Senior Process Development Scientist

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

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