Job Ref. ID:
Team Leader – Formulation
Research & Development
UNITED ARAB EMIRATES
UAE (RAK head office)
Team Leader – Formulation
Full Time Employment (Un-limited Contract)
Team Leader – the role holder is responsible to adhere with the cGMP principles and maintain them in an effective manner. Adhere to the health and safety policies and Standard Operating Procedures and ensure hundred percent in compliance with all applicable regulations, work performed in area of responsibility is conducted in right manner.
Responsible for formulation development of Generic Drug Products (QbD based), trouble shooting of Existing Formulations for quality improvement and Product processes optimization. In this role, you will be responsible to write and revise process document reports and process protocols and arrange the complete new product files for submission. Maintain awareness of relevant new and current technologies, capabilities, and effectively share this knowledge among team members.
Key responsibilities & Accountability:
• Responsible to adhere with the cGMP principles and maintain them in an effective manner.
• Ensure hundred percent in compliance with all applicable regulations, work performed in area of responsibility is conducted in right manner.
• Plan, design and perform formulation experiments for the new product development by QbD approach and generate the PDR in line with ICH guidelines.
• Lead the development of robust, stable and effective formulations to be used for in-house manufacturing for new product development.
• Responsible to prepare and supervise product experimental/manufacturing batch records and protocols at different product development stages, including from R&D prototype formulations to process optimization by following related SOPs and procedures; ensuring the detailed record and data keeping.
• Perform literature survey, patent search and preparation of Prototype Formulation Report of assigned projects.
• Identify the Reference product and initiating the process for procurement of Reference Product.
• Develop Quality Target Product Profile based on knowledge gained from literature search and Reference Product characterization as per the given product development timelines.
• Perform & conclude pre-formulation/ drug-excipient compatibility studies/prototype development of assigned projects. Research and compile raw material documentation for pre-formulation assessment to ensure compliance to testing specifications and regulatory requirements, for new products and existing products whereby and new material is sourced.
• Review of development data and systematic compilation of data and documents related to registration submission of new products and products for notifications.
• Formula & process optimization and initiation of developmental stability studies.
• Support manufacturing of pilot/scale-up batches/submission batches with necessary documentation and processes to production.
• Schedule multiple projects, set objectives and prioritize activities to meet the milestones in a fast pace environment.
• 4 years Bachelor’s degree in in Pharmacy or related Sciences.
• Master degree in Pharmacy is recommended.
• At least 7-9 years’ experience in the Formulation Development/Research in Pharmaceutical field.
• In terms of competency you are highly result oriented with strong sense of accountability & ownership.
• High on compliance adherence, having strong eye for process details.
• Must have a solution centric mind to understand issues and solve them within a stipulated time frame, ability to understand new issues quickly and make scientific decisions.
• Having an analytical mind with ability to think diversely, with outstanding planning and project management skills.
• Motivated and highly organized professional and should be able to juggle competing priorities, with high level of integrity and professionalism.
• Excellent communication, interpersonal, decision skills required
• You must have excellent understanding of Pharmaceutical Business with ability to multitask and easily adapt in a fast-paced environment.
• Ability to work under pressure, plan personal workload effectively and delegate.
• You are a team leader with a proactive and collaborative approach can take initiative and demonstrate a dynamic approach to adapt with changing business need and environment.
• Should have handled similar role for a better fitment of this role.
• Fluent in English is mandatory (communicating, writing and speaking).
• Proficient in MS Office (MS Excel and MS Word, specifically).
• In depth knowledge of the Active Pharmaceutical Ingredients, Pharmaceutical excipients, Pharmaceutical manufacturing process.
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