Research Associate II, OEM/Special Projects

LGC Clinical Diagnostics•Gaithersburg, MD

16d

About The Position

The Research Associate II, OEM/Special Projects supports research, development, verification, and optimization of molecular diagnostic products, reagents, and related processes. The role independently performs routine and non-routine laboratory procedures using cellular and molecular biology techniques to quantify, characterize, and manipulate genetic material. The position executes assigned experiments, maintains accurate documentation, analyzes experimental data, and contributes to project objectives within established timelines. Working with moderate supervision, the Research Associate applies scientific knowledge to troubleshoot routine technical challenges and collaborates with cross-functional teams to support product development. LGC’s Clinical Diagnostics Division develops and manufactures catalog and custom diagnostic quality solutions and component materials for the life sciences industry. It partners with IVD assay developers, pharmaceutical, CRO, and academic institutions throughout the diagnostic pipeline. The division’s operating entities include SeraCare Life Sciences, Maine Standards Company, and the Native Antigen Company. Its employees work in FDA-registered and ISO 13485-accredited facilities in the United States and an ISO 9001-accredited facility in the United Kingdom.

Requirements

Master’s degree in Biochemistry, Molecular Biology, Biotechnology, Biological Sciences, or a related scientific discipline; no prior experience required with this degree.
Alternatively, a bachelor’s degree in Biochemistry, Molecular Biology, Biotechnology, Biological Sciences, or a related scientific discipline with relevant laboratory experience.
Experience with molecular biology activities such as DNA/RNA purification, endpoint PCR, real-time PCR or digital PCR, DNA/RNA electrophoresis, and DNA/RNA processing or modifications.
First-hand experience with aseptic techniques.
Proficiency with Microsoft Office, particularly Outlook, Word, Excel, and PowerPoint.
Demonstrated communication skills and ability to communicate in various formats to internal teams.
Ability to work effectively in a team, adapt to change, and exert influence in a directive and positive manner.
Ability to collaborate in a cross-functional team environment.
Ability to work autonomously, self-start, and recognize when stakeholder engagement is appropriate.
Ability to manage and prioritize multiple tasks and responsibilities in a dynamic work environment.
Ability to perform preliminary data interpretation and analysis and communicate results effectively.
Strong organizational, planning, and documentation skills.
Ability to prioritize multiple projects and meet established timelines.
Strong problem-solving and troubleshooting abilities.
Commitment to laboratory safety, quality, and regulatory compliance standards.

Nice To Haves

Three or more years of relevant laboratory experience.
Experience working on third-party customer product development and manufacturing.
Experience with mammalian cell culture and viral cultures.
Experience guiding or training research associates on established procedures.
Experience interpreting and analyzing data after project execution for team review.
Proficiency with ERP systems such as IFS, SAP, or Microsoft Dynamics.
Experience handling products under an ISO 13485 quality management system.
Experience working in a GMP environment, following SOPs, and generating customer-facing documents and documentation for QA review and approval.

Responsibilities

Perform molecular techniques including nucleic acid purification, gel electrophoresis, RNA transcription, cell culture, and bacterial culture.
Perform nucleic acid analysis, including RNA/DNA integrity analysis, real-time qPCR, and digital PCR, and analyze results.
Culture cells using aseptic techniques and perform downstream processing of cultured cells.
Manufacture products according to standard operating procedures and work instructions.
Organize projects and data using Excel, Word, PowerPoint, and the EtQ document control system.
Work with a supervisor to plan and execute assigned experiments and tasks within timelines, ensuring documentation meets GLP/GMP requirements.
Record test results and data, obtain appropriate approvals, and file records according to established procedures.
Maintain, calibrate, and operate equipment according to established protocols; monitor operation and refer abnormal results to laboratory management.
Plan raw material requirements, maintain reagent inventory, and order reagents as needed through an ERP system such as SAP.
Collaborate with cross-functional teams on assigned custom project activities.
Maintain a clean, organized, and safe laboratory while following applicable safety and quality requirements.
Identify opportunities to improve laboratory processes, efficiency, and data quality, and contribute to continuous improvement initiatives.
Document laboratory activities, test results, observations, and data in laboratory notebooks and electronic systems in compliance with applicable quality and regulatory requirements.
Identify and communicate routine technical issues, recommend solutions, and assist with corrective actions.
Assist in developing, revising, and reviewing SOPs, work instructions, and technical documentation.
Manage laboratory inventory, monitor reagent supplies, and support procurement through ERP systems.
Adhere to the company’s personal protective equipment policy.
Perform other duties as required or assigned by management to meet business needs.

Benefits

Discretionary bonus program; participation and awards are not guaranteed.
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.
401(k) retirement plan with employer matching contribution.
Company-paid short- and long-term disability insurance, life insurance, and employee assistance program.
Flexible work options.
Pet insurance.
Eight additional weeks of enhanced parental leave.
PTO that begins immediately.
Monthly town hall meetings, employee recognition program, companywide social events, and frequent catered lunches.