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A BDN client is looking for an Associate Director of Program Management who has experience with NDA submissions. Strong Program Management experience is key with NDA experience being secondary. The Associate Director of Program Development is an experienced professional with demonstrated ability to manage drug development programs ranging from early to late stages. The individual will be responsible for managing development programs and enable successful completion of program milestones and corporate goals. This role is highly cross-functional and may involve close interaction with external partners.

A BDN client has an initiative this year to strengthen the Data Integrity in the labs with respect to Access Controls. They have completed an initial Gap Assessment for overall Data Integrity for all global sites. This will focus on the labs in each site (5) and perform the Gap assessment to the equipment families, HPLC, Analyzers, PH meters, Particle Counters, Balancers, etc. Identifying the Gap, providing Risk assessments, working with Department SME’s to develop remediation strategy and then validate is needed. This Validation team is needing 5 people to work as a collective unit to perform the Validation Execution to Automation Lab equipment (Lyophilizer’s, Filler’s, and Autoclaves) as well as the previous equipment mentioned.

A BDN client has an initiative this year to strengthen the Data Integrity in the labs with respect to Access Controls. They have completed an initial Gap Assessment for overall Data Integrity for all global sites. This will focus on the labs in each site (5) and perform the Gap assessment to the equipment families, HPLC, Analyzers, PH meters, Particle Counters, Balancers, etc. Identifying the Gap, providing Risk assessments, working with Department SME’s to develop remediation strategy, and then validating is needed. This Validation Team will be 5 people to work as a collective unit. The Validation Execution to Automation Lab equipment (Lyophilizer’s, Filler’s, and Autoclaves) as well as the previously equipment mentioned is needed. They will need to be validating and testing the access controls to the equipment and systems such as Audit Trails, Backup, Restore, etc.

A BDN client is starting the final phase of clinical trials and has both Pharmaceutical and Device elements to the product. This consultant needs to be a Subject Matter Expert with Quality Management Systems in a small start-up environment. The client does not want large Pharmaceutical or Medical Quality Systems that can be too cumbersome to work within. They are hoping to have an expert work with their team to build the initial framework of the systems. They would like this person to assess the systems and put a framework system that allows them to build out to cover the full range of products. Also, they have implemented a new PLM system (Arena) that should be going live very soon.

A BDN client is working on a pre-filled syringe, and they need a Senior Design Quality Engineer with experience in design control requirements, design input/output, design v&v, design transfer, risk management, human factors, and full product lifecycle development experience. This individual needs to create the SOPs for design control, come up with plans in terms of design input, create the IFU, perform task analysis, draft human factors protocol, and get device at least to stability. This is preparation for validation in June 2020.

A BDN client is in need of a Technical Writer to write IFU documents for NPIs in a format that can be translated to other languages. This individual will not be doing the translation, just making sure it includes guidelines, tables, margins and is formatted in an easy to use style. IFU type documentation, service documentation (maintenance, cleaning, etc.) is needed. No graphic design experience is needed. Experience with Visio & MS Word is required for this position. Medical device experience is required, but no specific class.

A BDN client is looking for a Senior Systems/Optical Engineer to assist with the design documentation and development of an optical instrument that projects microscopic images of cells through a brightfield/biological microscope and they need this person to continue the work that was being performed by a contract design house and be the in-house SME for this type of work. He/she will plan design requirements, specifications, and test procedures. They will also pilot manufacturing development. Opto-Mechanical Instrument experience, preferably Ph.D. level candidates with engineering/systems experience, is desired.

A BDN client is looking for a DMPK /Formulation scientist with 10 years of industry experience. For this client, the most important aspect of this role will be formulating compounds, formulation preparations and for this scientist to have experience creating a formulation from scratch. This formulation development will be of poorly soluble (BCS Class II/IV) compounds (small molecules). Other day to day activities include conducting bioanalysis of plasma, serum, biological matrices in vitro samples in a DMPK lab, preparing formulations for PK, pharmacology and safety studies via a variety of delivery routes.

A BDN client is looking for a QC Analytical Chemistry Consultant to build out their QC lab and bring in QC methods. Candidates should have experience with HPLC, capillary electrophoresis, UV-Vis Spectrophotometry, method optimization, qualification, and validation. A minimum of a Bachelor's Degree in Analytical Chemistry, preference for a Master's Degree is desired for this role.

A BDN client is looking for a Senior Mechanical Engineer. The consultant will be responsible for the span design, modeling, prototyping, transfer to manufacturing, and testing of mechanical systems, with a strong emphasis on CAD design, documentation, and modeling of airflow in systems. He/she should have a strong background in the design and production of electromechanical systems, fluency in using CAD design software (SolidWorks), and have experience with sheet metal designs and vendors. A Bachelor's Degree in Mechanical Engineering or a closely related field is desired for this role.