Cell Therapy Technician III
Location
Gaithersburg, MD | United States
Job description
Cell Therapy Technician III
Primary responsibilities Include:
- Adhere to SOPs and cGMP regulations, with the ability to accurately complete documentation associated with GMP manufacturing.
- Responsible for aseptic processing of clinical and commercial grade product, participates in editing SOPs and batch records, maintains and stocks clean room environment with released inventory, monitors temperatures, expiration of materials and calibrated equipment.
- Complies with processes, procedures, and instructions for all activities in which the team participates according to written guidelines and recognizes deviations from accepted practice.
- Completes required training assignments to maintain necessary technical skills and knowledge and to ensure compliance with cGMP requirements.
- Routinely monitors, cleans, prepares, and operates cell therapy manufacturing and support equipment in a clean room environment.
- Must have the ability to work, aseptically gown, and wear PPE as required per procedures in all cleanroom environments, such as, Grade D, Grade C, Grade B, and Grade A.
- Be able to push, pull, and lift 50lbs.
- Finds opportunities for improvement on the manufacturing floor from a Safety and Quality perspective.
- Perform other duties as required by the business.
- SME of the process with a requirement to be fully trained on the process, procedures, and equipment.
- Responsible for training other Cell Therapy technicians and fully trained on BioNTech’s Train the Trainer program.
- Perform initial on the floor daily review of batch records and logbooks and work in cohesion with Cell Therapy technicians and supervision to ensure accuracy.
- Authors and/or revises SOPs that are technically sound, provides clear instructions to align with cGMP requirements and supports efficient operations.
What you have to offer
Requirements:
- Bachelor’s Degree in Life Sciences or Engineering with 3 years of experience, or an Associate’s Degree (in any field) with 4+ years of cGMP experience.
- At least 2 years of Cell Therapy experience.
- Effective communication, organization skills, and willingness to learn.
- Must possess a positive attitude and promote BioNTech’s Core Values
- Ability to work different shifts and weekends.
Preferred Requirements:
- At least 2-3 years previous cell therapy experience; pre-clinical, clinical, and/or commercial.
- Experience using MES.
- Intermediate skills in Microsoft Office Suite.
- Experience in cGMP environments
- Experience using SAP.
- Willingness to learn aseptic processing and cell culture processing.
- Experience with automated cell processing equipment.
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Benefits for you:
BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to:
- Medical, Dental and Vision Insurance
- Life, AD&D, Critical Illness Insurance
- Pre-tax HSA & FSA, DCRA Spending Accounts
- Employee Assistance & Concierge Program (EAP) available 24/7
- Parental and Childbirth Leave & Family Planning Assistance
- Sitterstream: Virtual Tutoring & Childcare Membership
- Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
- 401(K) Plan with Company Match – could be convinced to use the word “competitive.”
- Tuition Reimbursement & Student Loan Assistance Programs
- Wellbeing Incentive Platforms & Incentives
- Professional Development Programs
- Commuting Allowance and subsidized parking
- Discounted Home, Auto & Pet Insurance (consolidate)
…and more! More details to be shared.
Have we kindled your pioneering spirit?
Then apply now for our location Gaithersburg and simply send us your application documents using our online form.
* BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!
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