Senior Manager, External Manufacturing

Obsidian Therapeutics•Bedford, MA

10h•$153,000 - $187,000•Hybrid

About The Position

Obsidian Therapeutics is pioneering engineered cell and gene therapies to deliver transformative outcomes for patients. Obsidian’s programs apply our cytoDRiVE® technology in Cell and Gene therapy products to control expression of proteins for enhanced therapeutic efficacy and safety. Obsidian’s lead program is currently in clinical development for the treatment of patients with metastatic melanoma and non-small cell lung cancer. We’re proud of our diverse talented team and committed to cultivating an environment of inclusion where each person feels a strong sense of belonging and is supported to continuously learn and contribute their best work. Our Research team is based in the heart of Cambridge, MA, and Technical Operations team is based in our purpose built facility in Bedford, MA. Obsidianites enjoy a highly collaborative culture, competitive salary and benefits, and potential for ownership through stock options. We are looking for a highly motivated Senior Manager External Manufacturing, with a strong background in CDMO management of cell therapy products. As a key contributor within the External Manufacturing organization, you’ll lead front-line oversight of cell therapy drug product and ancillary, drug substance operations, helping to drive the development of our first autologous cell therapy program targeting solid tumors. You’ll be responsible for the manufacturing value stream, including adherence to production scheduling, management of investigations, batch record revisions, change controls, site PIP management, CDMO operational performance, continuous improvement, financial reporting and budget adherence. As a member of our Technical Operations team, you will be a vital part of a highly collaborative team working to achieve Obsidian’s vision by translating innovative science into medical breakthroughs for patients starting with our lead program OBX-115, a novel engineered tumor-infiltrating lymphocyte (TIL) therapy. This is a unique opportunity to be a contributor in a well-funded clinical company with blue chip investors, field-leading advisors, best-in-class partners, and an experienced team. You'll help us build a dynamic, collaborative, innovative, passionate, and successful organization focused on delivering transformative therapies in areas of greatest clinical need. This is a Hybrid role located in our Bedford, MA office.

Requirements

Bachelor's Degree in Life Sciences, Engineering, or related discipline with 8+ years of experience in manufacturing or MS&T roles in the biotech/pharma industry.
Deep experience managing contract manufacturing and external supply networks, ideally in cell and gene therapy or other complex modalities.
Deep experience with batch record design, implementation of EBRs and MES integrated systems.
Proficiency with Lean tools and techniques.
Strong understanding of GMP compliance, quality systems, and regulatory expectations for advanced therapies.
Proficiency with SOW/ Change order creation, CDMO financial reporting and budget management.
Demonstrated ability to lead cross-functional teams to achieve ambitious goals, manage complex projects, and influence at all levels of the organization.
Ability to travel 20-40% of time.
Excellent planning, coordination, and time management skills.
Excellent oral, written, and visual communication skills. You listen to understand and communicate effectively and persuasively with partners, colleagues, and leadership.
A desire and ability to work in a dynamic, collaborative environment; building productive and healthy relationships within and across functions.
Collaborative and accountable – recognizes success requires teamwork and interdisciplinary thinking; you share feedback and constructively challenge and accept challenges to generate the best ideas to advance project and company goals.
Self-motivated, with a proven ability to meet objectives, timelines, and high standards managing multiple responsibilities in parallel.
Flexible – able to operate and adapt in a fast paced, rapidly developing environment.
Curious and humble – seeks and welcomes input/expertise of others, continuous learner.
Tenacious and resilient – is not easily overwhelmed by challenges, delivers on commitments, operates with urgency.

Nice To Haves

Experience with cell therapy commercialization internally or at a CDMO

Responsibilities

Develop proficiency in Obsidian’s drug product and drug substance manufacturing processes.
Oversee execution of drug product and ancillary drug substance manufacturing across a network of global CDMO partners to ensure supply chain continuity and high-quality supply to the clinic.
Manage or collaborate on CDMO investigations, MBR revisions, and change controls as needed to enable on time production and lot disposition.
Oversee CDMO performance metrics for manufacturing and internal stakeholders demonstrating strategic areas of focus and continuous improvement opportunities.
Contribute to cost-of-goods (COGS) optimization and value creation by leading continuous improvement initiatives with CDMO partners.
Participate in strategic sourcing, vendor selection, capacity planning, SOW/ forecast review, and ongoing supplier relationship management for key services.
Partner closely with Quality, MS&T, QC, CMC and Supply Chain to ensure systems are fit for purpose for program phase.
Coach CDMOs on phase appropriate standards for operations, including scheduling, operational performance metrics, batch release, equipment maintenance, and financial reporting.
Foster a high-performance culture with CDMO partners and internally.
Enable team success and individual growth through clear expectations, high standards/support, stretch assignments, and coaching.