Fraser Dove International · 1 week ago
Head of Process Development
United States
Full-time
Remote
Director/Executive
15+ years expFraser Dove International is partnering exclusively with a high growth PE backed organisation operating across North America, committed to advancing safe, scalable and compliant processes that bring innovative materials to patients and customers. The Head of Process Development will lead a high-performing team, establish efficient processes from lab to commercialisation, and ensure compliance with regulatory standards.
Human ResourcesRecruitingStaffing Agency
Hiring Manager
Allec Romero
Responsibilities
Build, direct and mentor Process Development teams covering process design, optimisation, scale-up, tech transfer, late-stage development and validation
Own process strategy for activated polymers, reagents and drug substances, ensuring processes are safe, scalable, robust and cost-effective at commercial scale
Plan and execute characterisation studies and statistical analyses to define design space and critical parameters
Lead risk management and stage-gate reviews from evaluation through commercialisation, including process safety and scale-up risks
Oversee development protocols, reports, batch records and data systems; approve cGMP and non-GMP documentation
Partner with Manufacturing, Quality Assurance and Process Sciences to ensure smooth transfer and on-time, in-spec batches; investigate deviations and drive corrective actions
Provide technical leadership for client programs; set expectations, communicate transparently and drive issue resolution to achieve high customer satisfaction
Contribute to proposals and RFP responses; represent the company at conferences through case studies, presentations and white papers
Own development budgets, resources and timelines; recruit, onboard and develop talent; enforce Health, Safety and Environmental standards
Qualification
Required
PhD in Chemistry or related field
15+ years in CMC (chemistry, manufacturing and controls), process development and analytics within biotech or pharma; 10+ years of leadership experience
Deep expertise in synthesis, purification, isolation and drying of activated polymers in regulated settings; fluency with varied polymer synthetic techniques
Proven delivery of process characterisation, scale-up, technology transfer and validation from pilot plant to commercial manufacturing
Experience within a CDMO (contract development and manufacturing organisation) and supporting partner programs from clinical through commercial stages
Strong project management, stakeholder communication and customer focus; able to manage multiple priorities and budgets
Thorough working knowledge of FDA, ISO and cGMP requirements; excellent compliance and safety practices
Company
Fraser Dove International
Fraser Dove International is a talent consultancy that offers recruitment services for life sciences industry.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Joseph Brown
Co-Founder
Company data provided by crunchbase