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

• 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.

Kindly email your resume in a detailed Word/pdf format to ashley@peopleprofilers.com 

We regret that only shortlisted candidates will be notified

People Profilers Pte Ltd

Tel:   6950 9753

EA Registration Number: R1111375

EA licence number 02C4944

EA Personnel: Lee Hui En Ashley