Description

Job Overview

The purpose of this role is to provide Subject Matter Expertise (SME) in the area of process chemistry and to perform and direct process development in Phlow's Advanced 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, perform and oversee process chemistry activities in the Phlow Advanced 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.

Responsibilities:

• Provide process chemistry subject matter expertise to support Phlow's Advanced Manufacturing CDMO business.
• Plan, organize, perform and oversee process chemistry activities.
• Ensure the deliverables to customer's projects are met on time and on budget.
• Work with customers for efficient technology transfers.
• Manage a team of process chemists within the Phlow Advanced Manufacturing R&D lab.
• Assist in screening, interviewing, and selecting 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 process 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.

Requirements

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.
• Extensive understanding of the business principles of a CDMO or like environment.
• Excellent 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.
• 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.

Physical Requirements

• Constantly required to see to utilize computer screens and monitors to perform job duties including reading & writing, as well as when presenting information and communicating with others.
• Frequently required to talk or hear to communicate with employees, candidates, vendors, and others, including presenting information in front of groups.
• Frequently required to reach with arms and hands performing repetitive motions and using finger dexterity to work primarily at a computer keyboard and with a mouse.
• Frequently required to sit, and occasionally required to stand or walk to move around primarily in an office environment.
• Occasionally lift and/or move up to 10 pounds.
• This position may require up to 10% to 25% travel with occasional increase in travel demands based on business needs.
• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.