Our client is a prestigious research university focusing on finding new treatments using cutting edge technologies in a start-up environment. They are looking for qualified scientists who can bring a strong QC background to continue to grow and lead the facility.
• The scientist will be responsible for assay qualification and validation in a phase appropriate manner according to ICH and FDA guidelines by authoring protocols, reports, and investigations Assay platforms include qPCR, multi-color flow cytometry, qqPCR, cell counting and cell based assays.
• Lead or support cGMP investigation and generating corrective action plan for out-of-specification and deviations.
• Write, review and edit accurate cGMP documents, including SOP, Test Procedures, Sampling Plan, Certificate of Analysis and Qualification/Validation Protocols
• Planning and implementing critical analytical assessment of quality attributes to support the Analytical CMC development by closely collaboration with Process Development & Manufacturing, Regulatory Affair, and Quality Assurance
• Oversee and support product specific QC operation is performed in consistent to sampling plan and manufacturing schedules – including the operational assignments to individual QC associates for a variety of in process, drug substance, and drug product testings, sample shipments, data management and reporting data to stakeholders in a comprehensive manner.
• Act as or collaborate with SME to ensure the cGMP compliance of facility and environment for clinical production of products at different phases.
• Direct selection criteria and justification for QC raw materials;
• Work with a cross-functional team as Liaison to ensure timely and comprehensive communication. .
* - Other duties may also be assigned
• Master’s degree or higher in relevant scientific disciplines with post-graduate work experience preferred – relevant scientific field may include Immunology, iPSC, stem cell biology, etc.
• Knowledge and proficiency in cell based assay development, qualification and technology transfer
• Proficiency of Multi-Color Flow Cytometry, ddPCR, qPCR and/or Immunoassays
• Willing to learn and ability to effectively work in fast pace environment with cross functional groups
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor’s degree and eight years’ experience or advanced degree and five years’ experience in relevant scientific relevant scientific discipline or other appropriate specialty (such as Chemistry, Life Sciences, and Engineering).
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
• Advanced experience applying multidisciplinary scientific principles and practices to provide technical leadership and influence experimental design and coordinate laboratory activity
• Extensive technical QC experience in clinical laboratory, hematology, blood banking, immunology or QC laboratory preferably in cGMP environment.
• Expert knowledge and understanding of cGMP requirements.
• Extensive experience in QC innovation and analytical methods and validation tests development.
• Experience with technology transfer methods.
• Ability to communicate effectively, both verbally and in writing. Ability to influence and advocate course of action of research project.
• Experience leading and/or managing technical professionals.
• Demonstrated resolution of complex issues in creative and effective ways
• Excellent organizational skills and attention to detail.
• Frequently sit, grasp lightly, use fine hand manipulation, repetitive pipetting, perform desk-based computer tasks, and lift, carry, push, and pull objects up to 15 pounds.
* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of the job.
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