Senior Process Development Scientist: Formulation & Transfers

Sun Pharmaceutical Industries, Inc.

Billerica (MA)

On-site

USD 120,000 - 160,000

Full time

7 days ago

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Job summary

Sun Pharmaceutical Industries, Inc (USA) is seeking a Senior Process Development Scientist to lead formulation and process development, oversee transfers to manufacturing, and drive continuous improvement of existing processes.

The role requires 7–10 years of related experience, a BS in a related field, hands-on analytical methods (HPLC, Karl Fischer, DSC, spectroscopy), aseptic techniques in a cGMP environment, and strong technical writing.

Qualifications

Minimum B.S. in related scientific field.
7–10 years related experience preferred.
Experience with parenteral formulation, lyophilization and sterilization techniques preferred.
Process validation experience.
Aseptic techniques in a clean room environment beneficial.
Experience working in a cGMP environment.
Understanding of Quality by Design principles and statistics preferable.
Process development experience and manufacturing process investigation skills.
Strong technical writing skills and resourceful problem solving.
Ability to work independently and in cross functional teams.

Responsibilities

Lead formulation, aseptic filling and lyophilization development of new products.
Design experiments using Quality by Design principles, execute and author reports in support of: Formulation development, process optimization and tech transfer.
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.