Product Stability Scientist

Product Stability Scientist

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 they 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.

The Product Stability Scientist is responsible for Colorcon's color stability program and provides data that will be used to support the warranty periods for its products. This position also supports the Product Development (PD) team in completing stability studies once the new product is launched. This role will gain experience and expertise in a wide array of laboratory equipment used for analytical testing and process operations, in addition to becoming very proficient in data analysis and technical writing.

Responsibilities & Duties

• Oversee color stability testing program and completes work in a timely manner to determine appropriate shelf-life.This includes preparation of stability protocols for each study, manufacturing of product for storage, maintaining and executing stability pulls and reports updating its progress.
• Work with lead PD scientist to guide routine stability testing of new products to completion in accordance with ICH
• Guidelines and reports findings to assess final product shelf-life.
• Broaden working knowledge of developments in solid oral dosage forms, including Colorcon's products.
• Enhance knowledge and understanding of product stability to continually improve Colorcon's program and train staff in the topic as they need to conduct stability studies; become subject matter expert.
• Document experimental work concisely and efficiently including detailed laboratory notebook keeping and/or other primary data sources.
• Prepare analysis and present summaries of experimental results and communicate in a concise and timely manner.
• Adhere to all relevant laboratory safety procedures and participate in safety program.
• Contribute up to 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.

Minimum Qualifications

• BS. in Pharmacy, Food Science, Biology, Chemistry, Materials Science or relatable degree required.

• Minimum 1 year of relevant work experience in a laboratory setting required.

• Working knowledge on a variety of laboratory testing equipment and procedures, along with operating pilot-scale pharmaceutical processing equipment. Examples include, but are not limited to:

• Weighing, blending and mixing equipment

• Coating equipment - perforated pans and fluid bed

• Compression equipment - tablet presses

• Analytical equipment - Dissolution and tablet testing equipment

• Physical property instruments - pH, gravimetric, viscosity, color, gloss, water activity, etc.

• Strong technical writing skills

• Proficiency in computer skills using Microsoft Office 365 suite and stability system software.

• Organizational skills and attention to detail with an emphasis on accurate data recording required.

• A strong team player with excellent oral and written communication skills is required.

• Strong understanding of pharmaceutical or dietary supplement excipients preferred.

Working Location

• On-site at Colorcon's Harleysville, PA location

Working remotely from a home office will be facilitated when applicable and is at the manager's discretion.

Location:

275 Ruth Road

Harleysville, Pennsylvania, 19438

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.