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.