Laboratory Analyst - Westborough, United States - SOTAX Corporation

Description

As a GMP Laboratory based Analyst you will perform a variety of complex sample preparation and analysis procedures to quantitatively measure pharmaceutical, biopharmaceutical and nutraceutical compounds in a variety of formulations and/or biological matrices.

You will support the development of a variety of dosage forms from First in Human (FIH) clinical studies up to commercialization, using common to state-of-the-art analytical technologies while maintaining Good Manufacturing Practices (GMP).

In this position you will primarily support routine and non-routine release and stability testing of new chemical entities (NCEs) along with executing on validation protocols including method robustness, which will be in compliance with ICH and USP guidelines.

In addition, there will be opportunities for analytical method development and troubleshooting where you will assist with basic and novel experimental approaches to answer scientific questions with the overall goal of developing and optimizing drug product formulations.

Working closely with and on a project basis for project leading Application Scientists, you will develop productive collaborations, and communications both within and across various scientific teams.

• Analytical characterization and assessment of pharmaceutical products (e.g. cGMP compliant stability and release testing for both drug substances and drug products)
• Understanding and adherence to corporate standards regarding code of conduct, safety, and cGMP compliance.
• Compliance with all applicable client policies and procedures.
• Documenting and technical review of experimental data.
• Ability to effectively present results in both oral and written reports.
• Maintaining laboratory equipment and optimizing laboratory operations for safe and efficient use of time and resources.
• Troubleshooting equipment and experimental problems.
• Reviewing and approving data of other scientists.
• Ensuring all laboratory records adhere to cGMP/GDP expectations
• Assisting in continuous improvement activities.
• Willingness to learn new analytical techniques as opportunities arise.

• Education: 24 years of coursework in a scientific discipline (Chemistry, Biology, Physics, Environmental Science or comparable).
• Experience in specialty techniques desired (Dissolution, Disintegration, HPLC, UVvis).
• Experience in analytical methodology, such as chromatography (HPLC/GC), KF, UVvis and common compendial methods required.
• Experience with basic bench chemistry skills such as weighing, pipetting, etc.
• Familiarity with GMP requirements.
• Experience with early and/or late phase method qualification/validation studies is a plus.
• Experienced in laboratory systems (LIMS, CDS, ELN) desired.
• Experience in Microsoft Office (Excel, PowerPoint, and Word) required.
• Proven ability to interpret data by performing trend analysis
• Proven ability in technical writing skills
• Ability to independently optimize analytical methods
• Proven problem solving and troubleshooting abilities
• Strong written and oral communication skills as well as organizational skills
• Strong attention to detail
• Time management and project management skills
• Ability to work in a collaborative work environment with a team

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

• 8 hour shift