Process Development Validation-Raw Material Associate

Job description

About this opportunity

Process Development Validation-Raw Material Associate provides support to Avecia’s chemical raw material onboarding programs, including the Vendor Assurance Committee, and manage inventory databases.

Key Job Responsibilities

Process Chemistry support for the development and improvement of raw materials specifications with responsibility for managing the raw material management databases. Support identification of trends and action plans obtained from raw material release testing data. Process chemistry support to writing, reviewing, and revision of vendor assessment plans and reports. Responsible for reviewing new Process Validation protocol and report documents to support process development, manufacturing and validation activities.

Review executed MFG batch records and PD experiment records to extract data for CPV and CSR activities. Process chemistry support to supplier audits and on-site supplier capability assessments when applicable. Support writing and maintenance of formal documents providing justification for specifications applied for release of raw materials. Coordinate raw material planning activities and raw material/engineering part inventory systems involving transactions in SAP.

Report status of assigned activities to project teams and to Validation / Raw Material Development leadership on a weekly basis or as needed. Maintain an appropriate level of training on company and departmental procedures as determined by Avecia Raw Material Development. Adhere to all company environmental, health and safety policies to support raw material handling, storage and distribution practices.

Job Knowledge Required

BS in Scientific Discipline and 2 years of experience in related field within a chemical development or manufacturing environment. Sufficient knowledge of organic chemistry procedures, concepts, and literature. Demonstrated proficiency in preparation of technical reports and publications in English language. Experience in cGMP preferred. The annualized salary range for this role is $68,000-$83,000.