Senior Process Development Scientist – Parenteral

Sun Pharmaceuticals, Inc; United States; On-site; USD 120,000 - 190,000; Full time

Job summary

Sun Pharmaceuticals, Inc. seeks a senior Process Development professional to lead new product formulation, process development, transfers into manufacturing and continuous improvement of existing processes.

You will design experiments using Quality by Design, execute development studies, perform analytical testing, and prepare cGMP documents such as SOPs, batch records and protocols. A BS in a related field and 7–10 years of experience are preferred.

Qualifications

• Minimum B.S. in related scientific field.
• 7–10 years of related experience preferred.
• Experience with parenteral formulation, lyophilization and sterilization techniques preferred.
• Process validation experience and knowledge of cGMP required.
• Strong technical writing and cross-functional collaboration skills.

Responsibilities

• Lead formulation and process development initiatives.
• Design experiments using Quality by Design principles.
• Execute transfers into manufacturing.
• Support aseptic filling and lyophilization development.
• Perform analytical testing for development studies.
• Prepare cGMP documents such as SOPs, batch records and protocols.
• Design and write technical reports to support filings.
• May direct the work of junior Process Development staff.
• Collaborate with external contractors to advance technology and solutions.

Skills

Quality by Design

Experiment design

Process development

Aseptic filling

Lyophilization

Continuous improvement

Troubleshooting

cGMP documentation

Technical writing

Cross-functional teamwork

Independent work

Education

B.S. in related scientific field

Tools

HPLC

Karl Fischer

DSC

Spectroscopy

Job description

Sun Pharmaceuticals, Inc. seeks a senior Process Development professional to lead new product formulation, process development, transfers into manufacturing and continuous improvement of existing processes.

You will design experiments using Quality by Design, execute development studies, perform analytical testing, and prepare cGMP documents such as SOPs, batch records and protocols. A BS in a related field and 7–10 years of experience are preferred.