Scientist II - Development Operations

Summary:

Provide analytical support in the Laboratory Operations Department by following standard practices. Assist with method development and evaluation activities. Perform method validations and Research & Development (R&D) analytical testing. Make detailed observations and review, document, and communicate test results.

Essential Functions:

• Document all experimental datain accordance withAttributable, Legible, Contemporaneous,Originaland Accurate (ALCOA).

• Independently carryout HPLC, dissolution, GCand physicaltesting analysistesting following established procedures Analytical Methods & Standard Operating Procedures (SOPs) required.

• Work Proficiency with Empower,NuGenesis, MS Word & Excel Software.

• Perform advanced troubleshooting to overcome system suitability failures.

• Author technical documents such as analytical methods andpreparesdata summaries.

• Follow method validation protocols and carryout method validation bench work.

• Assistwith method evaluation and development work.

• Recognize and report unexpected or OutOfSpecification (OOS) resultsimmediatelyto the Supervisor and conduct laboratory investigations under direction.

• Maintain a safe working environment and report potential hazards.

• Perform alternating or rotating shift work (asrequired)

REQUIRED QUALIFICATIONS

Education:

in chemistry.

Experience:

Minimum of 2 years of experience performinganalytical testing as assigned for on prototype to commercial batches supporting development and/or manufacturing operationsOR

Minimum of1 year demonstrated proficiency as a Scientist I

Equivalency:

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

Knowledge, Skills and 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.Works well independently and in a team environment.Proficiency with the English language.

Standards and Expectations:

Follow all Environmental Health & Safety Policies and Procedures. Work collaboratively with fellow team members,modellingpositive team principles and partnering to meet project and departmentalobjectives.Carry out all duties within strict compliancetoPatheon qualitysystems SOP'sand Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Actively engage in and adhere to departmental systemsin order tomaintaina smooth and efficient workflow (visual management, scheduling systems, etc.).Be client and patient conscious at all times.Understand Key Performance Indicators and strive to improve the performance of the team byidentifyingareas 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. Proactivelyidentifyareas for improvement in the execution of procedures. Communicate risks to timelines in a proactive manner. Consistently strives to improve skills and knowledge in relatedfield.

Physical Requirements:

Light physical effort and fatigue. Walks, sits or stands for limited periods. May require occasional equipment operation including keyboard equipment. Lifts light items for limited duration. Typically located in a comfortable indoor area. There may be regular exposure to mild physical discomfort from factors such as dust, fumes or odors, temperature extremes, loud noise, strong drafts, or bright lights.Use of Personal Protective equipment may be required and may include any of the following: safety glasses, safety shoes, lab coat, gloves,hair net, beard cover,safety apron, respiratoron occasionally.

Compensation

The salary range estimated for this position based in Canada is $62,–$93,