Technical Lead

Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd. (Biologics) - 8 Tuas Bay Lane Singapore

Job Purpose:
Responsible for developing, implementing and managing - through the team of Technical Experts - the Tech Transfer to site of new products to meet cGMP and quality requirements on time and on budget to ensure that programs are compliant with Regulatory Authorities’ expectations and related SOPs.
 
Key Responsibilities:
  • Support Product Steward in maintaining the process control strategy.
  • Provide technical expertise and facilitate establishment of Quality Risk Assessment (as needed).
  • Define and implement validation strategy (process, cleaning, ongoing verification) and defend to authorities.
  • Overall responsibility for establishment, prioritization, execution and tracking of Transfer Plan for process and, cleaning new product introduction.,
  • Ensure process and facility requirements for the introduction of a new product are defined for the site.
  • Establish and monitor transfer KPIs.
  • Reviews risk assessments for validation and OPV, provide guidance to facility impact and component criticality assessments.
  • Establish local procedures & templates for respective transfer documentation.
  • Ensure that all Site tech transfer activities are performed and are in line with the current Novartis requirements and cGMP, handling any deviations associated to these activities including oversight of pre-validation and validation resulting from technical changes.
  • Provide technical expertise (and may facilitate) pre-validation risk assessments using risk management tools.
  • Be a senior advisor in case of difficult technical challenges at Site.
  • Support Site MS&T Head in ensuring that responsible departments execute and maintain the transfer activities.
  • Partner with Engineering, IT, QC, AS&T to define the interfaces to equipment qualification / utilities qualification, system qualification, analytical method validation.
  • Contribute to providing experimental data obtained during the validation activities, which will be used to prepare the related registration documentation.
  • Own the Training Curriculum for own Profile and direct reports.
  • Represent site in transfer network.
 
Requirements:
  • Degree in Chemical Engineering, Biotechnology or related discipline
  • 8 year experience in manufacturing / manufacturing science and technology / technical development / quality.
  • Thorough understanding of manufacturing processes and related process equipment.
  • Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities.
  • 5 year experience in executing process validation, having led and managed validation projects.
  • Expert in reviewing and writing technical reports.
  • Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions).
  • Fundamental understanding of standard pharmaceutical analytical testing


Post Date 14 December 2017
End Date 28 December 2017

Other vacancies of Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd. (Biologics)

Snr / Manufacturing Supervisor, Shared Functions

Snr / Manufacturing Supervisor, Shared Functions

Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd. (Biologics) - Tuas (West)
16 Dec - 12:00 AM
QC Senior Biochemist

QC Senior Biochemist

Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd. (Biologics) - Tuas (West)
15 Dec - 12:00 AM
Manufacturing Engineer, Shared Functions

Manufacturing Engineer, Shared Functions

Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd. (Biologics) - Tuas (West)
14 Dec - 12:00 AM
Manufacturing Engineer, Downstream

Manufacturing Engineer, Downstream

Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd. (Biologics) - Tuas (West)
14 Dec - 12:00 AM
Manufacturing Biotechnologist, Downstream

Manufacturing Biotechnologist, Downstream

Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd. (Biologics) - Tuas (West)
14 Dec - 12:00 AM
Manufacturing Biotechnologist, Shared Functions

Manufacturing Biotechnologist, Shared Functions

Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd. (Biologics) - Tuas (West)
14 Dec - 12:00 AM
Manufacturing Biotechnologist Upstream

Manufacturing Biotechnologist Upstream

Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd. (Biologics) - Tuas (West)
14 Dec - 12:00 AM
Manufacturing Lead, Manufacturing Systems

Manufacturing Lead, Manufacturing Systems

Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd. (Biologics) - Tuas (West)
14 Dec - 12:00 AM
Technical Lead

Technical Lead

Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd. (Biologics) - Tuas (West)
14 Dec - 12:00 AM
Upstream Technical Expert

Upstream Technical Expert

Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd. (Biologics) - Tuas (West)
14 Dec - 12:00 AM
Technical Lead

Technical Lead

Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd. (Biologics) - Tuas (West)
29 Nov - 12:00 AM
Upstream Technical Expert

Upstream Technical Expert

Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd. (Biologics) - Tuas (West)
29 Nov - 12:00 AM

Company Profile

Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd. (Biologics)

Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd. (Biologics)

Singapore - West - Tuas

Novartis BioProduction Operations Singapore is a new entrant to the Singapore biologics sector. Our facility will focus on drug substance manufacturing based on cell culture technology. The site is designed to handle small and large scale volumes to support both clinical and commercial production of potential new products.