Distribution and Logistics Analyst, CMC Operations

PharmaEssentia U.S.A.•Burlington, MA

3d•$85,000 - $95,000•Hybrid

About The Position

We are looking for a detail-oriented and compliance-minded Distribution Analyst to join our integrated Technical CMC Operations and Supply Chain Management team. This role is central to ensuring that drug product reaches patients safely, on time, and in full regulatory compliance — from origin through final delivery. Reporting to the Associate Director, Technical CMC Operations, you will coordinate distribution execution, maintain GMP-qualified logistics partners, and support procurement and supply planning activities in alignment with our Quality Management System (QMS).

Requirements

Bachelor's degree in Supply Chain, Logistics, Business, or a related field.
2+ years of experience in pharmaceutical distribution, logistics, or supply chain operations, preferably in 3PL and / or Specialty Distributor operations.
Working knowledge of GMP supply chain and distribution for clinical and/or commercial drug product.
Experience managing GMP-compliant logistics providers and distribution partners.
Familiarity with SAP or other ERP/MRP systems, supply planning tools (e.g., Anaplan), and Quality Management Systems.
Experience with DSCSA serialization requirements and operational management of serialization systems (e.g., Tracelink or equivalent).
Knowledge of import/export requirements for FDA-regulated materials and drug product.
Strong analytical, organizational, and documentation skills with clear written and verbal communication.

Nice To Haves

Experience in biologics or similarly regulated therapeutic areas.
Familiarity with cold chain logistics, including temperature-sensitive shipment packaging, monitoring devices, and excursion management.
Fluency in Mandarin.

Responsibilities

Coordinate end-to-end distribution of commercial drug product, including third-party warehousing, cold chain logistics, and last-mile delivery.
Track material and drug product flow with full chain-of-custody visibility and documentation.
Monitor and report on distribution performance metrics — availability, lead time, backorders, serialization performance / report cards, and transportation costs — and drive corrective actions as needed.
Support import/export activities for FDA-regulated materials and drug product, including Incoterms interpretation and trade compliance requirements.
Maintain inventory plans aligned with the integrated production schedule and commercial demand.
Ensure operational procedures, SOPs, and work instructions are current and adhered to; flag compliance gaps for quality review.
Ensure all distribution activities are executed in a controlled, compliant manner using established change control and QMS processes.
Keep distribution partner documentation, specifications, and quality agreements current and inspection-ready.
Support qualification, requalification, and onboarding of logistics providers and distribution partners in partnership with Quality Compliance.
Maintain third-party logistics providers and service partners in a qualified GMP state.
Participate in investigations, deviations, and CAPAs related to distribution or logistics activities.
Serve as the subject matter expert (SME) for serialization operations in coordination with the Sr. Manager, SCM Quality & 3PL; ensure DSCSA compliance across all commercial distribution activity.
Monitor serialization data in Tracelink or equivalent system; investigate and resolve serialization exceptions, errors, and downstream partner queries.
Support the 3PL and channel partners on serialization-related onboarding, system issues, and compliance documentation.
Assist with preparation and maintenance of distribution-related SOPs, work instructions, and quality records.
Serve as a key end-user of SAP (MM module), Ariba, Anaplan, and Tracelink; ensure data accuracy and system hygiene across all platforms.
Maintain and champion CMC/SCM SharePoint organization, document libraries, and version control in coordination with the broader team.
Collaborate with Finance, 3PL, and channel partners on chargeback review and analysis, class of trade requests and questions, and contract updates.
Support project coordination for major initiatives.
Assist the team with preparation of presentations, SCM reporting slides, and executive meeting materials.
Identify and propose workflow improvements to increase operational efficiency and reduce manual effort in distribution and reporting processes.
Support due diligence, evaluation, and onboarding of new distribution service providers and logistics partners.
Assist with contract execution (MSAs, SOWs, Quality Agreements, amendments) as required.
Serve as an operational liaison between external partners and internal Quality and Operations leadership.
Collaborate closely with SCM Quality and SCM Procurement to ensure aligned, compliant supplier management.
Analyze supply chain data to support production planning, capacity assessments, and distribution network optimization.
Identify distribution and supply chain risks and contribute to mitigation and business continuity planning.
Support pre- and post-commercialization supply chain planning activities.
Drive continuous improvement initiatives across distribution and quality-integrated workflows.