Development Analyst – R&D 41 views

Purpose:

A global pharmaceutical company focused on agile and sustainable growth and complex generics is seeking a Development Analyst who will develop the intellectual property for analytical test methods of all new and existing products, in order to sustain a robust and commercially sound product pipeline, while ensuring that existing products comply with statutory requirements

Minimum Requirements:

• Honours Degree or Masters in Science
• Bachelor’s Degree in Science or National Diploma in Analytical Chemistry
• 4 to 5 years’ relevant industry experience
• 7 to 8 years’ relevant experience in in the Analytical Chemistry field
• Relevant experience in the conduct of analysis in pharmaceutical products, including development, validation and transfer of analytical methods
• Sound knowledge, understanding and application of international guidelines on the quality of pharmaceutical products, including method development, validation and transfers
• Sound knowledge and understanding of the quality attributes evaluated for pharmaceutical dosage forms including tablets, capsules, solutions, suspensions, creams and ointments
• Knowledge scientific principles which underlie the analytical methods and equipment used for such analyses
• Knowledge, understanding and application of a pharmaceutical quality management system as appropriate for the different stages of the pharmaceutical product life-cycle
• Sound knowledge and understanding of the quality-by-design concept and its application in analytical method development, as well as formulation development would be advantageous
• Experience in the review and interpretation of data would be advantageous
• Experience in scientific report writing

Key Job Outputs:

• Plan, organise and execute work as an individual contributor to fulfil the operational requirements of the method development team, which includes
• Design and present feasible, systematic, science and risk-based approaches to the development of analytical methods, which serve the intended purpose
• Conduct method development trials/ experiments, following the agreed protocols within the required timelines
• Assess appropriate pre-validation parameters based on risk to verify a developed-methods
• Generate scientifically sound analytical development reports which demonstrate robust analytical methods which are fit for the intended purpose
• Conduct analysis of formulation development lab and pilot trials, including stability
• Liaise with the formulations team to effectively interpret formulation development data in order to develop suitable finished product specifications which meet regulatory requirements
• Ensure that method development is effectively used to compile a suitable validation strategy/protocol with the method validation team
• Critically and effectively conduct analytical method investigations and associated risk assessments as well as the related provision of suitable preventative and corrective actions
• Design strategies for comparative dissolution studies with the intended purpose in mind
• Execute agreed protocols and within the required timelines
• Initiate quality management documentation such as OOS investigations, deviations, change controls, corrective actions and standard operating procedure updates when required with practical, but scientific justifications, risk/impact assessments and root cause analyses

Core Competencies:

• Attention to detail and accuracy
• Uncompromising on integrity and a commitment to quality of work
• Organised and professional
• Ability to think innovatively with sound problem-solving and decision-making skills
• Team player with sound interpersonal skills and emotional intelligence
• Sense of urgency and being results-driven with the energy to achieve stretch goals
• Leadership skills and qualities which includes the ability to lead oneself and a team
• Strong time management skills which include the ability to work under pressure, prioritising responsibilities and accountabilities while remaining flexible when priorities change
• Intermediate level computer skills such as MS Office Suite and the Empower System
• Ability to build inter-team relationships and communicate cordially and professionally within the R&D department
• Ability to interpret scientific data, draw valid conclusions and present scientific information in written reports and oral presentations which have a logical, organised flow and format

Salary:   Market related

Should you not hear from us within 2 weeks, kindly consider your application as unsuccessful.

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