Job DescriptionYour RoleThe Project Manager will play a key role in the planning, oversight, and leading of cross-functional project teams to ensure the delivery of projects are within scope, time, and budget. The successful candidate will have a strong background in technical project management, strong interpersonal abilities, and a deep understanding of the pharmaceutical/biologic industries with a background in drug product development, facility start-up, and operational readiness.
- 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.
Requirements- Bachelor's degree in engineering or related life sciences discipline.
- PMP certification is a plus.
- 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.
BenefitsOffering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.
- 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
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