PSC Biotech® Corporation · 1 month ago
Senior Project Manager - Operational Readiness
Holly Springs, NC
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expPSC Biotech is dedicated to providing essential services to the life sciences industry, ensuring health care products meet the highest standards. The Senior Project Manager will oversee cross-functional project teams, ensuring projects are completed within scope, time, and budget while collaborating with stakeholders and leading operational readiness initiatives.
BiotechnologyConsultingLife ScienceProject ManagementQuality AssuranceRental
No H1B
Responsibilities
Facilitate the development of high-level strategies for execution with the team and drive project completion
Collaborate with key stakeholders to define project objectives, scope, and deliverables
Track project schedules, timelines, and budget
Develop mitigation plans to resolve any project delays. Proactively identify and resolve potential risks
Lead project teams to execute projects according to plan, ensuring adherence to quality standards and regulatory requirements
Ensure effective communication and collaboration among team members and stakeholders
Provide clear direction and guidance to cross-functional project teams, fostering a collaborative and high-performance work environment
Identify resource needs and allocate resources appropriately to meet project goals
Ensure all project documentation is accurately recorded, updated, and communicated
Provide effective communication and coordination with other external parties such as government agencies, contractors, and vendors
Lead and support facility start-up activities including commissioning, qualification, and operational readiness planning
Coordinate cross-functional readiness efforts to ensure seamless transition from construction to operations
Develop and implement operational readiness plans including SOP development, training programs, and readiness assessments
Collaborate with manufacturing, quality, and engineering teams to ensure facility, equipment, and personnel are prepared for GMP operations
Additional responsibilities as required
Qualification
Required
Bachelor's degree in engineering or related life sciences discipline
5+ years' of project management experience in the life science industry
Advanced knowledge of industry regulations and guidelines
Prior experience in proposal, contract, and/or grant writing/development
Well-versed in PM tools
Previous background in drug development, product launch, and facility start-up
Experience leading operational readiness initiatives for GMP manufacturing facilities
Ability to define project goals, create a comprehensive project plan, set realistic timelines, manage budgets, and identify and mitigate risks
Strong analytical and critical thinking skills to identify issues, evaluate options, and make informed decisions that align with project goals
Adaptable and flexible, capable of adjusting plans and strategies in response to evolving requirements, priorities, or constraints
Strong attention to detail ensuring that deliverables meet specifications and adhere to quality standards
Must be authorized to work in the US
No C2C at this time
Preferred
PMP certification is a plus
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
Discounted rate at Anytime Fitness
Financial Perks and Discounts
Company
PSC Biotech® Corporation
Founded in 1996, PSC Biotech Corporation was created with the vision of providing life science companies unmatched support.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
John Clapham
CEO
Recent News
2025-12-18
2025-10-20
Company data provided by crunchbase