Director/Senior Director, Drug Substance Development in Cambridge, Massachusetts
Covid- 19 Mandatory Vaccination Requirement
Throughout the pandemic, we’ve done all that we can to keep our employees safe, and the employees coming in have been careful to take precautions to reduce the risk of bringing Covid into our work environment. As we reopen our office, we’re mindful that the pandemic is not yet over, and young children are not yet vaccinated. We are committed to continuing to protect our team and keep our office safe. Vaccination has proven to be the best thing you can do to protect yourself, your family, your colleagues and your community. Since we are striving for a 100% vaccinated workplace (including employees, contractors, vendors and guests), all NEW HIRES will be required to be fully vaccinated, and to present proof of their Covid-19 vaccination to our HR team as part of our on-boarding process.
We are currently seeking a Senior Director/Director of Drug Substance Development. The candidate would be responsible for the end-to-end strategy and oversight of Drug Substance development in a phase appropriate manner leveraging external and internal resources to support the portfolio. As a member of the Pharmaceutical Development leadership team, the candidate would work closely, partnering with Reg CMC, Quality and Research ensuring a streamline project progression of the portfolio. This position is critical for overseeing Drug Substance Development for our late-phase clinical assets as well as provide essential oversight for existing and future pre-clinical programs. The candidate will have excellent management skills, work co-operatively with others in a dynamic fast-paced environment, and have a genuine desire to be a part of a team that contributes at a high level to organizational and project team goals.
Ownership and Responsible for Process Development of Drug Substance
Leveraging molecular information and experience in a risk-based framework to support the overall control strategy.
Identify, selects, and manages CMO and CRO vendors, including assistance or oversight on due diligence efforts, audits, site visits, and person in plant for critical manufacturing campaigns
Reviews CMC project plans and execution, timelines, and budgets; assist in execution to ensure all projects are appropriately prioritized and key goals are met on time
Effectively works within the Product Development Teams with cross-functional team leaders to achieve corporate and program goals
Works closely with Research, Project Teams, Clinical Supply Operations, Finance, Regulatory Affairs and Quality
Oversees SOPs, Protocols/Reports for Pharmaceutical Development, CMC regulatory documents and appropriate quality and risk management
Understands and efficiently communicates project status and risks, presents data and strategies
Establishes and applies phase appropriate DS development concepts and standards in a resource responsible manner
Identifies and promotes opportunities to further streamline CMC development activities across relevant interfaces
Drives the incorporation of knowledge of current regulations, guidance and competitive environment into decisions and strategy
EDUCATION AND EXPERIENCE:
A PhD in pertinent life sciences or equivalent is required
10-15 years relevant industry experience, preferably with both biotechnology and pharmaceutical companies
Understands quality control cGMP production aspects
Proven experience with leading, developing and oversight of drug substance development from GLP toxicology supplies to cGMP Phase 3 clinical trial material
Ability to work in a matrix environment on interdisciplinary teams
Experience in a cross-functional, global environment, where interactions with other, equally talented individuals requires technical expertise, negotiating skills and diplomacy
Excellent understanding of both scientific and regulatory requirements related to pharmaceutical development, manufacturing and specifications is required
Contribute to maintaining an environment that fosters curiosity and taking risks, openness to new approaches, creativity, and opportunistic thinking.
Efficient time management, excellent management, organizational, writing, communication and problem-solving skills, and a high degree of flexibility.
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