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Lead Training Coordinator

2 months ago

Houston, Texas, United States Immatics US, Inc. Full time
Position Title: Senior Training Specialist - 2nd Shift

Classification: Exempt/Salary

Schedule:
Monday-Friday (On-Site); Weekends/Holidays as required.
Eligible for up to 1-day remote work weekly based on business requirements and performance.

Department:
Chemistry, Manufacturing, and Controls (CMC)

Reporting To:
Training Manager, CMC-GMP

Supervisory Responsibilities:
None

Position Overview:

The primary objective of this role is to deliver comprehensive classroom and practical training, along with coaching for both new and existing personnel within the CMC-GMP sector.


Key Responsibilities:


1. Conduct GMP onboarding and training sessions for Manufacturing Associates, covering essential topics such as sterile gowning, aseptic processing, and proper documentation practices.
2. Execute facility-specific training through observation and hands-on activities.
3. Ensure meticulous documentation of all training activities.
4. Participate in the development and evaluation of Standard Operating Procedures (SOPs) and Working Instruction documents.
5. Serve as a subject matter expert on critical manufacturing equipment and software.
6. Evaluate trainee competency and provide constructive feedback to both the trainee and management.
7. Collaborate with management to identify technical training needs and expectations, monitoring and sharing progress and outcomes.
8. Assess training programs for ongoing improvement, aiming for error reduction and enhanced operator knowledge and skills.
9. Support investigations, Corrective and Preventive Actions (CAPAs), and changes related to training.
10. Train personnel on patient PBMC isolations to support immunomonitoring assays.
11. Manage inventory of reagents and supplies for training activities.
12. Maintain annual sterile gowning qualifications.

Additional Responsibilities:
1. Provide on-site guidance during routine production processes in accordance with SOPs and facility requirements.

2. Author and review SOPs, Working Instructions, and Batch Record documents, ensuring compliance with FDA regulations.

3. Communicate relevant training updates to all Manufacturing Associates.
4. Deliver training in both classroom and manufacturing floor environments.

Required Competencies:

Independent Working:
Ability to perform routine tasks with minimal supervision; limited oversight for non-standard tasks.

Communication:
Proficient verbal and written communication skills; regular interaction with cross-functional teams.

Problem Solving:
Strong analytical skills to identify and communicate issues; advanced capability to propose effective solutions.

Critical Thinking:
Ability to reflect on processes and identify areas for improvement.

Initiative:
High motivation and initiative to exceed basic expectations.

Organizational Skills:
Intermediate skills required to prioritize and structure daily tasks.

Coachability:
Willingness to reflect on and suggest training for professional growth.

Leadership Skills:
Basic leadership skills necessary for on-the-job training and support of team members.

Work Environment:
Typical office setting with moderate noise levels (~20% of work hours). Regular use of phone, computer, and office equipment.
Engagement in cGMP clean room environments (~40% of work hours) and general laboratory spaces (~40% of work hours).

While performing duties, the employee may handle blood components and could be exposed to various temperatures and materials.


Physical Requirements:

Carrying:
Ability to transport objects using hands or arms.

Climbing:
Capability to move up or down step stools or ladders.

Communicating Verbally:
Ability to express or exchange ideas verbally.

Feeling:
Skill in detecting different materials or temperatures with fingers and hands.

Gowning:
Proficiency in donning or removing sterile personal protective equipment (PPE).

Hearing:
Capacity to hear and distinguish speech and sounds.

Typing:
Ability to enter data or text into a computer.

Lifting:
Capability to raise or lower objects (up to 25 lbs.).

Visual Acuity:
Clarity of vision at approximately 20 inches or less, with passing a color blindness evaluation required for this position.

Pushing/Pulling:
Ability to exert force upon an object.

Reaching:
Ability to extend hands and/or arms towards an object.

Sitting:
Ability to remain seated for at least 50% of the time.

Standing/Walking:
Ability to remain upright for extended periods.

Stooping:
Occasional bending of the body downward.

Travel Requirements:
May require daily travel between office and laboratory buildings. Occasional domestic travel for corporate retreats or professional development may be necessary.

Education and Experience:
Bachelor's Degree in Biology, Biochemistry, Biotechnology, or a related field.
Four (4) to six (6) years of experience in cell therapy manufacturing and training.
Thorough understanding of GxPs and requirements for cell therapy production.
Experience in molecular, cellular, and immunological techniques.

Preferred Qualifications:
Master's Degree in Biology, Biochemistry, Biotechnology, Healthcare Administration, or a related field.
Five (5) years of experience in cell therapy manufacturing.

Work Authorization:
Legal eligibility to work in the United States is required. The company participates in E-Verify.

Equal Opportunity Statement:
The company is an equal opportunity employer. All employment decisions will be based on merit, competence, performance, and business needs.

Note:
This job description is not intended to cover a comprehensive listing of activities, duties, or responsibilities. Duties may change at any time with or without notice.