Technical Project Leader II

4 weeks ago

Whitby, Canada Thermo Fisher Scientific Part time

Job Description

Summary:

Lead the design and evaluation of formulations and manufacturing processes as well as problem solves for solid, semi-solid or liquid dosage forms. Engage in the management of clientele, processes and equipment design for clinical, scale up and registration batches including tech transfer of projects to and from clients. Manage resources in the Pharmaceutics and Process Technology (PPT) work group to achieve project and team objectives and coach associates in their work group in areas such as the drug development process and Pharmaceutical Development Services (PDS) systems. Liaise with Project Management, Facility/Equipment Schedulers, Materials Management, Analytical Development and other functional areas to meet project and team objectives.

Essential Functions:

  • Lead the design/evaluation of formulations and manufacturing processes for solid, semi-solid, or liquid dosage forms.

  • Lead development of new formulations and scale-up procedures of solid, semi-solid, or liquid dosage forms at the pre-clinical, clinical, and post marketing stages of drug development.

  • Manage resources in their PPT work group to achieve project and team objectives.

  • Lead/participate in problem solving for formulations, equipment and processes.

  • Participate in relevant meetings/teleconferences with clients.

  • Write protocols for feasibility work and manufacturing batch records and clinical trial materials.

Write and ensure timely execution of protocols and provision of results in accordance with current Good Manufacturing Practices and company standards.

  • Write development reports.

  • Develop realistic proposals and timelines.

  • Coach associates in their work group in areas such as the drug development process and PDS systems.

  • Liaise with Project Management, Facility/Equipment Schedulers, Materials Management, Analytical Development and other functional areas to meet project and team objectives.

  • Maintain expert knowledge of pharmaceutical processes, equipment, instrumentation and procedures necessary to perform the tasks.

  • Keep current with scientific literature and industry trends relating to process technologies; disseminate relevant information.

  • As the key technical leadership role in Centre of Excellence Initiative; look for opportunities for publication/external presentations.

  • Promote a safe working environment, report potential hazards and ensure all direct reports follow Environmental Health and Safety procedures.

  • Select, develop (goal setting) and evaluate staff to ensure the efficient operation of the function. Work with and advises staff on administrative policies and procedures (if applicable).

  • Perform alternating or rotating shift work (as required).

REQUIRED QUALIFICATIONS

Education:

Bachelor of Science (B.Sc.) in pharmaceutical science or technology.


Experience:

Minimum 6 years of experience drug development.

Previous Project Management experience.

Previous Supervision and/or leadership experience an asset.


Equivalency:

Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills and Abilities:

Extensive knowledge and understanding of the drug development process. Demonstrated understanding of equipment, formulations and processes. Excellent Good Manufacturing Practices, Standard Operating Procedures and Food and Drug Administration (FDA) compliance knowledge. Established leadership skills. Demonstrable organizational skills relevant to drug development. Excellent written and oral communication skills. Ability to communicate and liaise with clients and other departments. Good organizational, documentation and housekeeping skills. Ability to work well independently and in a team environment with limited supervision. Excellent written and oral communication skills. Communicates and co-operates with others to meet project and team objectives. Ability to meet deadlines and prioritize multiple project deliverables. The ability to motivate and influence. Demonstrated computer proficiency with Microsoft Office programs. Proficiency with the English language.

Standards and Expectations:

Follow all Environmental Health & Safety Policies and Procedures. Work collaboratively 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 systems Standard Operating Procedures (SOPs) and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Actively engage in and adhere to departmental systems to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.). Be client and patient conscious at all times. Understand Key Performance Indicators 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 identify areas for improvement in the execution of procedures. Communicate risks to timelines in a proactive manner. Consistently strives to improve skills and knowledge in related field.

Physical Requirements:

Light physical effort and fatigue. Walks, sits or stands for limited periods. May require occasional equipment operation including keyboard equipment. Lifts light items for limited duration. Typically located in a comfortable indoor area. There may be regular exposure to mild physical discomfort from factors such as dust, fumes or odours, temperature extremes, loud noise, strong drafts, or bright lights. Use of Personal Protective equipment may be required and may include any of the following: safety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, respirator on occasionally.

  • Technical Project Leader Ii

    4 weeks ago

    Whitby, Canada Thermo Fisher Scientific Full time

    **Summary**: Lead the design and evaluation of formulations and manufacturing processes as well as problem solves for solid, semi-solid or liquid dosage forms. Engage in the management of clientele, processes and equipment design for clinical, scale up and registration batches including tech transfer of projects to and from clients. Manage resources in the...

  • Technical Project Leader II

    4 weeks ago

    Whitby, Canada Thermo Fisher Scientific Full time

    Summary: Lead the design and evaluation of formulations and manufacturing processes as well as problem solves for solid, semi-solid or liquid dosage forms. Engage in the management of clientele, processes and equipment design for clinical, scale up and registration batches including tech transfer of projects to and from clients. Manage resources in the...

  • Scientific Technical Writer Ii

    1 week ago

    Whitby, Canada Thermo Fisher Scientific Full time

    Summary: In addition to document preparation, provides training to other Scientific Technical Writers related to technical documents for the preparation of Annual Product Reviews (APRs) and Annual Stability Reports (ASRs) including compilation, statistical trending and assessment of critical production and product performance data. Essential Functions: -...

  • Project Manager

    2 weeks ago

    Whitby, Canada Deighton Associates Ltd Full time

    **Introduction**: As one of the leaders in the development and implementation of asset management software, Deighton offers an exciting combination of challenging opportunities and career diversity; where customer satisfaction is a fundamental value and where you can realize your personal and professional goals. Explore Deighton's opportunities, whether...

