Associate Director, Training Operations

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.

We have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.

The Sr. Manager/Associate Director (depending on experience), Training Operations will be responsible for the design, implementation, and delivery of learning programs for Orca Bio’s manufacturing functions. This role is responsible for the strategic planning, development, implementation, and management of the training programs and training compliance for Orca Bio’s cell therapy manufacturing and related functions.  The ideal candidate will bring expertise in training development cycles, instructional design, and compliance-driven training programs while ensuring that all initiatives align with industry regulations and organizational objectives.

Responsibilities:

Training Program Development and Execution

o   Develop and implement comprehensive, role-based training curricula tailored to Orca Bio’s cell therapy manufacturing.

o   Ensure training programs comply with GMP, FDA, EMA, and other regulatory requirements.

o   Oversee the development of hands-on workshops, e-learning modules, SOPs, and regulatory training content.

o   Collaborate with Subject Matter Experts (SMEs) to ensure training materials are accurate, relevant, and up to date.

o   Create and maintain training assessments and certification programs to track competencies and ensure compliance.

o   Drive efficiencies to improve the quality of training programs, reduce costs, optimize scalability, and enhance new employee onboarding.

Training Operations & Compliance

o   Oversee the planning and execution of training schedules, ensuring timely and effective delivery.

o   Manage training logistics, including scheduling, resource allocation, and trainer coordination.

o   Maintain detailed training records in compliance with regulatory standards.

o   Ensure training programs support audits and inspections, addressing compliance gaps proactively.

o   Monitor training KPIs to evaluate program effectiveness and identify areas for improvement.

Leadership & Continuous Improvement

o   Lead and develop a high-performing training team.

o   Foster a culture of continuous learning and operational excellence.

o   Stay up to date with industry best practices and emerging trends to refine training strategies.

o   Identify opportunities to enhance training methodologies, incorporating blended learning solutions.

o   Build relationships with key external partners to build and enhance training pipelines.

Qualifications:

o   Bachelor's degree in a relevant field such as Biotechnology, Engineering, or Education; advanced degree preferred.

o   Minimum of 6-10 years of experience in training and development, with at least 3 years of people leadership within the biotechnology or pharmaceutical industry. 

o   Strong understanding of cell therapy manufacturing preferred; cGMP regulations, and compliance requirements (FDA, EMA, GxP) required.

o   Experience designing and implementing training programs in a complex technical pharma or biotech environment.

o   Proficiency in Learning Management Systems (LMS) and digital training tools.

o   Exceptional project management skills with the ability to manage multiple priorities.

o   Strong communication and collaboration skills to work cross-functionally.

o   Analytical mindset to assess training effectiveness and drive improvements.

o   Certification in training and development (e.g., CPLP, CPTM) is a plus.

o   Detail-oriented, with a strong commitment to quality, compliance, and safety.

o   Ability to multitask and prioritize effectively in a fast-paced environment.

o   Strong problem-solving skills and a proactive mindset for process improvements.

o   Ability to work in cleanroom environments and follow GMP cleanroom protocols.

o   Comfortable working across various shifts when necessary.

o   Occasionally required to ascend/descend stairs, stand, walk, or work at a computer for extended hours.

The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. You will also be eligible to receive pre-IPO equity, in addition to medical, dental, and vision benefits, flexible PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include free daily lunches and snacks at our on-site locations.

Who we are

We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.

We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.

We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.

We maintain a start-up culture of camaraderie and leadership by example, regardless of title.

We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.

Notice to staffing firms

Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.