Sun Pharmaceutical Industries

Senior Process Development Scientist

Sun Pharmaceutical Industries • $110K — $130K *
Billerica, MA 01821In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • B.S. in a science-related field required.
  • 7-10 years of related experience preferred.
  • Experience with parenteral formulation and lyophilization techniques preferred.
  • Hands-on analytical experience with tools such as HPLC and spectroscopic techniques.
  • Knowledge of cGMP environment and Quality by Design principles.

Responsibilities

  • Manage tasks independently and assist in cross-functional project teams.
  • Design and execute experiments based on Quality by Design principles.
  • Conduct formulation and lyophilization development for new products.
  • Oversee continuous improvement and troubleshooting of current processes.
  • Transfer processes into manufacturing and prepare relevant cGMP documentation.
  • Conduct analytical testing to support product development studies.
  • Direct the work of junior staff in Process Development.

Benefits

  • Opportunity to lead innovative product development in a dynamic lab environment.
  • Collaboration with cross-functional teams, enhancing teamwork skills.
  • Exposure to advanced technologies and techniques in formulation and filling processes.
  • Gain experience in compliance with FDA regulations and cGMP standards.
  • Limited travel requirements, promoting work-life balance.
Full Job Description
Job Summary

Lead 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
  • Operates Lyophilizer, HPLC, pH meter, analytical balance, compressed gas cylinders, fume hoods, heating mantles, stirring equipment, temperature controllers, and computer/office equipment
  • Requires wearing protective clothing in lab areas - lab coat, safety glasses, and gloves
  • Lift up to 50 lbs.

Travel Estimate

Up to 5%

Education and Job Qualification
  • Minimum B.S. in related scientific field required

Experience
  • Minimum 7-10 years related experience preferred
  • Able to work with external contractors to find new technology, equipment or solutions to process issues
  • Experience with parenteral formulation, lyophilization and sterilization techniques preferred
  • Process validation experience
  • Cleaning validation experience
  • Analytical hands-on experience with techniques such as HPLC, Karl Fischer, DSC, and spectroscopic techniques
  • Experience with aseptic techniques in a clean room environment is highly beneficial
  • Experience working in a cGMP environment
  • Understanding of Quality by Design principles and statistics is preferable
  • Process development experience and manufacturing process investigation skills
  • Strong technical writing skills and resourceful problem solving skills
  • Ability to work independently and as a member of a cross functional team
  • Excellent verbal, written and interpersonal communications skills
  • Strong attention to detail and ability to manage multiple assignments concurrently
  • Able to lead cross functional teams to design experiments and address process issues

About Sun Pharmaceutical Industries

Sun Pharmaceutical Industries Limited is an Indian multinational pharmaceutical company that manufactures and sells pharmaceutical formulations and active pharmaceutical ingredients (APIs) primarily in India and the United States. The company offers formulations in various therapeutic areas, such as cardiology, psychiatry, neurology, gastroenterology, diabetology, and respiratory. It also provides APIs such as warfarin, carbamazepine, etodolac, and clorazepate, as well as anti-cancers, steroids, peptides, sex hormones, and controlled substances. Sun Pharmaceutical Industries was founded in 1983 and is headquartered in Mumbai, India.
Learn more about Sun Pharmaceutical Industries
Size
32,300 employees
Industry
Pharmaceuticals & Biotech
* Ladders Estimates

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