Summary: Seeking an Associate Director Drug Product and Device Development to support technical transfer and clinical manufacture of lyophilized drug product at Contract Manufacturing Organization (CMO) located in Europe. The successful candidate will be responsible for driving forward manufacture of EFX drug product (DP), drug/medical device combination product development, human factors studies, global regulatory filings, and commercialization of Efruxifermin. As such the role will include support of development activities and manufacturing operations at external vendors within a fast-paced entrepreneurial environment.
The candidate must have protein therapeutics experience in all aspects of drug product development, clinical manufacture, and drug delivery, in addition to helping manage external vendors and oversee outsourced activities. Working knowledge of drug/medical device combination products and human factors studies for self-administration of injectable biologics is preferred. Must also possess functional knowledge of formulation development and analytical techniques for the characterization of biopharmaceuticals.
- Provide technical support of drug product process transfer and clinical manufacture of lyophilized sterile injectable biopharmaceuticals in late-stage development and through commercialization
- Support Drug Product process characterization and process validation studies at external CMO
- Establish and implement phase-appropriate Drug Product development concepts and standards in a resource- and cost-effective manner
- Ensure high quality vendor management, meeting company standards and industry regulations for biopharmaceutical products and medical devices. Serve as person in plant as needed during critical operations.
- Provide scientific pharmaceutical development support for Efruxifermin and other subsequent projects at various stages of development
- Develop strategy and logistics for projects and technology transfers in support of process improvements and new product introductions
- Use sound scientific and engineering criteria to evaluate manufacturing processes, identify and execute process optimization strategies, and ensure successful manufacturing of sterile injectable biologics
- Manage contract manufacturers for development and production. Ensure process consistency, process robustness, and consistency of drug product-device based on critical product quality attributes.
- Execute programs and prepare documentation to support key regulatory milestones such as preparation and submission of INDs, BLA, PAI, and fulfilment of post marketing commitments
- Provide both strategic and detailed engineering/technology support for development and pre-marketing production of Drug Product and device development
- Support Design Controls activities and operations and Human Factors studies execution for drug/medical device combination product
- Participate in CMC and cross-functional development teams, as required, including due diligence of potential acquisition candidates
- Ability to self-start in a virtual organization, influence effectively in videoconference-based project team meetings, ability to engender shared commitment with CMO-CRO for delivering on agreed objectives
- 10 + years’ biotechnology industry experience with successful BLA/MAA submissions including commercialization of products
- Broad hands-on exposure to multiple injectable drug delivery technologies and dosage forms including development and/or significant optimization/robustness of drug product formulations.
- Working knowledge of CMC regulatory requirements for biopharmaceutical products in various stages of development as well as practical application of principles of quality by design (QbD)
- Direct relevant experience in drug/medical device combination product development and commercialization in US, EU, ROW
- Experience in lyophile technical transfer and scale up for sensitive biologics as well as GMP requirements for sterile injectables
- Experience outsourcing manufacturing/development activities at CMO/CROs
- Excellent oral and written communication skills
Advanced degree (MS/Ph.D.) in relevant scientific discipline e.g. Chemical/Bio Engineering, Protein Chemistry, Biological Sciences, Pharmaceutical Sciences
We invite qualified applicants who share our commitment to send your resume and cover letter to firstname.lastname@example.org.