Product Development Manager
2 days ago
We are seeking a highly experienced Product Development Manager to join our team at People Profilers Pte Ltd. In this role, you will be responsible for overseeing the commercial lifecycle of assigned products, from development to date.
Duties and Responsibilities- Maintain process knowledge and history of product(s) throughout their entire commercial lifecycle since transfer from development to date.
- Liaise with global teams and act as representative in assigned SRTs, with matrix reporting to Supplier Relationship Manager (SRM). Align work packages to support overall CMO strategy and SRT direction.
- Collaborate with EM&S SRT functions (Quality Assurance, Regulatory Affairs, Supply Chain, etc.) to establish partnerships with CMOs, focusing on ensuring and improving product process capability, maintaining knowledge of process, and keeping up-to-date product quality and manufacturing/packaging processes.
- Track CPV parameters provided by CMOs, monitor critical variables, and key variables as appropriate for assigned product(s) using statistical analysis and conducting regular product-specific data trending.
- Provide necessary data for technical activities involved in transferring a product and its process(es), focusing on existing knowledge, through appropriate documentation and supporting at giving/receiving site as needed.
- Initiate and support investigations and improvement projects (quality, efficiency) based on above data analysis, involving cross-functional teams.
- Bachelor's degree in Pharmacy, Pharmaceutical Technology, Chemistry, Engineering, or equivalent scientific degree. Master's degree or equivalent experience desirable.
- Minimum 5-8 years' experience in pharmaceutical and chemical manufacturing process development and lifecycle management as Production Manager, Process Development Expert, or comparable.
- Comprehensive knowledge 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 a plus.
- Fundamental understanding of standard pharmaceutical analytical testing and methods development.
- 5S/6S Lean Six Sigma Certification.
The estimated salary range for this position is $120,000-$150,000 per annum, inclusive of benefits and bonuses. We offer a competitive remuneration package, comprehensive benefits, and opportunities for career growth and professional development.
Please submit your detailed resume in Word format to Celeste Wong Xin Yann, EA Personnel, People Profilers Pte Ltd.
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