Pharmaceutical Production Lead - 1st/2nd Shift

• Acts as a technical and workflow lead by coordinating daily manufacturing tasks, prioritizing activities, and supporting efficient production flow without formal people management responsibility.

• Provides on-the-job guidance, mentoring, and training to manufacturing technicians and lower-level operators to ensure adherence to procedures, safety standards, and GMP requirements.

• Performs advanced, hands-on biopharmaceutical manufacturing activities, including media and buffer preparation, aseptic processing, equipment cleaning and sterilization, and any responsibilities to support production and schedule adherence.

• Sets up, operates, monitors, and adjusts bioprocessing equipment such as autoclaves, washer-sterilizers, filtration systems, fermenters, and fill-finish equipment.

• Prepares, cleans, assembles, and stages tanks, glassware, components, and systems for batch manufacturing operations in accordance with approved procedures.

• Monitors critical process parameters, production data, and outputs to ensure compliance with batch records, specifications, and quality standards.

• Identifies, documents, and escalates deviations, abnormal events, and process issues in accordance with quality systems and regulatory expectations.

• Maintains accurate and complete batch documentation, equipment logs, inventory records, and other GMP compliance documentation.

• Follows and reinforces standard operating procedures (SOPs), manufacturing instructions, and all applicable safety, quality, and regulatory guidelines.

• Collaborates with engineering, quality, and maintenance teams on troubleshooting, investigations, testing, and process optimization activities.

• Supports continuous improvement initiatives by providing technical input, identifying opportunities for efficiency or quality improvements, and assisting with implementation of approved changes.

MINIMUM JOB REQUIREMENTS

Education

• High school diploma or GED required

Work Experience

• 2-3 years of manufacturing experience.

• Experience in aseptic manufacturing experience in GMP and ISO-cleanroom environments.

Knowledge / Skills / Abilities

• Proven ability to operate, monitor, troubleshoot, and maintain biopharmaceutical manufacturing equipment.

• Demonstrated attention to detail with the ability to accurately complete GMP documentation and support investigations and escalate issues.

• Effective communication and interpersonal skills, including the ability to guide and collaborate with others.

• Comfortable working in cleanroom and controlled environments while adhering to gowning, safety, and quality requirements.

• Flexibility to work mandatory overtime based on business needs.

• Ability to speak, read, and write English with proficiency

PREFERRED JOB REQUIREMENTS

Education

• Bachelor's degree in STEM field

Work Experience

• 2 years of hands-on experience in GMP-regulated pharmaceutical or biopharmaceutical manufacturing.

• Demonstrated experience performing advanced manufacturing operations such as aseptic processing, media/buffer preparation, and equipment operation

Knowledge / Skills / Abilities

• Advanced knowledge of upstream and/or downstream bioprocessing operations

• Experience supporting audits, inspections, and regulatory interactions

• Familiarity with continuous improvement methodologies and operational excellence initiatives

• Strong problem-solving skills with the ability to work cross-functionally