Career Conversion Programme

5 days ago

Singapore GLAXOSMITHKLINE BIOLOGICALS Full time
Roles & Responsibilities

The Career Conversion Programme (CCP) (Train-and-Place with Commitment to Hire) for Advanced Biopharmaceuticals Manufacturing Executives/Professionals is a talent development programme aimed at building the next generation of skilled manpower for Singapore’s Biopharmaceuticals manufacturing industry in anticipation of hiring demand.


The training programme consists of 15 months of local attachment with GSK. Due to the nature of the programme, we can only consider Singapore Citizens and Singapore Permanent Residents. For more information, please visit Career Conversion Programmes (CCP) for Individuals.


Purpose:
  • To participate in preparations, operations and completion of assigned process stages to ensure the production of bulk drug substances within established timing and quality standards.
  • To ensure good housekeeping of the facilities so as 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

Senior Biotechnologist

  • 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

Senior Biotechnologist

  • 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.

Senior Biotechnologist

  • 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/Equipmen,t 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

Senior Biotechnologist

  • 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.
Decision Making:

Proposals & Recommendations

  • Recommendations of improvement to process operating method, material management, equipment upgrades, batch records standards
Skills:

Professional

  • NITEC/HIGHER NITEC/DIPLOMA in Biotechnology/Chemical Engineering/Life Science or other relevant field

Technical

Fermentation Biotechnologist

  • Basic knowledge of cGMP
  • Aseptic operations
  • Basic microbiology knowledge

Purification and Coupling Biotechnologist​

  • Chromatography
  • Ultrafiltration
  • Filtration and titration (coupling)

​Isolator Biotechnologist

  • Aseptic operations
  • Filtration

Material Prep Biotechnologist

  • CIP
  • Washing machine
  • Autoclave

Media/Buffer Prep Biotechnologist

  • Aseptic operations
  • Buffer and media re aration

Business

  • Good communication skills
  • Good documentation skills
  • Quality mindset
  • Disciplined
Competencies:
  • Ability to work independently
  • Ability to work in a team

Where will I be based?

You will be based at one of our manufacturing site in Singapore near Tuas.


Tell employers what skills you have

Operations Planning
Anticipation
Personal Protection
Technology Transfer
Fermentation
Ultrafiltration
Chromatography
Documentation Skills
Microbiology
Purification
Titration
User Friendly
Filtration
Decision Making
Biopharmaceuticals
Autoclave

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