Manufacturing Scientist I

Lgc-; Gaithersburg (MD); In loco; USD 72.000 - 80.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, dental, vision benefits

401(k) retirement plan

Flexible work options

Paid time off

Descrizione del lavoro

LGC Clinical Diagnostics is seeking a Manufacturing Scientist I to support the manufacture of immunoreagent products in a GLP/GMP setting. The role covers antibody purification and conjugation, bulk solution formulation, and execution of assays like ELISA and Western blotting.

You will organize data in MS Office and EtQ, plan experiments, and maintain documentation. The position emphasizes collaboration, data-driven experimentation, and adherence to quality systems, with a strong focus on

Competenze

• Bachelor's degree in Biochemistry, Molecular Biology, or related field with at least 3 years of industry experience.
• Experience with antibody purification and conjugation techniques.
• Experience with bulk solutions/buffer formulation.
• Proficiency with Microsoft Word, Excel, PowerPoint, and Outlook.

Mansioni

• Perform antibody purification and conjugation using manual and automated techniques.
• Manufacture large scale solutions using established SOPs.
• Perform ELISA, Western blotting, protein assays, and antibody-related assays.
• Organize projects and data using Microsoft Office and EtQ document control system.
• Plan and execute experiments to established timelines with GLP/GMP documentation.
• Record test results and data, obtain approvals, and file records as per procedures.
• Maintain, calibrate, and operate equipment per approved protocols; monitor parameters.
• Maintain raw-material and reagent inventory; order materials through SAP.
• Draft and update SOPs and product documents.
• Initiate deviations and nonconformity reports; investigate product complaints.
• Source and purchase production equipment; manage service contracts and preventive maintenance.
• Perform validations for new equipment and revalidations for existing equipment.
• Support product troubleshooting and new product introductions as needed.

Conoscenze

Antibody purification and conjugation

Bulk solutions/buffer formulation

Formazione

Bachelor's degree in Biochemistry, Molecular Biology, or related field

Master's degree in Biochemistry, Molecular Biology, or related field

Strumenti

Microsoft Word

Microsoft Excel

PowerPoint

Outlook

EtQ document control system

SAP

Descrizione del lavoro

• Department: Scientific / Technical Science

Company 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 >3,300 employees globally.

Job Description

The Manufacturing Scientist I advances the LGC Diagnostics & Genomics Division’s purpose of understanding disease by supporting the manufacture of immunoreagent products. The role applies advanced scientific knowledge and skills, building on Manufacturing Associate III responsibilities and education, to independently perform routine and non-routine antibody purification, conjugation and bulk solutions under Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) requirements.

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

Qualifications

Key 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 and ensure 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 elevate 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

Knowledge, Experience, Skills, and Certifications

Essential Knowledge and Qualifications:

• 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/buffer formulation.
• Proficiency with Microsoft Word, Excel, PowerPoint, and Outlook.

Desired Knowledge and Qualifications:

• Master's 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 preferred.
• Experience with cell culture and sterile techniques.

Behavioural and Interpersonal Competencies:

• Operate in alignment with LGC's core value behaviours: Passion, Curiosity, Integrity, Brilliance, and Respect.
• Critical thinker able to analyse data and respond quickly.
• Manage and complete assigned projects, multitask effectively, and adapt as priorities change.
• Work independently with minimal supervision while communicating results and status updates promptly.
• Collaborate effectively and contribute to other groups as needed.
• Demonstrate strong organizational skills and commitment to product development, continuous improvement, learning, and product integrity.
• Perform preliminary data interpretation and analysis and follow approved SOPs.
• Demonstrate independent thinking and self-directed learning.

Work Conditions and Environment

• Travel & Time Expectations: No travel required. Standard business hours are 8:30 a.m.-5:00 p.m., Monday through Friday, with flexibility for adjustment outside these hours.
• Work Setting: Primarily an office, laboratory, warehouse, or workshop setting with manufacturing exposure. The noise level is usually moderate.
• Distinctive Safety Conditions: Work is performed in a biosafety level 2 environment and may involve potentially infectious pathogens, human-source materials, hazardous materials, and hazardous waste. Required initial and annual refresher training and applicable safety precautions must be followed.
• Required Personal Protective Equipment (PPE): Required PPE may include steel-toe shoes, hearing protection, eye protection, and masks. Respiratory protection such as an N95 requires medical evaluation and fit testing under the OSHA respiratory protection program.

Physical Requirements

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 in its primary, standard work environment. LGC considers requests for reasonable accommodation in accordance with applicable law. Employees who believe they might require an accommodation to perform the essential functions of their role should contact Human Resources.

Additional Information

Maryland Pay Disclosure Statement:
The anticipated hiring salary range for this position is $72,042-$80,000 annually. Actual starting pay within this range will be determined based on relevant experience, education, skills, qualifications, and internal equity.

The full salary range for the position is $72,042-$97,469 annually and represents the broader compensation opportunity for the role, including potential salary progression over time. Placement at the maximum of the range is not the starting salary for the position.

This position is also eligible for a discretionary bonus program. Participation in the bonus program does not guarantee a bonus award. Bonus payments, if awarded, are determined by the company based on applicable individual and company performance results.

E-Verify:

LGC participates in E-Verify to confirm the identity and employment eligibility of newly hired employees.

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
• Caregivers leave
• PTO that begins to accrue immediately
• Town Hall monthly meeting onsite/virtual
• Cheers program where employees are recognized for outstanding work
• Company social events, including catered lunches and much more!

EEO:

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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