- Development of parenteral formulations and analytical methods for in-process testing.
- Conduct and lead pre-formulation and formulation activities of in-house new developed products and line extensions.
- Perform method validation/qualification for in-process testing.
- Perform, track and monitor stability testing as required.
- Draft batch records, supervise the manufacture of Exhibit batches and assist on the transfer of processes to Production.
- Ensure timely new product introduction in accordance with cGMP and ISO standards.
- Check formulation activities from other Formulation Scientists and supervise their training.
- Lead critical Investigations, problems and develop solutions in more unusual situations.
- Ensure equipment is adequately qualified and maintained in accordance with cGMP requirements.
- Maintain laboratory SOPs in a state of compliance.
- Elaborate documentation for product registration.
Key Activities of the Formulation Scientist
- To prepare, review and take responsibility on advanced area documentation (Laboratory notebooks, reagent logbooks, SOPs, Exhibit batch records, Protocols, Reports and Specification sheets).
- Recommend modifications to processes and understand the impact of these modifications on the broader research area.
- Attend and lead internal-external meetings with other Departments, organizations and CRO with the aim to fast-track Project development.
- Participate and consult with the internal and external scientific community to maintain a state-of-the-art knowledge for application to successful conduct of experiments and projects.
Key Activities of the Analytical Scientist
- Independently generate precise, reliable and reproducible data in a timely manner as part of the development, validation, and transfer of drug substance analytical methods
- Make fact based decisions utilizing literature and analytical data as available
- Execute analytical development against project timelines
- Transfer analytical methods to the Quality Control Group
- Develop new analytical methods
- Assess customer methods for validation readiness
- Execute method validation protocols for the CGMP release of drug substance batches
- Author reports and review data
- Provide analytical technical assistance to Quality Control and Process Chemistry areas
- Selected candidate will report to the Director of Analytical Method Development
- Develop analytical testing strategies based on provided customer technical package and/or process development synthetic routes
- Assure compliance with Regis Technologies safety, quality, and regulatory policies and government regulations
- Collaborate with customers and other functional areas to advance projects through development