Manufacturing Associate I
EntroGen is seeking a Manufacturing Associate I who will be responsible for independently performing production and validation related activities in a cGMP environment. The scope of the position includes manufacturing, packaging, and inspecting RT-PCR and NGS diagnostic test kits under GMP compliance. Other duties include performing routine equipment maintenance and calibration, independently performing experiments and validation/qualification procedures, analyzing data, and assisting in writing protocols and SOPs.
Essential Duties and Responsibilities:
- Independently perform production/manufacturing related activities in a clean-room facility according to good manufacturing procedures (cGMP) and standard operating procedures (SOP).
- Coordinates production tasks to meet an assigned schedule and manages changing priorities to meet deadlines.
- Routinely run RT-PCR assays including analyzing and interpreting data using excel.
- Pipette small volumes using precision pipettes.
- Prepare and maintain batch records.
- Maintain inventory of raw materials, controls, and samples.
- Label, package, and inspect finished goods.
- Maintain inventory of final product for shipment.
- Receive packages, inspect packages, and stock production area.
- Maintain and calibrate instruments and equipment.
- Identify, report, investigate, and resolve manufacturing and operational issues.
- Participate in process validation and qualification procedures.
- Contribute to the development of continuous manufacturing process improvements.
- Establish, write, and revise production related SOPs.
- Independently perform PCR runs, analyze data, and compile data into comprehensive reports.
- Accurately and comprehensively document all experimental details in a laboratory notebook.
- Participate in routine laboratory tasks.
- Provide support to scientific staff.
- Other duties as assigned.
Qualifications and Required Skills:
- Minimum Bachelor’s of Science in life sciences.
- 2+ years of laboratory experience is required.
- 2+ years of experience in production/manufacturing in related industry is highly desired. Knowledge of PCR and real time PCR instruments are highly desired.
- Solid understanding of cGMP compliance, ISO13485, and/or FDA 21 CFR Part 820 Quality Systems are highly desired.
- Strong attention to detail, multi-tasking skills, and accurate record keeping are required.
- Excellent organizational skills and adaptability to changing priorities are required.
- Proven ability to communicate clearly and effectively with others.
- Must possess above average computer skills and be comfortable using excel for data collection and calculations.
Must be authorized to work in the U.S. Local candidates only, please. No relocation assistance provided. No agencies.
EntroGen is a biotechnology company with a focus on molecular diagnostic products in the areas of hematology and oncology. EntroGen has a growing commercial portfolio of real-time PCR-based tests, with many of its products being used to guide and monitor targeted therapies for various malignancies. EntroGen’s footprint reaches every corner of the globe delivering reliable clinical and research products.