Job Description

** Responsibilities include, but are not limited to, the following** :

• Perform non-routine analytical activities by independently developing and characterizing stability indicating methods for early phase pharmaceutical small to medium molecules with pre-set timelines using instrumentation such as, but not limited to, UPLC/HPLC, Dissolution, GC, Thermogravimetric DSC/TGA, and KF titration
• Participate in technical discussions with project leads to recommend alternatives, research new methods/techniques and discuss potential solutions to problems.
• Plan critical laboratory experiments to investigate aberrant results, determine root cause and recommend action plan
• Write Standard Operating Procedures (SOPs), assist in generating technical reports, prepare data for presentations/technical discussions and transfer methods internally and externally
• Prepare method protocols, & technical reports for characterization of analytical methods based on separation techniques (HPLC, UPLC, GC), Spectro-analytical technique (Ultraviolet-Visible Spectrophotometry) and dissolution testing
• Assist and mentor junior level scientists on analytical techniques and troubleshooting issues.
• Ensure project deliverables are scientifically accurate and meet timeline expectations
• Comply with all laboratory safety guidelines including Personal Protective Equipments (PPEs)
• Maintain general cleanliness of the lab, including personal bench space and common use areas

Qualifications

** The ideal candidate would possess** :

• Deep understanding of analytical sciences, drug development process, GMP/GLP requirements, and pharmaceutical industry trends
• Previous experience in pharmaceutical oral solid dosage & parenteral drug product analytical testing
• Good knowledge of three main pharmacopoeias (Japanese; JP, US; USP and European; Ph. Eur.) and ICH guidelines related to method development and validation
• Experience in developing pharmaceutical small molecules analytical chemistry methods for dissolution multi-media screening and analyzing data using compendial methods
• Understanding of experimentation and data analysis using Empower software
• Excellent project management skills; Ability to communicate complex scientific findings/recommendations and project resource requirements (material, manpower, time, etc.), and elevate relevant issues to project lead and line-management
• Excellent communication (oral and written), attention to detail, effective problem-solving and decision-making skills
• Ability to work independently and as part of a team with internal and external clients, self‑motivation, adaptability, and a positive attitude
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
• Experience in exploration and application of innovative technologies/approaches to analytical development activities
• Experience with the transfer of analytical technologies
• Ability to drive performance by tracking and managing key performance indicators using internal and external metrics
• Ability to prioritize complex workloads and manage changing priorities
• Proficiency in IT-related skills such as Microsoft Excel, word, PowerPoint, etc

Basic Minimum Qualifications:

• Bachelor's degree in analytical chemistry, biochemistry, chemistry or other related degree concentration, or equivalent directly related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major)
• At least ten years of related experience with separation science to support pharmaceutical oral solid dosage & parenteral drug product/substance analytical testing
• Authorization to work in the United States indefinitely without restriction or sponsorship

Additional Information

Position is Monday-Friday 8:00 am- 5:00 pm Overtime as needed. Candidates currently living within a commutable distance of Indianapolis, IN are encouraged to apply.

• Excellent full-time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays
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• Authorization to work in the United States indefinitely without restriction or sponsorship

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.