Overview
Operational Readiness Manager – Project Farma is a full‑time, salaried role responsible for overseeing the execution of high‑impact life‑science projects across multiple U.S. locations. Candidates must be willing to travel domestically to meet client project requests.
Locations include Cambridge, MA, Columbus, OH, and various customer sites throughout the United States.
Key Responsibilities
- Serve as a trusted advisor to senior stakeholders, including Vice Presidents of Engineering and Operations, and Site and Quality Leaders.
- Provide strategic leadership in developing and executing Operational Readiness Plans and Assessments, either in‑house or as a consultant.
- Lead large, complex capital facility projects with budgets exceeding $5M.
- Demonstrate deep understanding of Operational Readiness stage‑gate processes and clearly articulate these to stakeholders and clients.
- Lead cross‑functional Operational Readiness teams in both internal and consulting environments.
- Possess end‑to‑end knowledge of capital project execution, from design through start‑up, including effective handoffs between Capital Project Execution and End‑User Operational Readiness teams.
- Lead cross‑functional teams (Engineering, Operations, Quality, Supply Chain) from Operational Qualification (OQ) completion through initiation of PPQ batches.
- Maintain strong knowledge of biopharmaceutical manufacturing facilities, including Drug Substance and Drug Product/Packaging operations.
- Lead and manage all start‑up readiness elements, including consumables and raw material planning, engineering asset induction, and CMMS configuration and implementation.
Leadership and Management
- Run large (10–20 people) cross‑functional teams in a start‑up environment, either in‑house or as a consultant.
- Prioritize and set key milestone targets for the Operational Readiness Team, then drive delivery of those milestones.
- Work effectively in a fast‑paced team environment with rapidly changing scope and priorities.
- Apply advanced technical knowledge and professional expertise.
Attributes for Success
- Innovation & Continuous Improvement: Seek better ways, adapt to change, and champion new ideas.
- Customer Focus & Professionalism: Represent Project Farma with consistent professionalism and appropriate escalation.
- Integrity & Humility: Demonstrate self‑awareness and put Project Farma’s mission above ego.
- Collaboration & Communication: Communicate clearly and proactively, driving transparent alignment with clients.
- Project Execution: Deliver reliably, manage priorities, and drive high‑quality outcomes.
- Growth Mindset: Show openness to new ideas, feedback, and change.
Experience Required
Bachelor’s Degree (or Master’s) in Life Sciences, Engineering, Regulatory, or related discipline OR equivalent experience in quality assurance, cGMP facility start‑up, regulatory assurance, relevant military and/or professional services.
- 8–14+ years of directly relevant experience.
- Minimum 7+ years of bio‑pharmaceutical industry experience.
- Capital Projects experience in a GMP pharmaceutical environment.
- Operational experience moving from capital execution to true facility start‑up.
- Willingness to travel as required to support project and business needs.
Preferred Qualifications
- Black Belt certification in Operational Excellence or Six Sigma.
Compensation
The annual compensation range for this full‑time position is $110,000–$155,000. Final base pay will be determined by internal equity, work location, and individual qualifications.
Equal Opportunity Employer
Project Farma is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law.