GMP Biotechnician job vacancy in BioLegend – Jobs in California

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Job Details
Company Name : BioLegend
Company Location : San Diego, CA
Job Position : GMP Biotechnician
Job Category : Jobs in California

Job Description :
BioLegend, Inc. (a PerkinElmer Company) develops world-class, cutting-edge antibodies and reagents for biomedical research, manufactured in our state-of-the-art facility in San Diego, CA. Our mission is to accelerate research and discovery by providing the highest quality products at an outstanding value, along with superior customer service and technical support. Our product expertise covers a diverse set of research areas including Immunology, Neuroscience, Cancer, Stem cells, and Cell Biology.

In 2021, PerkinElmer, Inc. (NYSE: PKI) a global leader committed to innovating for a healthier world, acquired BioLegend. The acquisition, the largest in PerkinElmer’s history, further expands the Company’s life science franchise into high-growth areas such as cytometry, proteogenomics, multiplex assays, recombinant proteins, magnetic cell separation and bioprocessing.
Job Summary

The GMP Biotechnician will work closely with several departments such as QA and inventory control to understand and streamline Manufacturing production processes. This position will be responsible for filling, capping, labeling, completing detailed batch records, putting away finished good inventory (FGI), data entry, equipment maintenance, supply inspections & storage. This role will require verification and sign off on records as well as label creation and inspections. Data entry responsibilities include scanning and attaching records into our system, CoA creation and processing work orders through our Enterprise Resource Planning (ERP) system. Lab duties will entail about 60% of the work and 40% of the work will be administrative tasks. BioLegend’s regulated product produced in our US FDA registered Good Manufacturing Practices (cGMP) manufacturing facility.

The duties include vialing of the product according to standard operating procedures. Another part of the job responsibility includes preparing product/project related documentation and maintaining the device history records for all the regulated products.

Essential Functions
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Perform vialing, and labeling of regulated products.
Maintain batch records and other documentations that are essential to be in compliance with ISO13485:2016 and MDSAP regulations.
Maintain laboratory equipment and manage laboratory supplies.
Receiving materials (inspection, organizing/labeling, & updating logs).
Printing labels for final product production.
General buffer formulation.
Washing lab glassware.
Data entry responsibilities.
Other projects or responsibilities as assigned.

iACT Competencies

innovate – Be better, keep improving, be more efficient, creative, and be in the forefront of development
Aspire – Have desire, purpose, and ambition challenging ourselves to push the limits and reach new heights
Collaborate – Foster teamwork, common goals, selflessness, communication and mutual support
Transform – Adapt, learn, re-invent and change for future development and growth

Minimum Qualifications – Education and Experience

High school diploma/GED or some college.
Demonstrated ability to be detail-oriented, organized, work well in small work groups and the ability to adhere to timelines.
6 months of relevant experience in a laboratory and/or biotech manufacturing and/or filling/bottling/packaging working environment.
Knowledge of Good Documentation Practices.
Knowledge of aseptic techniques in biosafety cabinet.
Ability to pipette small volumes.
Ability to perform simple math calculations.
Ability to communicate effectively both orally and in writing.

Preferred Qualifications – Education and Experience

Working experience in Biotechnology industry with quality system knowledge including ISO 13485 or cGMP regulation is a plus.
Associate’s Degree in Biology, Biochemistry, Chemistry, or other related area.
Advance pipetting skill is highly preferred.
Familiar with raw material supply receiving and inspection process.

Work Environment & Physical Demands
Lab

While performing the duties of this job, the employee regularly works in a laboratory environment performing lab bench work or data entry. Occasional exposure to a warehouse environment.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to use hands and fingers to handle, feel, or operate objects, tools or controls, and reach with hands and arms. The employee is frequently required to stand, talk and hear.