Project Manager

AppleOne Employment Services; Indianapolis (IN); On-site; USD 110,000 - 140,000; Full time

Job summary

AppleOne Employment Services seeks an experienced Project Manager to lead external manufacturing programs at a contract manufacturing organization. You will coordinate cross-functional teams across Quality, Supply Chain, Engineering, Regulatory, and Finance to ensure reliable commercial supply of therapeutics.

The role requires a strong background in GMP operations, project planning, budgeting, risk management, and change control, with 5+ years in pharma/biopharma operations and PMP or related

Qualifications

• Bachelor’s degree in Engineering, Science, or related technical field.
• 5+ years of relevant pharmaceutical/biopharmaceutical operations experience.
• MS, MBA, Master’s in Project Management, PMP, or related professional certification.

Responsibilities

• Manage project scope, integrated plans, timelines, milestones, and deliverables.
• Coordinate activities between internal teams and CMO/CDMO partners across Quality, Supply Chain, Engineering, Regulatory, and Finance.
• Oversee project risks, identify mitigation strategies, and develop contingency plans.
• Drive communication of project status, risks, decisions, and results to leadership.
• Develop project budgets and support financial governance; identify opportunities to improve processes, schedules, costs, and supply reliability.

Skills

Project management

GMP experience

Budgeting

Cross-functional leadership

Scheduling tools

Risk management

Quality oversight

Education

Bachelor’s degree in Engineering, Science, or related field

MS, MBA, Master’s in Project Management, PMP

5+ years pharma/biopharma operations experience

Tools

MS Project

Primavera P6

Smartsheet

Job description

We’re seeking an experienced Project Manager to provide strategic and operational leadership for external manufacturing programs at a contract manufacturing organization (CMO/CDMO). This role will coordinate cross-functional teams to support reliable commercial supply of key therapeutics.

Responsibilities

• Manage project scope, integrated plans, timelines, milestones, and deliverables
• Coordinate activities between internal teams and CMO partners
  Partner across Quality, Supply Chain, Engineering, Regulatory, and Finance
• Oversee project risks, identify mitigation strategies, and develop contingency plans
• Drive communication of project status, risks, decisions, and results to leadership
• Support deviation/CAPA, change control, quality oversight, and contract governance
• Develop project budgets and support financial governance
  Identify opportunities to improve processes, schedules, costs, and supply reliability
• Maintain project documentation and ensure disciplined project execution

Qualifications

• Bachelor’s degree in Engineering, Science, or related technical field
• 5+ years of relevant pharmaceutical/biopharmaceutical operations experience
• MS, MBA, Master’s in Project Management, PMP, or related professional certification.
• Experience with commercial or external manufacturing at a CMO/CDMO
  Experience with quality oversight, supply coordination, deviation/CAPA, change control, and contract governance
• Strong project management experience in a GMP environment
• Experience with scheduling, risk management, and phase-gate/stage-gate processes
• Strong organizational, communication, and team-building skills
• Proficiency with Microsoft Word, Excel, PowerPoint, and project scheduling tools such as MS Project, Primavera P6, or Smartsheet
• Bachelor’s degree in Engineering, Science, or related technical field
  5+ years of relevant pharmaceutical/biopharmaceutical operations experience
• Experience with commercial or external manufacturing at a CMO/CDMO
  Experience with quality oversight, supply coordination, deviation/CAPA, change control, and contract governance
• Strong project management experience in a GMP environment
  Experience with scheduling, risk management, and phase-gate/stage-gate processes
• Strong organizational, communication, and team-building skills
• Proficiency with Microsoft Word, Excel, PowerPoint, and project scheduling tools such as MS Project, Primavera P6, or Smartsheet
• MS, MBA, Master’s in Project Management, PMP, or related professional certification.

Equal Opportunity Employer / Disabled / Protected Veterans
The Know Your Rights poster is available here:
https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12.pdf
The pay transparency policy is available here:
https://www.dol.gov/sites/dolgov/files/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf
For temporary assignments lasting 13 weeks or longer, AppleOne is pleased to offer major medical, dental, vision, 401k and any statutory sick pay where required.
We are committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation for any part of the employment process, please contact your staffing representative who will reach out to our HR team.
AppleOne participates in the E-Verify program in certain locations as required by law. Learn more about the E-Verify program.
https://e-verify.uscis.gov/web/media/resourcesContents/E-Verify_Participation_Poster_ES.pdf
We also consider for employment qualified applicants regardless of criminal histories, consistent with legal requirements, including, if applicable, the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records, including, if applicable, the San Francisco Fair Chance Ordinance. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.