Manager, Manufacturing
Location: Philadelphia, PA
A leading Contract Development and Manufacturing Organization (CDMO) is seeking a dynamic Manager of Manufacturing responsible for floor management of the chemistry and bioconjugation cGMP manufacturing activities at their Manufacturing facility and providing leadership to ensure timely execution of duties in a safe, cGMP compliant environment.
Key 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/Skills:
- 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 requirement.
- 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.
This is a fantastic opportunity to be a key part of a cutting-edge CDMO in Philadelphia, helping to shape the future of the organization while ensuring the delivery of top-quality products in a safe and compliant environment.
Apply today to take the next step in your leadership journey!
