Senior Director, Drug Product Development

POSITION SUMMARY

Umoja is seeking a Head of Drug Product Development to join the Process Sciences team. This position will provide leadership for internal and external drug product manufacturing processes for lentiviral vectors, including formulation development, fill-finish and technology transfer activities for early and late-stage programs. Additionally, this position will lead the process aspects of a facility capital project to upgrade internal fill-finish manufacturing.

A successful candidate should have a thorough understanding of formulation development and fill-finish strategies and approaches for both early and late-stage products along with strong communication and collaboration skills to partner with leaders across Umoja.

This is a fully onsite role based at our Louisville, CO location with some expected travel. The level of this role will be determined based on candidate’s experience and qualifications.

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. Equivalent combination of education and experience will be considered. Minimum 6 years of people management experience.
• Senior Director Level: PhD/MS/BS in Biochemistry, Chemical Engineering, Bioengineering, Biology or related field with 15/17/20 years of relevant experience, respectively. Equivalent combination of education and experience will be considered. Minimum 10 years of people management experience.
• 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.
• Perform physical tasks required for the role, including standing, walking, bending, kneeling, sitting, working your hands in a biosafety cabinet, and occasionally moving materials up to 50 pounds.
• Project-oriented work in this role will require regular on-site presence to complete essential job-related functions.
• Ability to travel up to 20%

Director Level Salary Range: $197,300 - $243,700

Senior Director Level Salary Range: $233,500 - $288,400