Title: Project Manager Senior
Duration:6 months
Location: New Albany, Ohio – Fully onsite
Work Hours: 8 AM – 5 PM

Description:
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.


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 Client Values/Leadership Practices

Basic Qualifications    

• Doctorate degree and 3 years of experience OR Masters degree and 5 years of experience OR Bachelors degree and 7 years of experience OR Associates degree and 12 years of experience OR High school diploma / GED and 14 years of experience

Top 3 Must Have Skill Sets:    

• Program Management skills
• Strong organizational skills
• Initiate and lead cross-functional teams
• Smartsheet

Possible Extension:    

• Yes

Red Flags:    

• No pharma or med-device or similar regulated experience
• No hands-on project plan ownership
• Weak or basic Smartsheet-only exposure (they must be hands-on)
• Overqualification is not a concern as long as depth of PM experience aligns. EX: 10 years of total project management experience. Role does not need 10 years of “lead PM,” progression is fine (analyst ? coordinator ? PM ? lead)

Interview Process:    

• One on One with hiring manager. 1-2 additional leader/ peer interviews

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 57.40/hr.