Executive Director, Manufacturing Operations and MSAT

ABOUT THE ROLE

The
Executive Director of Manufacturing Operations and MSAT
(Manufacturing Science and Technology) is a unique technical leadership opportunity that combines a broad scope of responsibilities: operational oversight of multiple drug substance (DS) and drug product (DP) CDMOs, tech transfers and clinical supply logistics. Given the early stages of forming the Technical Operations organization at Marea in a start-up environment, this role is expected to provide strategic CMC thought partnership as well as hands-on operational execution leadership. This role is expected to develop Marea's manufacturing strategy across the portfolio with a goal to ensure reliable supply and at the same time ensure on-time and high-quality execution of planned scope of work through our external manufacturing and supply partners. Successful candidate will have a mix of technical/operational experience in both DS and DP disciplines at various stages of biologics development. Reporting to the CTO, this is a key role Technical Operations leadership team as we aggressively advance the first program towards late-stage development and our second program into early-stage clinical development. The candidate will work closely with other members of the technical operations team including technical development, quality and regulatory CMC as well as cross-functionally with research and clinical operations team to support the program goals. On the manufacturing operations part of the role, the candidate will oversee contract and agreement negotiations with the CDMO, operational oversight of the planned work and building a strategic combination of CDMOs/CTLs to enable capital efficient and aggressive CMC development and manufacturing path. AS part of the MSAT responsibilities, candidate will plan and execute tech transfers, process and method improvements (working with technical development) and resolve complex manufacturing issues in a timely manner. As part of the clinical supply chain role, candidate will partner closely with clinical operations to ensure oversight of all the nodes in the supply chain from the point of drug product release to drug product availability at the clinical site, including packaging, labeling, storage and shipping operations. Good understanding of the necessary ICH and USP regulations and experience supporting regulatory submissions at various development stages is desired.

KEY RESPONSIBILITIES

• Evaluate and select CDMOs and CTLs for the Marea Biologics portfolio, aiming for a strategic combination to provide necessary technical and operational capabilities to ensure reliable supply and on-time delivery of development work packages
• Responsible for day-to-day operational oversight of CDMOs and CTLs while ensuring that the external deliverables meet the needs of the internal CMC and project teams
• Negotiate service agreements and contracts and manage and ensure the needs of the CMC team are fully met through the contract
• Maintain ongoing relationships with CDMOs and CTLs both on the business as well as operational axis
• Work with the internal technical and quality SMEs in the Tech Ops team to ensure timely resolution of complex manufacturing and quality issues, investigations, CAPAs and regulatory requests
• Plan and execute technology transfers and major product life cycle improvements at the CDMOs, working closely with technical development and quality
• Partner with quality and technical development to enable on-time batch disposition
• Author sections of Module 3 for regulatory submissions such as briefing books, IND, amendments, information requests and in the future BLA. Coordinate inputs from the CDMOs and CTLs in support of such submissions
• Develop strategy and execute plans for clinical supply chain overseeing and coordinating operations across the supply chain nodes from cell banks, DS, DP, packaging/labelling, shipping, storage and final delivery to the clinical sites across multiple jurisdictions.
• Work with quality and regulatory to proactively identify risks in supply chain and develop mitigation and response plans upfront to enable uninterrupted supply for the ongoing clinical trials
• Develop plans, timelines and budgets for external manufacturing and supply chain activities and ensure these are captured as part of the short- and long-term operating plan
• Work with clinical operations to ensure alignment of assumptions for supply chain and clinical trial with an aim to ensure continuity of supply while minimizing waste and balancing risk

QUALIFICATIONS

• MS or PhD in Chemical Engineering or Life Science or related discipline with 15+ years of relevant experience in biologics development at all stages of clinical development.
• Combination of experience in manufacturing operations, MSAT and clinical supply chain. In addition, previous experience in CMC technical development is a plus.
• Hands-on experience in troubleshooting and resolving complex manufacturing issues
• Demonstrated experience to oversee large operational scope across multiple programs across multiple CDMOs/CTLs
• Demonstrated experience in developing and executing the strategy for tech transfers
• Strong people skills in the context of managing external CDMOs and working cross functionally internally with CMC team, project teams and senior leaders across Marea
• Proven experience in authoring content for regulatory submissions and interacting with health authorities
• Experience managing CDMOs and contract testing labs including negotiating complex terms and conditions and putting in place clinical and commercial agreements
• Experience in developing and implementing phase appropriate supply chain and logistics plans.
• Experience in developing and implementing raw material sourcing and supply strategies
• Broad experience (or working knowledge) across the CMC axis –drug substance and drug product process, final product configuration and components, familiarity product in-use considerations.
• Prior experience supporting supply and logistics aspects of global multi-site clinical trials
• Experience working with various electronic systems to support supply chain, data analysis and source documentation
• Strong leadership skills working cross-functionally with internal team and with external partners
• Exceptional ability to flex between strategic planning and hands-on execution in a lean, start-up environment.

WORKING CONDITIONS

• Travel to CDMOs/CTLs may be needed up to 25% of the time (variable, with some peak windows)
• Role is based in Marea's South San Francisco location. Remote location with hybrid arrangement may be considered for exceptional candidate.

We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state, and local law. We invite applications from minorities, women, the disabled, protected veterans, and all other qualified applicants.