Analytical Science & Technology Manager

people profilers pte. ltd.; Singapore; Presencial; SGD 120.000 - 180.000; Tempo integral

Benefícios oferecidos por esta vaga

21 days annual leave

Medical coverage

Completion bonus

Conversion/extension possibility

Resumo da vaga

People Profilers Pte. Ltd. seeks an experienced analytical methods leader to oversee end-to-end analytical methods for assigned products across CDMOs, from late-stage development through commercial lifecycle.

You will serve as SPOC to GPS, collaborate with EM&S, R&D, QA and regulatory teams, ensure method validation, transfer activities, and drive CPV data trending to support product quality. A strong background in cGxP, data analysis, project leadership and global regulatory familiarity is

Qualificações

• BSc in Pharmacy, Pharmaceutical Technology, Chemistry, Engineering, or equivalent scientific degree.
• Desirable MSc or equivalent experience.
• 5-8 years’ experience in pharmaceutical and chemical analytical methods development and lifecycle management as Lab Head or comparable.
• Know-how in analytical methods technologies for API, intermediates and excipients.
• Project management and team leadership experience.
• Solid data handling and applied statistics knowledge.
• Understanding of international regulatory cGxP requirements across multiple health authorities.
• 1 year contract with full benefits and potential conversion.

Responsabilidades

• Maintain oversight of analytical methods at CDMOs for APIs and starting materials to packaging where relevant.
• Act as SPOC to GPS on assigned product analytics and collaborate with cross-functional teams.
• Perform CPV data trending and statistical analysis to monitor process performance and product quality.
• Lead transfer of analytical methods and create necessary documentation for sending/receiving sites.
• Initiate investigations and improvements based on data analysis with cross-functional teams and CDMOs.
• Plan and oversee validation activities with CDMOs and QC labs, including protocols and reports.

Conhecimentos

Data handling

Applied statistics

Team leadership

Project management

Regulatory knowledge

Formação

BSc in Pharmacy / Pharmaceutical Technology / Chemistry / Engineering

MSc or equivalent experience

Descrição da vaga

Responsibilities

End to End Product analytical methods oversight and knowledge

• Maintain the oversight of the analytical methods of the assigned product(s) at given CMOs (including all analytics related to raw and starting materials to primary packaging, where relevant).
• Maintain the knowledge and the history of the product(s) analytical methods from late-stage (i.e., Phase III) development throughout the entire commercial lifecycle.

Single Point of Contact (SPOC) to GPS on assigned product(s) specific analytics

• Reports to the Head MSAT External Operations at global level and act as the MSAT Analytical Expert representative in assigned Supply Relationship Teams (SRT) for products manufactured at CDMOs.
• Work in close collaboration with EM&S, other GPS and R&D functions (e.g., Supply Relationship Team, Quality Assurance, Regulatory Affairs, Supply Chain, etc.), and establish strong partnership with CDMO QC teams with focus on ensuring and/or improve product process capability, to keep up to date the knowledge of analytical methods compliance with all applicable international guidelines and requirements, thereby warranting to maintain the product quality and the manufacturing / packaging processes in constant state of validation.
• Oversee and ensure maintenance of analytical documentation such as product specific analytical methods procedures, validation reports, Quality Risk Analysis (QRAs).

Continued Process Verification (CPV), data trending and statistical analysis

• In partnership with the Product Manager, verify CPV parameters provided by the CMOs and monitor all critical variables and key variables as appropriate for the assigned product(s) (Critical Process Parameters CPP, In Process Control IPC parameters, Quality Attributes, Characteristics of raw materials. etc.) using statistical analysis and conducting regular product specific data trending.
• Understand and run data trending and statistical analysis where needed to:
• Deepen and broaden the understanding and knowledge of the process performance and product quality.
• Detect issues in process capability, such as systematic quality defects.
• Identify trends of process deviations (e.g. deviation with common root cause).
• Issue/Approve quarterly/annual data trending report.
• Ensure data and trending is shared within SRT and conclusions aligned with the CMO, for reporting to the Head MSAT External Operations.

Transfer process

• Provide the necessary data for the technical activities involved in transferring the analytical methods for a product and its process(es), focusing on existing knowledge (e.g., Phase III development, in-licensing documentation) to create the appropriate documentation to support the sending/receiving site(s), as needed.

Investigations/improvement on product

• Initiate and support investigations and improvement projects (e.g., quality improvement, efficiency), based on the above data analysis, involving cross-functional teams and CDMO partners.
• Actively participate and represent the product(s) analytical topics in the relevant committee (e.g. MSAT Product Portfolio Monitoring Committee), where the improvements on weak point products are planned, prioritized, and monitored.

Validation

• Provide all necessary information to plan and execute the methods qualifications and validations activities with CDMOs and/or other Third-Party Laboratories, including the necessary documentation, align with other analytical expert and QC labs (i.e., CDMOs / CLOs) to organize, review and approve the study plans and samples management. The Analytical Sciences & Technical Manager is in lead for analytical methods qualification and validation.
• Supports other experts to assess the need to plan validations / re-validations / verifications, consulting approving and reviewing the process validation master plan, together with the Validation Lead or Validation Experts from the CMO.
• Compiles and approves both Validation Protocols and Report

Requirements

• BSc. In Pharmacy, Pharmaceutical Technology, Chemistry, Engineering, or equivalent scientific degree.
• Desirable MSc. or equivalent experience
• 5-8 years’ experience in pharmaceutical and chemical analytical methods development and lifecycle management as Lab Head or comparable (analytical methods development is a plus)
• Comprehensive know-how and expertise in pharmaceutical or chemical analytical methods technologies for API, intermediates, excipients and other raw materials and consumables, desired
• Project Management and team leadership experience
• Sound experience of data handling and applied statistics is a must
• Fundamental understanding of international regulatory cGxP requirements across multiple health authorities (e.g., US, EU, JP) - China is a plus.
• Fundamental understanding of standard pharmaceutical analytical testing and methods development.
• 1 year contract with full benefits (21 days annual leave, medical + completion bonus), MNC with possibility of conversion or extension.

All Successful candidates can expect a very competitive remuneration package and a comprehensive range of benefits.