Research Associate II, OEM/Special Projects

Company Description

LGC’s Clinical Diagnostics Division develops and manufactures a comprehensive portfolio of catalog and custom-developed diagnostic quality solutions and component materials for the extended life sciences industry. We partner with IVD assay developers, and pharmaceutical, CRO and academic institutions in commercialization activities across the entire diagnostic pipeline - from concept and early stage research, through expedited product development and onwards into routine clinical use. Laboratorians and diagnostic professionals across disciplines of clinical chemistry, immunochemistry, serology, molecular diagnostics and clinical genomics rely on LGC’s products to support accurate and reliable diagnostic results.

Our operating entities include SeraCare Life Sciences and Maine Standards Company, which are  in vitro  diagnostics (IVD) manufacturers of quality measurement tools (calibrators, controls, linearity, EQA/PT, biological materials) and the Native Antigen Company, which is a manufacturer and supplier of viral antigens. Our 300+ employees operate FDA-registered and ISO 13485-accredited facilities in Maine, Massachusetts and Maryland, USA, and an ISO 9001-accredited facility in Oxford, UK.

Each day, our world-class staff, scientific expertise, operational efficiency and superior quality systems are ready to support the range of advanced technologies that collectively improve patient outcomes - from the widely adopted and established through to cutting-edge NGS and precision diagnostics.

Job Description

The Research Associate II, OEM/Special Projects supports the research, development, verification, and optimization of molecular diagnostic products, reagents, and associated processes. This role independently performs routine and non-routine laboratory procedures utilizing cellular and molecular biology techniques to quantify, characterize, and manipulate genetic material. The position is responsible for executing assigned experiments, maintaining accurate documentation, analyzing experimental data, and contributing to project objectives within established timelines. The Research Associate II works with moderate supervision, applies scientific knowledge to troubleshoot routine technical challenges, and collaborates effectively with cross-functional teams to support product development activities.

To perform this job successfully, an individual must be able to capably perform each of the following essential duties:

- Perform general molecular techniques such as nucleic acid purification, gel-electrophoresis, RNA transcription, cell culture, and bacterial culture
- Perform nucleic acid analysis (RNA/DNA integrity analysis, real time qPCR, digital PCR) and analyze results
- Culture cells using aseptic techniques and downstream processing of cultured cells
- Manufacture product following standard operating procedures and work instructions provided
- Organize projects and data using Excel, Word, PowerPoint, and a document control system (EtQ)
- Work with supervisor to plan and execute experiments and tasks as assigned according to the timelines and ensure documentation meets GLP/GMP requirements
- Record test results and data records, seek appropriate approval and file according to established procedures
- Maintain, calibrate, and operate equipment according to established protocols. Monitor equipment for appropriate operation within set parameters and refer abnormal results to lab management
- Plan for raw material requirements by maintaining appropriate inventory of reagents and ordering reagents as needed through an ERP system (SAP)
- Collaborate with cross-functional teams to complete assigned custom project related activities
- Maintain a clean, organized, and safe laboratory environment while adhering to applicable safety and quality requirements
- Contribute to continuous improvement initiatives by identifying opportunities to improve laboratory processes, efficiency, and data quality
- Accurately document laboratory activities, test results, observations, and data in laboratory notebooks and electronic systems in compliance with applicable quality standards and regulatory requirements
- Identify and communicate routine technical issues, recommend solutions, and assist with implementing corrective actions
- Assist in the development, revision, and review of standard operating procedures (SOPs), work instructions, and technical documentation
- Manage laboratory inventory, monitor reagent supplies, and support procurement activities through ERP systems such as SAP
- Adhere to company Personal Protection Equipment (PPE) policy
- Perform other duties as required, or assigned by management, to meet business needs

Qualifications

- Master's degree in Biochemistry, Molecular Biology, Biotechnology, Biological Sciences, or a related scientific discipline with no prior experience required; OR Bachelor's degree in Biochemistry, Molecular Biology, Biotechnology, Biological Sciences, or a related scientific discipline with relevant laboratory experience
- Experience in Molecular Biology related activities such DNA/RNA Purification, PCR (endpoint, real time PCR or digital PCR), DNA/RNA electrophoresis and DNA/RNA processing and/or modifications
- First-hand experience with aseptic techniques
- Proficient with Microsoft Office, particularly Outlook, Word, Excel, and PowerPoint
- Demonstrated communication skills, with the ability to communicate in various formats to internal teams

Desired Knowledge and Qualifications:

- 3+ 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 in performing data interpretation/analysis after project execution for team review
- Proficiency in ERP systems such as IFS, SAP, or Microsoft Dynamics
- Experience handling products under ISO13485 quality management system
- Experience working in GMP environment, following SOPs, generating customer facing documents and documentation for QA review and approval

Behavioural and Interpersonal Competencies:

- Resonate and operate in line with LGC’s core value behaviors: Passion, Curiosity, Integrity, Brilliance, and Respect
- Ability to work well in a team environment, willingness to adapt to changes and a proven ability to exert influence in a directive and positive manner
- Ability to work collaboratively in a cross-functional team environment
- Demonstrated autonomy: ability to self-start and drive while recognizing the appropriate time for stakeholder engagement
- Adaptable and willing to take on multiple new tasks and responsibilities while managing and prioritizing multiple tasks within 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 maintaining laboratory safety, quality, and regulatory compliance standards

Additional Information

The typical pay range for this role is:

Minimum:  $27.00 USD per hour

Maximum:  $41.00 USD per hour

Entry level candidates and those who are already proficient and bring relevant experience typically fall between  $27.00 per hour  and  $30.00 per hour .

New hires receive the hourly rate between the minimum and maximum of the range, with the amount offered determined by factors such as internal equity, education, previous experience, skills relevant to the position.

This position is eligible for a discretionary bonus program. Participation in the bonus program is not guaranteed, and bonuses are awarded at the discretion of the company based on individual and company performance results.

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
- 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, Companywide social events, frequent catered lunches and much more!

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.

For more information about LGC, please visit our website www.lgcgroup.com

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