Job Description

As a Senior Biotechnologist in our Value Stream, you will participate in the preparation, operation and completion of assigned process stages to ensure the production of bulk drug substances is within establish timing and quality standards. You will also ensure good housekeeping of the facilities to keep them in good operational order in line with cGMP, safety and environmental requirements.

Key Responsibilities:

Operations

Adhere to cGMP and safety requirements

Ensure good housekeeping of associated production facilities so that they are kept in good operational order

Identify areas for improvement and participate in continuous improvement projects to enhance operational effectiveness and efficiency

Participate in commissioning and qualification activities as required

Carry out other related duties as assigned by the N+1

Assigned as in-charge by process/operations area to provide guidance/leadership to ensure processes are completed reliably

Planning

Follow the day-to-day planning

Assist Lead Biotechnologist or Shift Supervisor or Operations Superintendent in detailed team operations planning

Training & Development

Ensure that he/she is trained/qualified in the current effective SOP and OJT in accordance with the assigned training curricula prior to commencing operation.

Proactively engage N+1 to discuss personal development and follow up on agreed development plan.

To provide guidance and support to new joiner ensuring his/her smooth transition to the new environment

To develop oneself as a process SME

Guide junior employees to ensure knowledge transfer for business continuity.

Conduct classroom and on-the-job (OJT) training as assigned.

Quality

Comply with all relevant SOP/Batch record requirements.

Perform timely review of documentation and make necessary corrections.

Have good quality mindset and integrity to ensure products are manufactured with the highest quality

Participate in deviation investigation process (Process, Environmental, Maintenance/Equipment, QC) and implementation of Corrective and Preventive Action (CAPA)

Participate in cGMP self-inspections to ensure compliance with internal SOPs and regulatory requirements

Reporting/Documentation

Operate key computer applications related to production function

Ensure that batch record, checklist and logbooks are correctly recorded, cGMP complied and maintained

Maintain clear communication with N+1 and fellow colleagues, providing clear feedback of any items pertaining to safety, quality and efficiency

Participation in development and generation of production checklist, SOPs, validation protocols and the regular review and updates of these documents

Perform VS review of completed documentation to ensure adherence to GDP

To lead design/drafting of working instruction to ensure that it is user friendly to improve GDP

Technology Transfer

Participate in new technology and/or new process transfer

Security/Safety/Environment

Awareness and adherence to site safety procedure.

Ensure safe operations on the field

Identify and report all potential safety issues (personal protection requirement, equipment protection, way of working etc).

Ensure proper housekeeping of assigned production areas to minimize safety hazards

Participate in Safety Inspections

Participate in Workplace Risk Assessment

Interface with other Department/Team

Coordination with department colleagues to ensure timely supplies of materials and buffers Calibration/maintenance activities are supported.

Open communication on sampling requirements to QC department

Establish good working relationship with QA, QC, maintenance, calibration to ensure smooth operations.

Basic Qualifications

We are looking for professionals with these required skills to achieve our goals:

Min 2 years of experience in Pharmaceutical industry

Experience in GMP regulated areas

Experience in working with Pharmaceutical machine and equipment

Familiar with purification and fermentation

A good team player and able to work independently

Good communication and documentation skills

Has disciplined and quality mindset

Comfortable to work in a cleanroom environment.

To learn more about Singapore GSK and our people, please click on this link:

Why Us?

GSK is a global biopharma company with a special purpose \xe2\x80\x93 to unite science, technology and talent to get ahead of disease together \xe2\x80\x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93 as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. \xe2\x80\x8b

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it\xe2\x80\x99s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves \xe2\x80\x93 feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.\xe2\x80\x8b

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GlaxoSmithKline