Formulation Development Assistant Manager

4 months ago

Jeddah, Saudi Arabia Jamjoom Pharma Full time

Jamjoom Pharma has in a very short span of time emerged, as one of the leading pharmaceutical companies in the Afrasia region. The geographical focus of the company is on countries in the Middle East, Africa, and CIS regions. Strategic focus on selected therapeutic categories has contributed to the rapid growth, market acceptance, and overall success of the company.

**Role Summary**:
Generic product development of different dosage forms for regulatory submission. Technology transfer in collaboration with higher ups from lab to production scale with required documentation for new product registration. Liaise with AMD, Production, Supply Chain, RA and QA for timely deliverables and assist in trouble shoot the commercialized products to have compliance as per regulatory guidelines. Maintain lab areas as per GMP, Collaborate, Train and skill up-date for colleagues/subordinates

**Responsibilities**:

- Liaise with group leader to prepare project milestones for timely completion of assigned projects
- Support supply chain for sourcing and vendor development along with documents review as per applicability
- Prepare PCN for assigned products and perform the lab scale development as per related SOPs with required documentations
- Review and summaries the data, prepare presentations, present the project updates with higher ups.
- Technology transfer from Laboratory scale to production scale through system and SOPs with all required documentations.
- Preparation and review of all required documents for exhibit batch manufacturing
- Procurement initiation of raw materials / tooling with necessary documents.
- Under the supervision of group leader execution of exhibit batches in production facility and report preparation.
- Prepare and review BOM / BMR related to “new product - FOC” batches. And participate and monitor manufacturing of the batches.
- Under the supervision of group leader trouble shoot the commercialized products with required documentation to have compliance as per updated regulatory guidelines and market requirements.
- Preparation of 3.2.P for regulatory filing for new products
- Stability monitoring and reviewing of exhibit batch stability data
- Under the supervision of group leader support regulatory department by performing the tasks or by providing the justifications for responding the regulatory queries.
- Preparation and review of FP specification, RM specification, BMR, BOM, protocols, artworks and all product development documents as per the current requirements.
- Under the supervision of group leader preparation of investigation report, justification for QA / QC queries.
- Support group leader for implementation of formulation development SOPs and controls covering all areas of the departmental activities so that all relevant procedural / legislative requirements are fulfilled.
- Shoulder the responsibility of equipment management, scale up area management, Pilot lab management and formulation lab management
- Support group leader for identifying the need to new equipment
- Knowledge sharing / training subordinates in formulation development activity and other related assigned tasks as part of team development.

**Qualifications**:

- Minimum 8 - 10 years of experience in the field of formulation research and development of pharmaceutical / nutraceutical products.
- Master’s degree / Bachelor degree in Pharmacy / Science.
- Good knowledge and hands on working experience in formulation research and development of pharmaceutical / nutraceutical products with proven track record.
- Knowledge of DMF, CTD, cGMP / GLP and up-scaling of products is a must.
- Proven track record for handling of formulation with tight timelines.
- Updated knowledge of national and international regulations for pharmaceutical products is must.
- Knowledge of manufacturing instruments, equipment. PK and analytical studies are required.
- Excellent knowledge of formulation research and development, Technology transfer and troubleshooting of pharmaceutical / nutraceutical products even at shop floor.
- Well versed with regulatory guidelines - ICH, EMEA, USFDA, SFDA and handling regulatory queries.
- Well versed with GMP / GDP / GLP
- Excellent interpersonal, communication skills and team playing capability and ability to meet challenges and deadlines.
- Fluency in Arabic & English languages.

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