Method Development Group Leader

Responsibilities include but are not limited to the following:

• Lead a group of scientists to support nonroutine analytical activities (method development optimization qualification/characterization of stability indicating methods) for early phase pharmaceutical small to medium molecules with preset timelines using instrumentation such as but not limited to UPLC/HPLC Dissolution GC Thermogravimetric DSC/TGA and KF titration.
• Lead pharmaceutical drug development program as analytical development scientist to collaborate with other departments and support formulation development and manufacturing activities with preset timelines.
• 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) Spectroanalytical technique (UltravioletVisible 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
• Assist executive management in strategic planning business development and expansion initiatives
• 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 multimedia 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 linemanagement
• Excellent communication (oral and written) attention to detail effective problemsolving and decisionmaking skills
• Ability to work independently and as part of a team with internal and external clients selfmotivation 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 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:

• Bachelors 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 fulltime year of college in related major)
• At least 15 years related experience with separation science to support pharmaceutical oral solid dosage & parenteral drug product/substance analytical testing
• At least 8 years of experience in directly supervising and managing technical staff in a pharmaceutical laboratory environment
• Authorization to work in the United States indefinitely without restriction or sponsorship

Additional Information :

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

• Excellent fulltime benefits including comprehensive medical coverage dental and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays
• #LIEB1
• Authorization to work in the United States indefinitely without restriction or sponsorship

Eurofins is a M/F Disabled and Veteran Equal Employment Opportunity and Affirmative Action employer.

Remote Work :

No

Employment Type :

Fulltime