Associate Director, Formulation Chemistry, Biosurgery – MedTech

Position Title

Associate Director, Formulation Chemistry, Biosurgery – Med Tech

Raritan, New Jersey, United States of America

We are seeking an experienced, hands‑on Associate Director of Formulation Chemistry to lead and grow a multidisciplinary team of chemists and chemical engineers in Biosurgery R&D. This leader will oversee resource deployment across new product development and lifecycle improvement projects to design, develop, and refine chemistries used in medical devices (e.g., hemostats, sealants, adhesives, hydrogels, etc.). The role combines technical leadership, resource management, cross‑functional collaboration, and people development with strong attention to regulatory, quality, and manufacturability requirements.

• Daily oversight of technical project execution.
• Lead, mentor, and manage a team of formulation chemists and chemical engineers; hire, coach, set objectives, and perform performance reviews.
• Prioritize and allocate team resources across new product development and lifecycle projects to meet timelines, budget, and strategic goals.
• Define technical strategy for formulation and chemistry aspects of biosurgery product portfolio; translate business needs into project plans.
• Be the sounding board and provide scientific and technical direction for formulation development: polymer/biopolymer chemistries, adhesives, crosslinking strategies, rheology modification, drug/biologic incorporation where applicable.
• Oversee formulation optimization for functional performance, stability, sterilization compatibility, biocompatibility, process robustness, and scale‑up.
• Ensure design controls, risk management (e.g., DFMEA), and documentation meet regulatory and quality system expectations (ISO 13485, FDA 21 CFR where applicable).
• Drive development and execution of test methods for formulation characterization.
• Collaborate closely with cross‑functional partners: product development, device engineering, biocompatibility, regulatory affairs, quality, clinical, procurement, and external partners/suppliers.
• Represent the formulation function in leadership meetings; report project status, technical risks, and mitigation plans.
• Manage department budget and external vendor/contract research relationships.
• Promote a culture of safety, continuous improvement, innovation, and compliant documentation practices.

• A minimum of an MS is required; a Ph.D. in Chemistry, Chemical Engineering, Materials Science, Polymer Science, or related discipline is strongly preferred.
• 6+ years (PhD) or 8+ years (MS/BS) of progressive industry experience in formulation development and leadership.
• Demonstrated experience leading teams of chemists/engineers and managing technical resources across multiple projects.
• Deep technical knowledge of polymer/biopolymer chemistry, adhesives/sealants, hydrogels, crosslinking chemistries, and relevant analytical techniques.
• Track record of successful technology transfer and scale‑up of formulations to manufacturing.
• Strong working knowledge of regulatory requirements for medical devices and combination products, and experience supporting regulatory submissions.
• Excellent oral and written communication skills; ability to present complex technical concepts to cross‑functional and senior stakeholders.
• Proven ability to identify, prioritize, and mitigate technical risks to keep projects on schedule and within budget.
• Prior experience in medical devices, biosurgery, biomaterials, or combination products strongly preferred.
• Direct experience in biosurgery products (hemostats, sealants, adhesives) or related surgical device chemistry preferred.
• Familiarity with sterilization modalities (EO, gamma, e‑beam) and their impact on formulation stability and performance.
• Experience with design controls, clinical/biocompatibility testing strategies, and familiarity with DFx principles.
• History of patents, peer‑reviewed publications, or presentations in relevant scientific forums.
• Experience working with contract development/manufacturing organizations (CDMOs) and material suppliers.
• Travel:
  Domestic and international, up to 25% to manufacturing sites,…