Senior Director, Process Development

Description

Elektrofi is revolutionizing the delivery of biologic therapies by giving patients the ability to control how they want to receive and benefit from life‑changing medicines. Our breakthrough ultra‑high concentration microparticle technology platform resolves the limitations associated with intravenously administered biologic therapies by enabling convenient at‑home subcutaneous self‑administration. With a focus on monoclonal antibodies, therapeutic proteins, and other biologics, we partner with companies to develop and commercialize our novel Hypercon™ formulations.

We believe a patient‑centered healthcare approach can lead to a healthier world. We are headquartered in Boston and innovate globally. We are Formulating the Future of Biologics™.

Electrofi is seeking a motivated individual to join our biotech company as a Senior Director, Process Development to support the development of the novel Hypercon™ formulation platform. This individual is accountable for leading the Process Development function within our Pharmaceutical Development team. The successful candidate will be responsible for developing, scaling up, and technical transfer of ultra‑high concentration protein microparticle suspension drug products and advancement of manufacturing platforms and product candidates from formulation feasibility studies into clinical and commercial manufacturing.

• Lead and grow a nimble and high‑performing Process Development team, responsible for defining and implementing the clinical and commercial manufacturing strategy for novel protein microparticle suspension‑based products
• Provide strategic, technical and scientific leadership to the Process Development team and to cross‑functional program and initiative teams
• Build cutting‑edge process development capabilities that emphasize aseptic operations and deliver the desired physical characteristics of protein microparticles while preserving the biological properties of the active substance
• Maintain knowledge of current best practices of bioprocess and aseptic manufacturing. Identify emerging trends and technologies and lead implementation/feasibility assessment, as appropriate.
• Guide the execution of process development, scale‑up, characterization, manufacturing trouble‑shooting, and phase‑appropriate validation activities, as well as the transfer of processes to internal labs and external CDMOs
• Collaborate and communicate effectively with external corporate partners and internal stakeholders across the Technical Development team with groups including Drug Product Innovation, Formulation Development, Analytical Development, Quality, and Translational Development
• Author, review and approve technical documents, including but not limited to study protocols, process development and validation reports, batch records and process/manufacturing sections of regulatory documents
• Maintain and grow process development lab space and capabilities and oversee process development budget across our multiple programs
• Actively participate in preparation of domestic and international regulatory filings in collaboration with internal and external stakeholders.
• Foster the growth and development of process development staff
• Represent the company externally at meetings (professional associations, with regulatory bodies, etc.)

• Ph.D. or Master’s degree in Biological, Pharmaceutical, or Chemical Engineering, Chemistry, Biochemistry or related discipline
• Minimum of 12 years (15 years with a MS) of relevant process development experience, including a minimum of 5 years in a managerial capacity
• Extensive experience in manufacturing lifecycle management, including process development, scale‑up, and technology transfer in support of IND, clinical and/or commercial activities in the biotech or pharmaceutical industry.
• Prior experience in drug substance or drug product process development for biotherapeutics, with an established track record of translating lab‑based processes to a clinical manufacturing setting toward commercialization. Experience with microparticle production and characterization is highly…