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Elektrofi · 15 hours ago

Senior Director, Process Development, Pharmaceutical Development

Boston, MA

Full-time

Onsite

Director/Executive

$240K/yr - $275K/yr

12+ years exp

Elektrofi is a biotech company focused on revolutionizing the delivery of biologic therapies. The Senior Director of Process Development will lead the Process Development function, responsible for developing and scaling up ultra-high concentration protein microparticle suspension drug products for clinical and commercial manufacturing.

Alternative MedicineBiotechnologyTherapeutics

No H1B

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 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.)

Qualification

Process DevelopmentAseptic ManufacturingBiotherapeuticsGMP ComplianceRegulatory KnowledgeMonoclonal AntibodiesScale-Up ExperienceLeadership SkillsCommunication SkillsProblem-Solving Skills

Required

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 desirable

Experience developing and implementing GMP aseptic drug product filling processes highly desirable

Demonstrated leadership skills, including the ability to manage a scientific team, communicate, coach, mentor and develop employees

Strong 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 needed

Expertise with platform process design, scalability principles, and QbD methodologies

Strong communication skills and comfort working with internal stakeholders and external partners

Experienced with the regulatory expectations for biotherapeutic and aseptic manufacturing