About the Role:Under direct supervision, is responsible for development and execution of analytical test methods that facilitate drug product development / manufacturing and regulatory submissions for clinical study introduction through phase III trials. Activities includes test method development, qualification/validation, transfer and execution. Supports late stage troubleshooting and development of products, processes, and methods in support of product commercialization.
Your Contributions (include, but are not limited to):- With direct supervision, develops and executes chemical and instrumental methods (e.g. HPLC, GC, TGA, DSC, MS, FTIR, Water Content) of analyses of drug product development compounds
- Accurately follows established test methods, procedures, and pharmacopeia chapters (e.g. Dissolution, Content Uniformity) to generate data essential for strategic decision making
- With direct supervision, plans and executes forced degradation, informal stability, and excipient compatibility studies
- With direct supervision and as appropriate, assists/leads the development of analytical methods, investigations for out of specification, out of trend, and/or anomalous results
- With direct supervision, collaboratively plans and executes cross functional studies for formulation development
- Recognizes and responds to unexpected or anomalous observations in all activities
- Maintains complete and accurate records of laboratory work in conformance with company SOPs and training
- Provides detailed reviews of peer generated data as well as that generated from contracted service providers
- Other duties as assigned
Requirements:- BS/BA degree in chemistry or closely related field and some relevant industry experience preferred; Experience with Empower a plus
- Working knowledge of data systems for computer-controlled instrumentation
- Familiarity with performing analytical testing of solid oral drug products; Hands-on knowledge preferred
- Knowledge of conducting HPLC analysis and troubleshooting. Working knowledge of performing stability indicating method development a plus
- Familiarity with performing dissolution analysis and troubleshooting. Hands-on knowledge performing dissolution method development a plus
- Understanding of analytical data evaluation and ability to draw meaningful conclusions
- Ability to present analytical data clearly and demonstrate knowledge of the testing and the product
- Knowledge of cGMP expectations for laboratory records and quality systems
- Knowledge of ICH guidance and common testing per USP chapters
- Knowledge of statistical analysis a plus
- Ability to provide ideas for process improvements
- Able to execute experiments efficiently and suggest small process improvements
- Able to recognize patterns or inconsistencies in data results
- Able to deduce meaningful results while conducting routine analyses or troubleshoot minor issues. Good knowledge of one scientific discipline
- Developing knowledge of scientific principles, methods and techniques
- Good knowledge and some experience working with discipline specific laboratory equipment/tools
- Ability to work as part of a team
- Good computer skills
- Developing communications, problem-solving, analytical thinking, planning and organization skills
- Detail oriented
- Understands importance of meeting deadlines
- Proficient using MS-Excel, MS-Word
- Ability to work with a team of individuals to meet goals
- Ability to accomplish tasks in a timeline driven setting
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The hourly rate we reasonably expect to pay is $35.35-$47.34. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 15% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.
