Chemist II (Analytical)

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Job Description

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’s Code of Conduct. 

• Any other duties as assigned by supervisor 

What you bring to Takeda:

Education and Experience Requirements

• The candidate should have at least a Degree in pharmaceutical sciences, life sciences, biology, biotechnology chemistry, chemical engineering, or a related discipline.

• Certification and trainings such as auditor training or QP training will be advantageous.

• A minimum experience of 10 years, with 5 years of supervisory position, in the pharmaceutical or biotechnology in quality assurance, GMP compliance, operations or validation, ideally in a multinational company.

• FDA/EU cGMP know-how and a thorough understanding of ICH guidelines, together with exposure to the international regulatory network.

• Able to logically solve problems in order to find timely solutions.

• An ability to interact and communicate with all types of personalities in an effective and diplomatic manner

• Good decision-making capability

Key Skills and Competencies

• Project Management Skills 

o Organization and planning skills 

o Analytical and Logical thinking skills 

o Ability to work and collaborate within the team and with cross departments 

• Technical Skills 

o Has substantial knowledge and understanding in terms of regulatory standards requirements e.g. USP, EP, 21CFR, ICH etc. 

o 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 

o Knowledge in Empower and LIMS. 

o Knowledge in Microsoft Office. 

• Problem solving  o 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.

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