Distribution and Logistics Analyst, CMC Operations

Company: PharmaEssentia U.
Location: Burlington
Posted on: April 4, 2026

Job Description:

Location: Burlington, MA (hybrid/ 2-3 days per week in office) The Company: It’s not often you get the chance to make a real impact on the lives of others, while expanding your own possibilities. You’ll find that rare opportunity at PharmaEssentia USA. Join us, and let’s transform lives, together. PharmaEssentia USA Corporation is a rapidly growing biopharmaceutical innovator. We are leveraging deep expertise and proven scientific principles to deliver effective new biologics for challenging diseases in the areas of hematology and oncology, with one product approved in Europe and a diversifying pipeline. We believe in the potential to improve both health and quality of life for patients with limited options today through the combination of rigorous research and innovative thinking. Founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today we are listed on the Taipei Exchange (6446) and are expanding our global presence with operations in the U.S., Japan, and China, along with a world-class biologics production facility in Taichung. The Opportunity 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). What You'll Do Distribution & Logistics (Primary Focus) 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. Compliance & GMP Quality 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. Systems, Data & Cross-Functional Support 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. Procurement & Supplier Management 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. Planning & Analytics 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. 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. Preferred 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. The expected salary range for this position based on greater Boston, MA location is $85,000-$95,000. Actual salary pay will be based on multiple factors, including geographic location, experience, qualifications, and other job-related factors permitted by law. Benefits of working with our team: PharmaEssentia USA strives every day to improve the lives of patients as well as our employees. As a valued member of PharmaEssentia USA, you will enjoy the following benefits: Comprehensive medical coverage Dental and vision coverage Generous paid time-off 401(k) retirement plan with competitive company match Medical & Dependent Care Flexible Spending Account Up to $150 monthly cell phone reimbursement Employee Assistance Program Free parking EEO Statement At PharmaEssentia USA, we are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law. PharmaEssentia USA believes that diversity and inclusion among our team are critical to our success as a global company, and we seek to recruit, develop and retain the most talented people from a diverse candidate pool. PharmaEssentia does not accept unsolicited agency resumes. Staffing agencies should not send resumes to our HR team or to any PharmaEssentia employees. PharmaEssentia is not responsible for any fees related to unsolicited resumes from staffing agencies. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. At PharmaEssentia, our goal is to treat as many people with cancer as possible. That means challenging the status quo with better science that leads to better lives. By joining our team, you will not only expand your own possibilities, but you will contribute to expanding options for people with cancer. https://us.pharmaessentia.com/careers/

Keywords: PharmaEssentia U., New Bedford , Distribution and Logistics Analyst, CMC Operations, Logistics, Transportation & Drivers , Burlington, Massachusetts