Jobless Developer
Orca Bio logo
Orca Bio

Posted 1 month ago

Open

Specialist, Training - Night Shift

SacramentoOn-siteFull-time

AI Summary

Specialist, Training develops and delivers GMP-focused training programs for cell therapy manufacturing, ensuring SOP, equipment use, safety and regulatory compliance are taught and assessed.

About this role

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 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.

Night Shift Hours Worked:
• 6:00pm to 6:30am or
• 6:30pm to 7:00am
Work Week Schedule:
• Sunday, Monday, Tuesday + every other Wednesday or
• Thursday, Friday, Saturday + every other Wednesday

Physical Demands

  • Production Associate Roles: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.
  • Most roles must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.

    • Work Conditions

  • Many roles must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs, as well as regularly participate in video-based meetings. Also, may be required to work scheduled overtime, weekends, or holidays based on business needs.

    • 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

    • Skills

    CGMPClassroom TrainingCoachingDocument ControlFDA GuidelinesGMPHands-on TrainingLRMS/LMS (learning Management System)Quality SystemsRegulatory ComplianceSOPsTraining AssessmentsTraining Program DesignTraining Records

    Explore related jobs

    More jobs at Orca Bio

    Similar CGMP jobs

    Jobs in Sacramento

    Browse these categories

    Coaching JobsRegulatory Compliance JobsSOPs JobsJobs in SacramentoJobs in United States