Stability and Analytical Services Manager

Stability and Analytical Services Manager

Join to apply for the Stability and Analytical Services Manager role at Novocol Pharma, a Septodont company

Company Details

Novocol Pharma is a growing contract development and manufacturing organization (CDMO), specialized in sterile injectable cartridges and combination product manufacturing. With over 40 years in operation, our team of 600 employees and modern facilities, located in Cambridge, Ontario, provide a personalized and responsive experience for our customers. We are focused on serving our strategic partners and patients with quality, integrity, and value.

Job Summary

The Stability and Analytical Services Manager is accountable to the Director of Product Development. The position is responsible for managing the Stability and Analytical Services (SAS) activities (part of the Product Development (PD) unit) including stability, analytical testing (related to development and validation batches), support commercial analytical related activities for Pharma CDMO projects, and participate in technical transfer activities (method verification and transfer).

Responsibilities

• Provide leadership, training and technical direction to the SAS staff.
• Plan, assign, and delegate work to the SAS staff with the help of the SAS supervisor(s).
• Oversee the stability program for development projects, commercial products, annual commitments, and product life cycle management.
• Conduct hiring, performance evaluations, coaching and discipline in accordance with the company’s policies and procedures.
• Review and approval of protocols for stability studies, instrument validation and tech transfer.
• Oversee trending for stability data ensuring that OOT investigations are initiated in a timely manner.
• Review trend reports, identify and communicate trends to upper management and various stakeholders. Investigate these trends and provide recommendations regarding corrective / preventive actions when unfavorable trends are noted.
• Transfer, verify and implement test methods, review and approve SOPs and testing protocols required for testing in accordance with regulatory requirements.
• Develop and implement methods, practices and procedures that will increase the efficiency of the Laboratory.
• Ensure analytical methods are robust and validated as per current regulatory requirements.
• Act as the chemistry liaison to support new business initiatives and CDMO customers.
• Oversee the tech transfer of methods in and out of the group, between sites and 3rd party’s.
• Ensures the proper implementation (development, validation and transfer) of new or improved analytical test methods.
• Lead internal analytical investigations and supplier investigations.
• Acts as a subject matter expert representing the SAS group on root-cause investigation teams.
• Acts as a subject matter expert representing SAS during supplier investigations.
• Lead and provide support for special projects such as Quality Assurance Technical (QAT) studies, Quality Control Protocols (QCP) and Research and Development studies (R & D).
• Oversee the purchase, validation, and implementation of new laboratory equipment.
• Support dental initiatives for the Septodont group.
• Support commercial analytical related activities for Pharma CDMO projects and oversee the hand-over process (when applicable) to the QC Chemistry group during the commercial transition of projects.
• Develop and maintain the SAS group proficiency in the use of the LIMS system.
• Develop, maintain, and adjust KPIs to help monitor and improve the SAS group overall performance.
• Develop and maintain equipment utilization and resource planning metrics and tools. Assist in the preparation of annual SRED (Scientific Research and Experimental Development) reports for income tax purposes.
• Assist in preparation of the department budget.
• Ensure employees follow safety rules / regulations and report any workplace injuries or accidents immediately.
• Maintain a high degree of co-operation with other departments and participate in cross-departmental activities as required.
• Demonstrating the Company Mission, Vision and Values.

Qualifications

Education

Experience

What we offer

We are committed to diversity and inclusion, and thank all applicants in advance; however, we will be corresponding only with those selected for an interview. In accordance with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act, we are committed to providing an inclusive and barrier free recruitment and selection process.

#J-18808-Ljbffr