Senior Director, Process Development, Pharmaceutical Development

ABOUT ELEKTROFIElektrofi 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™. POSITION SUMMARYElektrofi 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 advance of manufacturing platforms and product candidates from formulation feasibility studies into clinical and commercial manufacturing.KEY RESPONSIBILITIES 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 productsProvide strategic, technical and scientific leadership to the Process Development team and to cross-functional program and initiative teamsBuild 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 CDMOsCollaborate 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 documentsMaintain and grow process development lab space and capabilities and oversee process development budget across our multiple programsActively participate in preparation of domestic and international regulatory filings in collaboration with internal and external stakeholders.Foster the growth and development of process development staffRepresent the company externally at meetings (professional associations, with regulatory bodies, etc.) RequirementsMINIMUM QUALIFICATIONSPh.D. or Master's degree in Biological, Pharmaceutical, or Chemical Engineering, Chemistry, Biochemistry or related disciplineMinimum 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 desirable.Experience developing and implementing GMP aseptic drug product filling processes highly desirableDemonstrated leadership skills, including the ability to manage a scientific team, communicate, coach, mentor and develop employeesStrong scientific reasoning, problem-solving and engineering skills, including knowledge and practical experience implementing relevant technologies/unit operations toward the scale-up of aseptic protein microparticle suspensions. Deep expertise with monoclonal antibodies, proteins, and/or vaccines.Excellent interpersonal, organizational, negotiation and communication (verbal and written) skills are essential.Ability to think, plan, and influence strategically on the process development priorities across multiple projects is necessary.Must be a leader willing to be both a "coach and a player".Willingness to travel domestically and internationally as neededExpertise with platform process design, scalability principles, and QbD methodologiesStrong communication skills and comfort working with internal stakeholders and external partners.Experienced with the regulatory expectations for biotherapeutic and aseptic manufacturing Our unique strength lies in transforming pioneering ideas into concrete, life-transforming solutions. To realize this ambitious vision, we are dedicated to nurturing an in-office work ethos. While remote work has its merits, it does not constitute a fundamental aspect of our working approach. Please apply at elektrofi.com/careers.EEOC Statement: Elektrofi provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. To all agencies, please, no phone calls or emails to any employee of Elektrofi about this requisition. All resumes submitted by search firms/employment agencies to any employee at Elektrofi via email, the internet, or in any form and method will be deemed the sole property of Elektrofi unless such search firms/employment agencies were engaged by Elektrofi for this requisition and a valid agreement with Elektrofi is in place. If a candidate submitted outside of the Elektrofi agency engagement process is hired, no fee or payment of any kind will be paid All candidates must be legally authorized to work in the US #LI-Onsite