Merida Biosciences · 3 months ago
Sr. Director, Drug Product Development
Cambridge,MA,US
Full-time
Onsite
Director/Executive
15+ years expMerida Biosciences is pioneering true precision medicines for antibody-driven diseases. They are seeking a Senior Director of Drug Product Development to lead the development, manufacturing, and commercial supply strategies for biologic drug products, overseeing formulation and process development, and ensuring compliance with regulatory standards.
BiotechnologyLife ScienceTherapeutics
Responsibilities
Define and execute the overall strategy for biologics drug product development, aligning with program and corporate objectives
Lead formulation and process development for biologics pipeline, including stability, compatibility, and manufacturability assessments
Drive development activities from preclinical through commercial stage, including support for IND/CTA/BLA/MAA submissions, responses to health authority questions, and support of regulatory inspections
Partner with analytical development, DS development, regulatory affairs, quality, and clinical to ensure integrated drug product strategies
Oversee technology transfer and manufacturing at external cGMP manufacturing sites, ensuring robust, scalable, and compliant processes
Build, mentor, and manage a high-performing team of scientists and leaders; foster a culture of collaboration, accountability, and continuous improvement
Qualification
Required
PhD/MS in a relevant scientific or engineering discipline
15+ years of relevant industry experience in biologics drug product development
Proven track record in high concentration liquid formulation development, fill-finish process development, and combination product development
Strong knowledge of global quality and regulatory requirements for biologics development
Demonstrated success in leading and developing high performance teams
Experience leading programs from preclinical development through commercialization
Excellent communication, influencing, and leadership skills with ability to operate in a fast-paced, matrixed environment
Prior experience working with CDMOs and managing outsourced activities for an emerging biotech company
Preferred
Familiarity with prefilled syringes, autoinjectors, lyophilized formulation development desired
Company
Merida Biosciences
Merida Biosciences is a biotech company focused on developing precision treatments, particularly for autoimmune diseases.
11-50 employees
H1B Sponsorship
Merida Biosciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (3)
Funding
Current Stage
Early StageTotal Funding
$121MKey Investors
Third Rock Ventures
2025-04-08Series A· $121M
2022-01-01Seed
Company data provided by crunchbase