Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, 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

Discover Impactful Work:
Join our team as an R&D/Manufacturing Scientist II at Thermo Fisher Scientific, where you'll contribute to pharmaceutical analytical research and development. You'll perform complex analytical testing, develop and validate methods, and ensure product quality while collaborating with cross-functional teams. This role offers the opportunity to work with advanced technology and contribute to life-changing healthcare solutions. You'll conduct sophisticated chemical and physical testing, lead technology transfer activities, and support manufacturing operations. Working closely with internal teams and clients, you'll help advance pharmaceutical development while maintaining the highest standards of quality and compliance.

Day in the Life:

• Consistently aligns with housekeeping standards.
• Maintains a clean and safe work environment including work area, instrumentation, and testing materials.
• Understands and works in compliance with all cGMP, OSHA, and safety regulations, BOPs and SOPs.
• Performs cGMP procedures, lab procedures, BOPs and SOPs.
• Performs daily instrument calibrations / verifications as required.
• Responsible for weekly/monthly inspection of safety equipment.
• Assembles and operates laboratory (bench scale) equipment and carries out experiments independently.
• Conducts routine and non-routine chemical testing and method development/qualification for pharmaceutical raw materials, in-process samples, and active pharmaceutical ingredient samples by internally developed and compendial test methods.
• Performs developmental and validated test methods using HPLC, GC, spectroscopy, GC/MS, LC/MS, and/or traditional wet chemical testing, and trains other employees on these techniques.
• Provides thoughtful technical review of data collected by other employees.
• Recognizes and reports/investigates out-of-specification or unexpected results and non-routine analytical and product problems. 
• Clearly and accurately communicates the results of work by documenting the testing/analysis and obtained results. Records and reports results of analysis in accordance with prescribed lab procedures and systems.
• Assists in preparing regulatory documents and other communications with outside agencies, clients, and/or colleagues from other corporate sites.
• Writes and reviews Analytical Methods, validation protocols, validation reports, and SOPs if needed.
• Solves problems related to the processing of chemical procedures.
• Ability to drive functional, technical and operational excellence.  Ability to inspire and drive team effectiveness.  Good knowledge of medical terminology, clinical data, and Good Manufacturing Practices (GMP).   Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint.  Effective written, interpersonal, and presentation skills.  Ability to work on multiple projects simultaneously.
• Position requires 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.

Keys to Success:
• Advanced Degree, no prior experience required, or Bachelor's Degree plus 5 years minimum of experience in pharmaceutical or related industry, preferably in GMP/GLP environment
• Preferred Fields of Study: Chemistry, Biochemistry, Pharmaceutical Sciences, or related physical science field
• Extensive hands-on experience with analytical instrumentation including HPLC, GC, LC/MS, spectroscopy, and dissolution testing
• Strong knowledge of pharmaceutical GMPs, regulatory requirements, and quality systems
• Proven expertise in method development, validation, and transfer of analytical methods
• Experience with data analysis, interpretation, and technical writing of protocols and reports
• Proficiency in Microsoft Office Suite and analytical software systems
• Strong analytical and problem-solving capabilities
• Demonstrated project management abilities and capacity to manage multiple projects
• Effective written and verbal communication skills for both technical and non-technical audiences
• Ability to work both independently and collaboratively
• Physical requirements include standing for extended periods, lifting up to 35 pounds, and working with laboratory equipment
• Must be able to follow safety protocols and wear appropriate PPE as required
• Demonstrated alignment with company values of Integrity, Intensity, Innovation, and Involvement

Excellent Benefits

·         Benefits & Total Rewards | Thermo Fisher Scientific

·         Medical, Dental, & Vision benefits-effective Day 1

·         Paid Time Off & Designated Paid Holidays

·         Retirement Savings Plan

·         Tuition Reimbursement

OTHER

·         Relocation assistance is NOT provided

·         Must be legally authorized to work in the United States now or in the future, without sponsorship

·         Must be able to pass a comprehensive background check, which includes a drug screening