Senior Process Development Scientist

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

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

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.