senior training specialist - Houston, TX, United States - Immatics NV

Description

It's fun to work in a company where people truly BELIEVE in what they're doing

We're committed to bringing passion and customer focus to the business.

FLSA Classification: Exempt/Salary

Schedule: Monday-Friday; ; 2nd shift /Weekends/Holidays, as needed.

Fully onsite- eligible for up to 1-day work from home per week, but not on a regular basis, depending on business need and performance.

Department: Chemistry, Manufacturing, and Controls (CMC)

Reports to: Training Manager, CMC-GMP

Supervisory responsibilities: No

Location(s):

• 2201 W Holcombe Blvd., Suite 205, Houston, Texas Avery Building
• 2130 W Holcombe Blvd., , Houston, Texas Life Science Plaza
• 13203 Murphy Road, Suite 100, Stafford, Texas Weatherford Building
• 1941 East Road, BBSB 6102, Houston, Texas University of Texas Health Science Center

Position Summary/objective:

The primary purpose of the position is to provide classroom, hands on aseptic and technical training, and coaching for new and existing CMC-GMP personnel.

Essential functions:

• Facilitates GMP onboarding and training activities for Manufacturing Associate personnel including but not limited to sterile gowning, aseptic processing, and good documentation practices.
• Performs GMP facility specific training including observation and hands-on activities.
• Maintains accurate documentation of training activities.
• Participates in the creation and review of SOPs and Working Instruction documents.
• Functions as a subject matter expert for all critical manufacturing equipment and software.
• Assess trainee competency and provide feedback to trainee and Manager.
• Liaison with Manager to identify technical training needs and expectations. Monitor and share progress and outcomes.
• Assess training programs for continuous improvement, error reduction, and increased operator aseptic and process knowledge and skill.
• Support investigations, CAPAs, and change controls related to training.
• Trains CMC-GMP personnel on patient PBMC isolations in support of immunomonitoring assays.
• Maintains reagents and supply inventory for training activities.
• Maintains annual sterile gowning qualification.

Secondary functions:

• Provide on-site guidance to personnel during routine production process according to SOPs, BRs, and facility requirements.
• Authors and reviews SOPs, Working Instruction, and Batch Record documents and maintains accurate documentation in compliance with FDA's Good Laboratory Practices, Good Manufacturing Practices, and Good Tissue practices regulations as well as standards set by other accreditation agencies including but not limited to FACT, CAP, and CLIA.
• Relays relevant training updates to all Manufacturing Associates.
• Provide training to trainees in both classroom and Manufacturing floor settings.

Competencies:

• Independent Working- minimal supervision of routine tasks; limited supervision of non-standard tasks.
• Communication- clear and efficient verbal and written communication; common courtesy; regular interaction with other teams or departments; basic presentation skills and efficient presentation of own work to small groups or own team
• Problem Solving- ability to identify, deeply analyze and communicate problems; advanced ability to develop and pro-actively propose suitable solutions.
• Critical Thinking- advanced reflection on standard and non-standard processes; identification of need and room for improvement within own or narrow scope; basic ability to anticipate future risks.
• Initiative- high degree of initiative and intrinsic motivation to exceed basic expectations of own tasks and responsibilities; pro-active contribution to development of the team structure and lab processes (beyond own tasks)
• Organizational & Prioritization Skills- intermediate organization skills required to structure own daily tasks according to predefined work packages, the manufacturing schedule and standard lab processes; good understanding of priorities within own/narrow scope; prioritization requires limited interaction with the manager.
• Coachability- actively reflect on and suggest trainings supporting professional development within or beyond current area of responsibility; high responsiveness to constructive criticism and ability to autonomously reflect on required improvements; timely implementation of suggested improvements.
• Leadership Skills, Training & Supervision- basic leadership skills required for on-the-job trainings and guidance/support of (new) team members (e.g. providing and receiving feedback, empathy, honesty, reliability); train, instruct and coordinate E level; train D & C level during onboarding.

Work environment:

• Typical office environment with moderate noise levels (~20% of work hours).
• Uses phone, computer, office equipment and supplies on a regular basis.
• cGMP clean room spaces and facilities (~40% of work hours).
• Grade A/B/C/D GMP environment with associated facility noise levels.
• Uses cleanroom phone, computer, variety of equipment and reagent/supplies.
• General unclassified laboratory spaces (~40% of work hours).
• Common laboratory equipment and noise levels.

While performing the duties of this job, the employee routinely handles blood components and is occasionally exposed to temperatures between -196°C and 40°C, liquid nitrogen, liquid nitrogen vapor, dry ice, and carbon dioxide.

Physical demands:

• Carrying- to transport an object - usually by holding it in the hands or arms but may occur on the shoulder.
• Climbing- moving up or down step stools or ladders while maintaining balance
• Communicating Verbally - expressing or exchanging ideas by means of the spoken word to impart oral information to others to convey detailed spoken instructions or other workers accurately, loudly, or quickly.
• Feeling- the ability to detect different materials or temperatures with fingers and hands.
• Gowning- sitting or standing to don or remove sterile PPE.
• Hearing - the ability to hear, understand, and distinguish speech and/or other sounds one-on-one, group or conference, telephone, and other sounds.
• Typing - entering data or text into a computer or other machine by means of a keyboard. Devices include a traditional keyboard, 10 key-pad, touch screens and others.
• Lifting - raising or lowering an object (up to 25 lbs.) from one level to another (includes upward pulling).
• Near Visual Acuity - clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers).
• Undergo and pass a color blindness evaluation and assessment of vision abilities required for this position.
• Pushing - Exerting force upon an object so that the object moves away from the object. Must be able to push carts and gas tanks on rolling wheels (approximately 50 lbs.).
• Pulling - Exerting force upon an object so that the object moves toward the force. Must be able to pull carts and gas tanks on rolling wheels (approximately 50 lbs.)
• Reaching- Extending both hands and/or arms perpendicular to the floor and in front of your body towards an object for extended periods of time.
• Sitting - remaining in a sitting position for at least 50% of the time.
• Standing/Walking - remain on one's feet in an upright position at a workstation.
• Stooping - occasional bending the body downward and forward by bending the spine at the waist - requiring full use of the lower extremities and back muscle.

Travel required:

• Travel may be required between the office building and laboratory buildings on a daily basis.
• Corporate retreats and/or professional development opportunities may require domestic travel 1-2 times/year.

Required education and experience:

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

Preferred education and experience:

• Masters Degree in Biology, Biochemistry, Biotechnology, Healthcare Administration, or other related field.
• Five (5) years of cell therapy manufacturing experience.

Work authorization/security clearance requirements:

Legal eligibility to work in the United States is required. Immatics participates in E-Verify and all new employees will be subject to the Department of Homeland Security requirements for employment.

Affirmative Action/EEO statement:

Immatics is an equal opportunity employer. All employment decisions including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, national origin, ethnicity, marital status, age, physical or mental disability, medicalconditions, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Other duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. This job description may not cover all duties that take place on a daily basis and may be changed as business needs change. Employee will be responsible for adapting and learning the duties as described above or as the new ones are introduced.