Project Manager overseeing operational aspects of ongoing projects at Ingalls Shipbuilding. Managing schedules, budgets, and serving as liaison between teams for U.S. Navy and Coast Guard ships.
About the role
- Project Manager overseeing TPM projects at Fresenius Kabi, ensuring compliance with GMP and regulatory requirements. Leading efforts in product lifecycle management and collaboration with cross-functional teams.
Responsibilities
- Provide strong leadership for TPM commercialized products to ensure finished drug products are in compliance with current GMP and regulatory requirements.
- Work closely with Third Party Manufacturing Organizations and/or Suppliers to successfully manufacture and release commercial and validation/launch batches.
- Evaluate, review and approve external change controls for TPM.
- Review TPM product validations to meet minimum compliance requirements for FK ANDA or when applicable.
- Review and approve methods, specifications, and artwork for TPM products.
- Create and maintain Technical Documents for all products at each CMO.
- Lead continuous improvement initiatives to update Standard Operating Procedures (SOPs).
- Collaborate with CMOs and Regulatory on evaluating product shelf-life extension.
- Lead TPM technical assessments and ad hoc project management (including Transportation studies, improve current processes, etc.)
- Manages internal and external resources to complete projects related to TPM and to meet current GMP and regulatory requirements.
- Act as a technical liaison between CMOs and internal FK teams to complete projects, come to resolutions, and support TPM product releases.
- Support Product Launches, business integration/acquisition activities based on business needs.
Requirements
- Bachelor’s in science degree required
- Master’s in science degree preferred
- 8+ years background in Chemical Engineering/Chemistry related to pharmaceutical processing/manufacturing
- Strong technical background in pharmaceutical manufacturing and API development
- Must have excellent analytical, problem solving, organizational, planning, project and quality management skills
- Proficient computer skills
- Proven experience with project management concepts
- Ability to travel 10% of time to Third Party Manufacturing sites.
Benefits
- Salary Range: $95,000-110,000
- Position is eligible to participate in an annual bonus plan with a target of 10% of the base salary.
- 401(k) plan with company contributions
- Paid vacation, holiday and personal days
- Employee assistance program
- Health benefits to include medical, prescription drug, dental and vision coverage.
Job title
Job type
Experience level
Salary
Degree requirement
Location requirements
Senior Project Manager/Estimator managing complex demolition projects for Veit, a leading specialty contractor. Finalizing bids, overseeing project management, and ensuring compliance with regulations.
Senior Project Manager leading Project Management across Corporate Architecture and Events for CYBEX, an innovative lifestyle and fashion brand for parents. Ensuring project delivery on time, within budget, and in line with quality standards.
Senior Project Manager driving corporate architecture and events at CYBEX, overseeing project management standards and global event execution.
Assistant Project Manager at Manchester Airport supporting the delivery of construction projects. Collaborating with teams to ensure projects are delivered safely and to the highest standards.
Project Manager leading environmental projects at Apex Companies. Managing assessment and remediation projects while guiding teams and engaging stakeholders effectively.
Capital Project Manager overseeing large construction projects and acquisitions for MAA. Responsible for inspections, reporting, and project coordination in Florida.
Project Coordinator at Körber supporting supply chain automation projects and managing workflows, documentation, and cross - functional team collaboration.
Project Manager implementing ILIAS Solutions aviation logistics software for military forces. Overseeing project delivery and ensuring integration with military operations and processes.
Project Manager responsible for RestaurantWeek operations in Germany. Collaborating with the CEO and leading project development from an operational perspective.