What You’ll Do
- Manages daily and weekly operations, including shift scheduling, task delegation, and execution of production plans per batch records and manufacturing standard of work
- Leads all shift-level upstream manufacturing activities, including single-use cell culture processing for mammalian systems, microbial fermentation operations, and associated recovery operations
- Executes production campaigns supporting pre-clinical, clinical (Phase I-III), PPQ, and commercial batches across multiple client programs
- Ensures equipment, materials, and supplies are available and successful delivery upon production supply schedule by proactively reviewing the schedule in advance to plan for manufacturing needs
- Coordinates resources and facilitates effective communication across management and across manufacturing to ensure adequate coverage and operational efficiency
- Serves as the primary point of contact during shift for cross-functional teams, troubleshoots upstream operations and equipment (including fermentation, cell culture, CIP/SIP, etc.) while ensuring manufacturing suites remain inspection ready
- Enforces team adherence to Good Manufacturing Practice (GMP), Environmental Health and Safety (EHS), standard operating procedures (SOPs) and compliance through GMP documentation review (including batch, formulation, and logbook records)
- Participates in audits, regulatory inspections, and internal quality investigations, as needed
- Initiates real-time deviations, escalates quality trends, process deviations or equipment failures, and supports related investigations or root cause analysis (RCA) and corrective and preventive action (CAPA) implementation
- Collaborates cross-functionally (e.g., Process Science, Operational and Business Excellence (OBX), Manufacturing Technology and Support (MT&S)) for equipment lifecycle, technology transfer, and continuous improvement projects to ensure operational success
- Administers company policies such as time off, shift work, and inclement weather that directly impact employees
- Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.)
- Serves as a coach and technical mentor for direct reports to foster professional development, enhance capabilities, and encourage empowerment
- Recognizes achievements, addresses performance gaps, employee questions and concerns, and partners with HR as needed for resolution
- Supports departmental goals by aligning team efforts to organizational goals and assessing development needs to improve team performance
- Performs other duties, as assigned
Knowledge and Skills
- Knowledge of bioprocessing techniques, including cell culture and microbial fermentation, using single-use and stainless-steel technologies
- Comprehensive knowledge of CGMP and EHS regulations
- Familiarity with production scheduling, planning, quality assurance practices, and audit processes
- Understanding of equipment lifecycle management and technology transfer principles
- Demonstrated leadership ability to hire, coach, and develop individual contributors and team, providing training and resolving conflicts
- Strong technical aptitude and problem-solving skills with in-shift troubleshooting capabilities for unit operations
- Effective communication, both written and verbal to effectively present information and liaise with cross-functional teams
- Proficient using Microsoft Office Suite (Word, Excel, PowerPoint) for data gathering, entry, and reporting
- Strong organizational skills and ability to manage multiple priorities
- Ability to foster a collaborative team environment, including motivating and empowering others
- Ability to maintain compliance and inspection readiness, execute production campaigns across various phases, and achieve operational efficiency
- Strong focus on continuous improvement, ability to adapt to an evolving environment, and effective risk management
- Ability to handle emergency situations and build consensus among departments to streamline operations and decision-making
- Must be flexible to support 24/7 manufacturing facility
Basic Requirement
- Master’s degree in an engineering discipline, Life Sciences, or other technical field with 3+ years of related experience; or
- Bachelor’s degree in chemical, biochemical, mechanical engineering, life sciences or other technical field with 5+ years of related experience; or
- Military technical training in science, engineering, or other technical field with 5+ years of supervisory experience in a related technical field; or
- Associate’s degree in chemical, biochemical, mechanical engineering, life sciences or other technical field with 7+ years of related experience; or
- High school diploma with 9+ years of related experience
- 2-4 years of people management experience
- Experience operating distributed control system (DCS) software, such as DeltaV, 800xA, or Unicorn
- Equipment-specific training on technologies related to a single-use and stainless-steel systems and processes
- CGMP certification or training
Preferred Requirements
- Lean Six Sigma Yellow or Green belt
- Bioworks, Biomanufacturing or relevant certificate
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
Will work in environment which may necessitate respiratory protection. No X Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. No X Yes
Ability to discern audible cues. No X Yes
Ability to ascend or descend ladders, scaffolding, ramps, etc. No X Yes
Ability to stand for prolonged periods of time. No X Yes 60 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)
Ability to sit for prolonged periods of time. No X Yes 60 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)
Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers. No X Yes
Ability to operate machinery and/or power tools. No X Yes
Ability to conduct work that includes moving objects up to X pounds. No X Yes If yes, 10 lbs. X 50 lbs.