Formulations Technical Specialist

Are you ready to join a growing, global drug development and manufacturing organization that puts people first?  Come to Adare!  We work closely with our pharmaceutical industry partners during all phases of drug development and commercial manufacturing with a mission of improving the lives of patients and medicines essential to people all over the world.  Each role and every department within Adare offer you a unique, customized experience with a chance to make a real impact, and is critical to our success.  With the help of people like you dedicated to our mission, Adare is transforming lives by transforming drug delivery!

Join our mission at Adare!

What can Adare offer you?


* Medical/dental/vision/life – low employee premiums


* 401k with a highly competitive match


* Generous PTO, including floating holidays


* Career growth and internal opportunities


* Tuition reimbursement


* Relocation assistance


* Performance-based bonus


* Employee Recognition Programs

We are seeking to hire a Formulations Technical Specialist to join our Formulations team…

If any of the below describes you, we would love to meet you! 

JOB SUMMARY

The Formulations Technical Specialist is responsible for supporting projects by developing and maintaining the necessary documentation and tasks required to fulfil project needs.

This person will work alongside project teams to drive activities, accelerate timelines, offer ideas to implement future enhancements/work efficiencies, and provide adequate quality oversight and expertise for the creation and review of internal quality documents.

 

RESPONSIBILITIES AND LEARNING OPPORTUNITIES


* Managing Clinical and Registration Batch Preparation and execution.  Responsibilities include:



* Initiate and retain stability samples per SOP procedures 


* Scheduling clinical batch execution with R&D, Logistics and Operations 


* Facilitate batch record training with Operations and R&D



* Initiation and completion of System Change Controls. 


* Managing actions with multiple departments, reviewing, approving action items until completion and Change Control closure.


* Serving on the Quality Systems Action Board as the Formulations representative 


* Overseeing the qualification of project raw materials by working with Supply Chain and the Global Quality department with updates on project status and material management from project conception to GMP manufacturing. 


* Contribute to the creation and/or review of project DMF and/or other Regulatory documents as needed


* Generating and approval of accurate and detailed GMP batch records for clinical trial supplies through Registration manufacturing. 


* Generation and revision of SOP, Work Instruction, and Controlled Forms, to support R&D processes


* Managing the procurement of raw materials for both formulation development and GMP batch manufacturing following the necessary proc...