Responsibilities
- Maintain the oversight of the process of the assigned product(s) at given CMOs (e.g., from raw materials to primary packaging). Maintain the knowledge and the history of the product(s) process throughout the entire commercial lifecycle since transfer from development to date.
- Liaise with Head at global level and act as the representative in assigned SRTs, with matrix reporting to the Supplier Relationship Manager (SRM). Align work packages to support the overall CMO strategy and SRT direction. Work in close collaboration with EM&S SRT functions (Quality Assurance, Regulatory Affairs, Supply Chain, etc.), and establish partnership with CMOs with focus to ensure and improve product process capability, to keep up to date the knowledge of process and to maintain the product quality and the manufacturing / packaging processes in constant state of validation.
Oversee and ensure maintenance of technical documentation such as product specific Quality Risk Analysis (QRAs). - Track CPV parameters provided by the CMOs. 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, contributing to the CMO Balanced Scorecard where relevant. Understand and run data trending and statistical analysis where needed. Ensure data and trending is shared within SRT and conclusions aligned with the CMO.
- Provide the necessary data for the technical activities involved in transferring a product and its process(es), focusing on existing knowledge, through the appropriate documentation and supporting at the giving/receiving site, as needed.
- Initiate and support investigations and improvement projects (quality, efficiency), based on the above data analysis, involving cross-functional teams.
- Provide all necessary information to perform the validation documentation, align with other process experts (i.e., CDMOs / CLOs) to organize, review and approve the study plans and samples management. Technical Manager is in lead for process 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 qualification / validation Protocols and Report
Requirements
- BSc. In Pharmacy, Pharmaceutical Technology, Chemistry, Engineering, or equivalent scientific degree. Desirable MSc. or equivalent experience
- Minimum 5-8 years experience in pharmaceutical and chemical manufacturing process development and lifecycle management as Production Manager, Process Development Expert, or comparable
- Comprehensive know how in pharmaceutical or chemical technologies such as API, Drug Product formulation, fill and finish (i.e., solutions, emulsions, and suspensions)
- 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 is a plus.
- Fundamental understanding of standard pharmaceutical analytical testing and methods development.
- 5S / 6S Lean Six Sigma Certification
- 1 year contract with full benefits (21 days annual leave, medical + completion bonus), MNC, high chance of conversion to perm.
- Job Reference: L7384VWX
All Successful candidates can expect a very competitive remuneration package and a comprehensive range of benefits.
Kindly email your resume in a detailed Word format to [email protected]
We regret that only shortlisted candidates will be notified
People Profilers Pte Ltd
Tel: 6950 9754
EA Registration Number: R22110899
EA License number: 02C4944
EA Personnel: Celeste Wong Xin Yann
