Director/Senior Director, Formulation and Drug Product Development Director/Senior Director, Formulation and Drug Product Development Get AI-powered advice on this job and more exclusive features. Direct message the job poster from EPM Scientific Job Title: Director/Senior Director, Formulation and Drug Product Development Location: Remote About the Company This is an opportunity to join a well-funded, publicly traded biotechnology company focused on developing innovative biologic therapies for immune and inflammatory diseases. The organization is committed to advancing differentiated antibody-based treatments that address significant unmet medical needs. With a strong emphasis on scientific excellence, advanced engineering, and patient-centric innovation, the company is reshaping therapeutic standards in immunology. The team operates in a fast-paced, collaborative environment where employees are empowered to take initiative, contribute to a dynamic culture, and grow professionally. The company values originality, resilience, empathy, and humility, and fosters a culture where these principles guide decision-making and teamwork. Position Overview The Director of Formulation and Drug Product Development will lead efforts in developing and optimizing drug product presentations and manufacturing processes for biologics, with a particular focus on pre-filled syringes and combination products. This role will oversee tech transfer activities, manage CDMO relationships, and ensure readiness for clinical and commercial supply. Reporting to the VP of Formulation and Drug Product Development, the position requires deep technical expertise in aseptic processing, device integration, and regulatory compliance. The role is embedded within a cross-functional development and manufacturing team and will collaborate closely with groups involved in drug substance development, analytical sciences, device engineering, and supply chain operations.

Key Responsibilities

Serve as the subject matter expert in pre-filled syringe development and aseptic manufacturing, providing strategic and technical leadership across teams. Develop late-stage and commercial strategies for drug product manufacturing and presentation formats. Design and implement robust manufacturing processes for biologic drug products, including monoclonal antibodies. Collaborate with device and formulation teams to support development of vials, pre-filled syringes, autoinjectors, and other advanced delivery systems. Lead tech transfer activities and oversee GMP manufacturing operations at external partners, including on-site support. Ensure CDMO performance aligns with project timelines, quality standards, and operational goals. Support development strategies across clinical phases, including scale-up, process characterization, PPQ, and launch readiness. Apply Quality by Design (QbD) principles to assess risks and define process development strategies. Analyze manufacturing data to identify opportunities for process optimization and improvement. Contribute to formulation and co-formulation development for protein therapeutics. Support clinical trial readiness through dose preparation and in-use stability studies. Collaborate with Quality and external partners to review batch records, resolve deviations, and support investigations. Author and review regulatory documentation including INDs, IMPDs, BLAs, and briefing materials. Ideal Candidate Profile 12+ years of experience in drug product development and manufacturing, with a strong background in biologics. At least 5 years of leadership experience in GMP operations for pre-filled syringe products. Proven track record in combination product development and regulatory compliance. PhD in chemical engineering, biochemical engineering, pharmaceutical sciences, or a related field (or equivalent experience). Expertise in aseptic processing, tech transfer, and CDMO management. Experience with process qualification and commercialization of biologic therapies. Strong cross-functional collaboration skills, especially with analytical, regulatory, clinical, and device development teams. Excellent communication and leadership abilities. Willingness to travel up to 25%, including regular visits to the company's lab facilities. What's Offered A collaborative and mission-driven culture built on values of empathy, originality, resilience, and humility. A dynamic work environment with opportunities to shape company culture and take on diverse responsibilities. Competitive compensation including base salary, performance bonuses, equity grants, and comprehensive benefits. Flexible paid time off and two company-wide breaks annually. Professional development support and regular in-person team gatherings. Seniority level Seniority level Not Applicable Employment type Employment type Full-time Job function Job function Science Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at EPM Scientific by 2x Get notified about new Director/Senior Director, Formulation and Drug Product Development jobs in Boston, OH . Cleveland, OH $130,000.00-$340,000.00 1 week ago Senior Director of Product Management, Pull Tab Marketing Senior Director, Partner Business Development Senior Director of Marketing - eGaming Division IT Product Owner - Applications Director We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr Experience: 12 years required