MIR Scientist
About The Position
We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated MIR Scientist. In this role, you will be responsible for managing the day-to-day manufacturing deviations (MIRs) Investigations within a section or functional area. Identify and assess quality risks in activities and processes related to manufacturing and follow Hikma's quality and current good manufacturing practices (cGMP). Participate and drive departmental Investigations to closure. Assist/drive and/or lead, Change Controls (CCRs), Customer Complaints and Annual Product Review (APRs).
Requirements
- Bachelor degree in the Sciences or Engineering.
- 3-5 years experience in pharmaceutical processes or manufacturing.
- Exceptional organizational skills and ability to plan and implement resolutions to technical problems.
- Familiarity with current good manufacturing practices and quality systems related to aseptic processing.
- Understand scientific strategies and be able to explore all avenues of investigation.
- Good interpersonal/ communication skills.
- Good project management skills.
- Working knowledge of FDA regulations with regards to Annual Product Review.
Nice To Haves
- Strong Chemistry and/or Microbiology background preferred.
Responsibilities
- Ensure timely closure of in process and finished product investigations (MIRs).
- Write and Review Annual Product Reviews.
- Perform/Assist in Customer Complaints by collecting and analyzing objective evidence regarding risks and corrective actions to remediate.
- Maintain a high level of Expertise in Hikma’s Quality Systems and Current Good Manufacturing Practices in resolving technical issues.
- Participate in manufacturing projects in the role of contributor, coordinator or leader.
Benefits
- Annual performance bonus, commission, and share potential
- Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
- A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
- 3 personal days (prorated based on hire date)
- 11 company paid holidays
- Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
- Employee discount program
- Wellbeing rewards program
- Career advancement and growth opportunities
- Tuition reimbursement
- Paid maternity and parental leave
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
