Training Manager - Commercial Manufacturing Operations

Over one million people in the world today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many patients, the transplant itself can prove fatal or lead to serious conditions, such as graft versus host disease.

Orca Bio's investigational, high-precision cell therapies are designed to replace a patient's compromised blood and immune system with a healthy one, while dramatically lowering the risk of developing life-threatening or debilitating transplant-related side-effects. The first application of Orca Bio’s platform is in blood cancer where the unmet need is most acute; with a robust pipeline of promising cell therapies, we plan to extend into autoimmune diseases and genetic blood disorders as well.

As we expand our operations with the establishment of a new commercial manufacturing facility in Sacramento, CA, we are seeking a highly skilled and motivated Training Manager to lead the training initiatives for our manufacturing operators. This role offers an exciting opportunity to contribute to the development and success of groundbreaking biotechnological advancements.   Responsibilities: ·        Develop and implement comprehensive training programs for manufacturing operators, ensuring alignment with company policies, procedures, and regulatory requirements. ·        Create training materials, including manuals, presentations, and hands-on demonstrations, to effectively convey operational procedures, safety protocols, and quality standards. ·        Collaborate with cross-functional teams to identify training needs, assess skill gaps, and tailor training solutions to address specific requirements. ·        Conduct training sessions, workshops, and assessments to facilitate learning and skill development among manufacturing operators. ·        Evaluate training effectiveness through feedback mechanisms, performance metrics, and proficiency assessments, continuously refining training programs to optimize learning outcomes. ·        Stay abreast of industry best practices, technological advancements, and regulatory updates relevant to manufacturing operations, integrating new knowledge into training curricula as needed. ·        Serve as a subject matter expert on manufacturing processes, equipment operation, and quality control measures, providing guidance and support to manufacturing staff as necessary. ·        Foster a culture of continuous improvement by promoting learning opportunities, knowledge sharing, and skills development initiatives within the manufacturing team. ·        Maintain training records, documentation, and compliance records in accordance with company standards and regulatory requirements. ·        Collaborate with management to develop succession plans, career pathways, and professional development opportunities for manufacturing operators.   Qualifications: ·        Bachelor's degree in a relevant field such as Biotechnology, Engineering, or Education; advanced degree preferred. ·        Minimum of 5 years of experience in training and development, preferably in a manufacturing or biotechnology environment. ·        Demonstrated expertise in instructional design, adult learning principles, and training delivery methodologies. ·        Strong understanding of cGMP regulations, FDA guidelines, and other relevant quality standards applicable to pharmaceutical or biotech manufacturing. ·        Excellent communication, presentation, and interpersonal skills, with the ability to engage and motivate diverse audiences. ·        Proven ability to manage multiple projects concurrently, prioritize tasks effectively, and adapt to changing priorities in a fast-paced environment. ·        Proficiency in MS Office applications and learning management systems (LMS) is required. ·        Certification in training and development (e.g., CPLP, CPTM) is a plus.