- 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 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).
-
Project Leader, PMO
3 days ago
Ontario Shores Centre for Mental Health Services Whitby, CanadaQualifications Required and Preferred- KEY DUTIES AND RESPONSIBILITIES: · - Lead or support strategic and operational projects that are currently underway, while developing strategies for new projects · - Manage all aspects of projects including proposal writing, budget creation, ...
-
Technical Project Leader Ii
2 days ago
Thermo Fisher Scientific Whitby, Canada**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 ...
-
Ppi Business System Specialist Ii
3 days ago
Thermo Fisher Scientific Whitby, CanadaAs 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 ou ...
-
Project Manager
4 days ago
Deighton Associates Ltd Whitby, Canada**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 yo ...
-
Deskside Support Specialist
3 days ago
Aecon Group Whitby, Canada**Come Build Your Career at Aecon** · As a Canadian leader in infrastructure development, Aecon is safely and sustainably building what matters for future generations to thrive We lead some of the most impactful infrastructure projects of our generation, at the forefront of trans ...
-
Human Resources Generalist, Whitby
1 week ago
Flanagan Foodservice Whitby, CanadaWe are the premier foodservice distributor in Ontario. Flanagan's provides customized foodservice delivery to a varied portfolio of clients; from restaurants to schools, hospitals and retirement homes, we provide the best quality ingredients to ensure Canadians have an amazing fo ...
-
Vice President Supply Chain Operations
20 hours ago
Ontario Power Generation Whitby, Canada**Location**:Whitby, ON, CA, L1N 9X1**Req ID**:46249**Status**: Regular**Working Conditions**: Onsite**Education/Certification Requirement**:University degree in Science, Engineering, Business or related field is required*** · **Location**: Oshawa, Ontario**Travel**: As required, ...
-
Outside Sales/business Development Manager
1 week ago
Paramount Pallet Whitby, CanadaParamount Pallets are looking for a new Hunter/Sales Leader or "Business Development Manager" (BDM). The primary function of this role requires an experienced hunter, sales leader to generate new business and manage accounts throughout the GTA region. As a key member of the Sales ...
-
Landscape Construction Foreperson
5 days ago
Allweather Landscape Whitby, CanadaThe Construction Foreperson is responsible for leading landscape construction installs. Bringing exceptional leadership and time management skills, the Construction Foreperson will guide their team through various construction projects, providing them with the skills and motivati ...
-
Quality Improvement and Accreditation Leader
1 week ago
Ontario Shores Centre for Mental Health Services Whitby, Canada***: · The Quality Improvement and Accreditation Leader is a strategic and tactical partner in helping to create a culture of continuous quality improvement at Ontario Shores and plays a key role in supporting the organization to advance the quality of care and ensure continuous ...
-
Field Technician
4 days ago
GHD Whitby, CanadaJoin a global professional services leader. We are committed to solving the world's biggest challenges in the areas of water, energy and urbanization. · As a Materials Technology Field and Laboratory Technician you will carry out geotechnical and construction material site inspec ...
-
General Manager
2 days ago
Amica Senior Lifestyles Whitby, Canada**Job Description**: · **_ · General Manager_** · **_ Amica Whitby_** · **_ Full Time_** · Amica Senior Lifestyles is setting a new standard for senior living in Canada by combining unparalleled premium hospitality and amenities with expert care and support to deliver a personali ...
-
Ontario Shores Centre for Mental Health Sciences Whitby, Canada Full timeReporting to the Vice-President of Communications and Patient Experience, the Communications Specialist and Team Lead works in collaboration with the Communications and Public Affairs team, along with leaders across the organization to develop, implement, support and evaluate var ...
-
Cosmetic Merchandiser
4 days ago
Match Retail Whitby, CanadaOverview: · **Match Retail is looking to grow its Merchandising Team** · As a provider of essential services in Canada, Match Retail supports major retailers and brands by assisting with innovation launches - visiting retailers to update their sections and make way for new produc ...
-
Support Analyst
3 days ago
Deighton Associates Ltd. Whitby, Canada**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 yo ...
-
Business Manager
6 days ago
Thermo Fisher Scientific Whitby, CanadaThe Business Manager develops and manages the business relationship with commercial clients, through understanding the client's organization and business needs, in order to maximize client service and satisfaction in the overall best interest of Patheon. The Business Manager is t ...
-
AECOM Whitby, CanadaCompany 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 communiti ...
-
Project Manager, Environmental Services
1 week ago
Cambium Inc. Whitby, Canada**Job Description**: · **STATUS**:Permanent, Full-time · **LOCATION**:Whitby, Kingston, Ottawa, Peterborough, or Barrie, ON · **APPLY BY**:May 27, 2024 · **WAGE RANGE**: $42-$60/hour (commensurate with experience) · **WHY WORK WITH CAMBIUM?** · You want to be a part of a successf ...
-
Event Coordinator
1 week ago
Deighton Associates Ltd. Whitby, Canada**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 yo ...
-
Operations & Maintenance Specialist
1 week ago
AECOM Whitby, CanadaCompany 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 communiti ...
Technical Project Leader II - Whitby, Canada - Thermo Fisher Scientific
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:
Write and ensure timely execution of protocols and provision of results in accordance with current Good Manufacturing Practices and company standards.
REQUIRED QUALIFICATIONS
Education:
Bachelor of Science ( 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.