Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
How will you make an impact?
Leads the design and evaluation of formulations and manufacturing processes as well as problem solves for solid, semi-solid or liquid dosage forms. Engages 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.
What will you do?
Leads the design/evaluation of formulations and manufacturing processes for solid, semi-solid, or liquid dosage forms. Leads 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. Manages resources in their PPT work group to achieve project and team objectives. Leads/participates in problem solving for formulations, equipment and processes.
Writes protocols for feasibility work and manufacturing batch records and clinical trial materials. Writes and ensures timely execution of protocols and provision of results in accordance with current Good Manufacturing Practices and company standards.
Provides direction, training, and developmental opportunities for PPT Technologists, PPT Technician and Technical Project Leader I’s.
Plans and executes own work and plans others’ work in relation to supporting PPT facility.
Coaches people in their work group in areas such as the drug development process and PDS systems.
Liaises with Project Management, Facility/Equipment Schedulers, Materials Management, Analytical Development and other functional areas to meet project and team objectives.
Maintains expert knowledge of pharmaceutical processes, equipment, instrumentation and procedures necessary to perform the tasks. Keeps current with scientific literature and industry trends relating to process technologies; disseminates relevant information. Key technical leadership role in Centre of Excellence Initiative; look for opportunities for publication/external presentations.
How will you get there?
Education:
Minimum Bachelor of Science (B.Sc.) in pharmaceutical science or technology
Masters of Science (M.Sc.) or Doctorate (Ph.D.) preferred
Experience:
Minimum 4 years of experience in drug development
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered
Knowledge Skills & Abilities
Extensive knowledge and understanding of the drug development process
Demonstrable organizational skills relevant to drug development
Excellent written and oral communication skills
Experience in technical/scientific discussions with clients.
Established quality, regulatory, and production mindset including an appreciation for client service and the contract manufacturing industry.
Works independently with minimal need for intervention by more senior management.
Proficiency with the English language.
Familiarity with Good Manufacturing Practices
Ability to recommend improvements relating to formulations, equipment, processes and systems
Experience supervising or organizing others’ work.
Demonstrates logical thinking.
Actively acquires new skills/knowledge relevant to the drug development process.
Responsible for significant portions of development programs.
Draws on experience and demonstrates innovative approach.
Plans and works autonomously under general direction to meet project and team objectives.
Demonstrated commitment to our fundamental principles of Integrity, Respect, & Excellence.
Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com
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