Merida Biosciences
Sr. Director, Drug Product Development
Merida Biosciences, Cambridge, Massachusetts, us, 02140
At Merida Biosciences, we are pioneering true precision medicines for antibody-driven diseases. We specifically target pathogenic antibodies and their cellular sources with bespoke Fc biotherapeutics engineered to selectively and completely eliminate the root causes of autoimmune and allergic diseases, and to achieve deep, durable responses while preserving essential immunity. We are looking for passionate individuals to join our mission to transform treatment paradigms across the spectrum of antibody-driven diseases.
Senior Director, Drug Product Development is a leadership role responsible for the end-to-end development, manufacturing, and commercial supply strategies for biologic drug products. This role involves overseeing formulation and drug product process development, technology transfers to CDMOs and external drug product manufacture.
Key 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.
Requirements
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. Familiarity with prefilled syringes, autoinjectors, lyophilized formulation development desired.
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.
Merida Biosciences is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
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Senior Director, Drug Product Development is a leadership role responsible for the end-to-end development, manufacturing, and commercial supply strategies for biologic drug products. This role involves overseeing formulation and drug product process development, technology transfers to CDMOs and external drug product manufacture.
Key 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.
Requirements
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. Familiarity with prefilled syringes, autoinjectors, lyophilized formulation development desired.
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.
Merida Biosciences is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
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