Overview

Ready to shape the future of science and global health? ATCC, a pioneer in biomaterials manufacturing, is seeking a full-time direct hire Lead Biologist for the cell GMP Bioproduction team to work onsite in Gaithersburg, MD, who embodies excellence in the field of cell biology. This pivotal role requires extensive background in manufacturing of cell biology products, exceptional demonstrated skills in cell culture, cell expansion, upscaling and biobanking. This role requires prior Manufacturing and cell banking experience under ISO and/or GMP regulations.

Responsibilities

• Manufacturing Operations: Serve as a technical lead for cell manufacturing and banking under GMP regulations. Strictly follow standard operating procedures (SOPs), work instructions, and established processes. Support QA compliance, laboratory safety, equipment procurement, qualifications and maintenance, and procurement of supplies.

• Documentation: Author and develop controlled documents for production runs in compliance with good manufacturing practices. Ensure accurate and meticulous documentation.

• Continuous Learning and Problem-Solving: Subject matter expertise of various cell biology manufacturing processes and handle challenges in alignment with organizational policies.

Qualifications

Education and Experience:

• Bachelor's degree in a scientific field with 8 years of relevant experience or equivalent
• Attention to detail and strong documentation skills.
• Ability to multitask and handle responsibilities of an advanced nature, simultaneously.
• Ability to adhere to corporate policies and strict manufacturing procedures.
• Excellent communication and interpersonal skills. Ability to function as a participant in a team environment and cross functional teams.
• Excellent time management and ability to meet required timelines.
• Ability to work long hours occasionally.
• Manufacturing, upscaling and biobanking of mid-sized banks of adherent and suspension cell lines (BSL-1 and BSL-2).
• Strong written skills and demonstrated extensive experience in creation/development of controlled documents.
• Experience with a quality management system.
• Extensive experience working with T-flasks, Cell stacks, cell rollers, Erlenmeyer flasks and spinner flasks.
• Manufacturing and cell banking under ISO and/or GMP regulations.
• Experience with risks assessments, change controls and ability to support investigations related to deviations, CAPAs and Non-Conformances.
• Prior experience with an ERP system and familiarity with the manufacturing, procurement, material transfer and inventory modules.

Preferred but not required:

• Experience with aggregates cell lines, specialized cell lines, and 3D cultures is a plus.
• Experience in training and mentoring team members is a plus.

Benefits

We Invest in You 

• Health & Wellness: 
  • Comprehensive medical coverage and company paid Life Insurance, Disability Insurance & AD&D.
  • Work life balance with Paid Holidays and PTO.
  • Fitness and cell phone subsidies, and additional benefits such as Aflac, legal services, and pet insurance.
  • Employee Assistance Program offering around-the-clock counseling.
• Financial security: 
  • 401(a) (6% employer contribution) and 403(b) (2% match) retirement plans.
  • Exceptional career advancement opportunities, recognition, and rewards. 
  • Corporate bonus program.
• Mission Focused:
  • Non-profit organization supporting critical life science research
  • We give scientists the tools they need to make discoveries that improve and save lives.
  • Contribute to community involvement and social responsibility.

Join ATCC, where we fuel your success, well-being, and development. We're a mission focused non-profit Equal Opportunity Employer, championing diversity and inclusivity. When you work at ATCC, you become a part of that mission, one we’ve committed to for almost 100 years. Shape the future of science with us. 

ATCC is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.