Title: Sr. Project Manager – New Product Introduction (NPI)
Duration: 12 Months (Possible Extension)
Location: New Albany, Ohio, 43054, Fully Onsite
Work Schedule
Standard hours: 8:00 AM – 5:00 PM
Occasional extended hours during project execution (up to 10–13 additional hours/week)
Not a second shift, but flexible start times (e.g., 10:00 AM) as required
 The position is fully onsite in New Albany, Ohio, with occasional extended hours during critical project phases.
 
Top 3 Must-Have Skill Sets

• Project Management expertise within Biotech or Pharmaceutical Manufacturing
• Hands-on experience with Smartsheet, NPI variations, and Change Control processes
• Strong cross-functional collaboration and leadership skills

 
Job Summary
The Senior Project Manager will lead and oversee end-to-end project execution supporting new product introductions (NPI) and facility expansion initiatives. This role requires a highly experienced individual with strong technical, organizational, and leadership capabilities to manage timelines, coordinate across Process Development, Capital Projects, Supply Chain, and Quality teams, and ensure seamless project delivery in compliance with organizational and regulatory standards.

Day-to-Day Responsibilities

• Lead NPI initiatives including process, facility, equipment, material, and training modifications.
• Develop and manage detailed project execution plans ensuring alignment with process and manufacturing requirements.
• Drive and oversee Change Control creation, implementation, and closeout activities.
• Coordinate manufacturing process modifications, equipment and technology implementation (from design through qualification), and support manufacturing readiness.
• Partner with cross-functional teams to develop process and technology transfer strategies that meet clinical and commercial timelines while minimizing transfer risks.
• Facilitate continuous improvement and optimization of NPI business processes.
• Collaborate with Combination Product Operations, Quality, and Regulatory Affairs to manage change controls, address regulatory queries, and support inspection readiness.
• Review, execute, and approve technical documentation including protocols, procedures, training materials, design control deliverables, and specifications.
• Ensure compliance with environmental, health, and safety standards while promoting a culture of operational excellence.

 
Basic Qualifications

• Doctorate degree and 3 years of experience
• OR
• Master’s degree and 5 years of experience
• OR
• Bachelor’s degree and 7 years of relevant experience
• OR
• Associate degree and 12 years of experience
• OR
• High school diploma / GED and 14 years of experience 

Preferred Qualifications

• Bachelor’s or higher degree in Science, Engineering, or Management
• 7–15+ years of experience in Biotech or Pharmaceutical Manufacturing
• Strong proficiency with Smartsheet and other project management tools
• Demonstrated expertise in NPI execution, variation management, and Change Control lifecycle
• Proven ability to lead cross-functional teams and communicate effectively with senior stakeholders
• Knowledge of QA, validation, and process development processes

 
Competencies / Skills

• Advanced project management and organizational skills
• Ability to lead and influence cross-functional and technical teams
• Strong communication, facilitation, and presentation skills
• Experience managing multiple concurrent projects under tight deadlines
• Strong problem-solving, risk mitigation, and decision-making abilities
• Knowledge of manufacturing, validation, QA/QC, and technology transfer processes

 
Possible Extension: Yes
 
Red Flags:

• Limited or no experience with Smartsheet
• Vague understanding of NPI or tech transfer
• Cannot describe role in PPQ or variation execution
• No prior Pharma/Biotech experience

 
Interview Process

• 1st Round: One-on-one interview
• 2nd Round: Panel interview

 
 
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: $ 59.91/hr.