Project Manager Senior

Location: New Albany, Ohio - Fully onsite

Work Hours:

Standard: 8 AM - 5 PM

However, occasionally ( 5% of the time) extended hours during project execution phase (up to 10-13 additional hours/week) this could include prototype builds or line tests occur on Second Shift or swing shift PM must be willing to support during those rare events. Not a second shift, but may occasionally shift hours (e.g., starting at 10 AM)

Not a permanent 2nd-shift assignment.

The ideal candidate will be a highly experienced Project Manager with a strong background in biotech or pharmaceutical manufacturing, specifically supporting new product introductions (NPI) and facility expansions.

They should have a minimum of a bachelor's degree in science, engineering, or management and at least 7 years of relevant experience (15+ years preferred). The candidate must demonstrate hands-on experience managing end-to-end project schedules, coordinating across cross-functional stakeholders including Process Development, Capital Projects, and Supply Chain.

Strong knowledge and experience with Smartsheet, NPI variations, and Change Control generation, implementation, and closeout are required.

Strong communication, organizational, and risk mitigation skills are essential. This role requires full onsite presence in New Albany, OH, with occasional extended hours during peak project phases.

Role Summary In support of s Quality Assurance program, manages and oversees the operations of a specific area(s) of responsibility.

Key Functions:

- Leading the NPI's for necessary process, facility, equipment, materials, and training modifications;

- Development of project execution plans; ensuring process requirements are effectively transferred into manufacturing; and coordination/execution of NPI activities,

- Change control management,

- Manufacturing process modifications, equipment and technology implementation (design through qualification), and supporting manufacturing readiness activities

- Engage with network partners to develop process and technology strategies that achieves clinical/commercial development schedules while minimizing transfer risks.

- Facilitate the development and optimization of NPI business processes.

- Collaborate with Combination Product Operations, Quality, and Regulatory partners to manage change control processes and respond to regulatory questions and/or audit findings within the scope of the NPI.

- Support generation, revision, review, execution, and approval of relevant technical documents (e.g., manufacturing procedures, protocols, training materials, design control deliverables, and specifications).

- Ensure design/process transfer requirements are appropriately implemented and aligned with current manufacturing strategies.

- Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.

Education / Licenses

Bachelor's degree in science, engineering, or management and at least 7 years of relevant experience (15+ years preferred)

Previous managerial experience directly managing people and/or leading teams, projects, programs, or directing the allocation of resources

Competencies / Skills

Project management skills

Strong organizational skills, including ability to follow assignments through to completion

Initiate and lead cross-functional teams

Collaborate and communicate with higher-level outside resources

Skill, knowledge, and experience with processes involved in manufacturing and distribution, QA, QAL, validation, and process development

Strong communication (both written and oral), facilitation, and presentation skills

Strong skill in working independently and effectively interacting with various levels

Ability to lead and influence staff outside own organization

Ability to motivate staff and manage and distribute workloads

Able to manage performance issues and conflict

Ability to provide direction and establish goals for individual staff members and work group

Ability to evaluate documentation/operations according to company and regulatory guidelines

Ability to interact with regulatory agencies

Demonstrate the *** Values/Leadership Practices

Job Posting Number of Positions

1