FLSA Classification: Exempt/ Salary
Schedule: Monday – Friday; 12:30pm - 9:00pm ; Weekends and Holidays as needed.
Department: CMC - GMP
Reports to: Associate Manufacturing Manager
Supervisory responsibilities: No
Location: 13203 Murphy Rd. Stafford, TX 77477 ; 1941 East Rd, BBSB 6102 Houston, TX 77054
Position Summary/objective:
The primary purpose of this position is to perform complex, highly specialized and time sensitive technical cell manipulation and testing procedures on irreplaceable cellular products during clinical manufacturing.
Essential functions:
Knowledge of current cGMP.
Fulfill the operator and verifier roles in performing cell growth and manipulation procedures such as cell enrichment, cell culture, cellular product cryopreservation, cell product thaw/wash.
Accurately perform procedures in compliance with FDA’s Good Laboratory Practices, Good Manufacturing Practices, Good Tissue practices, as well as standards set by other accreditation agencies including but not limited to FACT, CAP, and CLIA.
Adhere to ALCOAC++ and cGDocP requirements while accurately performing procedures and maintaining documentation in compliance with SOPs.
Document deviations and events, notify supervisor and quality management personnel in timely manner, and assist in investigation of root cause and any required corrective actions.
Responsible for aseptic handling of reagents and products to ensure the integrity and sterility of cellular products until final infusion to the patient. Must adhere to special cleaning and gowning requirements for the facility requiring specialized gowning such as masks, sterile jumpsuits, hair and shoe covers.
Ability to work productively and to participate in a highly creative and fast-paced environment.
Secondary functions:
Independently perform calculations to determine cell viability, dilutions, and cell concentrations.
Completes all appropriate logs and trackers.
Maintains GMP cleanliness: autoclaving, bleaching liquid waste, removing waste, general cleanliness and organization of the office and facility.
Maintains knowledge regarding donor evaluation, screening and testing, labeling and product acceptability and release criteria.
Conducts activities to support study plans, and IQ/OQ/PQs.
Reviews and provides assistance with change controls, WI, SOPs, study plans, reports, deviations, OOS/OOE, and CAPA’s as directed.
Provides improvement and troubleshooting ideas, and executes implementation plans.
Performs routine equipment maintenance and troubleshooting.
Prepares high level overviews and leads presentations, as needed.
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 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 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 (~80% 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, as needed.
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:
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.
Hearing – the ability to hear, understand, and distinguish speech and/or other sounds one-on-one, group or conference, telephone, and other sounds.
Keyboarding – 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). Carrying is to transport an object – usually by holding it in the hands or arms but may occur on the shoulder.
Near Visual Acuity – clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers).
Pushing - Exerting force upon an object so that the object moves away from the object.
Pulling - Exerting force upon an object so that the object moves toward the force.
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 muscles.
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
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 experience.
Preferred education and experience
Master's 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 . 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.