We are seeking a highly skilled and motivated Senior Quality Control Associate to join our dynamic team at a leading Midwestern biopharmaceutical company. This role is ideal for a professional with a strong background in Good Laboratory Practices (GLP) or Good Manufacturing Practices (GMP) and extensive experience in the development, optimization, qualification, and validation of analytical assays. In this position, you will have the opportunity to work with a broad and diverse portfolio, employing a wide range of techniques in a company that is pioneering a unique platform with significant scientific impact. As we move toward commercialization, you will play a crucial role in ensuring the highest standards of quality and innovation are maintained.

The Senior Quality Control Associate is expected to possess strong time management skills, handle multiple activities simultaneously, work with minimal supervision, be detail-oriented and accurate, and exhibit a passion for continuous improvement.

Essential Duties and Responsibilities:

Responsibilities include but are not limited to:

• Lead the development and validation of complex bioanalytical assays, including but not limited to ELISA, receptor binding, cell-based, immunoassays, bioassays, and ligand binding assays.
• Effectively communicate data at department and cross-functional teams and contribute to bioanalytical sections for IND reports and/or publications.
• Evaluate and revise specifications based on stability studies.
• Perform various scientific functions competently, including physical property characterization assays, HPLC, ELISA, PCR, gel electrophoresis, cell culture, and aseptic technique.
• Work proficiently under GLP and/or cGMP conditions, maintaining compliant records of scientific work.
• Assist in the development of analytical assays and laboratory systems, collaborating with technical support, CMO collaborators, and analytical consultants.
• Draft and revise ROPs, SOPs, Data Records, Study Protocols, and Study Reports.
• Provide general assistance in the function of the QC Laboratory.
• Participate in scheduled general cleaning of laboratory facilities.
• Assist in preventative maintenance and cleaning of equipment.
• Contribute to the training of junior associates in various activities.
• Mentor junior associates in assay development and laboratory techniques.
• Collaborate with external partners and vendors in assay development projects.
• Perform duties as directed by the supervisor.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Education, Experience and Certifications:

• Master’s degree and 3 years of experience OR
• Bachelor’s degree and 5 years of experience
• Demonstrated experience in an aseptic environment
• Extensive experience working under GLP or GMP.