Associate Director/Director Drug Product Development and Manufacturing, CMC

Company Profile:

At Verastem Oncology, our purpose is to create a world where no cancer patient ever runs out of options. This commitment is central to who we are as a company and the culture we nurture. We are laser focused in our efforts to establish avutometinib + defactinib as the backbone of therapy for RAS-mediated tumors. We look for people who share our perspective; when others see only a problem, we see an opportunity, when others give up, we step up. We partner with global leaders (and their teams!) and these relationships help us to serve the patients who need us most. We appreciate your candidacy for the Verastem Oncology team, and encourage you to learn more at www.verastem.com.

Summary:

This position is responsible for formulation development and drug product manufacturing activities of new and existing products at external Contract Manufacturing Organizations (CMOs). Activities include but not limited to formulation and 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, Process 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.

Responsibilities:

• Act as the formulation subject matter expert and manage external solid oral dosage formulation development activities to support advancing Verastem product candidates in clinical studies. Support Phase III 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.
• Oversee efforts and works closely with CMOs, Quality, Supply Chain, Regulatory CMC, and Analytical teams to ensure operational excellence and GMP compliance during manufacturing and timely release of drug product 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 and formulation development 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 or PhD degree in Pharmaceutical Sciences, Pharm D., Chemical Engineering or related life sciences discipline
• At least 8-10 years of hands-on experience in small-molecule pharmaceutical product development and commercialization. 6-8 years' experience with Ph.D.
• Strong technical background in developing and scaling up solid oral dosage formulations is required. Hands on experience with tableting, encapsulation, wet granulation and roller compaction are desirable. Pediatric formulation experience is a plus.
• Thorough knowledge of cGMP, regulatory requirements, and approaches for implementation of Quality by design (QbD) principles, Design of Experiments (DoE) in DP 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

• A Ph.D. degree in an engineering or life sciences discipline or a Pharm D.
• Experience in developing and commercializing drugs for oncology and/or orphan diseases is strongly preferred