Associate Director/Director, CMC Digital Business Partner

Associate Director/Director, CMC Digital Business Partner – Obsidian Therapeutics – Bedford, MA (HYBRID)

Obsidian Therapeutics is accelerating the delivery of breakthrough cell‑based medicines, and we need a strategic digital leader to own the end‑to‑end CMC (Chemistry, Manufacturing, and Controls) data ecosystem. As the Associate Director/Director, CMC Digital Business Partner, you will bridge cutting‑edge digital solutions with regulatory‑compliant manufacturing, ensuring that our 3PL networks, LIMS platforms, and 21 CFR Part 11 frameworks operate as a seamless, data‑driven engine. Your work directly influences product quality, speed to market, and the company’s ability to scale novel therapies worldwide. Reporting to the VP of CMC Operations, you will mentor a cross‑functional team of data scientists, IT engineers, and quality specialists, positioning yourself for future leadership roles such as Head of Digital CMC or Global CMC Strategy Director.

- Lead the design, implementation, and continuous improvement of a compliant, cloud‑based CMC data architecture that integrates 3PL logistics, LIMS, and electronic batch records.
- Translate regulatory requirements (21 CFR Part 11, CSA) into actionable digital workflows, ensuring audit‑ready documentation and traceability.
- Partner with manufacturing, quality, and supply‑chain leaders to define key performance indicators, drive data‑centric decision making, and reduce cycle times.
- Oversee vendor selection and management for digital tools, negotiating contracts that align with Obsidian’s cost and security standards.
- Champion data integrity and cybersecurity best practices across all CMC platforms, conducting risk assessments and remediation plans.
- Mentor and develop a high‑performing team, fostering a culture of continuous learning, collaboration, and innovative problem solving.
- Report progress, insights, and ROI to senior leadership, influencing strategic investments in digital transformation.

Why join Obsidian Therapeutics? Our mission‑driven culture celebrates scientific curiosity, bold thinking, and patient impact. You will work in a hybrid Bedford, MA (HYBRID) environment that blends collaborative on‑site teamwork with flexible remote options, supported by state‑of‑the‑art labs and a vibrant biotech community. We invest heavily in professional growth—offering tuition reimbursement, leadership training, and exposure to pioneering cell‑therapy pipelines that are reshaping the industry. As the digital backbone of our CMC organization, you will be at the forefront of industry trends such as AI‑enabled analytics, real‑time supply‑chain visibility, and next‑generation compliance automation. This role offers unparalleled visibility, the chance to shape enterprise‑wide digital strategy, and a clear path to senior executive leadership within a fast‑growing therapeutic innovator.