working in a multi-disciplinary team environment.
• Demonstrated ability to lead, mentor, influence, collaborate, and work with individuals, colleagues and clients.

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.
• Demonstrated experience with generic API development, technology transfer, and manufacture.
• Strong knowledge of the drug development process, ICH requirements, and current Good Manufacturing Practices (cGMP).
• Excellent analytical and problem-solving skills with ability to prioritize tasks according to business objectives and manage multiple programs within defined timelines and budgets.
• Experience working for a contract organization (CROs/CMOs/CDMOs)
• Experience managing third-party vendors (CROs/CMOs/CDMOs).
• Knowledge of chemistry-related CMC sections of IND/IMPD and NDA/MAA regulatory submissions.
• 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.

Working Conditions:

• Work environment includes exposure to chemical materials and high noise areas.
• Must have a high consciousness for personnel and equipment safety.
• May be required to use various personal protective equipment (PPE) including respirators, gloves, safety glasses, and protective clothing.

Physical Requirements:

• Work in various positions such as walking, standing, or sitting for prolonged durations.
• Exposure to indoor factory conditions and outdoor environments with varying temperatures.