Summary:
Lab Operational Effectiveness: Ensures that the Lab operations are scheduled in a manner that maximizes operating efficiencies while balancing the needs of clients and meeting Drug Product Services (DPS) and Pharmaceutical Development Services (PDS) site objectives for On Time Delivery (OTD).
Essential Functions:
Manage the sample management team and organize samples in the lab operations.
Schedule for lab testing and assign daily tasks for each chemist and book the required instrument (Dissolution bath, HPLC, UPLC and GC etc…) for the projects in Analytical Operations based on the DPS OTD and PDS delivery schedule.
Leads the operational excellence culture by using the lean lab methodology and schedule the testing efficient way by reducing the waste.
Develop the electronic board for each chemist per group and utilize it for scheduling tool and tracking chemist’s performance metrics and Analytical Operations Key Performance Indicators (KPI)
Helps with developing, assessing and implementing Analytical Operations strategy for long term growth
Manage and Lead lab schedulers to acquire information for lab testing/release schedule through internal (supervisors/management) and external (PDS huddle/production huddle/viz tool/SOR etc..) meeting.
Reviews and manages instrument / resource capacity with Lab Operations management
Build and maintain testing standard hours for existing/new products for Analytical Operations & Capacity Planning
Develops training curriculum for each level of chemists and new hired chemists.
Staff Leadership
Manages administrative documentation and payroll activities for lab schedulers/sample management team/co-op students
Clearly outlines key staff roles and expectations, as required.
Hires staff and administers performance improvement plans, up to and including termination when appropriate
Provides annual performance reviews to direct reports
Provides feedback on requirements for new hires and process improvements
Offers options and suggestions for process, capacity, and client services and staff morale improvements
Drives Change and acts as Change agent for Analytical Operations
REQUIRED QUALIFICATIONS
Education:
Minimum Bachelor of Science (B.Sc.) in organic chemistry, analytical chemistry or a related science
Experience:
Minimum 7 years’ previous pharmaceutical analytical development
Minimum of 5 years’ previous supervisory experience.
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.
Competencies:
Previous method and analytical instrumentation validation experience in the pharmaceutical industry. Exceptional Good Manufacturing Practices, Good Laboratory Practices, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and United States Food & Drug Administration (FDA) compliance knowledge. Ability to drive functional, technical and operational excellence. Ability to inspire and foster innovation, collaboration, transparency and team effectiveness. Ability to help others develop skills required in a research and development environment and helps others understand potential and areas for improvement. Ability to think strategically with the ability to direct the resolution of technical problems using innovative approaches. Applies data integrity and principles of Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA). Excellent interpersonal and communication skills (both oral and written), leadership ability, and organizational skills. Experience with Microsoft Office Applications. Proficiency in the English Language.
Core Competencies:
Put the Customer First – Think and act with a customer-centric mindset to deliver exceptional customer experiences. Own Your Results – Take personal accountability for all you do and always exercise good judgement. Find a Better Way Everyday – Be intellectually curious and embrace Practical Process Improvement (PPI).
Leadership Competencies:
Develop High Performance Team – Relentlessly attract and develop talent to deliver exceptional performance and achieve their full potential. Create Successful Work environments – Remove barriers to success and enable a work environment where colleagues can be their best self and motivated to excel.
Move Strategy to Action – Enable strategic focus by prioritizing work and resources across the team and organization to maximize impact.
Standards and Expectations:
Comply with all Environmental Health & Safety Policies and Procedures. Work harmoniously with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives. Carry out all duties within strict compliance to Patheon quality SOPs and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Actively engage in and adhere to departmental systems in order to maintain a smooth and efficient workflow (visual management, scheduling systems, shared laboratory assets). Be client and patient conscious at all times. Understand Key Performance Indicators (KPI’s) and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving. Models positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working. Proactively identifies areas for improvement in the execution of analytical procedures. Communicate risks to timelines of deliverables in a proactive manner. Consistently strives to improve skills and knowledge in pharmaceutical development (an asset).
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