Position Summary
Execute process development and scale-up of semi-solid products within the set timeframe. Perform pre-defined experiments according to the study plan and in compliance with GxP regulations and MedPharm’s QMS.
Essential Functions
* Adhere to MedPharm ethos and comply with MedPharm’s SOPs, policies and QMS systems.
* Maintain confidentiality of information and data.
* Execute projects in accordance with the study documentation, experimental designs, and SOPs, in agreed timelines and in compliance with MedPharm’s QMS.
* Maintain cross-functional communication with the internal stakeholders of the project(s) being worked on.
* Review literature (including equipment operating procedures) in preparation for studies and regularly update knowledge by reading appropriate literature and/or attending appropriate training courses/webinars.
* Manufacture and fill formulations as required for the stage of the project, including but not limited to working on BMRs to provide toxicology batches in Process Development and clinical batches in GMP.
* Characterise formulations during different project phases.
* Communicate the progress of studies to the Team Leader / Senior Scientist / Study Manager as appropriate and other internal stakeholders where required.
* Assist with data input for written project updates.
* Attend and contribute to internal project meetings as required.
* Plan and organise the work with a degree of autonomy with due consideration to the resources.
* Report any amendments and deviations from SOPs and study plans/testing protocols to Team Leader / Senior Scientist / Study Manager as appropriate.
* Ensure that all activities are carried out in line with MedPharm’s Health and Safety policy and COSHH regulations to ensure the safety of themselves and others in any procedures or tasks performed.
* Assist other team members as and when required to complete project work.
* Assist in the smooth running of laboratory activities and maintenance of laboratory standards in compliance with MedPharm’s QMS.
* Undertake general waste disposal and contribute to the general tidiness and cleanliness of the laboratory environment.
* Maintain training records.
* Be sufficiently trained to undertake GMP activities on request.
Supervisory responsibilities
None
Key Relationships
* Departmental Scientists of all grades
* Study Directors
* Head(s) of Department
* Technicians
* Quality assurance
* Project managers
* 3rd party suppliers
Travel requirements
None
Education and Experience
BSc in a relevant field
1 to 2 years relevant experience (desirable)
Knowledge, Skills, and Abilities
Knowledge
* Emulsions
* Excipients
* Testing according to a monograph, e.g., USP
* Moving through different scales of manufacture
Skills
* Solution-focused
* Attention to detail
* Problem solvingAbility to work independently and within a team
Physical Demands and Work Environment
* Regularly required to walk within production and laboratory areas.
* May be required to stand for extended periods.
* Exposure to cleanroom environments and temperature-controlled zones.
Other Duties
You may be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked.
Limitations and Disclaimer
The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position. The Company is committed to making reasonable adjustments to the workplace to ensure the role is accessible to all candidates, including those with disabilities. To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.
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