Analytical Scientist II

The Analytical Scientist performs entry level chemical analysis in pharmaceutical compounds making full use and application of standard chemical principles, theories, concepts, and techniques.  Utilizes established methods and procedures and laboratory equipment to perform analytical testing of substances.  Develop and write technical reports of testing results.  Works under general supervision. This position is NOT remote or hybrid. 

DUTIES & RESPONSIBILITIES: 

•    Executes method development, implementation, validation, and transfer protocols and procedures to support the analytical team using HPLC, GC, KF, and a variety of other instruments and techniques.

•    Drafts method validation and transfer protocols for execution in the analytical team

•    Analysis of bulk chemicals and pharmaceutical compounds which require a comprehensive knowledge of chemistry and laboratory techniques, in a quality GMP environment. This may also include qualification of primary and secondary reference material to be used as analytical standards.

•    Compilation of data obtained from analytical tests and validation, analysis of the data, and drafting reports summarizing results

•    Conducts peer review of data including laboratory notebooks, forms and through various laboratory software systems

•    Conducts peer review of reports before issuance to customers and stakeholders

•    Drafts methods used for testing in analytical and QC laboratories.

•    Write Quality Control Reports (QCRs) documenting deviations and laboratory events and assessing corrective and preventative actions.

•    General housekeeping including maintaining general cleanliness of laboratories and restocking reagents and laboratory consumables.

•    Develop methods for typical analytical techniques including HPLC, GC, KF and other wet chemistry techniques

•    With guidance, develop methods for non-standard techniques including various MS techniques, non-standard chromatography and other techniques

•    Demonstrates strong Good Documentation Practices (GDP)

•    With guidance, draft specifications for testing raw materials, in-process control, intermediate and final product compounds

•    Participate in the change control process, including revision of documentation and tracking approvals

•    May be responsible for leadership of an on-going or limited scope project.

•    May be involved in interfacing with customer at times, including communicating results and status.

•    May participate in integrated product team (IPT) meetings, providing updates on status of methods, specifications, and other analytical activities.

EDUCATION AND EXPERIENCE

•    Bachelor’s or Master’s degree required in Chemistry or related Chemistry discipline

•    2-5 years of experience in quality control, method development, validation and transfer.

•    1-2 years of relevant experience in a cGMP environment preferred.

•    Knowledge of the following instrumentation is highly desired:  HPLC, GC, KF, LCMS, GCMS and wet chemistry techniques

COMPETENCIES/SKILLS

•    Good judgement and an understanding of chemistry theories and concepts.

•    Must have a high consciousness for personal and laboratory safety.

•    Strong attention to detail.

•    Strong interpersonal and verbal communication skills.

•    Team oriented.

CERTIFICATIONS and LICENSES

•    Not Applicable

This job description does not constitute a contract of employment or otherwise limit employment-at-will rights at any time.