Logistics Specialist: 12-month Mat Leave Coverage
Hybrid: Stevenage, 2 days week in office (Mon required) 3 days from home.
Role Summary
There is an immediate opportunity for bright, enthusiastic person to join the manufacturing team committed to delivering high quality products for use in our clinical trial programmes. The role will be based in Stevenage, but there will also be opportunities to work within established centres in the London area.
Key Responsibilities
* Ensuring compliance with Good Distribution Practice (GDP), Good Manufacturing Practice (GMP) regulations, such as European Commission, UK HMRC and US FDA guidelines and regulations.
* Working with Autolus QC, CGT warehouse and the logistics provider to schedule and co-ordinate QC sample shipments relating to clinical batches to contract labs in a timely manner
* Scheduling and coordinating other non-clinical batch related shipments of both biological and non-biological materials.
* Working with outsourced / external contractors to co-ordinate the delivery and storage of Starting Material, Drug Product and other biological and non-biological materials. Ensure that any issues that arise during collection, shipping, delivery and receipt of shipments are addressed in a timely manner.
* Establish, create and maintain effective working relationships with the 3PL and logistics providers.
* Customs Trade Compliance – create and provide customs paperwork when needed. Ensure HTS codes, value for customs and incoterms information is accurate and up to date with the latest World Customs Organisation guidelines.
* Knowledge of dangerous goods transport requirements for both air and road.
* Cross functional co-ordination of shipments and sample movements ensuring accuracy.
* Periodic audit of customs entry packets to ensure accuracy.
* Ensure accurate customs clearance instructions are provided to logistics providers.
* Maintain relationship with Customs Brokers
* Maintaining spreadsheets and databases for activities.
* Become the site SME for logistics queries and perform training and knowledge transfer where required.
* Any other duties as required following consultation with the post holder
Demonstrated skills and competencies
E – Essential
P - Preferred
Experience
* At least 2+ years’ experience in a healthcare / pharmaceutical logistics environment (E)
Qualifications
* Bachelor’s degree in Logistics/Biology/Biomedical Science/Immunology/Haematology/Pharmacology/Engineering or related discipline or less than 2 years experience in a GMP field – (E)
Skills/Specialist knowledge
* Logistics and customs knowledge (E)
* IT literate with experience of using MS Office package (E)
* Enjoys team working and a natural team player (E)
* Excellent organisational skills with the ability to present results clearly and logically (E)
* Working co-operatively as part of a team as well as independently - – (E)
* Good attention to detail and ability to accurately follow SOPs – (E)
* Ability to identify and implement solutions – (E)
* Strong verbal and written communication skills – (E)
* Flexible, self-motivated and focus on team outcomes – (E)
* Commitment to high quality work – (E)
* Familiarity with GDP and GMP guidelines – (P)
* Knowledge of domestic and international shipping requirements and regulations (P)
* Flexible and adaptable (E)