New Product Introduction (NPI) Specialist – Manufacturing
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Job Location:
Durham County, NC - USA
Monthly Salary:
$ 133000 - 178000
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
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.
What youll Do
- 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.
Who You Are
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.
Required Skills
- Bachelors 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
Preferred Skills
- Masters 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 (EBR) platforms
Additional Information
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 $10000 per calendar year
- Employee Resource Groups participation
Why Biogen
We are a global team with a commitment to excellence and a pioneering spirit. As a mid-sized biotechnology company we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning growth and expanding their skills. Above all we work together to deliver life-changing medicines with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds cultures and perspectives make us a stronger and more innovative company and we are focused on building teams where every employee feels empowered and inspired.Read onto learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex gender identity or expression sexual orientation marital status race color national origin ancestry ethnicity religion age veteran status disability genetic information or any other basis protected by federal state or local law. Biogen is an E-Verify Employer in the United States.
Required Experience:
IC
Key Skills
- Sales Experience
- Marketing
- Customer Service
- Communication skills
- Military Experience
- Retail Sales
- Product Demos
- Customer Support
- Product Management
- Product Development
- Unity
- Microscopy
About Company
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities, ... View more
