CW Chemist Analytical Development chez Upsher-Smith Laboratories, LLC

Provides analytical and technical support to new product development. Completes method development, validations, USP/PF method verification, and various laboratory support functions. Participates in new technology evaluation and application.  Provide coaching and mentoring to junior chemists. 

• Responsible for development and validation of assigned analytical methods such as assay and impurities/degradation products, residual solvents, content/blend uniformity and dissolutions. Author method development reports, method validation protocols/reports.  Execute method validation testing. 
• Develops robust methods that are time tested in a routine quality control environment. Leads method troubleshooting and rectifies challenges effectively using a variety of techniques including advanced principles and concepts
• Reads understands and follows the current USP/NF, laboratory SOPs, analytical methods and study protocols. Applies applicable ICH and FDA guidelines to analytical method development and validations.
• Assists with establishing specifications for APIs, excipients and drug products. Develops justification of these specifications to be included in regulatory submissions.
• Documents equipment usages and analytical results in a manner that is consistent with cGMP, in-house SOPs, and can be readily followed by reviewers
• Is able to describe a testing challenge and present supporting data effectively in either a 1:1 or a small group setting.
• Reviews raw data timely and ensures it meets cGMPs and in-house SOPs, is scientifically sound and can be readily followed by auditors
• Shows expertise with analytical instruments such as HPLCs, GCs, dissolution apparatus, and other analytical equipment. Actively solves instrumentation issues and assists others with instrumentation startup and troubleshooting
• Serves as instrument owner. Perform requirement function including reviews and audits instrument calibrations. Performs routine instrument maintenance, and calibrations if needed. Oversees the qualification of new instruments and software when needed.
• Maintains personal and shared workspace in an organized manner. Cleans laboratory glassware and actively participates in lab-wide routine clean up and inspection activities.
• Identifies potential training, efficiency, compliance and and/or safety concerns and brings solutions to management. Actively participates in and leads the implementation of continuous improvement efforts associated with laboratory operation
• Ensures that analytical laboratory functions (e.g. methods and validations) of the CMC submission are completed according to ICH/FDA guidelines. Coordinates the gathering of necessary documents and assists with writing portions of the CMC submission document.
• Demonstrates cooperation and professionalism with all members of the Upsher-Smith organization

Requirements:

A bachelor's degree in chemistry or related field with 12 credits of college chemistry and typically 7 years analytical experience, preferably in the pharmaceutical industry. Alternatively, a MS degree with a minimum of 5 years experiences or a Ph.D. with a minimum of 1-year experiences in analytical method development in a drug product pharmaceutical industry. Knowledge of analytical chemistry, strong verbal and written communication skills. Ability to work independently, with others and to multitask. Advanced knowledge of analytical techniques, including HPLC, GC, dissolution, and FDA and ICH guidelines. Experience with method development and method validation in a cGMP lab environment, PC's, cGMP's , and USP testing. Proven problem solving and leadership skills

Compensation Range:

Upsher-Smith Laboratories, LLC is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Upsher-Smith Laboratories, LLC will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.