Louisville, CO30+ days ago
em> Extensive experience with early and late phase fill-finish process and formulation development, stability, clinical and regulatory expectations, including IND and BLA authoring and/or strategy Extensive experience with technical transfer and GMP manufacturing support, including Process Performance Qualification (PPQ) Experience with fill-finish capital projects and practical/working knowledge of EU GMP Annex 1 guideline Strong knowledge of drug product characterization, accelerated stability, container-closure selection and analytical methods Strong team and executive level communication and collaboration skills, along with self-motivation to contribute to the development of novel cancer immunotherapies Ability to balance multiple priorities in a fast-paced, cross-functional and dynamic environment and perform tasks across a variety of levels Preferred Qualifications: Strong understanding of sub-visible and sub-micron particle measurement and characterization Understanding and experience with viral drug products, preferably BSL2 or higher enveloped viruses Working knowledge of clinical supply chain Upstream, Downstream or other Process Development or Manufacturing experience PUPSIT process development, implementation and qualification Analytical method development experience, including stability indicating assay development Experience with frozen-in-vial and lyophilized/spray dried drug products Experience leading extractable and leachable studies Familiarity with small-molecule drug substance and drug product formulation and fill-finish Physical Requirements: 100% compliance with personal protective equipment (PPE) requirements in biological laboratory environments for wet lab work, including gloves, protective clothing, and eye safety glasses. CORE ACCOUNTABILITIES Specific responsibilities include: Build, mentor, and lead a high-performing Drug Product and Formulation team comprised of Scientists and Engineers including recruiting, performance management, and talent development Lead the Drug Product Development team activities for multiple products, including new product introduction for early phase formulation development, internal and external technical transfer, manufacturing support and clinical trial support for a frozen-in-vial lentiviral drug product Serve as the primary technical point of contact for external fill-finish technical transfer Drive the late-stage Drug Product Development strategy for formulation development, process qualification for manufacturing Lead and serve as the primary technical point of contact for a fill-finish capital project to improve Umoja's internal manufacturing capability Lead formulation and process improvements to stability, final filtration and dosage form Collaborate closely with the Process Sciences team (upstream, downstream and optimization), analytical development, manufacturing, supply chain, non-clinical, clinical and research teams Proactively communicate Drug Product Development strategy, plans, risks and mitigations to senior internal and external leaders Serve as Drug Product Development and/or Process Sciences subject matter expert for Program Teams and Governance Maintain familiarity with current scientific literature, experimental methods and manufacturing approaches The successful candidate will have: Director Level: PhD/MS/BS in Biochemistry, Chemical Engineering, Bioengineering, Biology or related field with 10/12/15 years of relevant experience, respectively.