Job Description

How will you make an impact?

Provides analytical support in the Laboratory Operations Department by following standard practices. Assists with method development and evaluation activities. Performs method validations and Research & Development (R&D) analytical testing. Makes detailed observations and reviews, documents, and communicates test results.

What will you do?

Documents all experimental data in accordance with Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA)

Independently carries out HPLC, dissolution, GC and physical testing analysis testing following established procedures Analytical Methods & Standard Operating Procedures (SOPs)

Works Proficiency with Empower, NuGenesis, MS Word & Excel Software

Performs advanced troubleshooting to overcome system suitability failures

Authors technical documents such as analytical methods and prepares data summaries

Follows method validation protocols and carries out method validation bench work

Assists with method evaluation and development work

Recognizes and reports unexpected or Out Of Specification (OOS) results immediately to the Supervisor and conducts laboratory investigations under direction

May be essential to perform alternating or rotating shift work (as required)

How will you get here?

Education

B.Sc. in chemistry or a related field.

Experience

Minimum of 2 years of experience performing analytical testing as assigned for on prototype to commercial batches supporting development and/or manufacturing operations OR

Minimum of 1 year demonstrated proficiency as a Scientist I

Equivalency

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

Knowledge, Skills, Abilities

Good understanding of basic chemistry.

Advanced understanding of chromatographic separations.

Good knowledge and understanding of chemistry and analytical instrumental technologies.

Good knowledge of qualitative and quantitative chemical or microbiological analysis.

Good knowledge of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs and descriptive organic chemistry.

Good problem-solving skills and applies a logical approach to solving scientific problems.

Good interpersonal and communication skills (both oral and written).

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.

Willingly assists junior chemists in problem solving and training.

Proficiency with the English language.

Works well independently and in a team environment.

Core Competencies

Put the Customer First: Think and act with a customer-centric mindset to deliver exceptional customer experiences.

Own Your Results: Take personal accountability for all you do and always exercise good judgement.

Find a Better Way Everyday: Be intellectually curious and embrace Practical Process Improvement (PPI).

Standards and Expectations

Follow all Environmental Health & Safety Policies and Procedures. Work collaboratively with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives. Carry out all duties within strict compliance to Patheon quality system SOP's and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Actively engage in and adhere to departmental systems in order to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.). Be client and patient conscious at all times. Understand Key Performance Indicators (KPI's) and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving. Models positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working. Proactively identify areas for improvement in the execution of procedures. Communicate risks to timelines in a proactive manner. Consistently strives to improve skills and knowledge in related field.

Physical Requirements

Position requires ordinary ambulatory skills and physical coordination sufficient to move about lab/lab 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 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, latex or similar gloves, safety apron, organic respirator occasionally.

Job Category

Manufacturing & Production, Research & Development, Scientist

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.