• Job title.
GMP Project Manager
The primary responsibility of the GMP Project Manager will be to oversee, monitor and manage GMP type projects such as ASRs, IVD oligos, research grade oligos used for IVD development, pilot runs for commercial products, VIP trial orders. This position is instrumental to ensure high-quality customized on time oligo products for the regulatory market which meet both the customers and regulatory requirements.
The GMP Project Manager will work along team members from Sales, Customer Care, Technical Support, Manufacturing and Quality Assurance as a single point of contact for internal communication as well as the communication to the customer.
• Essential job functions.
Independently manages projects for the manufacturing of GMP and trial products by gathering and translating customer requirements into production specifications and by overseeing the production process from order entry until shipment of the final product
Works closely with sales, customer care and production on technical requirements for GMP and trial orders.
Keeps track of all current requirements for new and ongoing projects and makes sure that all specifications are current, correct and communicated to the team.
Checks status and progress of all GMP and VIP orders on a daily basis and reports any issues, open questions or anomalies
Reviews all manufacturing and QA documents associated with the assigned GMP or trial orders for completeness and accuracy and reports any gaps or discrepancies.
Makes sure that all required documentation including QC documentation is prepared and delivered with the order
Conducts final inspects of products before shipment
Serves as single point of contact for GMP customers and handles the communication between manufacturing, sales and the customer unless agreed differently
Handles all GMP and trial related customer complaints and investigates root causes for non-conformances
Ensures positive ongoing customer relationship, satisfaction, and repeat business
Assists and supports customers with full cycle development from RnD to scale up and commercialization
Communicates effectively with all levels of production and management.
Ensures that all processes are ISO 9001-2008 and ISO 13485 conform and, if required, meet 21 CFR 810 FDA regulations.
• Qualifications required for the job.
PhD degree in Chemistry or related field
Strong background in the field of synthetic oligonucleotides with solid understanding of oligo nucleotide manufacturing processes, purification, formulation and kit manufacturing
Experienced with Product Management of oligonucleotide products including GMP-type products
Experience in Project Management and Customer Management
Excellent communication skills
Proven ability to successfully work in a team environment
Strong back ground in regulatory requirements such as GMP and ISO 9001
• Non-essential job requirements.
Experience with clinical trials
Experience with regulatory submission of IVD products to the FDA
• Reporting relationship.
The GMP Project manager reports directly to the VP of Manufacturing
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