Biologics Purification Specialist
2 months ago
About Next Level Group
Next Level Group is a leading provider of innovative solutions in the biotechnology industry. We are committed to delivering high-quality products and services that meet the evolving needs of our clients.
Biologics Purification SpecialistWe are seeking a highly motivated and experienced Biologics Purification Specialist to join our growing team. In this role, you will be responsible for performing various downstream processing operations, ensuring the production of high-quality biologics products.
Responsibilities- Adhere to strict safety protocols and quality standards in all aspects of work.
- Execute purification processes using large-scale tangential flow filtration (TFF) systems, chromatography columns, and related equipment.
- Operate and maintain a range of analytical instruments, including pH meters, conductivity meters, spectrophotometers, and peristaltic pumps.
- Perform column packing procedures, integrity testing on filters, and process analysis using spectrophotometry.
- Document batch records, standard operating procedures (SOPs), and qualification documents for downstream operations.
- Manage the procurement of raw materials and production supplies through SAP.
- Collaborate effectively with other departments involved in GMP manufacturing to ensure timely production, testing, and product release.
- Work closely with the upstream manufacturing team to provide support and resources as needed.
- Maintain a clean and organized work environment, adhering to disinfection procedures and safety guidelines.
- A 2-year biotechnology diploma is required; a Bachelor's degree or Post-Secondary education in life science (e.g., Biochemistry, Chemistry, Chemical Engineering, Biology) is preferred.
- 1-3 years of experience in pharmaceutical/biological manufacturing within a GMP environment is highly desirable.
- Proven experience in the purification of biologics using large-scale TFF and chromatography techniques.
- Strong understanding of TFF filtration and chromatography processes.
- Excellent interpersonal, communication, and written skills.
- Familiarity with production outlines, cGMP guidelines, and HSE regulations.
- Experience conducting investigations and writing deviations.
- Proficiency in MS Office Suite (Word, Excel, PowerPoint).
- Thorough understanding of quality systems and regulatory requirements.
- Ability to work flexible shifts, including 12-hour daytime shifts, 3-4 days/week, with potential overtime and weekend work.
- Willingness to assist in disinfection procedures involving hazardous chemicals, requiring the use of a respirator.
- Physical capability to lift, move, and maneuver small-medium sized equipment (up to 25lbs).
- Ability to stand for extended periods, climb ladders or stairs frequently.
- Capacity to read, write, understand, and comply with standard operating procedures.
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