Senior Project Manager - Operational Readiness

PSC Biotech; Raleigh (NC); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Medical benefits

401(k) matching

PTO & holidays

Education assistance

Life insurance

Job summary

PSC Biotech is seeking a Senior Project Manager - Operational Readiness to lead biopharma projects in the Raleigh/Durham area. You will shape strategic delivery, drive cross-functional readiness, and ensure regulatory compliance across all project stages.

The role requires 10+ years of project leadership in life sciences and strong knowledge of regulatory guidelines, CQV, and manufacturing operations. This is a full-time position focused on site readiness and operational excellence.

Qualifications

• Need Bachelor's or advanced degree in engineering or related life sciences.
• PMP certification is a plus.
• Minimum 10 years leading biopharma projects.
• Experience with biologics drug substance manufacturing.
• Knowledge of regulatory guidelines and CQV activities.

Responsibilities

• Develop project plans and integrated operational readiness workstreams.
• Maintain integrated schedules and risk registers.
• Identify risks and ensure quality/regulatory compliance.
• Lead meetings, workshops, and execution forums.
• Coordinate across interdependent project activities.
• Communicate status updates to management.
• Align readiness plans with construction, commissioning, qualification.
• Support issue management and risk mitigation across lifecycle.
• Facilitate workshops to improve team alignment and readiness planning.

Skills

Project management

Regulatory compliance

Biopharma manufacturing

Stakeholder management

Cross-functional leadership

Education

Bachelor's or advanced degree in engineering or life sciences

Tools

Trackwise

LIMS

Maximo

MES

Job description

Senior Project Manager - Operational Readiness

Raleigh/Durham, United States | Posted on 07/15/2026

PSC Biotech provides essential services to the life sciences, ensuring that health care products are developed, manufactured, and distributed to the highest standards and in compliance with all applicable regulatory requirements.

Our Senior Project Managers lead biopharma projects, providing strategic delivery guidance, reducing execution risk, ensuring regulatory compliance, and optimizing overall project performance.

• 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.

Requirements

• Bachelor's or advanced degree in engineering or related life sciences discipline. PMP certification is a plus.
• 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.

Benefits

• Medical, Dental, and Vision – PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents.
• Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability, and related insurance options.
• 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.

Equal Opportunity Employment Statement

PSC is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, the company complies with all applicable federal, state and local laws concerning employment discrimination. Accordingly, discrimination is prohibited in all aspects of employment, including recruitment, interviewing, hiring, evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination, and employer‑sponsored activities. Employment decisions are made without regard to an applicant’s, employee’s, or intern’s actual or perceived race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.