Bioanalytical QC Specialist — Cell-Based & ELISA Focus

Ferring Pharmaceuticals SA; Parsippany-Troy Hills (NJ); On-site; USD 77,000 - 143,000; Full time

Job summary

Ferring Pharmaceuticals in Parsippany, NJ is seeking a Specialist, QC Bionalytical to perform bioanalytical testing of raw materials, in-process samples and finished products, ensuring regulatory compliance and internal quality standards.

Responsibilities include conducting ELISA, PCR and HPLC assays, maintaining instruments, documenting results, and collaborating with R&D, Manufacturing and QA to drive product development and process improvements in a GMP environment.

Qualifications

• Bachelor’s or Master’s degree in biology, Cell and Molecular Biology, Biochemistry, Biological Chemistry, Pharmaceutical Sciences, or related field.
• A minimum of 2 years of experience in bioanalytical testing within a GMP, QC Analytical or in the biotechnology or pharmaceutical industry.
• Working knowledge following SOP
• Proficiency in ELISA, PCR, Flow Cytometry, Spectroscopy and HPLC (preferred).
• Understanding of regulatory requirements (FDA, EMA, ICH) for bioanalytical method validation and sample analysis.
• Strong problem-solving skills and attention to detail.
• Effective communication and interpersonal skills, with the ability to work collaboratively in a diverse team environment.
• Strong attention to detail, i.e., reviewing documentation for adherence to SOP format requirements; accurate data entry of documentation into a database.
• Punctual and having some flexibility in work schedule
• Comfortable to work in a cell culture lab area and viral based gene-therapy drugs.
• Proficient using Microsoft office such as Word, Excel, Powepoint and others

Responsibilities

• Conduct bioanalytical testing and analysis using a variety of techniques such as Cell-Based Assay, ELISA, PCR and HPLC.
• Perform assays for the quantification of biomarkers, proteins, nucleic acids, and other analytes.
• Execute routine QC testing, method validation, verification, and transfer activities in accordance with regulatory guidelines.
• Maintain and troubleshoot analytical instrumentation to ensure optimal performance and data integrity.
• Document test results, observations, and deviations accurately in laboratory notebooks and electronic systems.
• Collaborate with cross-functional teams including Research & Development, Manufacturing, and Quality Assurance to support product development and process improvement initiatives.
• Participate in investigations of out-of-specification (OOS) results and non-conformances, and implement corrective and preventive actions (CAPAs) as needed.
• Adhere to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP) and Good Documentation Practices (GDP) in all laboratory activities.
• Contribute to the continuous improvement of laboratory procedures, protocols, and documentation.

Skills

Bioanalytical testing

GMP

GLP

SOP adherence

Data integrity

Microsoft Office

Cell culture knowledge

Education

Biology degree

Cell & Molecular Biology

Biochemistry

Pharmaceutical Sciences

Tools

LIMS

TrackWise

Job description

Ferring Pharmaceuticals in Parsippany, NJ is seeking a Specialist, QC Bionalytical to perform bioanalytical testing of raw materials, in-process samples and finished products, ensuring regulatory compliance and internal quality standards.

Responsibilities include conducting ELISA, PCR and HPLC assays, maintaining instruments, documenting results, and collaborating with R&D, Manufacturing and QA to drive product development and process improvements in a GMP environment.