Job Description

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Job Title: Chemist II (Analytical)
Location: Woodlands, Singapore

About the role:

• This position is required perform all tasks associated with the QC analytical lab operations which include chemical analysis, biochemical analysis, equipment calibration/maintenance, records review, records approval, deviation/investigation write up/review, equipment qualification, method validation, method transfer and other tasks as assigned.

How you will contribute:

Core Responsibilities:

• Perform chemistry, biochemistry analysis of in-process samples, bulk drug substance (BDS), non-routine samples.
• Ensure tests assigned are performed in a timely manner in compliance to Standard Operating procedures
• Perform equipment calibration and maintenance.
• Perform review/approval of QC records/ log books.
• Perform trending of lab results.
• Initiate, participate and complete in Out Of Specification (OOS), Invalid test and Lab Deviation Investigation/ Write-Up and assist in timely closure of laboratory invalid results, lab investigation and CAPA with minimum guidance
• Write/revise SOPs, forms, training qualifications (TQ) and risk assessments (RA).
• Act as a Subject Matter Expert (SME) to provide technical advice to QC Personnel in laboratory related troubleshooting, e.g. lab equipment failure, method
• Provide appropriate training for the QC Analytical Team.
• Participate in method validation/ transfer or equipment qualification when necessary
• Ensure proper, safe handling and disposal of wastes; ensuring a safe working environment

General Responsibilities:

• Carry out 5S and ensures good housekeeping of Analytical Lab area.
• Support and participates in Operation Excellence initiatives (such as GEMBA and GMP walk).
• Lead in cross functional investigation.
• Coach and mentor junior Chemist.
• Participate in projects towards improving safety performance and continuous improvement initiatives
• Demonstrate strong technical knowledge and associated regulatory expectation.
• QC Chemist may cover for another QC Chemist of similar functions/areas in his/her absence by signing documents on his/her behalf.
• Assist Supervisor to support internal and external compliance audits.

• Responsibility to adhere to any applicable EHS requirements.
• Commitment to a fair and respectful relationship to others and behavior in accordance with Takeda\xe2\x80\x99s Code of Conduct.
• Any other duties as assigned by supervisor

What you bring to Takeda:

Education and Experience Requirements

• Bachelor Degree in Chemistry, Biochemistry, Biotechnology or equivalent, preferably with more than 4 years of experience in Pharmaceutical, Biopharmaceutical or related manufacturing environment.
• Demonstrated strong technical experience e.g. in the area of method validation, method transfer, equipment qualification, OOS investigation and associated regulatory expectation.
• Demonstrated ability to collaborate with cross functional or cross sites to achieve objectives.

Key Skills and Competencies

Project Management Skills:

• Organization and planning skills
• Analytical and Logical thinking skills
• Ability to work and collaborate within the team and with cross departments

Technical Skills

• Has substantial knowledge and understanding in terms of regulatory standards requirements e.g. USP, EP, 21CFR, ICH etc.
• Knowledge in Ion Chromatography (IC), High Performance Liquid Chromatography (HPLC), Fluorescence spectrometer (FLS), pH, Conductivity, Gel electrophoresis (SDS Page or Western Blot), Potency and ELISA
• Knowledge in Empower and LIMS.
• Knowledge in Microsoft Office.

Problem solving

• Solves problems and implements corrective actions using six sigma tools.
• Be a subject matter expert in given areas of responsibilities and able to solve issues related to his/her area of expertise.
• Knowledge in safety principles, practices, regulations and procedure related to the work

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.

Locations

SGP - Singapore - Woodlands

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Takeda