Serialization Senior Associate

Breckenridge Pharmaceutical develops and markets high-quality, added-value and cost-effective generic drugs in the United States. Our products are developed in the group's own R&D facilities and through strategic partnerships with manufactures from around the world.The Senior Associate, Serialization will report to the Manager, Serialization and is accountable for ensuring accuracy and completeness of all Serialization transactions as part of the serialization program at BPI. The individual will be part of a fast-paced team seeking to comply with a rapidly evolving landscape of US serialization regulations as well as leveraging new capabilities to improve the way BPI makes and delivers products to patients. This role will interact with a wide range of business functions (and 3rd party consultants and service providers) to manage transactions, resolve transactional errors, understand processes, improve capabilities, and deploy new technologies quickly and effectively.This role will be accountable for responding to verification requests of data scans ensuring that verification requests are legitimate. This role will support the management of serialization efforts with our customers, 3PL, and Contract Manufacturing Organizations (CMO's) in a timely and professional manner.DUTIES AND RESPONSIBILITIES: Serialization - 70%Proactively monitor the systems daily to avoid delaying product release to market.Identify any gaps and suggest improvements based on industry best practices.Maintain procedures and compliance with serialization regulations in a timely fashion.Assist in investigating and verifying negative responses to salable return verification requests.Support the development and implementation of process and procedures to exchange serialization data with downstream partners.Onboard new partners and products for exchange of serialization information.Troubleshoot serialization related issues. Formal investigation of support issues, communication with impacted stakeholders, vendors, resolution/closure of the issue, and updating appropriate knowledge management records.Support evaluation and development of internal and external SOPs to ensure compliance with current and future DSCSA requirements.Manage master data to ensure accurate data exchange with upstream and downstream trading partners.Collaboration - 30%Collaborate with external Supply Chain partners (CMO's, 3PLs, Wholesalers, Customers) for real time visibility to support serialization activities.Communicate effectively and build cooperative and supportive working relationships across the wide range of functions involved in ensuring compliance to applicable regulations.Communicate and interact regularly and comfortably across various departments, from individual(s) to discuss solutions that foster strong relationships and continued success of the project.ESSENTIAL QUALIFICATIONS, EDUCATION AND EXPERIENCE:Bachelor's degree or commensurate experience.Knowledge of the Drug Supply Chain Security Act requirements.Normally requires at least one (1) to three (3) years' relevant experience.Work experience in pharmaceuticals and/or manufacturing environments.Experience using Rfxcel or similar L4 serialization software.PREFERRED SKILLS:Excellent interpersonal and collaborative skills, the ability to work independently and effectively in a highly dynamic environment.Ability to collaborate with cross functional teams from multiple geographical locations.Coordinate and conduct regular stakeholder meetings.Track project deliverables using appropriate tools.Ability to identify issues and risks and, in conjunction with the stakeholders, formulate plans to mitigate risks.Demonstrated sense of urgency with strong follow-up skills.Detail oriented and able to work in a team setting.Effective oral and written communication skills.Highly adaptive and flexible to accepting new ideas, people and procedures.Strong analytical skills to make quantitative projections.Must demonstrate effective listening, sound judgment, be well organized, take initiative, be flexible, and work well under pressure.

Created: 2025-02-06