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Bioanalytical QC Specialist

R&D Partners
Philadelphia, PA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

We are looking for a person that have hands-on laboratory experience of primary cells, cell lines, cell based assays, ELISA and flow cytometry. Support of the ramp up of QC and other activities in a newly built facility for cell therapy products. This working schedule for this position can be either:

· 4x 10hrs Sun-Wed or Wed-Sat,

· 5x 8hrs Tuesday-Saturday, Sunday-Thursday

Specific Responsibilities

· Perform daily GMP quality control laboratory testing activities with minimal to no errors and ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations

· Perform data analysis and final result reporting to support product lot release with adherence to turnaround times.

· Support thorough GMP investigations for out of specification test results and other quality events.

· Support technical problem solving for issues pertaining to GMP quality control.

· Support product stability programs including execution of stability testing, stability data analysis, and final reporting of stability data.

· Support generation and revisions of documentation, such as SOP, protocols, and reports.

· Act as a subject matter expert (SME) on one or more assays and train new laboratory personnel

· Perform peer review of laboratory data and logbooks

· Trending of analytical performance

· Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results.

· Support Health Authority inspections

· Provide input to functional laboratory meetings.

Education and Qualifications

· Minimum of a Bachelor’s degree in Biology, Biochemistry, Microbiology, Chemistry, or related scientific field is required; advanced degree (MSc., Ph.D.) preferred.

· Experience in the pharmaceutical industry within a Quality Control role; experience with cell therapy products is a plus.

· Basic knowledge of Compendial (e.g., USP, EP, JP, etc.) requirements and standards

· Solid understanding and functional knowledge with hands-on experience with the following: Flow Cytometry, Cell based ELISA, cell culture (primary cells and cell lines)

· Proficient in performing technical writing (e.g., test methods, SOP's, protocols, etc.)

· Successfully interface with multi-disciplined teams.

· Extremely detail-oriented with strong technical skills.

· Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.

· High level of ownership and accountability.

· Demonstrate sense of urgency; ability to recognize time sensitivity.

· Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint)

R&D Partners

Address

Philadelphia, PA
USA

Industry

Manufacturing