Manufacturing Research Associate I

2 weeks ago

Gaithersburg, United States LGC Clinical Diagnostics Full time
Job DescriptionJob DescriptionCompany Description

LGC Clinical Diagnostics Business Unit is comprised of our operating entities including LGC Clinical Diagnostics, Inc. (f/k/a Maine Standards Company & SeraCare Life Sciences), Technopath Clinical Diagnostics, and the Native Antigen Company. Our 400+ employees operate FDA-registered and ISO 13485-accredited facilities in Maine (USA), Massachusetts (USA), Maryland (USA), Tipperary (Ireland), and an ISO 9001-accredited facility in Oxford, UK. LGC Clinical Diagnostics is owned by LGC Group, a UK-headquartered life sciences measurement and testing business with >$510m of annual revenue and >3,500 employees globally.

SeraCare Life Sciences, Gaithersburg Inc. is a manufacturer and leading partner to global in vitro diagnostics manufacturers and clinical laboratories. They provide quality control materials for infectious disease testing through their ACCURUN® reagents as well as in the fast growing clinical next-generation sequencing (NGS) market, which it addresses through its Seraseq® brand of products for oncology, NIPT and inherited disease testing.

Job Description

The Research Associate I position will advance LGC Clinical Diagnostics Division purpose of understanding disease by supporting the manufacture of precision diagnostic products. Support includes independently performing routine and non-routine applications of cellular/molecular genetic technology to quantitate and manipulate genetic material all under GLP/GMP.

  • Formulate bulks using production batch records.
  • Perform general molecular techniques such as cloning, plasmid purification, gel-electrophoresis, RNA transcription, and bacterial culturing.
  • Perform nucleic acid analyses (RNA/DNA integrity analysis, real time qPCR, digital PCR) and analyze results.
  • Filling product vials and assembly of kits.
  • Maintenance of different cell lines in cell culture (viral or bacterial) and manufacture of cell-based products.
  • Organize projects and data using Excel, Word, PowerPoint and a document control system.
  • Work in collaboration with the Quality Assurance group to fulfill Quality Management Goals and proactively address problems under an ISO quality system.
  • Monitor, maintain and calibrate laboratory equipment as needed
  • Plan for raw material requirements by maintaining appropriate inventory of reagents and ordering reagents as needed through an ERP system (SAP).
  • Maintain a clean and safe lab environment.
  • Material consumption using SAP system.
  • Cycle count and inventory management.
Qualifications

  • A Bachelor’s degree in Biochemistry or Molecular Biology or a related field or associate’s degree with at least 2 years of relevant experience.
  • Experience in manipulating and quantitating DNA/RNA, including DNA/RNA Purification, PCR (endpoint, real time PCR or digital PCR), DNA/RNA electrophoresis.
  • Demonstrated ability to follow SOPs for the purpose of manufacturing products.
  • Experience in Molecular Biology techniques such as DNA/RNA Purification and quantitation, PCR (Endpoint or Real time PCR), DNA/RNA electrophoresis.
  • First-hand experience with aseptic techniques.
  • Proficient with Microsoft Office Suite, including Word, Excel, PowerPoint, and Outlook
  • Proficient writing/editing SOPs.
  • Experience in cell culture is preferred. 


Additional Information

What we offer (US based-employees):

  • Competitive compensation with strong bonus program
  • Comprehensive medical, dental, and vision benefits for employees and dependents
  • FSA/HSA Pre-tax savings plans for health care, childcare, and elder care
  • Deductible Buffer Insurance and Critical Illness Insurance
  • Great gym onsite
  • 401(k) retirement plan with matching employer contribution
  • Company-paid short- and long- term disability, life insurance, and employee assistance program
  • Flexible work options
  • Pet Insurance for our furry friends
  • Enhanced Parental leave of 8 additional weeks
  • PTO that begins immediately
  • Town Hall monthly meeting onsite/virtual, Cheer program where employees are recognized for outstanding work, Company wide social events, frequent catered lunches and much more

All your information will be kept confidential according to EEO guidelines. 

We participate in E-Verify.

LGC strongly believes that every job applicant and employee should be valued for their individual talents regardless of age, disability, race, color, ethnic or national origin, sex, sexual orientation, gender reassignment, marital or civil partnership, pregnancy or maternity, religion, or belief. Short listing, interviewing and selection will always be carried out without regard to gender, sexual orientation, marital status, color, race, nationality, ethnic or national origins, religion or belief, age, or trade union membership.

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