Reporting to the R&D Supervisor, the R&D Analyst is responsible for the performing analytical testing to support the R&D Department.
Key Role Specific Requirements:
Analytical Testing and Reporting
- Perform accurate timely analytical testing on pharmaceutical samples to support R&D activities.
- Analyze and interpret data to provide clear actionable insights. Prepare detailed reports and presentation.
- Maintain the stability schedule for pre-commercial stability campaigns of appointed products.
- Review and check basic and advanced area documentation (laboratory notebooks, laboratory reagent logbook, SOPs, protocols, reports and specification sheets).
Method Development and Validation
- Conduct method development, verifications, validations, and transfers as needed.
- Stay updated on industry and regulatory developments to ensure method align with current standards.
Equipment Management
- Take ownership of assigned laboratory equipment, liaising with external vendors to ensure calibrations and maintenance is up to date and equipment fit for purpose.
- Ensure prompt reporting of any deviations or nonconformance and provide support implementing corrective actions as required.
Collaboration and communication
- Work closely with the R&D team in formulation development and other departments to meet project milestones.
- Seek and apply guidance from colleagues, supervisors and external training sources to enhance personal and project outcomes.
Continuous Improvement
- Actively seek opportunities for skill development, including learning of new analytical techniques and attending.
- Propose and implement process improvements to enhance efficiency and compliance.
Compliance and Documentation
- Ensure proper documentation of all experimental work adhering to GxP and SOP requirements in a timely manner.
Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.
Competencies Required for the Role:
- ANALYTICAL THINKING/PROBLEM SOLVING - The ability to identify the information needed to clarify a situation, seek that information from various sources, and then tackle a problem by using a logical, systematic, and sequential approach. The ability to identify and separate the key components of problems and situations, and to interpret information from a range of sources to spot patterns and trends, deducing cause and effect from this.
- CRITICAL THINKING – The ability to be thoughtful and draw pertinent conclusions after a discussion or meeting; can eventually support the final outcomes and decisions.
- INITIATIVE - Identifying what needs to be done and acting before being asked or before the situation requires it.
- DETAIL ORIENTED – Ensuring that one’s own and others’ work ad information are complete and accurate; carefully preparing for meetings and presentations, following up with others to ensure that agreements and commitments have been fulfilled.
- FLEXIBILITY -The ability to be open to different and new ways of doing things, and willingness to modify one’s preferred way of doing things. Able to see the merits of perspectives others than one’s own.
Performance Expectations:
Accuracy and Reliability:
- Consistently deliver high quality error-free analysis
Proactive Equipment Management:
- Ensure assigned equipment is functional and well maintained.
Collaboration:
- Demonstrate openness to advice from more experienced colleagues and contribute constructively to team goals.
Continuous learning
- Show a commitment to improving knowledge and skills to enhance performance.
Required Qualification & Experience
Essential:
- Minimum of 1 year’s experience within an analytical laboratory environment.
- BSc Degree in Chemistry, pharmacy or other related discipline.
- Strong analytical/quantitative skills.
- Previous experience with HPLC/UPLC and Dissolution and analytical troubleshooting.
- Familiarity with cGMP and quality systems.
- Ability to work independently and manage competing priorities with minimal supervision.
- Self-initiating and self-directed.
- Ability to troubleshoot analytical issues.
Desirable:
- Previous experience with Empower software.
- Knowledge of pharmacopeial standards
Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products and has over half a century’s experience in providing science-driven solutions to optimize the health, wellbeing and productivity of the world’s animals.
Bimeda’s global innovation program sees state-of-the art R&D centers across four continents collaborate on an enviable product development pipeline which anticipates the ever-evolving needs of the animal health industry.
Bimeda’s manufacturing facilities across seven countries allow the company to manufacture a broad range of preventative, curative and nutritional products including sterile injectables, vaccinations, nutritional boluses, feed additives, tablets, water-soluble powders, pastes and non-sterile liquids.
Globally, the company focuses on the development, manufacture and commercialization of quality Bimeda-branded products while also being the partner of choice for contract manufacturing and R&D services for prominent companies within the animal health industry.
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