Job Information
Sun Pharmaceuticals, Inc Senior Process Development Scientist III in United States
Job Description
Provide support for 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 10 lbs.
Travel Estimate Up to 5%
Education and Job Qualification
Minimum B.S. in related scientific field required
Experience
Minimum 4-6 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
Process validation experience is a plus
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.
The presently-anticipated base compensation pay range for this position is $102,500 to $113,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.
The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.If hired, employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.
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.