Scientist III, QC Life Cycle

Scientist III, Development & Lifecycle

Overview

To perform routine and non-routine, work-flow processes on highly technical analytical projects within the Quality Control Laboratory to meet regulatory (FDA & ICH), internal and external customer requirements by testing of starting materials, intermediates, non-commercial finished products, method development and validation while ensuring regulatory compliance standards are met by Hikma Pharmaceuticals.

Responsibilities

Regular and predictable onsite attendance and punctuality.

· Perform non-commercial qualitative, quantitative developmental chemical and physical test for highly technical projects as specified by compendia (USP, JP, BP), regulatory authority (FDA & ICH) for starting materials, packaging components, intermediates and finished products.

· Review and approve test results to ensure consistent quality standards are met.

· Interface with new products Analysis, development and validation in order to facilitate appropriate, consistent compliance and approaches. Perform analytical transfers for Multi-source and brand products internally and externally.

· Perform Gap Analysis of current and older Validation reports to ensure consistencies in compliance with national and international quality standards are met.

· Develop and validate analytical methods to meet SOPs, ICH, JP, EP, USP, EMEA, and FDA requirements; perform analytical transfers for Multi-source and brand products internally and externally.

· Coordinate validation and chromatographic data to assist/write technical reports.

· Mentor and train analysts on new or improved methods, techniques and instrumentation to ensure RFT and compliance.

· Develop and implement policy and procedures to ensure consistent regulatory compliance.

Independently leads project(s) and perform continuous improvement activities. Influence scientist, engineers and regulatory officials and others, to plan and review projects and to provide technical assistance from early stage development and small-scale operations through full production and life-cycle management.

Skills

Must be able to perform compendia and non-compendia testing for multiple projects at one time

· Knowledge of the most current national FDA/ICH guidances and national Pharmacopeias is required

Qualifications – Education and Experience

• Ph. D. in Chemistry, Pharmaceutics, or Engineering with at least 3 years of experience in analytical Chemistry in the Pharmaceutical Industry, or
• MS in Chemistry, Pharmaceutics, or Engineering with at least 4 years of experience, or  
• BS in Chemistry, Pharmaceutics, or Engineering with at least 5 years of experience in analytical Chemistry in the Pharmaceutical Industry
• Validation, execution and transfer of analytical methods, with minimal supervision for evaluation and release of Active Pharmaceutical Ingredients (APIs) or Pharmaceutical products
• Analytical techniques including APIs Advanced instrumentation such as MS;
• Preferred: Experience with Empower data analysis software is desirable

 

 

 

What We Offer

• Clean climate-controlled working environment (Operator roles at the top)
• Annual performance bonus potential
• 401k employer match up to 6% of your contributions
• 23 vacation/personal days
• 11 paid Company holidays
• Generous healthcare benefits
• Employee discount program
• Wellbeing rewards programs
• Safety and Quality is a top organizational priority
• Career advancement/growth opportunities
• Tuition Reimbursement
• Maternity and Parental Leave

 

*Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to a specific plan or program terms.