Senior Manufacturing Associate

FLSA Classification: Salary, Exempt

Schedule: 1230 – 2100; Monday to Friday; On-site; weekends and holidays as needed

Reports to: Associate Manufacturing Manager

Location: 13203 Murphy Road Suite 100 Stafford, TX 77477

What You’ll Do:

As a Senior Manufacturing Associate, you will play a key role in supporting our manufacturing operations:

• 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.

Required Experience and Education:

• Bachelor’s Degree in Biology, Biochemistry, Biotechnology or other related field.
• Four (4) to six (6) years of cell therapy manufacturing experience.

Preferred Experience and Education:

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

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 (~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.

Travel required: Travel may be required between the office building and manufacturing facility on a daily basis.

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.

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, medical conditions, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

What do we offer?

At Immatics, we believe in investing in our team’s health, safety and well-being. Here’s what you can expect if you join Immatics

Comprehensive Benefits:

• Competitive rates for Health, Dental, and Vision Insurance
• 4 weeks of Paid Time off, granted up front each year and prorated for first and last year of employment.
• Sick Time Off – 56 hours
• 12 Paid Holidays
• 100% Employer-Paid Life Insurance up to at 1x annual salary, up to 100K ( club together)
• 100% Employer Paid Short- and Long-Term Disability Coverage
• 401(k) with Immediate Eligibility & company match…
• You are eligible for 401(k) plan participation as of your first paycheck.
• The company will match 100% of your contributions up to 3% of your base salary for the first two years of employment, 4% for years 2-3 of employment, and up to 5% of your salary from the fourth year onward of continued employment.
• Partially paid Parental Leave for eligible employees. (3 weeks)
• Additional voluntary employee paid coverages including Accident, Hospital Indemnity, and Critical Illness Employee Paid Identity Theft Protection and Pet Insurance.

Professional Growth:

• Opportunities to work with leading experts in the field of T-cell immunotherapy.
• Company provided learning and development opportunities
• Fast paced, high demand collaborative and dynamic environment.