Scientist II - Analytical Operations

Work Schedule

Second Shift (Afternoons)

Environmental Conditions

Able to lift 40 lbs. without assistance. Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc. allowed. Cold Room/Freezers -22 degrees. Loud Noises (Equipment/Machinery). Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.). Strong Odors (chemical, lubricants, biological products etc.). Will work with hazardous/toxic materials.

Job Description

Business Title: Scientist II – Analytical Operations

Effective Date: 28.OCT.2022

Revision #: 1

Version #: 2.0, CURRENT

Replaces: 28.MAY.2021

Summary:

Provides analytical support in the Laboratory Operations Department by following standard practices. Performs analytical testing as assigned for prototype, CTM (Clinical Trial Material) and Commercial batches supporting development and/or manufacturing operations. Makes detailed observations and reviews, documents, and communicates test results.

Essential Functions:

1. Documents all experimental data in accordance with Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA).
2. Independently carries out HPLC, dissolution, GC, and physical testing analysis following established procedures, Analytical Methods & Standard Operating Procedures (SOPs).
3. Works Proficiently with Empower, NuGenesis, MS Word & Excel Software.
4. Performs advanced troubleshooting to overcome system suitability failures.
5. Prepares data summaries and interprets results.
6. Recognizes and reports unexpected or Out Of Specification (OOS) results immediately to the Supervisor and conducts laboratory investigations under direction.
7. Maintains a safe working environment and reports potential hazards.
8. Performs alternating or rotating shift work (as required).

REQUIRED QUALIFICATIONS

Education:

B.Sc. in chemistry or a related field.

Experience:

Minimum of 2 years of experience performing analytical testing for prototype to commercial batches supporting development and/or manufacturing operations OR minimum 1 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 and experience with common laboratory equipment and operation. Advanced understanding of chromatographic separations. 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 tasks such as determination of test reliability, analysis of variance, and correlation techniques. Works well independently and in a team environment. Demonstrated computer proficiency with Microsoft Office programs. Proficiency in the English Language.

Standards and Expectations:

Follow all Environmental Health & Safety Policies and Procedures. Work collaboratively with fellow team members, modeling positive team principles and partnering to meet project and departmental objectives. Carry out all duties within strict compliance to Patheon quality systems Standard Operating Procedures (SOPs) and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Actively engage in and adhere to departmental systems to maintain a 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 by identifying areas for system improvements and engaging in problem solving. Model positive thinking and be 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 strive to improve skills and knowledge in the related field.

Physical Requirements:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about 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.

Disclaimer:

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as a comprehensive statement of work, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully align with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.