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

• Standard: 8 AM – 5 PM
• Occasional extended hours during project execution phase (up to 10–13 additional hours/week)
• Not a second shift, but may occasionally shift hours (e.g., starting at 10 AM)

 
Top 3 Must Have Skill Sets:   

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

 
The ideal candidate will be a highly experienced Project Manager with a strong background in biotech or pharmaceutical manufacturing, specifically supporting new product introductions 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. Experience with Smartsheet/office construction projects is a plus. 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 the company’s Quality Assurance program, manages and oversees the operations of a specific area(s) of responsibility.
 
Day to Day Responsibilities/Key Functions:

• Responsible for hiring, training, supervising, and performance management of staff.
• May perform or oversee the following functions:
• Review and approve product MPs
• Approve process validation protocols and reports for Mfg. processes
• Approve Environmental Characterization reports
• Approve planned incidents
• Represent QA on NPI team
• Lead investigations
• Lead plant audits; participate in site audits
• Approve change-over completion
• May perform work of QA Specialist
• Work with various NPI support groups to develop, maintain, and execute the NPI project plan.
• Principal Engineer will function as the Sr. project manager and is accountable for NPI scope, schedule, resources, and risk management.
• Responsibilities include issue resolution in a timely manner and escalation to various levels of management as appropriate.

 
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 company’s 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

 
Red Flags:      

• No flexible for extended hours.
• Lack of real project management experience in biotech
• No prior experience working in matrixed or multi-stakeholder project environments

 
Interview Process: 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: $57.40/hr.