Stability and Analytical Services Manager

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).

• 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 companys 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 partys.
• 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.

EDUCATION:

• University Degree in chemistry or related discipline.
• . or Ph.D. is preferred.

EXPERIENCE:

• At least 5 years experience in the pharmaceutical industry with related experience in pharmaceutical analysis or related field with 2 years of direct management experience or equivalent supervisory experience with direct reports and team management responsibilities.
• Self-motivated strong communication interpersonal and problem-solving skills with the ability to manage multiple projects.
• Experience working in a self-directed team environment is essential.
• Experience with regulatory audits.
• Experience with: HPLC HPLC-MS GC pH meter Balance Density meter UV IR Karl Fischer Titrator DSC etc as well as complex techniques including new instruments.
• Experience with cartridge component testing break loose glide force (BLGF) and combination device performance testing would be preferred.
• Strong leadership skills with the ability to coach and develop staff as well as work within cross-functional teams.
• Demonstrated experience guiding conflict resolution and facilitating employee relations activities.
• Proven knowledge of Health and Safety legislation and other Employment related legislation such as the Employment Standards Act.
• Demonstrated project management experience with the ability to manage multiple priorities with minimal direction.
• Effective communication skills both verbal and written.
• Proven analytical and problem-solving skills with the ability to make sound business decisions.
• Experience in planning and execution of significant projects utilizing formal project management and methodology
• Flexibility to be periodically present on all shifts

What we offer:

• Excellent compensation/benefits package
• Bonus and reward programs
• Discounted gym memberships
• Programs supporting work life balance (EAP)
• Employee recognition program
• Professional and personal development programs
• Social events and spirit days

Compensation:

Starting at approximately $118000.00 CAD annually with potential for growth based on qualifications and experience. Total rewards include comprehensive benefits bonus eligibility and professional development support.

We are committed to diversity and inclusion and thank all applicants in advance; however we will be corresponding only with those selected for an 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.