Position Summary
The Scientist (Analytical) plays a key role in supporting research and development studies by performing analytical testing of pharmaceutical compound, drug substance and drug product. This role is integral to the development of new drug formulations, ensuring accurate data generation to guide formulation design and process development. Working independently with guidance from team leaders and senior scientists, the Scientist is responsible for executing analysis through HPLC and GC in compliance with internal protocols and industry standards. The position involves HPLC method development and optimisation to support early and late-stage pharmaceutical development. This role requires strong technical and organizational skills, attention to detail, and a commitment to scientific excellence in a fast-paced, collaborative R&D environment.
Essential Functions
- Responsible for executing a variety of analytical techniques such as HPLC and GC to support the development of pharmaceutical drug products as well as assist in the day-to-day running of the laboratory in compliance with MedPharm’s QMS.
- Performing and planning pre-defined experiments according to internal standard operating procedures (SOP) (e.g. forced degradation of substance and product, saturated solubility, excipient compatibility and formulation stability).
- Support analytical method development and validation in accordance with ICH guidelines including contributions to formal update writing.
- Accurately document all experiments and results and have a good understanding and demonstration of good laboratory practice (GLP), data integrity and quality.
- Analyze data using Empower and interpret results to support formulation development, stability studies and product release.
- Take active responsibility for your analytical work with respect to quality and compliance, particularly in the support of the analytical team.
- To drive the progression of the study by collaborating with other departments, with oversight from your supervisor where appropriate. To attend meetings and contribute when appropriate.
- To be involved in the department’s method development and continuous improvement strategies
- Adhere to Health and Safety and COSHH regulations and read relevant safety data sheets and risk assessments prior to undertaking work.
- To maintain your training file (physical and MasterControl based) and to not use any equipment or handle any chemicals without following the appropriate health and safety guidance.
- To undertake general waste disposal and contribute to the general tidiness and cleanliness of the laboratory environment
- To conduct yourself in concordance with the MedPharm Ethos, professionalism and confidentiality.
Supervisory responsibilities
N/A
Key Relationships (examples: Depts or Individual positions that this position will be working closely with)
- R&D Laboratory staff
- Analytical Team Leaders
- FD, PD and PT Study Managers
- Project Management team
- QC team
- Quality Assurance team
- 3rd Party suppliers and vendors
- Auditory and Regulatory bodies
Travel requirements
N/A
Education and Experience
- Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences or related discipline.
- Familiarity with common analytical equipment and instrumentation (e.g. analytical balance, pH meter, HPLC, GC)
- >2 years of relevant industry experience
Knowledge, Skills, and Abilities
- Computer literate and knowledgeable in Microsoft Office Applications
- Effective oral and written communication
- Good observation skills and ability to document accurately
- Strong ability to work in teams and collaboration
- Good time management and organizational skills
- Good knowledge and practical experience in analytical laboratory
Physical Demands and Work Environment
While performing the duties of this job, there may be certain physical demands required for the position.
Example:
- Occasionally required to lift up to 20kg
- Requires standing for extended periods
- May be exposed to loud noise levels
- May be exposed to hot or cold temperatures
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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