Manufacturing Manager
Bristol, PA
Manufacturing – Manufacturing /
Full Time /
On-site
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 of Manufacturing is responsible for on the floor management of the chemistry and bioconjugation cGMP manufacturing activities at the Bristol Manufacturing facility and providing leadership to ensure timely execution of duties in a safe, cGMP compliant environment.
Responsibilities
- Scheduling activities and allocating resources to support the planned activities.
- Leading the Daily Tier 1 Operations meeting.
- Ensuring processes, procedures and equipment are adequate to support the operation.
- Collaboration and Leadership to support functions ensuring no delays to the production schedule.
- Ensure that all operations are in strict compliance with cGMP, FDA, and other regulatory requirements.
- Escalate to senior management of significant quality, compliance, supply, and safety risks.
- Identify risk and threats to the operation and pro-actively moved toward resolution.
- Training, growth, and development of staff.
- Daily review of GMP documentation including batch records and logbooks.
- Ownership of deviations, CAPAs and Change Controls
- Recommend strategies for improving batch records and procedures.
- Responsible for specifically assigned projects, to include monitoring project timelines and communication of project status to senior management.
- Develop effective working relationships with both internal and external partners.
- Represents departmental activities as needed, including project teams, task forces, audits and business or technical meetings.
- Performs other related duties as required.
Qualifications
- BA/BS or MA/MS degree in Chemistry, Biochemistry, or engineering with a Minimum 6 years of experience in cGMP manufacturing environment (Experience in biopharmaceutical or chemistry preferred).
- Supervisory experience a must.
- Demonstrated ability to observe technical issues and directs troubleshooting of process and equipment problems.
- Ability to organize workload, oversee workload of direct reports, and relevant resource requirements.
- Skill in leadership duties, to include time management and planning.
- Ability to successfully perform multiple tasks, when required.
- Ability to safely operate production equipment in accordance with established practices.
- Experience in Lean manufacturing and 6 Sigma operations
FLSA: Exempt
