About the position
Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. As a Senior Analyst, Quality Control you will be diving into a world of rigorous testing and meticulous sampling, forming the backbone of our manufacturing, validation, and process development endeavors in a GMP-compliant setting. Your expertise in HPLC will not just be valued, but will be instrumental in steering continuous improvement journeys, positioning you as a catalyst for innovation and excellence. With us, your analytical prowess will be the linchpin for ensuring product stability and driving transformative changes that echo throughout the entire production landscape. Your role is not just about maintaining quality, but elevating the operational efficacy to new pinnacles, making every day a rewarding challenge.
Responsibilities
- Conduct and review meticulous HPLC and CE assays, adhering to well-defined analytical procedures.
- Engage in aseptic sampling, visual inspections, and clean room operations, ensuring a seamless blend of accuracy and compliance.
- Contribute to, revise, and craft test methods and standard operating procedures, potentially delving into trending analysis to drive continuous enhancement.
- Step into the role of Study Lead for validation projects, method development, and investigations, showcasing your analytical prowess and project leadership capabilities.
- Write and contribute to study protocols and reports, sharing knowledge and fostering a culture of continuous learning and improvement.
- Train and mentor other analysts, acting as a nexus of knowledge and expertise within the team.
- Collaborate cross-departmentally to refine and implement QC procedures and policies, ensuring a harmonized approach to quality control.
- Maintain a thorough understanding of company cGMPs and industry regulations, ensuring compliance across all job functions.
- Participate in regulatory inspections, showcasing our laboratory’s adherence to current Good Manufacturing Practices.
- Exhibit laboratory operations' compliance to FDA officials, reaffirming our commitment to adhering to federal regulations.
- Support and drive continuous improvement initiatives, ensuring test methods and procedures are current and aligned with good manufacturing practices.
- Leverage instrument software for precise calculations, streamlining processes and minimizing manual calculation time.
- Perform other tasks as assigned.
Requirements
- B.S. in Chemistry/Biology or a related field
- 4+ years of industry experience in a QC or analytical lab setting, or an equivalent blend of education and experience.
- Experience with analytical testing and equipment handling, showcasing adeptness in conducting and reviewing HPLC and CE assays.
- Demonstrated ability in drafting reports, procedures, and specifications, aligning with the responsibility of revising and crafting test methods and standard operating procedures.
- Solid understanding and adherence to GMPs and regulatory audits, essential for participating in regulatory inspections and ensuring compliance with industry regulations.
- Strong background in HPLC, Analytical Biochemistry, and Chemistry, crucial for various analytical and validation tasks inherent in the role.
- Versatile experience encompassing protein characterization, electrophoresis, and various chromatography techniques (including normal phase, reverse phase, size exclusion, and ion exchange), pivotal for method development and validation projects.
- Proficiency in aseptic techniques, aligning with the responsibility of performing aseptic sampling and working in clean room areas.
- Hands-on experience with assay and validation/qualification processes, instrumental for acting as a Study Lead in validation projects and method development initiatives.
Benefits
- Competitive compensation packages including a base salary and performance-based bonuses.
- Comprehensive benefits such as health, dental, and vision insurance.
- 401(k) matching.
- Paid time off.
- Opportunities for career growth and development.
- Supportive and inclusive work environment.
