Manager, Supply Chain Logistics - Emeryville, United States - BeiGene

Description

**_General Description:_**

The Logistics Manager is responsible for the planning, coordination and execution of distribution for BeiGenes Finished Products (FP), Active Product Ingredients (API), Drug Products (DP), Samples and any other products. This includes managing budgets, organizing schedules & routes, depot supplier management, facilitating imports/exports, and ensuring legal/regulatory compliance is always adhered to. The Logistics Manager will interface cross-functionally with Commercial Planning, Manufacturing, Procurement, QA and a network of CMOs to provide logistic support in execution of production plans. In this role, you will use your experience with cGMP and GSP/GDP environments and help BeiGene build a robust logistics infrastructure, optimizing the overall supply chain to help achieve the ultimate goal of delivering BeiGenes pipeline to patients.

**_Responsibilities:_**

+ Performs all responsibilities in compliance with internal SOPs and external regulations. Brings compliance issues to the attention of management.

+ Ensures adherence to cGMP, GSP/GDP and SOX regulations.

+ Implements solid transportation & storage relationships and distribution methods and protocols.

+ Executes national and international distribution, of temperature-controlled products (API, DP and finished goods), ensuring safe compliant, on-time delivery and exemplary customer service.

+ Identifies and implements solutions to improve the quality and efficiency of the supply chain.

+ Facilitates and coordinates with warehouses, logistics carriers and couriers, and customs brokers regarding all aspects of transport service, including but not limited to order placement, building and reviewing shipping documents, tracking, receipt confirmation, and ensuring the physical and thermal quality of the product during transit.

+ Manages import and export process including ensuring compliance with local and regional import/export regulations particularly for US, EU and other regions.

+ Serves as liaison with Commercial Planning for distribution order management, transportation, delivery and resolution of challenges in support of the production schedule with CMOs and internal manufacturing sites.

+ Identifies and communicates any shipment risks and supports recommendations and implementation of corrective actions to minimize supply risks.

+ Establishes operational procedures for activities such as verification of incoming and outgoing shipments, temperature data logging, and on-time/at-temp delivery performance.

+ Develops, implements and enforces SOPs for all aspects of logistics management, including import and export activities, transportation risk analysis and shipping validation for API, DP and Finished Goods.

+ Manages and assess courier vendors performance and reports operational metrics (KPIs) to senior management, as well as any regulatory reporting requirements related to transportation and logistics activities.

+ Lead and measure processes to ensure logistics operations are completed with excellence.

+ Process the necessary ERP transactions according to standard operating procedures and SOX compliance guidelines and collaborate closely with Finance / Taxes teams.

+ Collaborates with corporate and facility-based QA and QC counterparts to ensure audit readiness, and process control for all logistics activities. Participates in regulatory audits as needed.

+ Coordinates with quality team on deviations/CAPA for incidents that occur during transportation.

+ Support and oversee daily and ongoing expenses to ensure that financial capital is used effectively.

+ Assists with the annual budgeting of logistics expenses.

+ Assists Packaging Engineers in compiling Lane Risk Assessments.

+ Performs other duties as assigned, in a dynamic "start-up" environment.

**_Competencies:_**

+ 5+ years progressive experience in Supply Chain within the biotech/pharmaceutical industry. A minimum of 3 years in a logistics management role for Clinical and/or Commercial products, including experience in import/export processes, lot-level inventory management, chain of custody and traceability, budget management, warehousing technologies, and temperature-controlled distribution protocols, in a regulated pharmaceutical/biotech environment

+ Understands comprehensive global pharmaceutical regulatory requirements (e.g. cGMP, GDP, 21 CFR Part 11, and Annex 13) and knowledgeable of relevant commercial laws and regulatory guidelines.

+ Experience working in a global, complex supply chain organization within the biopharma industry.

+ Strong understanding of import/export requirements and customs practices for US and EU. Direct experience with US customs audits is a plus.

+ Strong ability to flex commercial processes

+ Experience in vendor oversight and managing external partnerships and relations

+ Experience with biologics (cold chain) and/or small molecule supply chain

+ Strong understanding of import/export requirements and customs practices

+ Experience with lane risk assessments, and shipping lane/process qualification including IQ,OQ, PQ is a plus.

+ Experience in change management, deviation investigation and CAPA implementation.

+ Ability to foster a culture of continuous improvement and operational excellence and perform as an influential leader without positional authority

+ Strong ability to collaborate and build strategic relationships with internal (Commercial, Quality, CMC, Finance etc) as well as external (3PLs, CMOs, Couriers, etc.) stakeholders

+ Ability to work effectively in cross-functional and multi-cultural teams

+ Excellent organizational skills, enough to multi-task in an extremely fast-paced environment with changing priorities while maintaining attention to detail

+ Strong analytical, problem solving and critical thinking skills

**Education Required:** Bachelors degree in Business Administration, Operations Management, Engineering or similar required. Advanced degree preferred. 5+ years progressive experience in Supply Chain within the biotech/pharmaceutical industry.

**Ethics** - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

**Planning/Organizing** - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.

**Communication** - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.

**Teamwork** - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.

**Adaptability** Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.

**Technical Skills** - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.

**Dependability** - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.

**Quality** - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

**Analytical** - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.

**Problem Solving** - Has the ability to define problems, collect data, establish facts, and draw valid conclusions and work collaboratively with cross-functional teams to conquer obstacles in a timely manner

**Project Management** - Communicates changes and progress; Completes projects on time and budget.

**_Computer Skills:_**

+ Proficient in Microsoft Office applications and SAP ERP (SD module is a must) system

+ Experience with a warehouse management system is a plus

**_Other Qualifications:_**

+ Experience in vendor oversight and managing external partnerships and relations.

+ Familiarity with risk management tools (FMEA, etc).

+ Due to the global nature of the company early morning or evening meetings are required

**Travel:** 10%

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.