Coating Place, Inc. has been in the contract manufacturing industry for the last 40 years. Our continued goal to provide the highest quality Wurster processing has kept us at the forefront of the “fluid bed micro-encapsulation” market. Our company mission helps us to maintain this focus.
“Coating Place is an established pharmaceutical contract manufacturer specializing in Wurster fluid bed processing and delivery system development. We provide our customers with modified and extended release bulk active products through innovative development and manufacturing capabilities with an integrated quality philosophy.”
It is our mission to continue urging the next generation, candidates like you, into these fields and further expand the capabilities of the industry through their capabilities.
Coating Place is a stable and growing company that offers a friendly work environment and an incredibly competitive benefits package including: health, dental, and vision insurance, a generous paid time off program to help balance work and personal life, and pre-tax 401(k) and after-tax Roth 401(k) contribution options with the company matching up to 5% of gross wages that is 100% vested at the time it is added to the employee’s account. In addition, Coating Place may choose to make a profit sharing contribution to your account!
POSITION OVERVIEW:
The QC New Product Development (NPD) Team Leader will primarily assist the Formulations and Production Departments by assisting with scheduling and/or performing the analyses of pharmaceutical samples delivered to the Quality Control (QC) laboratory. Support will be provided by ensuring that samples are analyzed using various procedures including, but not limited to, internal procedures, specifications, analytical methods, compendial monographs, client procedures, research procedures, and/or miscellaneous protocols. Sample analysis will mainly support product development, materials being released for clinical trials, stability studies, and process validation. Additionally, the QC NPD Team Leader is expected to assist the Level 1-3 Analytical Chemists, Associate Scientists, Scientists, or Senior Scientists with analyses as needed.
The QC NPD Team Leader will perform and oversee method development and method qualification activities (i.e. method validations, compendial method verifications, method transfers, etc.). The QC NPD Team Leader is expected to understand internal procedures and ensure the QC Analytical Chemists follow and understand all internal procedures. The QC NPD Team Lead will have an understanding of USP, ICH, and FDA guidelines as they relate to development and qualification activities, and will help support laboratory investigations (i.e. quality investigations, out of specification investigations, etc.) as necessary.
The QC NPD Team Leader will be the Analytical or Supervisor Project Lead for projects that are determined in coordination with the QC NPD Supervisor. The position requires assisting with scheduling or performing analyses related to each project.
ESSENTIAL JOB FUNCTIONS:
Mentors, trains, and assists in the supervision of the New Product Development team.
Serves as a technical resource for the team regarding troubleshooting equipment, good documentation practices, and document review.
Interacts with clients, vendors, and/or contract laboratories from the development phases through clinical trial (i.e. GMP phase).
Composes and provides review feedback on: SOPs, R&D/analytical methods, master specifications, deviations, and/or out-of-specification investigations.
Approves R&D/analytical methods, test requests and master specifications.
Enters, reviews, and signs off on OOS System Suitability Failures.
Generates and provides review feedback on protocols and summary reports related to stability studies, method validations, method transfers, and/or method verifications.
Performs and oversees testing involving dissolution, HPLC, GC, UV analysis, and various wet chemistry procedures.
Develops and validates methods and material specifications based on compendia or client transferred methods.
Assists with process improvements/changes with routine input from QC NPD Supervisor and Director of Quality Control.
Maintains awareness of changing regulatory and industry requirements (i.e. USP, FCC, EU, JP, etc.).
Performs final review of laboratory notebooks and equipment calibrations.
Participates in laboratory cleaning activities and maintenance.
Conducts annual performance reviews and meetings.
Follows all CPI cGMP practices, policies, and procedures.
Follows all CPI safety practices, policies, and procedures.
Other duties as assigned.
EDUCATION/SKILLS/KNOWLEDGE REQUIRED:
Bachelor's degree in chemistry or related field.
A minimum of 3 years of experience at Coating Place, Inc. or applicable experience in a cGMP/GLP or similar environment. An advanced degree may be substituted in place of experience.
An understanding of USP, ICH, and FDA guidelines as they relate to development and qualification activities.
Thorough knowledge and understanding in the use, methodology, and troubleshooting of QC analytical equipment (i.e. HPLC, GC, and/or dissolution apparatus) and method development.
Ability to establish and maintain effective working relationships with team members, co-workers, vendors, and/or clients.