What are the responsibilities and job description for the Manufacturing Manager position at Abzena?
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.
Responsibilities
Operational Execution
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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.
Responsibilities
Operational Execution
- 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
- 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
- Experience with Lean manufacturing or Six Sigma preferred
- 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
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.