Production Lab Tech Lead

Merck Group; Missouri; On-site; USD 45,000 - 70,000; Full time

Job summary

A leading company in the biotechnology field is seeking a Production Lab Tech Lead in St. Louis, Missouri. This role involves overseeing production processes, ensuring compliance with GMP and regulatory standards, and supporting team training and improvements. Candidates should possess a high school diploma or GED with at least one year of experience in production or a Bachelor’s degree in a Life Science discipline. Strong communication skills and professional conduct are essential.

Qualifications

• 1+ years of experience in production or manufacturing required.
• Knowledge of GMP, FDA regulations preferred.
• Effective communication skills essential.

Responsibilities

• Perform tasks related to all production processes.
• Train team members and support cross-training.
• Ensure compliance with Quality and Regulatory standards.

Skills

Compliance with GMP

Communication

Professionalism

Education

High school diploma or GED

Bachelor’s degree in Life Science

Tools

SAP

QMS

Job description

Work Location: St. Louis, Missouri
Shift: No
Department: LS-SC-PMLPCCC Cell Marque Downstream
Hiring Manager: Codi Labeda

This information is for internal use only. Please do not share outside of the organization.

Your Role

Under moderate supervision, the Production Lab Tech Lead performs tasks related to all production processes, including standard and new operating procedures, area clearance, and data recording on documents and batch records. Responsibilities include filling, packaging, and labeling, performed independently with attention to GMP regulations. The Tech Lead serves as a SME and troubleshooting resource, supporting SAP, Dev/CAPA investigations, and maintaining lab safety and cleanliness. Compliance with cGMP, FDA, OSHA, EPA, and Quality System regulations is required. Additional duties include participating in investigations, meetings, composing emails, and presenting DMS Boards. The role adheres to standards such as MDSAP, ISO 13485, IVDR, and the site Quality Manual. Strong communication and professionalism are essential. Specific responsibilities include:

• Supporting production efficiency
• Training team members and supporting cross-training
• Contributing to KPI achievement
• Using computer systems for data entry and record keeping
• Ensuring compliance with Quality and Regulatory standards
• Supporting process improvements and reporting areas needing enhancement
• Utilizing QMS and other databases effectively
• Using safety equipment and PPE properly

Who You Are

Minimum Qualifications:

• High school diploma or GED and 1+ years of experience in production or manufacturing

OR

• Bachelor’s degree in any Life Science discipline

Preferred Qualifications:

• Knowledge of SAP, SAPNEXT, or other ERP systems
• Understanding of GMP, FDA QSRs, ISO 13485
• Experience in FDA-regulated biotech or pharma environments
• Knowledge of safe laboratory practices
• Proficiency with QMS
• Understanding of metric systems
• Effective communication skills within and outside the organization

The Company is an Equal Employment Opportunity employer. Discrimination based on race, color, religion, age, sex, sexual orientation, national origin, disability, veteran status, genetic information, gender identity, marital status, or other protected classifications is prohibited. Concerns should be reported to HR, Legal, or Compliance. The Company will not retaliate against individuals reporting discrimination.