Job Description
Description:
Role Summary:
This position serves as a quality control expert within the Quality Control Sciences and Validation group, providing critical support for analytical method transfer and validation activities across global pharmaceutical operations. The role requires an individual contributor who can independently manage complex technical projects while ensuring compliance with current Good Manufacturing Practices and regulatory standards. This scientist will serve as a technical authority for method transfer initiatives, working across multiple internal and external testing sites to support drug development programs. The position demands strong analytical expertise combined with excellent project management capabilities to coordinate deliverables and maintain timelines. Success in this role requires the ability to balance multiple priorities while maintaining rigorous attention to detail and scientific integrity throughout all validation and transfer activities.
Responsibilities:
Support Project Leads for method transfer and validation activities internally and externally for assigned pharmaceutical development programs
Author and review protocols and reports for method transfer, method validation, method bridging, and other technical development documentation associated with analytical methods
Plan and track method transfer and validation deliverables to ensure timely completion of project milestones
Collaborate and interact with internal global quality control testing sites and laboratories, external testing sites, project leads, and functional representatives
Review method transfer and validation assays, perform data verification, conduct non-routine data mining, and execute in-depth data analysis
Represent quality control in intra-department projects and initiatives or cross-functional teams in support of program and company goals
Skills:
Expertise in designing and evaluating method validation and transfer studies including partial re-validation, co-validation, and cross-validation approaches
Technical writing skills for authoring analytical methods, validation protocols, and transfer study reports
Expert knowledge of scientific principles and expertise with monoclonal antibodies, antibody-drug conjugates, vaccines, and gene therapy products
Strong analytical mindset and technical skills in analytical methods and plate-based methods, with preference for analytical separation method experience including size exclusion chromatography, imaged capillary isoelectric focusing, and capillary electrophoresis sodium dodecyl sulfate
Project management skills with demonstrated experience managing multiple projects simultaneously
Strong data interpretation, method troubleshooting skills, and sound scientific judgment
Excellent time management skills with attention to detail and commitment to achieving team and individual goals
Strong communication skills to lead teams and influence leaders or cross-functional team members
Understanding of regulatory guidance and requirements pertaining to method transfer, method validation, and regulatory submissions
Experience:
8-10 years of relevant experience in pharmaceutical or biological drug product development, analytical chemistry, or quality control within a regulated biotechnology or pharmaceutical company
Progressive levels of responsibility throughout career demonstrating increasing technical and leadership capabilities
Qualifications:
Bachelor's degree in analytical chemistry, biology, biochemistry, pharmaceutical science, or related technical discipline in life sciences
Post-graduate degree in a related field is preferred
This is an exceptional opportunity to join a leading pharmaceutical organization where you will play a pivotal role in ensuring the quality and regulatory compliance of critical analytical methods that support life-saving therapies. You will work at the intersection of science and quality, collaborating with talented professionals across global sites while contributing to innovative drug development programs that make a real difference in patients' lives.
Please note that contractors are engaged to provide services to Pfizer on a temporary basis in connection with a specific assignment. Contractors are hired and employed through Atrium, our third-party payrolling partner.
This job posting is for a temporary role as an employee of Atrium on assignment at Pfizer. The individual selected for this role will be offered the role as an employee of Atrium; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by Atrium upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements.
Pay Rate Range
50 - 58 USD hourly
Benefits Information
Comprehensive Benefits Package available based on eligibility
Medical, Dental, Vision
Short-Term Disability (STD)
Long-Term Disability (LTD)
Supplemental and Voluntary Life Insurance
401(K)
Commuter Benefit Program
