Senior Scientist

Job Summary

The Sr. Scientist Analytical Development performs extensive laboratory work to support pre-formulation, formulation development, technology transfer activities, clinical trials, and evaluation of product performance and stability.

The Sr. Scientist, with minimum supervision, manages projects to ensure all tests are completed on time, results are accurate, and all activities are documented. The Sr. Scientist effectively communicates to all stakeholders the analytical activities and findings.

Job Description

• Performs extensive laboratory work to support pre-formulation, formulation development, technology transfer activities, clinical trials, and evaluation of product performance and stability.
• Conducts analytical method development, method validation, and transfer.
• Performs analytical laboratory work to support product development.
• Accurately and timely document the experiments and results in the notebooks, ELN, and LIMS (if required).
• With minimum supervision, manages projects to ensure all tests are completed on time, results are accurate, and all activities are documented.
• Effectively communicates to all stakeholders the analytical activities and findings.
• Follows SOPs/OIs and analytical laboratory practices to ensure work quality and compliance.
• Writes the analytical methods, specifications, method validation reports, experimental reports, and SOPs/OIs
• Performs GMP comprehensive review of analytical activities such as but not limited to method development, method validation, method transfer, testing of analytical product development batches, process optimization batches, stability submission batches, and instrument technical records.
• Interact with analysts on the data review to recommend appropriate corrections, modifications, and/or improvements needed to build consistency with respect to documentation practice guidelines.
• Perform other duties as assigned.

Skills Required

• Must have QC or R&D experience in the pharmaceutical industry.
• Specific Hands-on experience with Waters & Agilent HPLC / UPLC and dissolution apparatus (USP Type 1 and 2).
• Understand fundamental analytical chemistry and chromatography.
• Able to troubleshoot testing and/or analytical method-related issues.
• Understands and follows GMP / SOP requirements.
• Familiar with analytical laboratory documentation practices.
• Expertise in Waters Empower3 CDS.
• Expertise in MS Office, such as Word, Excel, and PowerPoint.
• Good communication and interpersonal skills
• This individual must be highly motivated, have a positive “can-do” attitude, and the ability to work in a fast-paced environment as a collaborative team player.
• Practical knowledge and experience with the application of analytical method development and method validation activities.

Education/Training/Certifications

• A Bachelor’s degree in Science, or international equivalent, with 7+ years of proven Pharmaceutical Analytical Laboratory experience.
• A master’s degree or higher in science, or international equivalent, with 5+ years of proven Pharmaceutical Analytical Laboratory experience.

Additional Requirements

• Shift: AM - 08:00 AM

Type of Employment

• Anticipated contract of 1 year

"We are an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws."

JOB-10040691