Manager Supply Chain Systems - Serialization

Location
Rensselaer, NY, United States
Posted
Mar 23, 2019
Ref
16159BR
Required Education
Bachelors Degree
Position Type
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary:

Manage all serialization initiatives for Regeneron to stay compliant with product identification related regulations in the US, EU and other markets, and identify opportunities to leverage serialization information for better supply chain visibility and tracking.

Keep track of the changing regulatory landscapes in different markets, streamline serialization related activities for new product launch, onboard new contract packagers, support launch in new markets, and, manage related systems like Tracelink, line serialization systems, and interfaces with partners or government organizations.

Essential Duties and Responsibilities include, but are not limited to, the following:

Serialization Requirements

• Lead the US DSCSA and EU FMD serialization implementations

• Lead serialization related projects and participate in product launch (with or without collaboration partners, across multiple countries)

• Act as a subject matter expert for any serialization system and related packaging and distribution processes, including line serialization systems like Optel or Systech.

• Adhere to strong IT Governance and change control process for all changes in a FDA regulated environment including validation.

• Understand & raise awareness of serialization, product identification, DSCSA or EMVO related guidances (FDA, HDA, EU) and changes in regulations.

• Lead the integration and validation of interfaces with various parties (CMOs, 3PLs, Distributors, collaboration partners)

• Provide ongoing support and maintenance of deployed serialization solutions including SOPs, Technical Assessments and Work Instructions.

• Identify opportunities and lead efforts to improve processes through continuous improvement and business process re-engineering.

Design and Development

• Assist I.T. with serialization validation documentation including creation of functional, design specifications, Test plans and Trace matrix.

Testing, Training and Cutover

• Assist the team with end-to-end testing, system validation and change management.

• As a serialization subject matter expert - bring all the cross functional teams up to speed with new regulations and challenges.

• Manage drafting, review and approval of project documents.

• Manage end-user training and cutover activities.

Education, Experience, & Certifications

• BS/BA in business, information systems, or a scientific discipline Required (May substitute relevant industry experience)

• Masters in Business Administration Preferred Certification

• Project Management Professional (PMP) preferred

• Pharma / Biotech (or equivalent industry)

• Supply Chain or Manufacturing Function required

• Serialization Experience (End to End) 3 years' experience

• Tracelink Serialization System preferred

• Business Analysis or Project Management 4 years experienced

• People Management 2 years' experience preferred

• GS1 Standards, EPCIS, HDA Standards preferred

• Microsoft Excel Advanced, Microsoft PowerPoint, Visio, Project Intermediate

*Level will be determined based on skills and related experience.*

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.