The Specialist, Training develops and delivers training programs for GMP operations, ensures compliance with SOPs and safety protocols, and assesses trainee competencies.
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.
The Specialist, Training works to develop, deliver and optimize classroom and hands on training programs that support the development and enhancement of skills related to GMP operations in a commercial manufacturing environment. The role ensures that personnel are trained effectively on standard operating procedures (SOPs), equipment use, safety protocols, and regulatory compliance to achieve production goals and maintain quality standards.
Key Responsibilities:
- Develop comprehensive training programs and materials for roles across the GMP commercial operations of cell therapies including, but not limited to, manufacturing, quality control, and warehousing.
- Create training modules, presentations, and manuals that align with regulatory requirements, GMP guidelines, and company policies.
- Conduct classroom training sessions, workshops, on the job training, and hands-on demonstrations, on a daily basis, to impart technical knowledge and skills to staff.
- Assess trainee competencies and learning outcomes through practical evaluations and knowledge assessments.
- Provide constructive feedback and coaching to trainees to support their skill development and performance improvement.
- Maintain accurate training records and documentation to demonstrate compliance with training requirements.
- Optimizes training programs to support scalability and reduced time to operator proficiency.
- May require shift, weekend, or holiday coverage to support manufacturing and patient treatment timelines.
- Supports training system compliance and other duties as assigned
Minimum Qualifications
- Bachelor's degree in a relevant field such as Biotechnology, Engineering, or Education; advanced degree preferred
- Minimum of 2 years of relevant experience in training and development, preferably in a manufacturing or biotechnology environment
- 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
Preferred Qualifications
- Experience in quality control or GMP within a cell therapy or biopharmaceutical manufacturing environment is preferred
- 2+ years of experience in quality control testing, analytical development, or GMP quality operations
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 competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized 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.
Top Skills
Learning Management Systems (Lms)
MS Office
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