Director, Process Chemistry (Small Molecule)
Director, Process Chemistry (Small Molecule)
About This Role
Our client is seeking a highly motivated and creative Director of Process Chemistry to join the Small Molecule Chemical Development team. In this role, you will lead and mentor scientific and engineering teams while guiding projects from early-stage research through late-stage development. You will oversee the design, optimization, and scale-up of manufacturing processes for a range of small molecule therapeutics, supporting both preclinical and clinical programs.
This position plays a critical role in advancing innovative therapies through the development of safe, efficient, economical, and sustainable chemical processes. The successful candidate will combine scientific leadership, technical expertise, and strong cross-functional collaboration to drive program success and enable the delivery of new medicines to patients.
Who We Are
A team of organic chemists and chemical engineers dedicated to developing innovative processes that bring new medicines to patients. The work focuses on creating safe, scalable, sustainable, and cost-effective manufacturing solutions to support clinical development and commercial launch across a variety of therapeutic modalities.
Driven by scientific rigor, data-driven decision making, and collaboration, we strive to solve complex development challenges and advance transformative therapies.
What You'll Do
- Lead cross-functional development and manufacturing teams in the design, execution, and interpretation of experiments aimed at improving process understanding, robustness, productivity, and scalability.
- Develop and implement strategies to advance small molecule development programs from route selection through commercial manufacturing.
- Drive the design, optimization, characterization, and control of chemical processes to ensure safe, efficient, and reliable production.
- Manage and mentor a team of scientists and engineers, fostering professional growth and developing future technical leaders.
- Generate the process knowledge required to support successful scale-up and technology transfer to manufacturing partners and external organizations.
- Collaborate closely with Process Engineering, Analytical Chemistry, Solid State, Separations, and other CMC functions to support clinical supply and regulatory submissions.
- Contribute to CMC strategy and documentation, including technical reports, regulatory filings, and presentations to internal governance teams.
- Manage relationships with contract research and manufacturing organizations (CROs and CMOs), including oversight of external development activities and occasional travel.
- Initiate and lead innovative research efforts that enhance process understanding, improve manufacturing efficiency, and expand technical capabilities.
- Represent the organization externally through scientific publications, industry consortia, conferences, and collaborations.
Who You Are
You are passionate about applying chemistry and process science to solve complex development challenges and bring innovative medicines to patients. You thrive in a collaborative environment and are driven by scientific excellence, accountability, integrity, and continuous improvement.
Qualifications
- M.S. or Ph.D. in Chemistry, Chemical Engineering, or a related discipline with 12+ years of relevant pharmaceutical or biotechnology industry experience, including people leadership.
- Deep expertise in pharmaceutical process chemistry and process development, including synthetic route design, impurity control strategies, purification and isolation techniques, process characterization, technology transfer, and process safety.
- Demonstrated success leading multidisciplinary teams responsible for the development and delivery of APIs across multiple stages of development.
- Proven ability to effectively lead, mentor, and influence teams in a highly collaborative environment.
- Excellent written, verbal, and interpersonal communication skills.
Preferred Qualifications
- Experience managing external development and manufacturing partners.
- Familiarity with global regulatory requirements and CMC activities supporting drug development programs.
- Demonstrated experience representing organizations in external scientific, industry, or regulatory settings.
- Track record of driving innovation in process chemistry, scale-up, and manufacturing sciences.
FAQs
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