Manages analytical projects 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 launches. Troubleshoots and improves analytical methods. Manages analytical project time-lines, and coordinates analytical activities to meet the business deadlines. Coaches and mentors peers.
- Takes the analytical lead on the assigned projects with minimum supervision, identifying and performing the required analytical tasks in support of product development, registration lot release, pre and post regulatory submission activities. Develops workable action plans and coordinates the activities of other scientists under supervision to ensure that the tasks are completed. Performs activities within the assigned timelines 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 with no supervision.
- Proactively participates in activities in support of process changes (e.g. processes, procedures, etc...). Suggests and leads process improvements to refine current systems and improve efficiency. Mentors peers in method development, validation, troubleshooting, instrumentation, laboratory practices, and processes. Conducts trainings on selected topics of interest for the department.
- 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 project status. Monitor project status and proactively communicate to supervisor potential delays and challenges. Participates and represents the department in cross-functional teams.
- PhD in a scientific discipline with a minimum of 5 years experience,or
- MS in a scientific discipline with a minimum of 8 years experience, or
- BS/BA in a scientific discipline with a minimum of 10 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, GC and particle size is required. Experience in one of the following techniques is preferred: DSC/TGA, DVS, MS, XRD.
- For Product: experience in HPLC and dissolution is required. Experience in two of the following techniques is required: GC, droplet size, particle size, DSC/TGA, DVS, MS, XRD, AA, NIR.
- In-depth knowledge of the critical functions/variables of the analytical techniques, and proven ability to troubleshoot methods is also required.
- Experience with data acquisition software is required.
- Knowledge of the most current FDA/ICH guidance’s, national Pharmacopoeias, and c-GMP regulations is required. Good understanding of analytical regulatory requirements for ANDA/NDA submissions is required.
- Must be able to work in a team environment approach to accomplish tasks assigned. Coaching skills are required.
Notification to Agencies
Please note that Hikma does not accept unsolicited resumes or calls from third-party recruiters or employment agencies. In the absence of a signed Master Service Agreement and approval from HR to submit resumes for a specific requisition, Hikma will not consider or approve payment to any third-parties for hires made.