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A BDN client is looking for a GMP QA Specialist who will review and evaluate Batch Production Records for API, Drug Product, Packaging, as well as document integrity. This person will also partner with QC to review protocols and reports associated with stability, and method transfer, initiate internal deviations, Change Controls, CAPAs, complaints and participate in the review of CMO non-conformances. Writing and reviewing SOPs and work instructions as well as supporting the Quality Management Review and Annual Product Quality Review is needed.

A BDN client is looking for a Process Engineer (Tech Transfer) Consultant with strong Tech Transfer experience. The client is transferring 10 product lines over the next 6-9 months. They have the SOP’s and templates already in place and they have already had their tech transfer package approved. This would be going from R&D to Commercial manufacturing. This is a liquid dietary supplement and OTC which is the more complex product where it involves mixing/compounding of the solution and transferring R&D to Batch Records.

A BDN client is looking for a QC Data Reviewer to perform data review of in-process, release, and stability testing of raw materials, bulk drug products, and vialed drug products in a cGMP setting. This position includes drafting certificates of analysis for bulk drug and vialed drug products. Reviewing certificates of analysis for bulk drug products and vialed drug products is also needed. Participating in investigations for OOS/OOT results and Unplanned Events (deviations), as well as CAPAs and Change Controls is necessary.

A BDN client is looking for a Senior Director of Quality GCP who will be responsible for the strategic and operational management of the GCP Quality group and will ensure that the appropriate processes, systems, and activities are performed to protect the rights, safety, and welfare of clinical patients. This person will assess and directly work to continuously improve GCP quality processes, and support the state of GCP compliance.

A BDN client is looking for a Regulatory Affairs Manager with 5-6 years of experience. The client is working on a next-generation insulin pump (closed system loop) so someone who is familiar with Class 2 Medical Devices is preferred. This consultant is expected to have experience authoring and reviewing an entire 510k while also being able to address any questions the FDA may have regarding this matter. This person will also be working closely with 1-2 other associates working on platforms for ad-promo review.

A BDN client is looking for a Regulatory Affairs (RA) Senior Specialist with 3-4 years of experience. The client is working on a next-generation insulin pump (closed system loop) so someone who is familiar with Class 2 Medical Devices is preferred. This consultant will be working closely with the Senior Manager of RA in providing RA support to the R&D team. This person will be responsible for drafting regulatory documents, reviewing technical documents and contributing to the 510k.

A BDN client is looking for a Mechanical/Electrical Design Engineer. Tasks assigned will include, but not limited to, supporting the E&E project team with Electrical Design, installation, troubleshooting, maintenance, etc for Electrical Equipment, MCCs, sensors, testing, PLC, controls, etc. The candidate should have a working knowledge of AutoCAD & Electrical Engineering. The client is looking for a Mechanical/ Electrical Design Engineer who is an experienced Designer with a minimum of 10 years of experience.

A BDN Medical Device client needs a Quality Systems Engineer to assist with the execution of updates to their Quality Systems to meet EU MDR compliance. General knowledge of EU MDR is required but they do not need a Subject Matter Expert, the client has completed their Gap Assessment of what needs to be updated and needs the consultant to help execute it. The consultant will perform procedural updates, update their documentation, develop templates, update work instructions, as well as SOPs.

A BDN client is looking for a Senior Level CSV Consultant to come in and help with meeting deadlines. Specifically, the client is seeking help with Change Controls, Lab Equipment (FTIR, UV, Dissolution Equipment, ect.), Data Integrity, Validation Deliverables, GAMP 5, 21 CFR part 11, cGMP, writing documents, IQ/OQ/PQ’s, and SOPs. They are looking for a self-starter, someone to drive projects across finish lines and work closely with a team of 3-4.

A BDN client is preparing to begin their first clinical trial (Phase I Oncology study) and will need a consultant to function as the Associate Director of Clinical Operations. The consultant will provide oversight of the CRO and other partners/vendors, be responsible for set-up, implementation and execution of the Phase I study, oversee study timelines and budgets, work with the investigators, provide MSA oversight/direction by understanding the level of responsibilities of those parties involved in the agreement/contract, review documentation and clinical operations-related activities.