EntroGen is seeking a Manufacturing Associate who will be responsible for independently performing production and manufacturing related activities in a cGMP environment. The scope of the position includes manufacturing, packaging, and inspecting RT-PCR and NGS diagnostic test kits, performing routine equipment maintenance and calibration, independently performing experiments and validation/qualification procedures, and analyzing data.
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).
- Aliquot and label raw materials, components, and products.
- Prepare and maintain batch records.
- Maintain inventory of raw materials, controls, and samples.
- Label, package, and inspect finished goods.
- Receive packages, inspect packages, and stock production area.
- Maintain and calibrate instruments and equipment.
- 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.
- 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.
- Provide support to scientific staff.
- Other duties as assigned.
Qualifications and Required Skills
- 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 desired.
- Knowledge of PCR and real time PCR instruments is 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.
Must be authorized to work in the U.S. Local candidates only, please. No relocation assistance provided. No agencies.
Please send resume and salary history to firstname.lastname@example.org. No agencies, please.
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.