Senior Process Development Scientist III

SUN PHARMA; Billerica (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

A global pharmaceutical company located in Billerica, Massachusetts, seeks a dedicated professional to support new product formulation and process development. The role involves managing tasks independently and contributing to cross-functional project management teams. Ideal candidates should have a background in analytical testing and be familiar with cGMP documentation. The job offers dynamic work conditions in an office and lab environment with exposure to various chemicals and materials.

Qualifications

• Experience in process development or formulation sciences.
• Ability to manage tasks independently and in teams.
• Familiarity with analytical testing methods.

Responsibilities

• Provide support for new product formulation and process development.
• Manage tasks in cross-functional project management teams.
• Prepare cGMP documents and technical reports for FDA filings.

Job description

Job Description

Provide support for new product formulation, process development, transfers into manufacturing, and continuous improvement of existing processes.

Area Of Responsibility

• Manage tasks at independent level and contribute to cross functional project management teams
• Design experiments using Quality by Design principles, execute and author reports in support of:
• Formulation, aseptic filling and lyophilization development of new products
• Continuous improvement, troubleshooting and investigations of existing processes and products
• Process transfers into manufacturing
• Perform analytical testing in support of product development studies
• Prepare cGMP documents such as SOPs, batch records and protocols
• Design, execute and write technical reports to support FDA filings
• May direct the work of junior Process Development staff
• Other duties as assigned

Work Conditions

• Office
• Lab
• Warehouse
• Exposure to noise, hazardous and non-hazardous chemicals, syringes and needles
• toxic metals

Physical Requirements

• Stand, sit, walk, use hands and fingers to handle or feel, reach with arms and hands
• Talk or hear
• Close, and color vision; depth perception, ability to adjust focus
• Use of repetitive motion