Develops new formulations and scale-up procedures of solid, liquids, and semi-solid dosage forms at the pre-clinical, clinical, scale-
up to registration, and validation stages of drug development.
Essential Functions :
Perform manufacturing activities including set-up, run and clean of equipments and rooms
Participates in or leads the design / evaluation of formulations and manufacturing processes for solid, semi-solid or liquid dosage forms.
Participates in or leads problem solving for formulations, equipment and processes.
Participates in writing protocols and manufacturing cards for feasibility and clinical trial materials.
Participates in writing development reports.
Participates in inter departmental co-ordination for documentation and equipment related tasks.
Participates in training, qualification of equipments, and writing Standard Operating Procedures (SOPs).
Presents interpreted results and updates to Client Services, PDS, Operations, and individual clients.
Records results in accordance with current Good Manufacturing Practices and company standard.
Other duties as required
Bachelor of Science (B.Sc.) in pharmaceutical science or technology.
Minimum 1 year of pharmaceutical formulation / technology experience.
Demonstrable understanding of pharmaceutical formulation science.
Basic Good Manufacturing Practices and United States Food and Drug Administration (FDA) compliance knowledge.
Demonstrated understanding of equipment, formulations and processes.
Ability to lift up to 50 lbs.
Able to perform job requirements while wearing Personal Protective Equipment (PPE) -Powered Air Purifying Respirator (PAPR), Tyvek suit and double gloves.
Good understanding of Good Manufacturing Practices guidelines, Standard Operating Procedures and safety standards.
Ability to communicate and liaise with client 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.
Proficiency with the English language.
Thermo Fisher Scientific is an equal opportunity employer andis committed to the principle of diversity and is particularly interested in receiving applications from a broad spectrum of people.
Accommodations for job applicants with disabilities are available upon request.