Holly Springs, North Carolina, United States · On-site
Senior+
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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 requi…
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Full-time
bachelor degree, professional certificate
Medical Insurance, Dental Insurance, Vision Insurance, Employee Assistance Programs, Basic Life Insurance, Short Term Disability
Posted 29d ago
~40 hrs/week
Responsibilities
Lead cross-functional teams to ensure projects are delivered within scope, time, and budget, specifically focusing on facility start-up and operational readiness. Coordinate the transition from construction to GMP operations through SOP development, training, and readiness assessments.
Requirements
Requires a Bachelor's degree in engineering or life sciences and at least 5 years of project management experience in the life science industry. Candidates must have a background in drug development and experience leading operational readiness for GMP manufacturing facilities.
Full job description
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.
The Experience
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.
Your Role
The 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.
Benefits
Offering 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
Equal Opportunity Employment Statement
PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be 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.
PSC Software®, a division of PSC Biotech® Corporation, provides inspection management and enterprise quality management software solutions that enable businesses to safely and efficiently deliver their products to market. Applications developed by PSC Software® address the needs of organizations that must maintain compliance in regulated industries. Our principle is that software should be affordable and user-friendly in order to provide a competitive advantage to our customers.
To learn more, visit www.pscsoftware.com.
Offices: 700 Corporate Center Dr, Pomona, CA 91768, US
EQMSenterprise quality management softwareauditinginspectionsregulatory compliancedocument management21 CFR Part 11workflow managementcloud-basedhosted
PSC Software®, a division of PSC Biotech® Corporation, provides inspection management and enterprise quality management software solutions that enable businesses to safely and efficiently deliver their products to market. Applications developed by PSC Software® address the needs of organizations that must maintain compliance in regulated industries. Our principle is that software should be affordable and user-friendly in order to provide a competitive advantage to our customers.
To learn more, visit www.pscsoftware.com.
Offices: 700 Corporate Center Dr, Pomona, CA 91768, US
EQMSenterprise quality management softwareauditinginspectionsregulatory compliancedocument management21 CFR Part 11workflow managementcloud-basedhosted