Product Development Scientist II

Colorcon® is a world leader in the development, supply and technical support of formulated film coating systems, modified release technologies, specialty excipients and functional packaging for the pharmaceutical, nutritional, and animal health industries. Our best-in-class products and technologies are complemented by our extensive formulation experience, application data and value-added services to support all phases of solid oral dose design, development, and manufacture.

Our focus on market issues and technology development has earned Colorcon an international reputation as a pharmaceutical supplier of choice. That reputation is based on superior product quality, unparalleled technical support, extensive regulatory assistance and reliable supply from multiple locations, with our Global Headquarters located in Harleysville, Pennsylvania.

Colorcon has 26 technical service laboratories globally and more than 2100 employees exclusively dedicated to its customer base.

We are a successful company thanks to our diverse workforce and global reach. We believe that our operating principles define our culture, values and organizations and are key to achieving our mission and vision, strategies and goals.

Platinum Rule: We treat others the way we want to be treated
Empowerment: We trust our colleagues with responsibility and decision-making
Keep Getting Better: We create an environment for constant improvement, to be the best we can
Teamwork: We embrace the value of collaboration; work together to exceed what is possible as individuals
Customer Focus: We put our customers’ needs at the heart of everything we do
Global Respect: We are citizens of a diverse world and behave with respect for the communities in which we operate

Our People Enjoy a Wide Offering of Employee Benefits, including but not limited to:

• All employees are eligible to participate in our company-wide bonus program
• Employees have the choice between three medical plans
• 100% company-paid Dental Insurance for all employees and their qualifying dependents
• Optional Vision Coverage
• Fitness and Wellness Programs
• Employee Assistance Programs (EAP)
• Corporate Social Responsibility Groups (CSR)
• Parental Leave
• Tuition Reimbursement; up to $8,000 per calendar year
• 401(k) Company Matching
• Paid Time Off
• Paid Holidays

Colorcon is committed to maintaining a diverse workforce and an inclusive and equitable work environment. This includes all employment-related decisions and business dealings on the basis of race, color, ethnicity, national origin, age, sex, sexual orientation, religion, disability, veteran status, or any other legally protected status.

Position Summary:
This position contributes to new product screening, develop new process and technologies development and commercial launch based on Product Development Stage Gate process. Polymer and material screening and characterization are key responsibilities for this position. Performs formulations of solid dosage forms with specific focus on technology and excipient properties affecting manufacturing and drug release performance.

Responsibilities & Duties:

• Leads the development of innovative product concepts of commercial and strategic value to Colorcon.
• Develops protocols and guides routine stability testing in accordance with ICH Guidelines and reports findings to assess product shelf-life.
• Lead development of scale up support from lab to production scale.
• Efficiently uses resources to conduct background research, obtain patents, journal articles and other relevant scientific publications in this area.
• Maintains a sound working knowledge of developments in solid oral dosage forms, including Colorcon’s products and engages in continuous learning activities to broaden their knowledge base and train other staff.
• Documents experimental work concisely and efficiently including detailed laboratory notebook keeping.
• Prepares analysis and presents summaries of experimental results and communicates in a concise and timely manner.
• Develops and writes laboratory SOP’s, test methods and operating instructions for equipment and processes, which could be transferred to other departments.
• Familiar with testing equipment and procedures, and operates pharmaceutical processing equipment including, but not limited to weighing, blending and mixing of coating and solid dosage formulations. Operation of coating equipment – perforated pans and fluid bed; Compression equipment - tablet presses; Analytical equipment - Dissolution and tablet testing equipment.
• Contributes to screening of new materials and platform technologies as required and prioritized.
• Ensures team adhere to all relevant laboratory safely procedures and provide supervision and training.
• Develops models and analyzes data for formulation and process optimization using, statistical tests, design of experiment methodologies, or multivariate analysis whenever applicable.
• Contributes about 10% of time to innovation projects including testing new materials, new processes and innovative concepts through collaboration with colleagues both inside and outside the department.

Required Qualifications:

• BS. in Pharmacy, Food Science, Chemistry, Materials Science or equivalent experience required.
• A strong understanding of pharmaceutical or dietary supplement excipients and experience in developing solid oral dosage forms preferred.
• Good organizational skills with an emphasis on accurate data recording required.
• A strong team player with excellent oral and written communication skills required.
• Up to 5% travel required.

Location:
275 Ruth Rd
Harleysville, Pennsylvania, 19486
United States

Colorcon participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, this employer is required to give you written instructions and an opportunity to contact Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue before the employer can take any action against you, including terminating your employment. Employers can only use E-Verify once you have accepted a job offer and completed the Form I-9.
E-Verify Works for Everyone
For more information on E-Verify, or if you believe that your employer has violated its E-Verify responsibilities, please contact DHS.