About the role:

As Head of CMC, you will be responsible for internal CMC or Process Development (PD) activities in addition to managing all outsourced contract manufacturing activities. You will be responsible for driving interactions with CDMOs to execute formulation and analytical activities, as well as for drug-substance and drug-product GxP manufacturing. The successful candidate will also have a deep understanding of global CMC regulatory requirements for biologic products, including extensive experience authoring the CMC sections of US and global regulatory filings and previous experience representing companies as the CMC expert before regulatory authorities. This role will report directly to the CEO and will be expected to present at Board of Director meetings from time to time. You will lead and support cross-functional interactions between the R&D and CMC teams to achieve our corporate goals in a fast-moving environment, while simultaneously growing and mentoring the CMC team..

Responsibilities

• Lead all CMC development and manufacturing activities with overall responsibility for all drug substance and drug product process and analytical development and manufacturing activities from pre-IND through clinical development.
• Identification, selection and management of CDMOs for process optimization, cGMP manufacture of Drug Substance and Drug Product (DP) in support of ongoing clinical programs in compliance with cGMP, ICH and FDA regulations.
• Prepare CMC sections of INDs, CTAs, BLA/MAAs and other regulatory submissions; represent the company as the CMC expert before regulatory authorities.
• Create integrated CMC budgets and timelines for all of the company drug development programs. Work with finance, senior leadership, and external partners to monitor financial and timeline variences to control costs and critical timelines.
• Lead and manage outsourcing of manufacturing activities, contract drafting and negotiation.
• Coordinate the design and execution of cross-functional CMC project plans to support research activities through to early clinical development.
• Lead authorship of SOPs, Protocols/Reports, BPRs and Specifications for drug substance and drug product manufacturing activities
• Review CMC project plans and timelines and assist in execution to ensure all projects are appropriately prioritized and key goals are met on time

Qualifications

• MS in an applicable field of study with 15+ years, or a PhD in an applicable field of study with at least 12+ years of industry experience. Experience in biologics is required and experience in advanced biologics such as antibody-drug conjugates or cell/gene therapy preferred.
• Experience developing and implementing CMC strategy throughout the span of CMC development from pre-IND through late stage development. The ability to apply a phase appropriate approach to CMC development and manufacturing is essential.
• History of successfully growing and nurturing third party CRO and CDMO partnerships and contract development for GLP-Tox and Phase 1 clinical supply manufacturing of biologics.
• Hands-on experience developing and troubleshooting drug substance and drug product manufacturing processes for biologics.
• Direct experience with upstream development (USP) for biologics such as stable cell line development, cell culture process development (bioreactor) and scale-up. Experience with DoE and other QbD approaches.
• Direct experience with downstream development (DSP) for biologics such as UF/DF & TFF at benchtop and manufacturing scales, and liquid chromatography for protein purification.
• Experience developing, implementing, and troubleshooting ICH compliant analytical assays for the product release and stability testing of biologics drug substance and sterile drug product.
• Extensive experience crafting the CMC sections of US and global regulatory filings and successfully negotiating with global regulatory authorities is required.
• In-depth knowledge of and ability to interpret and strategically apply FDA, EMA and ICH guidance to support biologics development, manufacturing, and stability studies.
• Experience building CMC teams, mentoring, and developing members of the CMC team to expand capabilities.
• Excellent written and verbal communication skills with an ability to convey CMC strategies and results to a varied audience.
• Strong diplomatic and negotiating skills; ability to deal with uncertainty in a constructive manner and generate options for moving forward.
• Meticulous, self-motivated, decisive, and independent with a willingness to work in a fast-paced start up environment