Position Summary:
The R&D Specialist supports and gives assistance to the R&D Team and collaborate with her/his co-worker on all products developed and formulated products, performance of daily R&D activities, maintains and monitor all documents related to the R&D processes.
Job Scope:
- Assists in the research and development of new products and protocols
- Material Qualification and Accreditation
- Product Costing
- Perform SAP (Systems Application Product) transactions as required to support SBUs directly linked to R&D processes
- Consolidation and safe-keeping of researches and related studies
- Re-formulation of products and redirection of manufacturing processes as needed
- Generation/ Preservation and Revision (if needed) of Master Production Documents
- Trouble Shooting of problems regarding materials, processes, products and other related activities
Duties & Responsibilities:
In-charge of the manufacturing process trouble-shooting activities such as but not limited to:
- Re-processing with advance under-studies product formula and recommends pertinent percentage inclusion level to the original formulation for commercial process manufacturing
- Ensures that the following parameters are satisfied within the covered monitoring:
- Chemical analysis recovery is within the specified requirement
- Physical and testing conformity
- Commercial batching conform the re-processing guide;
- Stability, if necessary
- Compilation of test result/s and monitoring intact
- Perform the SAP (Systems Application Product) transactions required for raw material reservation/requisition for developmental products and trial batches
- Conducts study, review and pre-qualification of alternative source/s of applicable raw material substitution to existing component in the product formulation/s as a resolution to the identified trouble-shooting made and recommends accordingly
- Performs research activities, the collation and orderly safe-keeping of the researched data information, hand-outs, or related dossiers that supports the commercial trouble-shooting or the recommended product enhancement or fortification of the existing product formula
- Conducts supporting trial testing parallel to the commercially-identified trouble to rule out root-cause and recommends appropriate corrective actions/ Support on answering and investigation on product complaint
- Prepares Master Production Documentation of all Re-processing formulation and the applicable registration to the Document Control Center (DCC)
- Conducts pilot scale and production scale batch trials and technology transfer for new products developed
- Plays vital role for the developmental project’s first three (3) commercial process validation protocol run and the applicable documentation and change control
- Responsible for preparing the documents required by Regulatory for Product Registration
- SOP Creation and Revision if needed
- Collation and Preparation of Product Quality Review
- Responsible for the updating of file record of the Master Batch Production Record (MBPR) and assures the complete attachment of the relevant supporting documents of the product dossier per envelope
- Responsible for the requisition of the office and laboratory supplies pertinent to the department’s activities
- In-charge of the Monthly Developmental Progress Reporting and the need to call for any related coordination meeting with the manufacturing related departments
- Ensures safe-keeping and the corresponding inventory management of glass wares and RPDD Laboratory Equipment plus its preventive maintenance and calibration requirements
- Authorized signatory for the following documents in the absence of the RDD Manager such as: Product Label, Costing Approval, MBPR/MPDR or its BPR/PDR approval, and any Raw/Packaging Material’s accreditation
- Represents the Department for scheduled and unscheduled meetings and other technical presentation/ trainings or suppliers’ product presentation in the absence of R&D Manager
