Head of Process Chemistry, Director/Senior Director

Job Overview

We are actively seeking a dynamic and accomplished professional for the newly established role of Director/Senior Director, Head of Process Chemistry. This pivotal position presents a unique opportunity to significantly influence the development and optimization of manufacturing processes for our small molecule pipeline. The selected candidate will spearhead a multidisciplinary team, leveraging both internal and external resources to ensure the streamlined and effective transition from process chemistry development to drug substance manufacturing.

Key Responsibilities

• Lead the innovation and production of small molecule drug substances.
• Oversee the development of drug substance process chemistry, scale-up, and manufacturing for GLP studies and GMP production at Contract Development and Manufacturing Organizations (CDMOs).
• Formulate scalable, safe, cost-effective, and environmentally responsible manufacturing methodologies.
• Manage relationships with Contract Research Organizations (CROs) and CDMOs, including their selection, technology transfer, and compliance with cGMP standards during API manufacturing.
• Collaborate with external consultants and CROs to resolve challenges related to synthesis, salt formation, polymorphs, particle size attributes, reaction kinetics, process safety, and impurity profile management.
• Partner with Medicinal Chemistry to facilitate the scale-up synthesis necessary for candidate nomination.
• Utilize expertise in process design, production equipment, and scale-up challenges.
• Work closely with the Development Project Lead and CMC Head to establish timelines, production scales, and budgets for development candidates.
• Collaborate with the Quality Assurance and Regulatory teams to review and sanction analytical documents, stability results, manufacturing batch records, and regulatory submissions pertaining to drug substances.
• Contribute to the preparation of process development reports and sections for regulatory submissions.
• Provide CMC technical information and support across various cross-functional teams.
  
  

Required Skills

• Extensive experience in process chemistry development and scale-up.
• Proven expertise in cGMP manufacturing and oversight of CRO/CDMOs for the production of regulatory starting materials and drug substances.
• Familiarity with regulatory submission processes and associated requirements.
• Experience with Quality by Design (QbD), process validations, and statistical design of experiments (DOE) is highly desirable.
• Strong communication and writing proficiency.
• In-depth understanding of ICH guidelines, GMP/GLP manufacturing protocols, and regulatory standards.
• Willingness to travel domestically and internationally as necessary.
  
  

Qualifications

• Ph.D. in Organic Chemistry with a minimum of 10 years of experience in small molecule drug development and manufacturing within the biotech or pharmaceutical sector, or a Master's degree accompanied by 15 years of relevant experience.
• Substantial background in process chemistry development, scale-up, technical transfer, and drug substance characterization.
• Strong foundation in early to late-stage process development is highly preferred.
  
  

Career Growth Opportunities

This role provides remarkable avenues for professional growth and leadership development, allowing you to engage in critical projects and lead multidisciplinary teams, thereby enhancing your network within the industry.

Company Culture And Values

We pride ourselves on nurturing a diverse and inclusive workplace, where collaboration and mutual success are paramount. Our organizational culture emphasizes open communication and teamwork.

Compensation And Benefits

We offer a competitive salary range of \(205,000 to \)275,000, contingent upon qualifications, skills, and experience. In addition, our comprehensive benefits package includes healthcare coverage, retirement savings options, and various other employee perks.

Employment Type: Full-Time