Phenikaa Pharma

Deputy Manager of Injectable R&D (GMP-EU Pharmaceutical Manufacturing)

Posted: 2 days ago

Job Description

1.   Job Description· Research, design, and optimize formulations for injectable dosage forms: solutions, suspensions, emulsions, and lyophilized injections.·   Plan and execute process scale-up from lab → pilot → manufacturing.·   Conduct pilot trials, record data, and analyze scale-up differences.·  Technology transfer: develop master formulation and master packaging procedures; develop and validate manufacturing processes (formulation, filling, sterilization, lyophilization); support implementation and supervise technology transfer activities in the production area.·   Support quality evaluation and stability studies.·  Technical documentation and product registration: review technical dossiers of raw materials; prepare registration dossiers (Module P1, P2); support the Regulatory Affairs Department in technical responses to authorities.·   Ensure compliance with quality standards and support risk management activities.·   Collaborate with QA, QC, Production, Marketing, Warehouse, and Procurement during project execution.·   Perform other tasks assigned by the direct supervisor.Details will be discussed during the interview.2.   Candidate Requirements·  Bachelor’s degree in Pharmacy or higher (Master/PhD in Pharmaceutics/Pharmaceutical Technology is preferred).·   Knowledge & Experience-      Strong knowledge of sterile injectable formulation and manufacturing technologies.-    Minimum 5 years of experience in injectable R&D at a GMP-certified pharmaceutical plant (GMP-EU/PIC/S preferred).-      Experience in developing parenteral products such as infusions, injectable emulsions, sterile solutions, and lyophilized products is an advantage.-      Hands-on experience in scale-up, process validation, and technology transfer.·    Skills-      Strong teamwork skills.-      Problem-solving skills.-      Proficient in English.-      Proficient in Microsoft Office.-      Good communication and team management skills.3.    Benefits-   Salary: Negotiated based on competency and experience.-   Full participation in social, health, and unemployment insurance according to labor law.-   Eligible for other welfare and benefit programs as regulated by the Company.-   Professional, open, and friendly working environment with strong opportunities for career advancement.-  Enjoy special preferential policies for employees and their family members when using education and healthcare services within the Phenikaa ecosystemWork Location: Hoa Lac Hi-Tech Park (company shuttle bus provided)

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