Apply on Employer Site

Adare Pharma Solutions · 1 day ago

Formulations Technical Specialist

Vandalia, OH

Full-time

Onsite

Mid Level

3+ years exp

Adare Pharma Solutions is a growing global drug development and manufacturing organization dedicated to improving lives through innovative drug delivery. The Formulations Technical Specialist will support projects by developing and maintaining documentation, driving activities, and providing quality oversight for internal documents.

CommercialManufacturingPackaging ServicesPharmaceuticalProduct Design

Responsibilities

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 procedures in order to meet aggressive timelines

Detailed management of formulation projects, processes, and procedures to support Formulation Scientists meet aggressive timelines

Implement procedural changes to existing internal systems to gain efficiencies to get products to clinical trial status earlier by working with Quality Assurance as well as other departments to implement change

Participates in the development and implementation of methods, procedures and regulations necessary for the smooth operation of the business

Other miscellaneous tasks as required