Manager, Development

Ossiums mission is to improve the health vitality and longevity of human beings through bioengineering. We develop manufacture and bank cell therapy products that apply the power of stem cell science to revolutionize treatment for patients with blood immune and orthopedic diseases. At Ossium we empower our employees maintain the highest standards of operational excellence and are a force for good.

Were hiring a Development Manager to lead the end-to-end development of novel biomaterial products with a primary focus on our decellularized bone matrix (dCBM) program. This is a high-impact role at the intersection of science strategy and operations driving programs from early-stage research through process optimization and transition to clinical-scale manufacturing.

You will lead and manage a team of Associates fostering a high-performing and collaborative team culture focused on operationalizing product development. Youll get to own the strategic direction and day-to-day execution of the decellularized bone matrix product development program from bench to clinical production.

This is an opportunity for someone to drive cross-functional alignment with Quality Assurance Regulatory Affairs Manufacturing and Clinical Production to ensure successful program delivery. Youll define project timelines manage resources and present progress and recommendations to senior leadership as we build out an impactful new product.

This position reports directly to the Chief Science Officer.

• MS in life sciences or bioengineering 3 years of directly relevant industry experience or BS in life sciences or bioengineering 5 years of directly relevant industry experience
• Demonstrated experience managing scientific teams in a GMP or regulated development environment
• Experience with aseptic technique and mammalian cell culture in an industrial or clinical setting
• Experience with molecular biology techniques (Western blot IHC ELISA PCR next-gen sequencing) and flow cytometry
• Strong statistical analysis skills; experience with JMP Prism or equivalent software
• Track record of authoring and revising SOPs development reports and quality documents
• Excellent written and oral communication skills
• Capability to operate with a high level of organization and excellent time management in a dynamic startup environment
• This position is based on site in our Indianapolis office; employees will report to Ossiums facility Monday through Thursday and have the option to work remotely on Fridays

• PhD in life sciences or bioengineering
• Experience in decellularization extracellular matrix biology or bone/orthopedic tissue engineering
• Background in technology transfer and scale-up of biological or tissue-derived products
• Familiarity with (Human Cells Tissues) and/or 21 CFR Part 211 (GMP) requirements
• Experience with cryopreservation and processing of bone or other musculoskeletal tissues

• Lead end-to-end development of Ossiums non-viable tissue product platform.
• Define and oversee analytical characterization strategies including histological assessment sterility testing and biocompatibility evaluation
• Partner with Regulatory Affairs to develop the regulatory strategy for new products and support IND/IDE submissions and technical documentation as needed
• Collaborate with Manufacturing and Quality to develop technology transfer packages and scale-up strategies ensuring process reproducibility and GMP compliance as needed
• Design experiments plan project timelines and perform complex statistical analysis; prepare presentations and recommendations for leadership review
• Write and review development reports SOPs and other quality-related documents
• Participate in regular meetings with senior leadership as well as the broader Development Research Manufacturing and Production groups
• Initiate and ensure compliance with applicable safety procedures
• Perform activities in accordance with Good Laboratory Practices (GLPs)

In your first six months some projects youll work on include:

• Conducting a full audit of existing non-viable tissue product development data and establishing a 12-month product development roadmap
• Implementing or refining process parameters and establishing release testing criteria for the non-viable tissue products
• Building out team capabilities through development of direct reports
• Establishing cross-functional working relationships with Regulatory Affairs and Quality to align on product development and compliance strategy

We offer a full slate of employee benefits including:

• Competitive salaries
• Stock options
• 401(k) matching
• Medical dental and vision coverage
• Four weeks of PTO accrued (vacation & sick time) annually 11 company holidays
• Employer paid life insurance and long term disability
• Gym membership/recreational sports reimbursements