Senior Process Development Scientist - Formulation

SUN PHARMA; Billerica (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

SUN PHARMA is seeking a senior Process Development Lead in Billerica, MA to drive formulation, process development, transfers into manufacturing, and continuous improvement of existing processes. You will design experiments using Quality by Design principles, execute and author reports in support of formulation, aseptic filling and lyophilization development.

Applicants should have 7–10 years of related experience and a minimum B.S. in a related scientific field.

Qualifications

• Minimum B.S. in related scientific field required.
• Experience with parenteral formulation and aseptic processing is implied by responsibilities.
• Strong technical writing and problem-solving skills are essential.

Responsibilities

• Lead formulation, aseptic filling and lyophilization development for new products.
• Design experiments using Quality by Design principles and author reports.
• Manage process transfers into manufacturing and support FDA filings.
• Perform analytical testing for product development studies.
• Prepare cGMP documents such as SOPs, batch records and protocols.
• Direct work of junior Process Development staff as needed.
• Collaborate with cross-functional teams on process improvements and investigations.

Skills

Process development

Lyophilization

Aseptic techniques

HPLC

Karl Fischer

DSC

Spectroscopy

cGMP

Quality by Design

Statistical analysis

Education

B.S. in related scientific field

Tools

Lyophilizer

HPLC equipment

Job description

SUN PHARMA is seeking a senior Process Development Lead in Billerica, MA to drive formulation, process development, transfers into manufacturing, and continuous improvement of existing processes. You will design experiments using Quality by Design principles, execute and author reports in support of formulation, aseptic filling and lyophilization development.

Applicants should have 7–10 years of related experience and a minimum B.S. in a related scientific field.