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A BDN client is looking for an experienced Formulation Consultant to provide guidance and expertise as the company works on the drug product formulation and is looking to understand how best to design the dosage form to achieve the required PK for a drug that is extremely water-insoluble. In the current form, the product is having to be administered 2-3 times per day and the client would like to explore modified release/controlled release. The consultant would need experience in the following: formulation expertise with very poorly soluble small molecules, oral dose forms – suspension, liquid-filled capsules, sprinkles, tablet/capsule of poorly soluble drugs, as well as expertise in drug delivery platforms across CDMO industry.

A BDN Medical Device client is in need of a Product Development Engineering Consultant to come in and work on the development and design of Medical Devices from initial design through to manufacturing transfer. Product development experience is key for this role, taking the product through to market. Candidates must have experience with Design Control, Design Validation, packaging requirements, IFU, testing protocols, Risk Management, manufacturing transfer, and taking products to final launch. The client has Manufacturing Engineers on-site, so the consultant does not need a particular manufacturing experience. Class 2 Medical Device experience is required; Class 3 is a plus.

A BDN client is looking for a Mid-Level Clinical Trial Manager with around 5-7 years of experience. This consultant will be responsible for the planning, implementation, execution, and management of Phase 1 clinical research studies and authoring key documents such as the protocol. They will need experience managing clinical outsourcing to CROs and other vendors such as IXRS, labs, IRBs, etc. In addition, their experience must include significant clinical research experience (5+ years) with evidence of increasing responsibility within a pharmaceutical company or CRO or similar organization and experience leading cross-functional teams.

A BDN client is looking for Commissioning Engineer(s) to join their company. The consultants will clean utilities such as Clean Steams, WFI, Nitrogen, process Air, compressed air, helium systems, carbon dioxide systems, vacuum systems, and RO/DI Systems. Experience with Electrical systems, Chilled water systems, fire sprinklers/alarm systems, Domestic Water systems, and HVAC systems are needed for this role. Experience with walking down Piping and Instrumentation Drawings is also needed. He/she must have great written and verbal communication skills along with a full understanding of current GxPs (GDPs, GMPs, GLPs).

A BDN client is looking for a Clinical Pharmacologist with 5 years of industry experience. This Pharmacologist is expected to be familiar with all aspects of PK/PD and Clinical Studies. They will also need to have experience working with PK data, writing PK Reports and any PK documents in relation to safety/PV standards. Experience with Phoenix WinNonlin (software) is a MUST for this position. A minimum of a Master's Degree is required; a Ph.D./PharmD Degree is highly preferred.

A BDN client is looking for a Senior Process Engineer R2 to support the client's R2 Facility, which has a lot of autoclaves and parts. Washer experience with sterilizers is helpful for this role; they use a lot of Kaye validators. The consultant will be doing process improvements, and the pre-validation work to set up the validation team to have to complete 1-2 runs for full validation. He/she will also be working on process improvements to the manufacturing lines and commodities as well. Experience with aseptic/sterile environments, autoclaves, sterilizers, and parts washers are needed. 10 + years of Process Engineering experience and a minimum of 5 years in pharmaceuticals is needed.

A BDN client is looking for a Quality Assurance Director. The client is preparing to begin their first clinical trial (Phase I Oncology study) and will need a QA Director to help to develop the necessary quality-related documentation, prepare for and perform due diligence, quality audits for the client’s vendors, CROs, and sites, provide expertise to identify and resolve quality issues, provide QA oversight to vendors, ensure GCP compliance and other related activities. The first activity the consultant will perform is to prepare for a due diligence audit of the client’s primary CRO, which would include performing a GCP compliance audit, cross-functional assessment and risk mitigation action plan, develop the report and present findings.

A BDN client is looking for a PV Medical Director - Safety Physician to add to their growing team. This individual will primarily be performing SAE cases reported from clinical trials, performing sponsor causality assessments, and determining regulatory reportability. He/she will work with the PV and Drug Safety teams to gather, evaluate, and perform medical assessments of each individual case safety report. This individual should be able to review adverse events and medical history and medication codes into WHO-Drug, and MedDRA codes, as well as accurately identify safety issues that may require further evaluation.

A BDN client is looking for Senior Level Biostatistician. The client is looking for a contractor with a Clinical Studies background. He/she will help with the sample size testing, create a scientific hypothesis, and do the Clinical Study Analysis. They will also make sure protocols are reading correctly. The consultant will be expected to help with protocol development/review, statistical analysis planning for study analyses (interim, final), sample size calculation, and provide review/feedback of study results. Medical Device experience is preferable for this position.

A BDN client is looking for a LABVIEW Test Engineer to develop test solutions for aerospace electromechanical actuation products. Immediate tasks start with hardware documentation and move to software tasks after the hardware arrives. The consultant must have 5+ years of LabVIEW experience; 10+ years is preferred. The client has a strong preference for candidates with TestStand, cRIO, or LabVIEW FPGA experience. He/she must also have experience with serial bus communication. Experience operating and automating COTS test equipment (power supplies, oscilloscopes, function generators, DMMs, etc.) is needed for this role.