Hybrid Associate Director – Drug Substance Development and Manufacturing, CMC

at Verastem Oncology

• Job title: Associate Director – Drug Substance Development and Manufacturing, CMC
• Job type: Full Time
• Experience level: Senior
• Salary: $173,000 - $210,000 per year
• Degree requirement: Postgraduate Degree
• Location requirements: Hybrid, Boston, United States

About the role

• Associate Director/Director of Drug Substance Development and Manufacturing at Verastem Oncology overseeing CMC activities. Responsible for driving innovations in cancer care through advanced therapies and regulatory compliance.

Responsibilities

• Act as the drug substance subject matter expert and manage external DS development activities to support advancing Verastem product candidates in clinical studies.
• Support clinical phase and potential commercial launch activities.
• Support technology transfer for manufacturing of clinical supplies from CMO to CMO to support scale up and late-stage development activities.
• Develop, review, and approve technical reports and controlled GMP documentation such as manufacturing batch records, protocols, specifications, campaign reports, regulatory submission documents.
• Oversee efforts and works closely with CMOs, Quality, Supply Chain, Regulatory CMC, Formulation and Analytical teams to ensure operational excellence and GMP compliance during manufacturing and timely release of drug substance for clinical use.
• Provide technical support for change controls, process deviations, root cause identification and CAPA implementation associated with manufacturing deviations and quality events in a collaborative manner with Quality Assurance (QA).
• Develop phase-appropriate pharmaceutical project plans and manage successful execution of these plans consistent with corporate timelines and compliant with cGMP/regulatory requirements and expectations.
• Interprets complex data and makes recommendation on new processes directions.
• Keep up with the latest regulatory and cGMP guidance.
• Maintain awareness of state-of-the-art manufacturing practices.
• Sources relevant scientific literature within field.
• Displays greater ability to productively disseminate ideas across discipline.
• Develop and maintain strong relationships with CMOs and participate in periodic business and technical review meetings with relevant CMOs.

Requirements

• MS/Ph.D. degree in Organic chemistry
• At least 10 years of hands-on experience in small-molecule drug substance development and commercialization
• 8 years’ experience with Ph.D.
• Strong technical background in developing and scaling up small molecule drug substance is required
• Thorough knowledge of cGMP, regulatory requirements, and approaches for implementation of Quality by design (QbD) principles, Design of Experiments (DoE) in DS development, process validation
• Ability to work successfully in a team/matrix environment and independently, as required
• Desire to work “hands on” and setting priorities and meeting timelines
• Can-do attitude, Flexible, Ability to take initiative
• Pragmatic, solution-oriented thinker with excellent verbal and written communication, and strong interpersonal and organizational skills.
• Fluency with standard computer software packages (MS Word, Excel, PowerPoint) and statistical tools.
• Ability to travel as needed (about 10%) to support critical manufacturing campaigns, among other activities.

Benefits

• competitive benefits package
• annual bonus
• equity compensation