Associate Scientist, Process Development

General Information:
 

Position Summary

To assist the Scientist / Senior Scientist in executing projects within the set timeline. 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.
• Assist more senior team members in executing 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.
• Under the guidance of a more senior team member, 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.
• To communicate the progress of studies to the Team Leader / Scientist / Senior Scientist / Study Manager as appropriate and other internal stakeholders where required.
• Assist Team Leader / Scientist / Senior Scientist / Study Manager with data input for written project updates.
• Attend and contribute to internal project meetings as required.
• Plan and organise the work with a certain degree of autonomy with due consideration to the resources.   
• To report any amendments and deviations from SOPs and study plans / testing protocols to Team Leader / Scientist / 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.
• To undertake general waste disposal and contribute to the general tidiness and cleanliness of the laboratory environment.
• Maintain training records.
• To be sufficiently trained to undertake GMP activities on request.

Supervisory responsibilities:

None

Key Relationships:

• Departmental Scientists of all grades
• Study managers
• Head of Department
• Technicians
• Quality assurance

Travel requirements:

None

Education and Experience

BSc in a relevant field

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 solving
• Ability to work independently and within a team

Physical Demands and Work Environment

While performing the duties of this job, there may be certain physical demands required for the position.

• 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.