Manager, Manufacturing

4 weeks ago

Philadelphia, United States AL Solutions Full time

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

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