The Role
Lead biopharma operational-readiness projects by developing execution strategies, integrated schedules, risk registers, and cross-functional workstreams. Coordinate construction, commissioning, qualification, validation, manufacturing launch, technology transfer, and new product introduction activities. Facilitate meetings and workshops, resolve issues, manage risks, communicate status to leadership, and drive alignment across stakeholders while ensuring regulatory compliance and site readiness.
Summary Generated by Built In
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
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
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
- Fitness Perks and Discounted Rates
- 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.
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Skills Required
- Bachelor's or advanced degree in engineering or a related life sciences discipline
- Minimum of 10 years leading and managing projects within life sciences and regulated manufacturing operations
- Strong working knowledge of biologics drug substance manufacturing operations
- Advanced knowledge of regulatory requirements and guidelines
- Experience supporting operational readiness and related project execution activities
- Experience with biopharma new product introduction, technology transfer, or manufacturing launch and readiness activities
- Knowledge of the validation lifecycle and CQV activities
- Experience with manufacturing and operations systems such as TrackWise, LIMS, Maximo, and MES
- Strong analytical, stakeholder management, communication, and meeting facilitation skills
- Ability to work effectively in a matrixed, cross-functional environment and drive stakeholder alignment
- Ability to adapt plans and strategies to changing requirements, priorities, or constraints
- PMP certification
- Must be authorized to work in the United States
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The Company
What We Do
Founded in 1996, PSC Biotech Corporation was created with the vision of providing life science companies unmatched support. To date, PSC Biotech Corporation now serves 1000 clients in more than 35 countries worldwide through professional services consulting, cloud-based software solutions, pharmaceuticals contract manufacturing, life science investment consulting, and metrology services. PSC Biotech Corporation has six unique divisions within the parent company – each representing one of our areas of expertise: PSC Biotech, PSC Software, BioTechnique™, PSC Partners, PSC Metrology and PSC Investments. Additionally, PSC Asia and PSC Biotech Ltd represent PSC Biotech Corporation in Asia and Europe, respectively. Together, these divisions enable us to meet the ever-changing needs of our clients with a commitment to excellence and superior quality.
