Position Overview

This role leads a shift team and is responsible for manufacturing bulk drug substance. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours.

Job Description

What You’ll Do

Project Phase (Through Mid-2025)

• Supports Factory Acceptance Testing (FAT) at the vendor site as required
• Supports Site acceptance Installation Verification (IV), Operational Verification (OV), and Performance Qualification (PQ) testing, including protocol generation, as applicable
• Performs other operational readiness tasks as required, such as: document review/approval, team onboarding, and materials management
• Supervises manufacturing associates on technical and operational topics, such as: area unit operations and equipment
• Administers company policies, such as, but not limited to: travel & expense, time reporting, and time off that directly impact employees

Operations Phase (Starting Mid-2025)

• Provides on-the-floor leadership for a shift team of up to 7-10 manufacturing associates
• Coordinates the execution of the manufacturing schedule through daily shift assignments, lead daily huddles, and manages escalations
• Fosters an inclusive, people-first culture with regular communication, conducting 1:1s on a defined cadence with direct reports
• Maintains a safe and cGMP compliant environment by ensuring direct reports have correct and up-to-date training
• Supports manufacturing investigations and continuous improvement projects
• Coordinates with other functional areas for additional activities requiring access to the manufacturing space and equipment, such as but not limited to: maintenance, calibration activities and the use of manufacturing equipment
• Administers company policies, such as but not limited to: time reporting, time off, shift policies, and inclement weather that directly impact manufacturing employees
• Performs other job as assigned

Basic Requirements

• High School Diploma or GED with 8 years of experience from a similar role in large pharma/biotech operations or projects

Preferred Requirements

• BA/BS Degree in Life Sciences with 4+ years of experience from a similar role in large pharma/biotech operations or projects OR
• Associates Degree in Life Sciences and 6+ years of experience from a similar role in large pharma/biotech operations or projects OR
• Military Experience of equivalence
• Experience in manufacturing of biological products, familiar with GMP/GLP requirements
• Previous experience leading, supervising or managing others

PHYSICAL REQUIREMENTS

PHYSICAL DEMANDS

• Will work in an environment which may necessitate respiratory protection
• May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearting conservation program
• Ability to discern audible cues

WORKING ENVIRONMENT

PHYSICAL DEMANDS  

• Ability to ascend or descend ladders, scaffolding, ramps, etc.
• Ability to stand for prolonged periods of time
• Ability to sit for prolonged periods of time 
• Ability to conduct activities using repetitive motions that include wrist, hands and/or fingers.
• Ability to conduct work that includes moving objects up to 10 lbs.

ENVIRONMENTAL CONDITIONS

• Will work in heights greater than 4 feet