Logistics Specialist for Biopharmaceutical Manufacturing – Boehringer Ingelheim Pharmaceuticals – Fremont, CA, USA
Located in one of the world’s most innovative biotech hubs, the Boehringer Ingelheim Fremont Inc. facility is a fully integrated development and manufacturing site, for mammalian cell culture derived biopharmaceuticals. Our 300,000 square foot state-of-the-art facility includes a cGMP warehouse, QC labs and a newly constructed filling facility, complete with an Isolator filling line. We have created a new center of excellence in biopharmaceutical process & technology development to support our pipeline of novel biologics, biosimilars as well as our contract development and manufacturing business.
This Logistics Specialist of Biopharmaceutical Manufacturing will independently enforce company-wide compliance with US Customs Regulations and internal policies/procedures concerning the import of goods; including providing guidance to employees and maintaining accurate and complete records. This is a critical role in protecting Boehringer Ingelheim Fremont Inc. against Custom’s fines and penalties and the ability to export goods from the BIFI facility.
The individual will ship materials from the BI Fremont site in a manner that supports and or adheres to Policies and Procedures that are designed to meet or exceed standards set by regulatory agencies, including but not limited to, United States Customs and Border Protection, Food and Drug Administration, United States Department of Agriculture, United States Department of Transportation, United States Census Bureau.
Moreover, this position is also required, when needed, to perform administrative and physical tasks focused on warehouse receiving and material transfer in addition to all shipping activities. The individual will serve as a subject matter expert (SME) for a single process (i.e., shipping/exports). This Specialist will assist in all aspects of delivering a lean, optimized and efficient logistics function within a single facility. This position will work within a team environment to make problems visible & to take direction to ensure performance excellence and compliance at all times.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies’ success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim’s high regard for our employees.
Duties & Responsibilities:
- Works with cross functional teams and with external customers to ensure transportation requirements are meet in the most cost effective manner.
- Ensures compliance with and performs all company business in accordance with Government (cGMP, FDA, DEA, OSHA, and Safety) and Company Policies, Procedures, Goals and Objectives.
- Act as intermediary and primary point of contact between in-house personnel and Customs.
- Ship all material in accordance with all governing laws
- Conduct, review, and sign off of all shipments prior to release into the stream of commerce thus ensuring accuracy and adherence to all policies and procedures
- Conduct periodic audits of shipping documentation.
- Ensure compliance with retention schedules.
- Maintain shipping files in accordance with policy.
- Serve as primary backup for the Import Specialist.
- Liaise with internal customers, forwarding agents, carriers and brokers.
- Identify areas of opportunity and recommend process improvements to ensure compliance and optimized operations of all aspects of the logistics team
- Perform other duties as required within the Logistics area of responsibility.
- Broker on all export transactions. Lastly, with the help of the local Customs Compliance team member, this position will require resolving irregularities or ambiguous information for individual export transactions as needed.
- Provide hands on guidance to other Logistics staff through subject matter expertise.
- Supports other OPU’s during audits
- Collaborates within team and department in order to follow best practices and meet department goals.
- Must be able to perform physical activities requiring the lifting up to 70 Lbs., pushing/pulling carts is excess of 500 Lbs.
- Participates in continuous process improvements
- 8 – 10 years’ experience working within a compliant import/export program in the Pharmaceutical/Biopharma or Chemical industry, preferably shipping drug product, bulk, drug substance and/or hazmat materials.
- Strong knowledge of US Customs and import/export compliance.
- Hold a current or previous IATA/DOT certification in the shipment of hazardous materials and have hands on experience shipping these types of materials.
- Strong customer service skills with the ability to create and develop cross functional relationships both internally and externally.
- Familiarity with inventory control systems and computer office programs (Microsoft Office, SAP, CTPAT, FedEx PowerShip)
- Ability to work within cGMP regulations.
Desired Experience, Skills and Abilities:
- Previous experience working within cGMP regulations.
- Cold Chain Supply experience is a plus.
- Previous experience participating in continuous process improvement activities and projects.
- Project management skills.
- Must be legally authorized to work in the United States without restriction.
- Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background.
- Must be willing to take a drug test and post-offer physical (if required)
- Must be 18 years of age or older