  • Experienced Geoscientist

    4 weeks ago

    Whitby, Canada Water Canada Full time

    WSP’s Earth & Environment group is a global leader, with a technical network unrivaled in the industry. WSP’s reputation for technical excellence and client focused service has been developed over decades and remain as strong as ever. Our team is growing, and as a result WSP’s Earth & Environment group is currently seeking an Intermediate Environmental...

  • Experienced Geoscientist

    2 weeks ago

    Whitby, Canada Water Canada Full time

    WSP’s Earth & Environment group is a global leader, with a technical network unrivaled in the industry. WSP’s reputation for technical excellence and client focused service has been developed over decades and remain as strong as ever. Our team is growing, and as a result WSP’s Earth & Environment group is currently seeking an Intermediate Environmental...

  • Experienced Geoscientist

    2 weeks ago

    Whitby, Canada Water Canada Full time

    WSP’s Earth & Environment group is a global leader, with a technical network unrivaled in the industry. WSP’s reputation for technical excellence and client focused service has been developed over decades and remain as strong as ever. Our team is growing, and as a result WSP’s Earth & Environment group is currently seeking an Intermediate Environmental...

  • Technical Account Manager

    4 weeks ago

    Whitby, Canada SIMNET Full time

    Work closely with the project manager and sales team to understand the technical requirements of clients and develop solutions to meet their needs. - Serve as a technical advisor to clients, providing guidance and support on cloud infrastructure, security, and best practices. - Assist in the onboarding process for new clients, including helping to define...

  • Ppi Business System Specialist Ii

    4 weeks ago

    Whitby, Canada Thermo Fisher Scientific Full time

    As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals...

  • Instrumentation Scientist Ii

    3 weeks ago

    Whitby, Canada Thermo Fisher Scientific Full time

    Summary: Calibrates and qualifies all new and existing analytical equipment according to a set schedule and current Patheon Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs) and corporate quality standards. Essential Functions: - Conducts maintenance and calibrations for each new and existing piece of analytical equipment...

  • Instrumentation Scientist II

    3 weeks ago

    Whitby, Canada Thermo Fisher Scientific Full time

    Job DescriptionSummary:Calibrates and qualifies all new and existing analytical equipment according to a set schedule and currentPatheon Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs) and corporate quality standards.Essential Functions:ñ Conducts maintenance and calibrations for each new and existing piece of analytical equipment...

  • Instrumentation Scientist II

    3 weeks ago

    Whitby, Canada Thermo Fisher Scientific Full time

    Job DescriptionSummary:Calibrates and qualifies all new and existing analytical equipment according to a set schedule and currentPatheon Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs) and corporate quality standards.Essential Functions:ñ Conducts maintenance and calibrations for each new and existing piece of analytical equipment...

  • Project Specialist

    4 weeks ago

    Whitby, Canada AECOM Full time

    Company Description At AECOM, we’re delivering a better world. We believe infrastructure creates opportunity for everyone. Whether it’s improving your commute, keeping the lights on, providing access to clean water or transforming skylines, our work helps people and communities thrive. Our clients trust us to bring together the best people, ideas,...

  • Experienced Geoscientist

    2 weeks ago

    Whitby, ON, Canada Water Canada Full time

    WSP’s Earth & Environment group is a global leader, with a technical network unrivaled in the industry. WSP’s reputation for technical excellence and client focused service has been developed over decades and remain as strong as ever. Our team is growing, and as a result WSP ’s Earth & Environment group is currently seeking an Intermediate...

  • Manager Technology Transfer Project Management

    4 weeks ago

    Whitby, Canada Thermo Fisher Scientific Full time

    **Summary**: Manages the coordination of the activities of the Technology Transfer (TT) function on site and is responsible for the department results. Accountable for the performance of the team within TT and the management of the transfer projects of pharmaceutical products from clients to Thermo Fisher Scientific. The transfer takes place through...

  • Manufacturing Project Coordinator

    4 weeks ago

    Whitby, Canada Kratos Antenna Solutions Full time

    **Position Overview** Kratos Antenna Solutions is looking for a Program Coordinator/Account Manager with a technical background that includes experience managing projects/programs within the automotive, aerospace, or healthcare sector. The Project Coordinator/Account Manager is responsible for ensuring delivery of engineering products. Projects are managed...

  • Plant Technical Trainer

    4 days ago

    Whitby, Canada Ball Corporation Full time

    **Further your career at Ball, a world leader in manufacturing sustainable aluminum packaging. Achieve extraordinary things when you join our team, and make a difference in your professional development, the community, and around the globe!** **Primary Purpose of the Position**: Executes training of plant floor personnel using classroom and on-the-job...

  • Project Manager

    5 days ago

    Whitby, Canada ATX Networks Toronto Corp Full time

    **RESPONSIBLITIES**: The following duties outline, but do not limit, the regular position requirements. These may be revised from time to time as business conditions dictate, at the discretion of the Manager. - Daily project monitoring and managing, i.e. tracking of tasks, milestones and risks; - Prepare and distribute weekly and ad hoc project update...

  • Experienced Geoscientist

    3 weeks ago

    Whitby, Canada WSP Canada Full time

    The Opportunity:Our team is growing, and as a result WSP's Earth & Environment group is currently seeking an Intermediate Environmental Consultant to join our Contaminated Lands team in Whitby, Ontario. Reporting to the Team Lead, Contaminated Lands - GTA-East, you will support our ambitious plans to enhance our service offering in the province through your...

  • Project Coordinator

    3 weeks ago

    Whitby, Canada AECOM Full time

    Company Description **At AECOM, we’re delivering a better world.** We believe infrastructure creates opportunity for everyone. Whether it’s improving your commute, keeping the lights on, providing access to clean water or transforming skylines, our work helps people and communities thrive. Our clients trust us to bring together the best people, ideas,...