JOB TITLE: Associate Director, Manufacturing Business Operations & StrategyLOCATION: Remote (WA or MA preferred) - candidates based in the following states will be considered: IN, MA, NC, NJ, NH, NM, NY, PA, SC, SD, TX, KY or WA.
SALARY RANGE: $203,000 to $228,000
ABOUT THE POSITIONAurion Biotech is seeking an Associate Director, Manufacturing Business Operations & Strategy to provide strategic, technical, operational, and business leadership across the Manufacturing organization as Aurion advances through late-stage development, BLA submission, commercialization, commercial launch, and lifecycle management.
Serving as Head of Manufacturing Business Operations & Strategy, this person will serve as the strategic and operational integrator for Manufacturing, partnering across External Manufacturing, MSAT, Supply Chain, Quality, Regulatory, Finance, Legal, and external manufacturing partners. The successful candidate will combine technical understanding of biologics or cell therapy manufacturing with commercial operations experience, strategic thinking, and business acumen. This individual will develop creative manufacturing strategies and scenarios for how, where, when, and with what resources manufacturing activities are executed to achieve technical, regulatory, supply, and business objectives.
KEY RESPONSIBILITIES- Own the Manufacturing team book of work, detailed timelines/smartsheets, integrating technical milestones, dependencies, budgets, and external commitments to drive portfolio prioritization and execution.
- Lead Manufacturing SOW, contract, budget, PO, and invoice management, translating technical strategies into clear scopes, deliverables, schedules, financial commitments, and business arrangements.
- Support Manufacturing leadership (ExM and MSAT) and technical leads to develop integrated late-stage, commercialization, commercial manufacturing, and operational project timelines and dependencies at site.
- Develop creative, risk-based manufacturing scenarios and contingency plans that optimize activities, resources, investments, and network capabilities while protecting supply and preserving future optionality.
- Lead commercialization and manufacturing network planning across sites, including capacity, sourcing, redundancy, business continuity, cross-site integration, CDMO strategy, and major lifecycle transitions.
- Other duties as assigned
QUALIFICATIONS AND EDUCATIONTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- B.S., M.S., or Ph.D. in a scientific or engineering discipline
- Preferred 8-10 years of experience in MSAT, Manufacturing, or PD for biologics/cell therapies. Significant experience in Manufacturing, MSAT, External Manufacturing, Technical Operations, Process Development, Manufacturing Strategy, or a related technical operations function.
- Experience in late-stage / commercial cell and gene therapy required. Experience with multiple commercial cell therapy products, a plus.
- Proven track record of managing books of work, contracts, and technical strategies in support of late-stage or commercial GMP manufacturing.
- Experience supporting CMC sections of regulatory submissions and informational requests.
- Experience with manufacturing network planning, site selection, capacity planning, business continuity, second sourcing, or cross-site manufacturing integration preferred.
- Solid understanding of GMPs, ICH guidelines, and regulatory expectations for cell therapies.
REQUIRED SKILLS AND ABILITIES- Background in cell therapy, viral vector, or other complex biologic modalities highly preferred.
- Strong knowledge of technology transfer, commercial GMP manufacturing, validation/PPQ, comparability, investigations, process performance, and commercial lifecycle management.
- Strong combination of technical manufacturing expertise, strategic thinking, business acumen, commercial operations, and program leadership.
- Ability to translate complex technical strategies into executable plans, SOWs/contracts, budgets, schedules, and operating models.
- Demonstrated ability to drive complex initiatives to completion and develop creative, practical, risk-based solutions in fast-paced, resource-constrained environments.
- Strong leadership and communication skills with the ability to influence across functions, external partners, and executive stakeholders; excellent technical writing and document review skills.
- Proficiency with Microsoft Office and project/portfolio management tools; financial planning, ERP/procurement, and data visualization experience preferred.
- Ability to travel up to 25%.
Salary Description
$203,000 to $228,000
