Associate Director/Director Drug Substance Development and Manufacturing, CMC

Company Profile:

At Verastem Oncology, we're advancing innovation and addressing the urgent needs of patients living with cancers driven by RAS/MAPK pathway mutations, a key driver of tumor growth and treatment resistance. The FDA approval of AVMAPKI FAKZYNJA CO-PACK delivered the first therapy specifically for women living with recurrent KRAS-mutated low-grade serous ovarian cancer, a rare cancer with significant unmet need. We’ve successfully launched this innovative combination therapy in the U.S. and are exploring regulatory pathways for Europe and Japan.

We are continuing to advance our pipeline of drugs that we believe will help block cancer cell survival, inhibit tumor growth, and overcome treatment resistance. With clinical trials underway, we have an exciting opportunity to shape the future of cancer care and make a meaningful impact in the lives of patients.

Summary:

This position is responsible for development and drug substance manufacturing activities of new and existing products at external Contract Manufacturing Organizations (CMOs). Activities include but not limited to drug substance synthetic process design, scale up, technology transfer, process validation, testing, analysis, and interpretation of data of varying complexity. In this cross functional role, he/she works directly with Analytical, formulation Chemistry, Supply Chain, Quality and Regulatory teams at Verastem. Position reports directly to VP, CMC.

The ideal candidate for this position would be an individual with a growth mindset who is looking for high impact contribution and the opportunity to learn and expands beyond his/her current knowledge and skills.

Essential Duties and 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.

Qualifications and 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

Preferred Qualifications

• Experience with high potency drug substance is preferred

The base salary range (151K-246K) provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, location, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.