Location: Everett Bioprocessing Facility, Everett, Pennsylvania, United States (On-site)
Reports to: Laboratory Manager
Position Overview:
Our client is seeking a highly skilled Purification Scientist to join their team at a bioprocessing facility in Everett, Pennsylvania. The Purification Scientist will play a critical role in antibody purification processes, supervising staff and ensuring adherence to cGMP standards to deliver high-quality products.
Key Responsibilities:
Antibody Purification: Lead and execute antibody purification processes, including Protein A and Protein G chromatography, ensuring consistent, high-quality results.
Column Building: Develop and oversee affinity column construction to support efficient antibody purification.
Labeling & Conjugation: Design and scale processes for labeling and conjugation of antibodies for production needs.
SOP & Documentation: Draft, review, and revise Standard Operating Procedures (SOPs) and Batch Records (BRs) to meet quality standards.
Team Supervision: Train, guide, and manage purification staff, ensuring smooth operations and adherence to best practices.
Laboratory Operations: Operate and maintain laboratory equipment, ensuring compliance with safety and regulatory standards.
Quality Compliance: Work in accordance with cGMP regulations to ensure processes and products meet quality and regulatory requirements.
Continuous Improvement: Drive the development and optimization of new techniques and technologies for antibody purification.
CAPA Support: Assist in the preparation of investigation reports as part of the Corrective and Preventive Action (CAPA) program to address nonconformance issues.
Qualifications:
A bachelor's degree in a scientific field (biochemistry, molecular biology, or related disciplines) is required; an advanced degree is preferred.
3-5 years of hands-on experience in antibody purification or bioprocessing, ideally within a cGMP-regulated environment.
Expertise in chromatography techniques (Protein A, Protein G) and experience with labeling and conjugation processes.
Proficiency with Microsoft Word, Excel, and other Windows-based software.
Strong organizational skills and the ability to manage multiple priorities effectively.
Excellent written and verbal communication skills, with the ability to lead, train, and mentor staff.
Familiarity with cGMP regulations and manufacturing operations.
Why Apply?
This is an exciting opportunity to join a dynamic team working on the forefront of bioprocessing and antibody purification. You will be part of a fast-paced environment that fosters innovation, with ample opportunities for professional development and growth.