Experience Inc. Jobs

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials

Job Description

How will you make an impact

A method development (MD) scientist will perform method development, method validation, and analytical testing activities for clinical development materials in a fast-paced environment. Personnel will manage technical/scientific project activities at the task level.

What will you do

• We perform complex testing using various analytical techniques, such as HPLC, Dissolution, GC, PXRD, FT-IR, DSC, and KF.

• Build and perform method development experiments for small molecules and oral solid dosage forms using various techniques(i.e. HPLC, GC, Dissolution, KF) with limited mentorship.

• Write and carry out validation protocols in accordance with regulatory guidelines and method validations.

• Record and report results of analysis in accordance with lab procedures, GDP, and ALCOA.

• Create documentation detailing results (e.g. Certificate of Testing, Reports, PowerPoint Slides)

• Review and interpret complex analytical test results. Make recommendations based on data and limited guidance.

• Recognize and report deviations, validation discrepancies, or unexpected results and recommend solutions.

• Research current methodologies and assist with implementation of new or improved methodologies and processes.

• Clean, calibrate, and troubleshoot analytical instrumentation as needed.

• May interact with customers and auditors.

• We lead initiatives to improve laboratory operations and complete assignments with little to no guidance.

• Train and mentor other scientists.

• Author training materials and other documents as needed.

• Collaborate with various functional areas to meet project and team objectives.

• Manage projects at the broad task level under little to no supervision, ensure deliverable are met, and identify next steps.

• Perform all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintain the necessary compliance status required by company and facility standards.

How will you get here?

• Bachelor of Science in Chemistry, Biochemistry, Biology, or related physical science.

• At least 3 years of method development and validation experience.

• At least 2 years of HPLC experience performing assay/related substance analysis and other chromatographic techniques. Experience with Empower software is helpful.

• Experience with dissolution and other analytical techniques is helpful.

• Equivalent combinations of education, training, and relevant work experience may be considered.

Competencies:

• Excellent analytical testing skills including: HPLC, GC, Dissolution

• Ability to work independently and in a team setting.

• Solid understanding of Good Manufacturing Practices and data integrity (ALCOA).

• Good knowledge of method development and validation requirements as defined by regulatory bodies (e.g. USP, ICH).

• Excellent attention to detail and critical and logical thinking skills.

• Ability to read, analyze, and interpret technical procedures and governmental regulations.

• Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).

Physical Requirements:

Typically requires standing and walking for a shift. Occasionally requires lifting of up to 20 pounds. Requires manual dexterity and visual abilities.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.