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Associate Director/Director, Formulation Development - Cambridge, United States - Third Rock Ventures
Description
A Third Rock Ventures Stealth NewCo is seeking a talented formulation expert who is interested in joining a highly dynamic team.
This position will offer a tremendous opportunity to lead formulation and DP manufacturing for a innovative portfolio of 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.
Responsibilities:
Develop and implement comprehensive strategies for early-stage formulation and process development for biologics, including characterization, pre-formulation, evaluation of multiple formulation options, process design and optimization, scale-up, and manufacturing of drug product under both non-GMP and cGMP
Lead development of stable formulations for biologics portfolio, 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 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
Qualifications:
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
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