Senior Project Manager - Operational Readiness

PSC Biotech • Durham, NC

1d

About The Position

PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success. With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents. We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn. At PSC Biotech®, it’s about more than just a job—it’s about your career and your future.

Requirements

• Bachelor's or advanced degree in engineering or related life sciences discipline.
• Minimum of 10 years leading and managing projects within the life sciences and regulated manufacturing operations.
• Experience in and strong working knowledge of biologics drug substance manufacturing operations is required.
• Advanced knowledge of regulatory requirements and guidelines.
• Proven experience supporting operational readiness and related project execution activities.
• Strong background supporting biopharma new product introduction, technology transfer, or manufacturing launch/readiness activities.
• Proven background in and knowledge of validation lifecycle and CQV activities.
• Experience in manufacturing and operations systems such as Trackwise, LIMS, Maximo, MES, and related.
• Strong analytical skills to establish strategic plans, identify issues, evaluate progress, and make informed decisions that align with project goals.
• Strong stakeholder management, communication, and meeting facilitation skills.
• Ability to work effectively in a matrixed, cross-functional environment and drive alignment across multiple workstreams and stakeholders.
• Adaptable and flexible, capable of adjusting plans and strategies in response to evolving requirements, priorities, or constraints.
• Must be authorized to work in the US.
• No C2C at this time.

Nice To Haves

• PMP certification is a plus.

Responsibilities

• Develop project plans and execution strategies, defining and integrating cross-functional operational readiness workstreams, proactively driving communication, issue resolution, and execution activities.
• Develop, manage, and maintain integrated schedules and risk registers.
• Proactively identify and resolve potential risks, ensuring adherence to quality standards and regulatory requirements.
• Lead recurring meetings, working sessions, workshops, and execution forums to support progress, issue resolution, and accountability.
• Partner with other project managers to maintain coordinated execution across interdependent project activities.
• Effectively communicate project status updates and plans to management.
• Ensure Operational Readiness plans remain aligned with construction, commissioning, qualification, and overall site readiness activities.
• Support issue management, gap identification, risk mitigation planning, and cross-functional decision-making throughout the project lifecycle.
• Facilitate workshops to improve team alignment, resolve project challenges, and support broader site strategy and readiness planning.

Benefits

• Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
• Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more
• 401(k) and 401(k) matching
• PTO, Sick Time, and Paid Holidays
• Education Assistance
• Pet Insurance
• Fitness Perks and Discounted Rates
• Financial Perks and Discounts

What This Job Offers

• Job Type: Full-time
• Career Level: Senior