Location: Athens
"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact.
Your Role
As a Project Manager, leads complex new product development/introduction efforts per NPD/NPI procedures. The Project Manager also leads customer-driven CDMO projects in compliance with the aforementioned procedures as well as the developmental product requirements. Primary responsibilities include leading an interdepartmental project team to meet project deliverables (scope, schedule, cost, and quality), coordinating resources from multiple internal functions to achieve business objectives, and facilitating communication between project team and key stakeholders (customers and upper management).
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following
- Builds and leads a multi-departmental team and leads the team through the execution of the project as described in the NPI/NPD procedures through all 7 stages of the program (Feasibility to Aftercare). May lead and coordinate work with an external manufacturing network on a project- basis.
- Builds and leads a multi-departmental team from kick-off through completion of customer-driven CDMO projects.
Reviews and assists with assembly of proposals for customers.
- Utilize business excellence and/or project management tools/methodology to develop project workflows, identify and manage risks, and ensure successful delivery of project Critical to Quality (CQA) attributes/specifications. Leads
development and justification of specifications.
- Cultivates internal relationships and partnerships and serves as project team problem solver, conflict resolution facilitator and meeting facilitator.
- Establish and coordinate with operations the scheduling, permit coordination, capital appropriation, plant readiness, documentation, and SAP set-up for new products.
- Serve as the subject matter expert for the overall project including product development, project timelines, budgets, status and interdependencies.
- Communicate and track project team action items, milestones and key decisions. Communicate to all levels of the organization, as appropriate.
- Prepare and present project status updates to senior management
- Maintains knowledge of cGMPs, process safety practices, environmental standards, and ICH guidelines.
- Review and approve development documents, production documents, test procedures, and drug master file sections required for each new process introduction, validation, and regulatory submission.
- Understands and can execute technical transfers from development to production (both internal and external to Siegfried)
- Will be required to simultaneously manage multiple projects at various stages within the NPI and Developmental Product procedure.
- The ability to work autonomously. Anticipates and resolves problems with little assistance or direction. Comply with EHS rules, polices and practices with the intent to maintain a safe and compliant working environment.
Report all safety incidents, accidents or injuries to supervisor immediately.
Your Profile
ADDITIONAL POSITION REQUIREMENTS
- May serve as a liaison to external customers or suppliers.
- May serve as a project manager for commercial process improvement projects or line extension efforts.
- Must be able to produce high quality and accurate work in a timely manner to meet the project schedule.
- Must be able to communicate information timely in a clear concise manner.
- Must be able to convey technical information to non-technical audiences.
- Must be able to coordinate multiple project priorities and work effectively across the organization in completing
projects on time and in budget.
- Complies with all company and site policies and procedures, carrying out duties in compliance with all state and
federal regulations and guidelines, including FDA, EPA, OSHA and DEA.
- Follow all applicable aspects of the site Environmental Management System as it pertains to normal job duties.
- Successfully complete regulatory and job training requirements.
- Be available for overtime work on a scheduled or emergency basis.
- Up to 25% travel may be required for introductions at other facility locations.
- Lead and complete other projects or assignments as requested by management.
Job description provided by Siegfried.
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