CMC SME (Drug Substance & Analytical) - Contract
Boehringer Ingelheim, Ridgefield, CT, United States
Job Description
Primary responsibility to oversee process and analytical development and manufacturing activities at external CDMOs to support pre‑clinical and clinical programs. Proven track record 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, provide guidance to external manufacturing partners on raw materials sourcing strategy, document review (batch records, deviation, CAPA, change control, etc.), and troubleshoot manufacturing challenges. Represent the DS team at cross‑functional meetings and operate at the interface of QA, Regulatory, Analytical Science, Drug Product, Supply Chain, etc. Experience in technology transfer and regulatory document preparation (IND) highly desirable. Key Responsibilities
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 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.
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Primary responsibility to oversee process and analytical development and manufacturing activities at external CDMOs to support pre‑clinical and clinical programs. Proven track record 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, provide guidance to external manufacturing partners on raw materials sourcing strategy, document review (batch records, deviation, CAPA, change control, etc.), and troubleshoot manufacturing challenges. Represent the DS team at cross‑functional meetings and operate at the interface of QA, Regulatory, Analytical Science, Drug Product, Supply Chain, etc. Experience in technology transfer and regulatory document preparation (IND) highly desirable. Key Responsibilities
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 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.
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