Analytical Scientist

Job Summary:

The Analytical Scientist will be part of a team of drug development professionals responsible for the continued development and regulatory approval of thin film drug products containing a wide range of therapeutic compounds.

Job Responsibilities:

• Hands-on laboratory analysis of R&D drug substance and drug product samples.
• Method development method transfer and validation of analytical methods developed in-house or from client.
• Provide analytical support during pre-formulation formulation development and manufacture of prototype formulations clinical trial materials and process scale-up.
• Perform characterization release and stability testing of raw material and drug product samples for conformance to specifications.
• Prepare and update/review SOPs for the analytical laboratory.
• Observe and maintain compliance with applicable DEA and safety regulations cGLP/GMP guidelines and Aquestive policies and procedures.
• Interact in a team atmosphere providing expertise in general analytical techniques.
• Troubleshooting and repair of minor problems in analytical instruments.
• Responsible for laboratory work area housekeeping.
• Assist with raw data review analysis report writing and laboratory investigations (OOT/OOS).
• Ensure that responses to regulatory inquiries are conducted in accordance with regulatory guidelines and in consideration of business implications.

Job Qualifications:

• BS/MS in Chemistry.
• Minimum 3 - 5 years of pharmaceutical experience in an R&D analytical laboratory supporting small molecule protein and peptide development programs.
• Strong analytical skills proven experience in wet chemistry HPLC Dissolution KF GC and spectrophotometry.
• Thorough knowledge of cGMPs compendia requirements FDA and EMA regulations.
• Experience working with and interpreting regulatory documents such as CFRs FDA and ICH Guidance documents.
• Excellent written and oral communication skills with an ability to prepare and present concise technical data reports to non-scientific counterparts.
• Prior experience with FDA/EMA inspections and audits a plus.
• Proficiency in standard office software (MS Word Excel PowerPoint).
• Must be detail oriented and organized with excellent documentation practices.

The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities duties and skills required. Aquestive reserves the right to make changes to the job description whenever necessary.

As part of Aquestives employment process final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place.

Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race color religion age sex national origin disability status genetics protected veteran status sexual orientation gender identity or expression or any other characteristic protected by federal state or local laws.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors which may include but not be limited to the primary work location and the chosen candidates relevant skills experience and education. Expected Base salary range: $75000.00 to $100000.00 USD

Required Experience:

IC