R&D/Mfg Scientific II
R&D/Mfg Scientific II
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Able to lift 40 lbs. without assistance 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.)Job Description
How will you make an impact
- Investigate and validate new scientific methodologies used to control raw materials production intermediates and final products on a complex scope of projects.
- Work on technical/scientific project activities to execute strategies and technical solutions that meet client needs and expectations.
- May be involved in pre-clinical clinical and/or post-marketing stages of drug development.
- Participate in technical discussions with clients with a high level of technical proficiency.
- Typically work in a specific scientific area such as analytical development.
- Work with management and senior staff to develop options to solve complex problems.
What will you do
- Participate in the validation of test methods for pharmaceutical raw materials and finished products for strength impurities identity potency and dissolution by HPLC GC dissolution spectroscopy and traditional quantitative analysis utilizing HPLC GC LC/MS dissolution spectroscopy and compendial testing. Support internal development and/or manufacturing operations.
- Make detailed observations and analyze resolve issues document in accordance with prescribed lab procedures and systems and communicate test results. Perform complex analyses in a chemistry environment and participate in development of scientific strategy.
- Assist in developing strategies to resolve out-of-specification or unexpected results and analytical and product problems.
- Maintain and troubleshoots analytical instrumentation as needed. Perform audits on equipment periodically to verify proper calibration and use.
- 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
- May be in meetings/teleconferences with clients participating with the team. Assist with management in the coordination of development of methods and processes that meet or exceed the expectations from clients and provide innovation as necessary.
- Liaise with internal scientific analytical and laboratory functional areas to meet project and team objectives.
- Contribute to the departments talent acceleration by training Entry Level Scientists.
How will you get here
- Bachelors of Science in Chemistry Biochemistry Biology or related physical science with 3 years in a related life sciences field in pharmaceuticals Masters degree with 2-3 years of related experience.
Knowledge Skills Abilities
- Excellent knowledge and understanding of chemistry and analytical instrumental technologies.
- Excellent knowledge of qualitative and quantitative chemical analysis.
- Excellent problem solving skills and logical approach to solving scientific problems.
- Excellent proficiency with HPLC GC LC/MS and Dissolution techniques (method development validation and transfer)
- Experience in small molecules (Finished Product and/or API) required
- Excellent proficiency Dissolution techniques preferred but not required
- Experience in Biologics (SEC RP Peptide Mapping SDS Elisa iCEF) sterile Liquids and/or Lyo for injections preferred but not required
- Experience in Empower preferred.
- Experience in writing investigations CAPA Deviations.
- Excellent understanding of quality and regulatory requirements in the pharmaceutical industry including pharmaceutical GMPs. Ability to read analyze and interpret technical procedures. Ability to write standard operating procedures and policy manuals.
- Excellent interpersonal and communication skills (both oral and written).
- Good proficiency in Microsoft Office Suite (Word Excel and PowerPoint). Excellent critical and logical thinking skills.
- Ability to work on multiple projects simultaneously. Ability to develop knowledge and skills in pharmaceutical processes equipment instrumentation and procedures. Ability to keep current with scientific literature and industry trends relating to process technologies. Ability to develop technical solutions.
Our global team of more than 75000 colleagues delivers an unrivaled combination of innovative technologies purchasing convenience and pharmaceutical services through our industry-leading brands including Thermo Scientific Applied Biosystems Invitrogen Fisher Scientific Unity Lab Services and Patheon. For more information please visit .
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.
Employment Type
Full-Time
