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Manager, Manufacturing Learning & Development
- Tustin, California, United States
- Tustin, California, United States
À propos
Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. Your Role: The Manager, Manufacturing Learning & Development (L&D) is responsible for building, governing, and continuously improving the training programs that support Avid's GMP manufacturing operations, including Upstream, Downstream, and Formulation. This role ensures that all manufacturing personnel are trained, qualified, and developed in accordance with GMP expectations, ALCOA+ data integrity principles, and site operational goals. This position partners closely with Manufacturing, QA, QC, MSAT/Process Development, Facilities, EHS, and HR to create a comprehensive, scalable learning strategy that strengthens workforce competency, supports compliance, and increases operational readiness across all manufacturing areas.
Key Responsibilities:
- Develop and oversee the Manufacturing L&D strategy supporting Upstream, Downstream, and Formulation operations.
- Conduct learning needs assessments, skills-gap analyses, and competency evaluations across all manufacturing departments.
- Define, maintain, and continuously improve training curricula, qualification paths, and skill matrices.
Training Program Development & Delivery
- Design and implement training programs using structured instructional design methodologies.
- Develop training materials including SOP-based modules, technical process training, e-learning content, and hands-on OJT/SOJT qualifications.
- Deliver training through classroom sessions, floor-based coaching, and virtual platforms.
- Ensure training content reflects current manufacturing processes, documentation expectations, and regulatory requirements.
Training Compliance & Documentation Standards
- Serve as the site Learning Management System (LMS) subject matter expert overseeing training records, curriculum updates, and compliance metrics.
- Ensure all training reinforces Good Documentation Practices (GDP) and ALCOA+ principles.
- Monitor training completion, effectiveness, and compliance readiness; escalate gaps appropriately.
Operational Support & Cross-Functional Collaboration
- Partner with Manufacturing SMEs and leadership to ensure training readiness for new equipment, processes, product introductions, and tech transfers.
- Provide on-the-floor coaching and support for SOJT/OJT qualification processes.
- Support internal and external audits as the Manufacturing L&D representative.
- Collaborate with HR and operational leaders to standardize onboarding, cross-training, and development pathways.
Metrics, Reporting & Continuous Improvement
- Create and maintain training dashboards tracking compliance, documentation performance, corrections, qualification status, and trend data.
- Evaluate training effectiveness and implement initiatives to reduce documentation errors and increase consistency.
- Conduct Training Impact Assessments and support change management for curriculum updates.
Leadership & People Development
- Lead and develop the Manufacturing L&D team.
- Promote a culture of learning, accountability, and operational discipline.
- Identify workforce competency gaps and support development plans.
Minimum Qualifications:
- Bachelor's degree in Biology, Biotechnology, Instructional Design, Education, Organizational Development, or related field.
- 35 years of experience in biotech/pharmaceutical GMP manufacturing or manufacturing support.
- 2+ years of relevant experience in Learning & Development, technical training, or instructional design.
- Experience designing, implementing, and evaluating training programs.
- Strong understanding of GMP, GDP, and ALCOA+ requirements.
- 4+ years of cGMP purification experience.
- 1+ years of leadership experience or equivalent.
Preferred Qualifications:
- Experience supporting Upstream, Downstream, or Formulation operations.
- Ability to analyze metrics and build training dashboards.
- Strong facilitation, communication, and stakeholder engagement skills.
Position Type/Expected Hours of Work: This role is a full-time onsite position. Days of work are Monday through Friday. Must be available to work extended hours when needed. Compensation: We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off. The compensation range for this role is $116,800 to $131,400 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.
Who you are:
- You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
- Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
- You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
- You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment: In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
Compétences linguistiques
- English
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