Cell Therapy Technician II
Location
Gaithersburg, MD | United States
Job description
Cell Therapy Technician II
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 1-2 support roles within the process determined by their individual training plan.
- Responsible for advancing their knowledge base of the process by continuing to learn the more critical process steps and becoming an SME
What you have to offer
Requirements:
- Bachelor’s Degree in Life Sciences or Engineering with at least 2 years of experience, or an Associate’s Degree (in any field) with 3+ years of cGMP experience.
- At least 1 year 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 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 the well being of our team members and offers a variety of benefits supporting our diverse employee base. 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, STD and LTD Insurance
HSA & FSA Spending Accounts
Health & Wellness, including free onsite gym access
Adoption & Surrogacy Assistance
Vacation and Unlimited Sick Time
Holidays and Floating Holidays, including discretionary winter shutdown
401(K) Plan with Significant Company Match
Tuition Reimbursement and Professional Development
Commuting Assistance and subsidized parking
Discounted Home and Auto Insurance
Pet Insurance
Plus more benefits that will be shared upon hire!
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!
BioNTech - As unique as you
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