Position: Assistant Innovation & Development Manager - Formulation
Job Location: Cheng, Melaka, Malaysia
Duties and Responsibilities:
- To design and perform formulation workshop experiments to determine the appropriate prototype formulation to support NPD and reformulation, product improvement projects. This includes applying existing or new scientific methods and theories to solve problems during NPD and reformulation projects.
- To be actively involved in the CDO (Outsource development plan), this includes attending meetings, project tracking, and traveling with a team during the execution phase.
- To summarize experimental findings, review and perform data analysis and present study conclusions, and update plans to management.
- To prepare technical protocols and reports.
- To review technical documents prepared in NPD, reformulation, product improvement, CDO technology transfer projects.
- To coordinate review of active pharmaceutical ingredient (API) and source selection for use in NPD and reformulation projects.
- To support I&D staff and coordinate with QC staff (when required) to provide material and information in support of product development and manufacturing.
- To interact with other functional groups like Technical Services, Analytical testing service, Regulatory affairs, Production to define the product content and system requirements.
- To provide technical support to the Business Pipeline department, who acts as the central resource to coordinate with marketing, regulatory, manufacturing, quality and test laboratories as the new products [or services] move to completion.
- To provide technical guidance in identifying and implementing of NPD pipelines to meet customer's requirements.
- To oversee the activities which may include devising research methods; setting up laboratory equipment; building models and prototype; calculating and analyzing test results and preparing detailed reports with conclusions and recommendations.
- To engage actively with the regulatory affair team for the on time completion of dossier documents for NPD, improvement product development reports for reformulation projects, technical justification for screening and Variation application.
- To manage and keep abreast of the clinical affairs policies and SOPs within the company, with the current requirements.
- To provide technical guidance and in coordinating (internal and external) and implementing bioequivalence studies [and other clinical studies] to meet regulator's requirements in multiple countries.
- To lead or take part in the trial monitor during the conduct of bioequivalence/clinical studies.
- To manage the engagement of new centres /sites for bioequivalence / clinical studies, which includes, but is not limited to, selection, audit, qualification of new centres /sites
- To ensure NPD activities conform to ISO 9001:2008, Good Laboratory Practices (GLP), and current Good Manufacturing Practices (cGMP) regulations.
- To direct and supervise the I&D team consisting of direct reports and/or matrix resources to achieve goals.
Minimum Requirements:
- Master's degree in Pharmacy, Science, or equivalent knowledge in pharmaceutical product formulation and research.
- At least 9 years of experience, preferably with relevant experiences in a similar industry for pharmaceutical research, development, and technical field, management of multiple projects, and knowledge of quality assurance.
- At least 5 years of project experience and people management experience or handling a team of 2- 4 formulators.
- Well experience in handling development with QBD and DOE concepts.
- A subject matter expert in product development of Oral, Liquid, Topic, and sterile dosage forms.
- A pro-active self-starter who can operate both individually and as part of a team
- Outstanding needs analysis, positioning, business justification, and closing skills
- Superior presentation and excellent oral and written communication & influencing skills and preferably with basic financial management skills.
- Possess a unique combination of creative and analytical talents and must be able to conceptualize new ideas, research new ideas, and evaluate them objectively from a market and financial standpoint.
- Have a high degree of tolerance for uncertainty since new product development is ever-changing.
