Product Introduction; NPI Specialist – Manufacturing

About This role

We are seeking a dynamic and detail-oriented New Product Introduction (NPI) Specialist to join our RTP Bio Manufacturing team. This highly visible role sits within the Manufacturing organization and is responsible for ensuring new products are successfully introduced into the RTP Bio manufacturing facility. The NPI Specialist plays a critical role in driving timelines, coordinating cross-functional stakeholders, and enabling operational readiness to support on-time manufacturing start-up for new products.

• Support cross-functional project teams responsible for introducing new products into manufacturing operations.
• Manage and execute detailed project plans, timelines, and deliverables for NPI initiatives, ensuring milestones are met on time and within budget.
• Track and drive completion of key deliverables required to ensure overall site readiness.
• Present project progress, operational status, and timeline-related risks at appropriate governance forums.
• Identify, assess, and mitigate risks related to operational readiness and new product launches.
• Drive continuous improvement initiatives to enhance NPI processes and reduce time-to-market.

A proactive and organized project leader who thrives in a fast-paced, cross-functional manufacturing environment, with the ability to clearly communicate complex information to a wide range of stakeholders. Highly detail-oriented with a strong problem-solving mindset, able to anticipate, assess, and manage risks effectively. Comfortable balancing multiple priorities while maintaining focus on timelines, deliverables, and overall project success.

• Bachelor’s degree in engineering or related STEM field from an accredited college or university
• At minimum 5 years of experience in pharmaceutical manufacturing, process development, or related discipline
• Experience with technology transfer, process validation, and equipment qualification
• Proven ability to work effectively in a deadline-driven, dynamic environment in support of a successful execution of site readiness plan
• Strong knowledge of cGMP, regulatory requirements, and pharmaceutical manufacturing processes
• Demonstrated project management experience, including leading cross-functional teams
• Excellent communication, organizational, and analytical problem-solving skills

• Master’s degree in engineering or related STEM field from an accredited college or university
• Project Management certification (PMP or equivalent)
• Familiarity with Lean Manufacturing and/or Six Sigma methodologies
• Proficiency with documentation systems and electronic batch record (E ) platforms

Job Level: Management

The base compensation range for this role is: $-$

Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.

In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the…