R&D/Mfg Scientist I

Work Schedule

Environmental Conditions

Job Description

The Drug Product Division - North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization.

POSITION SUMMARY

Provides routine analyses in a biochemistry environment within defined procedures and practices. Performs analytical methods for moderately sophisticated testing on samples, stability, and production intermediates to support process development and/or manufacturing operations. May research and implement new methods and technologies to improve operations. Makes detailed observations and reviews, documents, and communicates test results.

Key Responsibilities:

• Perform analyses including instrumental and automated methods utilizing prescribed procedures and techniques.
• Maintain well-documented laboratory notebooks and records.
• Perform calculations to convert laboratory data into a reportable form.
• Compare laboratory results with specifications for acceptability and determine if repetition or OOS is required.
• Report results on the appropriate database.
• Interpret test results.
• Schedule activities to meet target dates in order to meet the needs of the supported area.
• Prepare summary reports and memos.
• Write and review SOPs and revise analytical procedures.
• Ensures safety, housekeeping and compliance issues are maintained. It is the responsibility of each employee to work in a safe and responsible manner in order to create an injury free and incident free workplace. Comply with all job-related safety and other training requirements.

Qualifications:

• Bachelor Degree in Chemistry, Biochemistry, Molecular Biology, or related physical/biological science field minimally required with 2+ years laboratory related experience, or
• Masters degree, in Chemistry, Biochemistry, Molecular Biology, or related physical/biological science field
• Experience with HPLC and Dissolution.
• Experience performing method development and validation, chemical tests with chromatographic, spectroscopic, or other analytical techniques preferred
• Experience with EMPOWER preferred.
• Equivalent combinations of education, training, and meaningful work experience will be considered.
• Good knowledge and understanding of chemistry and analytical instrumental technologies.
• Good knowledge of qualitative and quantitative chemical or microbiological analysis.
• Good problem-solving skills and logical approach to solving scientific problems.
• Strong interpersonal and communications skills, written and oral
• Routine use of MS Excel, MS PowerPoint, MS Access, and MS Word is essential.
• 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.

Physical Requirements:

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. Safety glasses, safety shoes, lab coat, nitrile or similar gloves, safety apron, organic respirator occasionally.

BENEFITS

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us ( As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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