Director, Chemical Development & Drug Substance Manufacturing

About the position

We are seeking an exceptional and highly motivated individual to lead the Chemical Development team. Successful candidate will be passionate about synthetic chemistry, excited to solve complex problems in a fast-paced environment, and comfortable in the multidisciplinary environment of drug development research. The Director, Chemical Development & Drug Substance Manufacturing is self-motivated and demonstrates initiative in responsibilities and always strives to do the job better.

Responsibilities

• Plan and execute appropriate research techniques towards the solution of various chemical problems arising in the synthesis, analysis, development, or production of drug substances in the plant.
• Strong understanding of solid-state properties of small molecule.
• Manage development activities for cGMP drug substance manufacturing of small molecule drugs at CMOs.
• Direct experience in working with CROs and CDMOs from USA and Europe in previous role is preferred.
• Design process development studies according to the principals of Quality by Design (QbD), specification justification studies to establish limits, process characterization studies such as one-variable-at-time (OVAT) and DOE studies to identify proven acceptable ranges (PARS) of critical process parameters (CPP), including identification of edge-of-failure (EoF).
• Ability to identify the critical quality attributes for the process intermediates and API.
• Maintain a current, easily understood laboratory notebook in accordance with company policy.
• Ability to review the Master/Executive batch records on regular basis and provide his/her suggestions in a timely manner.
• Route scouting by applying organic chemistry knowledge and principles.
• Work closely with chemists to understand/improve chemical process by applying fundamental process chemistry principles.
• Utilize all available techniques and analytical instrumentation for monitoring laboratory experiments and the analysis of compounds synthesized effectively.
• Communicate effectively in verbal and written form on research results, issues, and plans; able to work cross functionally.
• Working as part of the project team and collaborating with cross-functional project groups to ensure delivery timelines and API quality.
• Demonstrating expertise in core laboratory skills required to support development and scale up of chemical processes.
• Complying with all safety and GMP guidelines.

Requirements

• Master's degree with 10 years or more or Ph.D. with 7 years or more relevant experience in small molecule process chemistry.
• In depth understanding and knowledge of cGMP regulations and compliance.
• Experience in drafting drug substance sections of INDs, IMPDs and marketing applications.
• Strong experimental background and a rigorous, analytical approach to problem solving.
• Ability to prioritize responsibilities, multi-task, and remain flexible and motivated in a fast-paced environment.
• Strategic thinking to address technical challenges and provide creative solutions.
• Good communication and interpersonal skills; able to work cross functionally.
• Aspire to the highest levels of scientific and ethical standards.
• Keen to improve processes and overcome inefficiencies.
• Familiarity with current manufacturing processes and equipment used in chemical development and validation.

Benefits

• Competitive cash compensation including discretionary bonus program
• Equity awards
• Comprehensive benefits program