Job Description

Job Title: Method Development Scientist II

Requisition ID: 153230BR

When you2019re part of the team at Thermo Fisher Scientific, you2019ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you2019ll be supported in achieving your career goals.

Location/Division Specific Information:

62925 NE 18th Street, Bend OR / Remote

How will you make an impact?

An analytical development scientist will develop, evaluate, and validate analytical methods for release of pharmaceutical, clinical development material. In addition, this position will provide analytical support for pre-clinical and clinical development material. Personnel will manage technical/scientific project activities at the broad task level.

What will you do?

* Work in a fast-paced environment performing testing using various analytical techniques, such as HPLC, Dissolution, GC and KF.
* Develop analytical methods for small molecules and oral solid dosage forms using various techniques, such as, HPLC, GC, Dissolution, KF.
* Write and execute validation protocols in accordance with regulatory guidelines.
* Record and report results of analysis in accordance with prescribed lab procedures and systems.
* Clearly and accurately communicate the results of work by creating documentation of the testing/analysis and obtained results to the internal team and external clients.
* Review and interpret analytical test results. Make recommendations based on data.
* Contribute to maintaining a clean and organized laboratory workspace consistent with management expectations.
* Research current methodologies and assist with implementation of new methodologies and processes with supervisor support and approval.
* Collaborate with internal scientific, analytical, and laboratory functional areas to meet project and team objectives.
* Manage projects at a broad task level under minimal supervision, ensure deliverables 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?

Education:

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

Experience:

* At least 3 years working in a regulated laboratory environment. GMP experience preferred.
* At least 2 years of HPLC experience performing assay/related substance analysis and other chromatographic or spectroscopic techniques.
* At least 1 year of method development and validation experience.
* Experience with Dissolution and other analytical techniques.
* Experience with small molecules and oral solid doses preferred.
* Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills, Abilities:

* Good knowledge of method development and validation requirements as defined by regulatory bodies (e.g. USP, ICH).
* Good knowledge and understanding of basic instrumental technologies.
* Good knowledge of qualitative and quantitative chemical analysis.
* Knowledge of Good Manufacturing Practices and data integrity (ALCOA).
* Good critical and logical thinking skills.
* Effective written, interpersonal, and presentation skills.
* Ability to read, analyze, and interpret technical procedures and governmental regulations.
* Ability to apply mathematical operations to such tasks as determination of test reliability, analysis of variance, and correlation techniques.
* Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).
* Ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission2014enabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com

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.