Assoc Director or Director, Process Development & Manufacturing

Position Summary:  

Reporting to the Executive Director, Process Development and Manufacturing, the Associate Director or Director, Process Development and Manufacturing is responsible for the design and execution of experiments to support process development and provides technical oversight of contract development and manufacturing organizations (CDMOs) for small molecule programs ranging from research phase to clinical development and eventually commercial production.  The Associate Director or Director takes a drug substance lead role on one or more programs and manages projects independently.  

Essential Duties and Responsibilities:  

• Design, develop, and implement robust chemical synthesis processes for starting materials, intermediates, and APIs for research and development programs 
• Support technical transfer of starting material, intermediate, and API processes between sites as needed 
• Collaborate with medicinal chemistry team during lead optimization and candidate selection phases 
• Manage and mentor junior scientists and support their professional development 
• Function as a highly effective communicator and team player in a dynamic team culture 
• Perform phase appropriate process R&D to support both early stage and late stage programs 
• Perform fate and purge studies, mutagenic impurity evaluation and establish the framework for the control strategy of the drug substance from early development with a long-term vision of the commercial process 
• Work closely with cross functional teams to ensure seamless transitions between drug substance and drug product programs and vendors 
• Critical review of proposals from CMOs and CROs; perform appropriate due diligence as needed to ensure CMOs and CROs can support the requirements of individual chemical development programs effectively 
• Support PAR studies and pre-validation and validation activities for drug substance 
• Author relevant CMC sections for US and ex-US regulatory filings as needed 
• Up to 25% travel for scientific project management and monitoring of critical project activities 
• Perform all duties in keeping with the Company’s core values, policies and all applicable regulations 

Required Education, Experience and Attributes:  

• PhD in synthetic organic chemistry with a minimum of 10 years of industry experience developing small molecule pharmaceuticals  
• Laboratory experience in synthetic organic chemistry and small molecule process development required 
• Chemical development experience with synthesis and crystallizations of chiral molecules preferred 
• Thorough understanding of the synthetic and analytical techniques necessary for proper polymorph screening, optimization and patent protection 
• Thorough understanding of cGMP, ISO, and ICH guidelines and industry best practices 
• Experience and understanding of Design of Experiments (DOE) and Quality by Design (QbD) principles 
• Experience managing and overseeing development and manufacturing activities at CDMOs 
• Ability to build strong relationships with co-workers of various backgrounds and expertise; flexibility and integrity are both paramount 
• Ability to function at a high level in a team setting whether as manager, lead scientist, or individual contributor 
• Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment 
• Effective interpersonal and communication skills; a collaborative team player with a can-do attitude, desire to pitch in where and when needed, and the ability to identify and implement creative solutions to complex technical problems 
• Strong learning orientation, curiosity, and passion for science and patients 

ADA Notation:  

In this work environment, the employee is occasionally exposed to moving mechanical parts, unpleasant odors, and loud noises. Interaction with laboratory equipment, samples, supplies, and laboratory personnel may be required whereby appropriate precautions are to be taken per the Company’s Safety and Injury, Illness and Prevention Plans.

The anticipated salary range for this position is $180,000 to $220,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etcetera. In addition to base salary, the hired applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the form of the option to purchase stock in the future for a specified price.