Manufacturing Scientist I

LGC Group•Gaithersburg, MD

7h•$72,042 - $97,469•Onsite

About The Position

The Manufacturing Scientist I supports the manufacture of immunoreagent products and advances the LGC Diagnostics & Genomics Division’s purpose of understanding disease. Building on Manufacturing Associate III responsibilities and education, the role applies advanced scientific knowledge and skills to independently perform routine and non-routine antibody purification, conjugation, and bulk-solution work in accordance with Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) requirements. The position performs laboratory manufacturing and testing, plans and documents work to established timelines and procedures, maintains equipment and inventory, supports product documentation and quality investigations, and contributes to equipment validation, troubleshooting, and new product introductions. The role is based on-site and works standard business hours of 8:30 a.m. to 5:00 p.m., Monday through Friday, with flexibility for adjustments outside those hours. No travel is required. Work takes place primarily in an office, laboratory, warehouse, or workshop setting with manufacturing exposure and usually moderate noise. The role is performed in a biosafety level 2 environment and may involve potentially infectious pathogens, human-source materials, hazardous materials, and hazardous waste. Required safety training and precautions must be followed. PPE may include steel-toe shoes, hearing protection, eye protection, and masks; use of an N95 requires medical evaluation and fit testing under the OSHA respiratory protection program.

Requirements

Bachelor’s degree in Biochemistry, Molecular Biology, or a related field, with at least 3 years of industry experience.
Experience with antibody purification and conjugation techniques.
Experience with bulk solutions and buffer formulation.
Proficiency with Microsoft Word, Excel, PowerPoint, and Outlook.
Ability to plan and complete assigned projects, multitask, adapt as priorities change, and work independently with minimal supervision.
Ability to communicate results and status updates promptly and collaborate effectively with other groups.
Strong organizational skills and commitment to product development, continuous improvement, learning, and product integrity.
Ability to perform preliminary data interpretation and analysis and follow approved SOPs.
Ability to think independently and engage in self-directed learning.
Ability to follow required safety precautions and training for work in a biosafety level 2 environment.

Nice To Haves

Master’s degree in Biochemistry, Molecular Biology, or a related field with 2 or more years of industry experience.
Experience conducting independent laboratory research.
Experience with DNA/RNA purification and quantitation, endpoint or real-time PCR, and DNA/RNA electrophoresis.
Experience with cell culture and sterile techniques.

Responsibilities

Perform antibody purification and conjugation using manual and automated techniques.
Manufacture large-scale solutions using established standard operating procedures.
Perform ELISA, Western blotting, protein assays, and antibody-related assays.
Organize projects and data using Microsoft Excel, Word, PowerPoint, and the EtQ document control system.
Plan and execute experiments and assigned tasks to established 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 approved protocols; monitor operation within established parameters and escalate abnormal results.
Maintain appropriate raw-material and reagent inventory and order materials through SAP.
Draft and update standard operating procedures and product documents.
Initiate deviations and nonconformity reports and investigate product complaints.
Source and purchase production equipment; maintain service contracts and schedule preventive maintenance.
Perform validations for new equipment and revalidations for existing equipment.
Participate in product troubleshooting and new product introductions as needed.
Perform other projects and duties as assigned by management.

Benefits

Competitive compensation with a strong bonus program.
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 insurance, life insurance, and employee assistance program.
Flexible work options.
Pet insurance.
Enhanced parental leave of 8 additional weeks.
Caregivers leave.
PTO that begins to accrue immediately.
Monthly Town Hall meetings, onsite or virtual.
Cheers recognition program.
Company social events, including catered lunches.