Associate Director/Director Drug Product and Formulation Development

Merida Biosciences•Cambridge, MA

10h•$200,000 - $270,000

About The Position

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 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. We are seeking a talented Drug Product expert who is interested in joining a highly dynamic team. This position will offer a tremendous opportunity to lead formulation and DP manufacturing for an innovative biologic medicines. Experience in design and scale-up of high concentration formulations for biotherapeutics is critical. Successful candidates will be innovative, thrive in a startup environment and use their creative and imaginative problem-solving skills to help bring new products to patients.

Requirements

MS/Ph.D. in Pharmaceutics, Material Sciences or related discipline with a minimum 8 years' experience in formulation development and cGMP manufacturing of biologics.
Proven track record of developing high concentration biologics formulations, including hands-on experience.
Strong understanding of analytical characterization for biologic molecules (e.g., monoclonal antibody, bispecific antibodies, fc-fusion molecules, etc).
Pre-formulation experience working with internal discovery teams and a creative mind for novel ideas to resolve technical issues.
Experience working with CRO's and CMO's in directing drug product development and manufacturing.
Goal oriented team player with excellent communication skills, flexibility, and ability to work in a fast-paced environment with multiple teams across the company.

Responsibilities

Develop and implement comprehensive strategies for early-stage formulation and process development for biologics, including characterization, pre-formulation, evaluation of multiple formulation options, DP manufacturing process design and optimization, scale-up, and manufacturing of drug product under both non-GMP and cGMP.
Manage Contract Research Organizations in the development of stable formulations for biologics, including excipient evaluation, selection of primary drug container closure systems, and identification of degradation pathways.
Collaborate with research to ensure appropriate workflows for developability screening are implemented prior to development candidate nomination.
Lead interactions with Contract Manufacturing Organizations to ensure technology transfer and delivery of GMP drug product for clinical studies, including review of MBR and EBR and associated documents. Work closely with internal colleagues to ensure timely delivery of drug product supplies for non-clinical and clinical studies as appropriate. Work closely with CMC colleagues to ensure consistent manufacturing timelines across drug substance, drug product, and QA/QC.
Author technical reports (formulation development, tech transfer, batch records, etc.) and regulatory documents (IND, IMPD, BLA, etc.) as necessary.