AS Chemist IV- Lead (2nd shift)

at  The Ritedose Corporation

The Analytical Services Chemist IV Lead role is for a laboratory professional, subject matter expert, and developing leader with responsible for performing and providing guidance for analytical testing related to raw materials, compounding and cleaning validation support activities, and final product and stability testing in the Analytical Services Laboratory. In addition, the Analytical Services Chemist IV- Lead role may perform analytical method validations and transfers, perform product development studies, and perform data integrity reviews for commercial product support.
Responsibilities:

Primary Job Responsibilities:

• With assistance from Laboratory Management, provides technical guidance and supervision to other analysts in the laboratory.
• Responsible for project tracking and timely completion as a project team leader for assigned testing, validations/transfers, complaints, investigations, etc.
• Responsible for developing and proposing method validation strategies and performing tests associated with method validations and transfers as assigned, including cleaning and equipment validations.
• Assist in scheduling and organizing workload of Laboratory.
• Responsible for training as a designated trainer.
• With assistance from Laboratory Management, functions as a technical expert regarding analytical methodology and instrumentation used in the laboratory.
• Lead/complete OOS investigations and laboratory investigations, as assigned.
• Generating and tracking laboratory Metrics.
• Practical understanding of ERP database including the ability to track material status in ERP database to determine test requirements.
• Coordinate outsourcing of materials to outside laboratories.

General Responsibilities:

• Provide technical guidance in the execution of laboratory procedures to other analysts.
• Performing chemical raw material (sampling, testing and release), in-process (including product formulation activities), and final product including stability and complaint sample testing.
• Notify Laboratory Management immediately of out of specification results and assist in the investigations of OOS and deviations as assigned by Laboratory Management.
• Responsible for laboratory notebook data, batch record data, and report review when assigned.
• Assist in special projects and regulatory audits as requested by the Laboratory Management.
• Assist in the creation and collaboration of laboratory documents as assigned.
• Responsible for ensuring that routine maintenance and troubleshooting of instrumentation, is performed as stated in the instrument manual and contacting the manufacturer for assistance when needed.
• Responsible for the general maintenance of the Chemistry Laboratory including good housekeeping and a safe working environment.
• Follow Standard Operating Procedures, documentation, safety, health, and cGMP Guidelines.
• BS degree in Chemistry or related field with a minimum 6 years of experience, or a MS degree in Chemistry or related field with a minimum 4 years of experience, in a pharmaceutical laboratory environment required, or a PhD in Chemistry.
• Demonstrated aptitude for technical leadership.
• Experience in the analysis of Ritedose’s commercial product portfolio preferred.
• Expertise with standard laboratory techniques, wet chemistry tests, titration, spectroscopy, HPLC, GC, and modern Data Acquisition Systems required with an ability to perform non-standard or complicated analyses with minimal supervision and guidance.
• Comprehensive understanding of the theory behind at least one advanced instrumental technique such as ICP-MS, Malvern PSD, aPSD, Particulate Matter testing, Breathing Simulation Testing, etc. with an ability to operate and maintain laboratory instrumentation and correct common instrumental and procedural problems.
• Strong documentation skills and proficiency with current word processing, spreadsheets, and database software required.
• Ability to conduct failure investigations and develop experimental protocols with minimal supervision.
• Ability to communicate technical and non-technical information in a clear and organized manner both verbally and in writing.
• Ability to effectively train, coach and lead others.
• Must be detail focused, have a strong work ethic, and the ability to participate in and contribute to a team-oriented work environment by developing positive working relationships within the laboratory and between other departments.

Primary Job Responsibilities:

• With assistance from Laboratory Management, provides technical guidance and supervision to other analysts in the laboratory.
• Responsible for project tracking and timely completion as a project team leader for assigned testing, validations/transfers, complaints, investigations, etc.
• Responsible for developing and proposing method validation strategies and performing tests associated with method validations and transfers as assigned, including cleaning and equipment validations.
• Assist in scheduling and organizing workload of Laboratory.
• Responsible for training as a designated trainer.
• With assistance from Laboratory Management, functions as a technical expert regarding analytical methodology and instrumentation used in the laboratory.
• Lead/complete OOS investigations and laboratory investigations, as assigned.
• Generating and tracking laboratory Metrics.
• Practical understanding of ERP database including the ability to track material status in ERP database to determine test requirements.
• Coordinate outsourcing of materials to outside laboratories

General Responsibilities:

• Provide technical guidance in the execution of laboratory procedures to other analysts.
• Performing chemical raw material (sampling, testing and release), in-process (including product formulation activities), and final product including stability and complaint sample testing.
• Notify Laboratory Management immediately of out of specification results and assist in the investigations of OOS and deviations as assigned by Laboratory Management.
• Responsible for laboratory notebook data, batch record data, and report review when assigned.
• Assist in special projects and regulatory audits as requested by the Laboratory Management.
• Assist in the creation and collaboration of laboratory documents as assigned.
• Responsible for ensuring that routine maintenance and troubleshooting of instrumentation, is performed as stated in the instrument manual and contacting the manufacturer for assistance when needed.
• Responsible for the general maintenance of the Chemistry Laboratory including good housekeeping and a safe working environment.
• Follow Standard Operating Procedures, documentation, safety, health, and cGMP Guidelines.
• BS degree in Chemistry or related field with a minimum 6 years of experience, or a MS degree in Chemistry or related field with a minimum 4 years of experience, in a pharmaceutical laboratory environment required, or a PhD in Chemistry.
• Demonstrated aptitude for technical leadership.
• Experience in the analysis of Ritedose’s commercial product portfolio preferred.
• Expertise with standard laboratory techniques, wet chemistry tests, titration, spectroscopy, HPLC, GC, and modern Data Acquisition Systems required with an ability to perform non-standard or complicated analyses with minimal supervision and guidance.
• Comprehensive understanding of the theory behind at least one advanced instrumental technique such as ICP-MS, Malvern PSD, aPSD, Particulate Matter testing, Breathing Simulation Testing, etc. with an ability to operate and maintain laboratory instrumentation and correct common instrumental and procedural problems.
• Strong documentation skills and proficiency with current word processing, spreadsheets, and database software required.
• Ability to conduct failure investigations and develop experimental protocols with minimal supervision.
• Ability to communicate technical and non-technical information in a clear and organized manner both verbally and in writing.
• Ability to effectively train, coach and lead others.
• Must be detail focused, have a strong work ethic, and the ability to participate in and contribute to a team-oriented work environment by developing positive working relationships within the laboratory and between other departments