Job Description

• This candidate will have the primary responsibility to oversee process and analytical development and manufacturing activities at external CDMOs to support pre-clinical and clinical programs.
• The successful candidate needs to demonstrate a proven track record of working in a virtual environment with external CDMOs to manage process & analytical development and manufacturing activities of pre-clinical and clinical stage small molecule APIs.
• Reporting to the Director of EACD, this individual will provide guidance to the external manufacturing partners on raw materials sourcing strategy, document review (batch records, deviation, CAPA, change control etc.), and most importantly trouble-shooting manufacturing challenges.
• This role will represent the DS team at the cross-functional meetings and will operate at the interface of other closely related functions (QA, Regulatory, Analytical Science, Drug Product, Supply Chain etc.).
• Experience in technology transfer and regulatory document preparation (IND) is highly desirable.

Key Responsibilities:

The successful candidate will lead the EACD DS development & manufacturing activities through the following areas/interactions:

• Responsible for route scouting, process and analytical method development & optimization, scale-up and manufacturing of drug substance at external CDMOs
• Solve technical issues relating to drug substance manufacturing by providing technical expertise & oversight to external CDMOs
• Work with quality function to review/manage technical reports and quality documents (such as batch record, change controls, deviations & CAPAs)
• Compare and contrast lab and manufacturing data to provide insights into how efficiencies could be gained, and improvements could be realized
• Keep up with the latest CMC and regulatory literature and guidance.
• Develop phase-appropriate manufacturing timelines & plans, participate in CDMO technical selections, and manage successful execution of these plans consistent with overall program budget & timelines
• Serve as the drug substance technical lead and coordinate activities with regulatory, drug product, analytical and supply chain functions
• Identify key knowledge gaps and execute plans to ensure necessary process understanding is gained
• Ensure that the manufacturing is compliant with both relevant regulations and regulatory commitments.

 Experience:

• Proven track record of solving manufacturing challenges and continuous process improvements
• Understanding and knowledge of cGMP/ICH regulations and ability to apply them to drug substance development and manufacturing
• Excellent verbal and written communication skills.
• Strong interpersonal communication skills, proven ability to participate and maintain collaborative, effective internal and external relationships.
• Experience in drafting CMC sections of regulatory documents (IND/NDA)
• Ability to travel to Ridgefield (CT) and overseas manufacturing partner sites (Europe) (if deemed necessary, 20 % of time) – not mandatory – same time zone (MA, NY, NJ, CT)
• PhD. in Organic Chemistry with minimum 8 years (or MS with 14 years) of relevant industry experience