Associate Manager, Manufacturing Upstream

Position Overview

The Associate Manager of Manufacturing leads daily manufacturing operations during a 12-hour shift. This position is responsible for managing a cross-functional team of technicians executing cell culture and microbial fermentation processes using both single-use technologies and stainless steel, ensuring compliance and efficiency in a fast-paced, modular multiproduct environment. This role has direct impact on the delivery of manufacturing focused site key performance indicators (KPIs). Additionally, this role incorporates prior hands-on bioprocessing experience, thrives in a regulated and client-facing environment, and demonstrates operational leadership and mentorship across varying clinical and commercial production phases.

Job Description

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