Job Description

cGMP Consulting is looking for a Technology Transfer Scientist to provide assistance with the transfer and implementation of defined processes for new products to the plant manufacturing site. Responsible for preparing master batch records and protocols for the manufacture of development, stability, and process performance qualification batches. The ideal candidate for this job is resourceful, independent, organized, and capable of working in a fast-paced environment.

Responsibilities

• Assist with the transfer and implementation of defined processes for new products
• Author master batch records and protocols for the manufacture of development, stability and validation batches.
• Support cleaning validation / verification program by calculating limits, acting as study director for protocols, swab sampling, and evaluating products for cross contamination.
• Assesses feasibility of simple research and design concepts related to modernizing a product / product family or enhancing knowledge of a product / product family which includes but not limited to compatibility studies for tubing, vials, and stoppers, thermal cycling studies, light studies, and studies which support product insert.
• Translates development findings into manufacturing processes.
• Provide information and documentation needed for regulatory submissions or responses as required.
• Provide technical support for Investigations, Action Plans and Change Requests as required.
• Collaborate with quality, regulatory, manufacturing, engineering and global I&D teams.
• All employees are responsible for ensuring the compliance to company documents, programs and activities related to Health, Safety, Environment, Energy and Quality Management System as per your roles and responsibilities

Position skills and requirements:

• Bachelors degree in physical science, engineering or equivalent experience in pharmaceuticals
• Knowledge of basic technical theories and principles
• Knowledge of parenteral product development manufacturing processes, validation, cGMPs and FDA regulations
• Position required to be on site
• Highly motivated and independent individual.
• Detail oriented and comfortable working in a fast-paced office environment.
• Exceptional communication and leadership skills.
• Superior organizational, communication, and interpersonal skills are necessary.