Manages and conducts analytical activities in support of the development of a manufacturable multi-source pharmaceutical product. Conducts testing, analytical method development and validation in support of regulatory submissions and product launch activities. Participates in method transfer activities. Troubleshoots and improves analytical methods. Coaches and mentors peers.
- Takes the analytical lead on large portions of the assigned projects, identifying and performing the required analytical tasks with minimum supervision in support of product development, registration lot release, pre and post regulatory submission activities. Performs activities within the assigned time-lines and in compliance with cGXP's, regulatory requirements and company practices and procedures.
- Performs analytical method development, validation and project support. Identifies, offers, and implements contingency plans to prevent and overcome analytical issues and perform method trouble shooting. These activities will be performed with minimum supervision.
- Pro-actively participates in activities in support of process changes (e.g. processes, procedures, etc...). Suggests process improvements to refine current systems and improve efficiency. Mentors peers in method development, validation, troubleshooting, instrumentation, laboratory practices, and processes.
- Follows work instructions, SOPs, company practices and regulatory guidances/regulations. Documents analytical activities and results accurately, in a timely manner and right-first time. Reviews and checks analytical data generated by peers and maintains integrity of data. Supports activities to maintain the laboratory status of compliance to FDA/regulatory standards.
- Communicates effectively with peers, supervisor, management and internal customers about the project status. Pro-actively communicates to supervisor potential delays and challenges. Participates in cross-functional teams.
- PhD in a scientific discipline with a minimum of 2 years experience. or
- MS in a scientific discipline with a minimum of 5 years experience, or
- BS/BA in a scientific discipline with a minimum of 7 years of experience.
- The work related experiences include development, validation, execution and transfer of analytical methods for APIs or drug products.
- For API: experience in HPLC is required. Experience in two or more of the following techniques is required: GC, particle size, DSC/TGA, DVS, MS, XRD.
- For Product: experience in HPLC is required. Experience in two or more of the following techniques is required: GC, particle size, dissolution, droplet size, AA, DSC/TGA, DVS, MS, XRD, NIR.