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Trainer - GMP Operations

Orca Bio

Orca Bio

This job is no longer accepting applications

See open jobs at Orca Bio.See open jobs similar to "Trainer - GMP Operations" DCVC.
Operations
Sacramento, CA, USA
Posted on Jul 23, 2024
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 Commercial Manufacturing Trainer works to develop and deliver 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) and equipment use, safety protocols, and regulatory compliance to achieve production goals and maintain quality standards.

Key Responsibilities

  • Develop comprehensive training programs and materials for various roles across the GMP commercial operations of cell therapies
  • 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 to impart technical knowledge and skills to manufacturing 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

Education & Experience Requirements

  • Bachelor's degree in a relevant field such as Biotechnology, Engineering, or Education; advanced degree preferred
  • Minimum of 2 years of 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
  • Certification in training and development (e.g., CPLP, CPTM) is a plus

Personal Qualities & Physical Demands

  • Highly detail oriented with special attention to quality, compliance and safety
  • Ability to multitask and handle multiple responsibilities simultaneously; able to prioritize
  • Demonstrates strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment
  • Strong interpersonal skills and ability to communicate effectively
  • Ability to work in a collaborative manner, independently and part of a team
  • Ability to work in a fast-paced start-up environment while following SOPs
  • Highly tolerant and respectful of all team members
  • A sense of humor is always appreciated
  • Ability to work in cleanroom environments and, at times, across various shifts
  • Follow cleanroom protocols, e.g. no cosmetics including make-up, painted nails, jewelry or piercings, and must disclose any shedding skin condition
  • Occasional need to ascend/descend stairs within workspace; job requires standing/walking
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.

This job is no longer accepting applications

See open jobs at Orca Bio.See open jobs similar to "Trainer - GMP Operations" DCVC.
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