Manufacturing Manager

Abzena Inc.•Bristol, PA

19d•Onsite

About The Position

With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing. Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely. We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services. We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient. The Manager, Manufacturing is responsible for the day-to-day execution of chemistry and bioconjugation cGMP manufacturing operations at the Bristol site. This role ensures that production activities are completed safely, on schedule, and in compliance with cGMP standards. The Manager is accountable for frontline leadership, execution of the production plan, and immediate problem solving to maintain operational performance. This role operates primarily on the manufacturing floor and drives performance through direct team engagement and Tier 1 accountability.

Requirements

BS or MS in Chemistry, Biochemistry, Engineering, or related field
Minimum 5 to 10 years of experience in cGMP manufacturing
Prior supervisory experience required
Strong troubleshooting ability for process and equipment issues
Ability to manage multiple priorities in a fast-paced environment
Ability to stand or walk for extended periods
Ability to lift up to 50 pounds
Ability to work on the manufacturing floor for the duration of shift

Nice To Haves

Experience with Lean manufacturing or Six Sigma preferred

Responsibilities

Execute the daily manufacturing schedule and ensure alignment to the production plan
Allocate personnel and resources to meet operational needs
Lead Tier 1 daily operations meetings and escalate issues as required
Monitor progress throughout the shift and adjust resources to maintain schedule adherence
Manage multiple activities across chemistry and bioconjugation operations
Ensure all manufacturing activities comply with cGMP, FDA, and internal procedures
Perform daily review of batch records and logbooks for accuracy and completeness
Initiate and support deviations, CAPAs, and change controls
Escalate quality and compliance risks to leadership in a timely manner
Supervise and develop manufacturing staff, including supervisors and operators
Ensure training is current and aligned with job responsibilities
Reinforce a culture of safety, accountability, and adherence to procedures
Address performance issues and support employee development
Ensure equipment, materials, and documentation are available to support operations
Identify gaps in readiness and coordinate with support functions to resolve
Support troubleshooting of process and equipment issues
Partner with Quality, MSAT, Supply Chain, and Engineering to support execution
Communicate production status, risks, and needs to stakeholders
Support audits, client visits, and internal reviews as required
Identify and implement improvements to increase efficiency and reduce errors
Support Lean and Six Sigma initiatives
Contribute to improvements in batch records and procedures
Support technology transfer activities from development to manufacturing
Execute assigned projects and provide status updates to management
Operate in alignment with company policies and ethical standards
Communicate clearly and effectively across teams
Work collaboratively to support site objectives