Job Description

Summary:

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.

Essential Functions:

• Documents all experimental data in accordance with Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA).
• Independently carries out HPLC, dissolution and physical testing analysis testing following established procedures Analytical Methods & Standard Operating Procedures (SOPs).
• Works Proficiency with Empower, NuGenesis, MS Word & Excel Software.
• Performs basic troubleshooting to overcome system suitability failures.
• Follows method validation protocols and carries out method validation bench work.
• Supports ECS (excipient compatibility study) testing.
• 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)

REQUIRED QUALIFICATIONS

Education:

B.Sc. in chemistry or a related field.

Experience:

Previous experience in a science related environment, academic or industry.

Equivalency:

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

Knowledge, Skills and Abilities:

Good understanding of basic chemistry and experience with common laboratory equipment and operation. Good understanding of chromatographic seperations. Knowledge of qualitative and quantitative chemical or microbiological analysis. Awareness of quality and regulatory requirements in the pharmaceutical industry. Good problem-solving skills and logical approach to solving scientific problems. Demonstrable interpersonal and communication skills (both oral and written). Ability to read 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 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 \xe2\x80\x8bexcep\xe2\x80\x8btional customer experiences\xe2\x80\x8b. 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 systems 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.

PPD