Product Development Formulation Specialist

1 day ago

Hyderabad Secunderabad Telangana, India beBeeFormulation Full time ₹ 1,04,000 - ₹ 1,30,878
Formulation Development Specialist

We are seeking a highly skilled Formulation Development Specialist to join our team. As a key member of the Formulation Development team, you will be responsible for developing product formulations, ensuring successful pilot and pivotal bio studies, scaling up and exhibiting, and responding to deficiencies with proper justification.

Your primary focus will be on reviewing and analyzing data, collaborating with the Strategy Design team to prioritize product criticality and plan preformulation studies. You will also coordinate with the Preformulation team to strategize reverse engineering studies for comprehensive characterization.

In this role, you will evaluate available information and consult with experts to devise contingency strategies, ensuring proactive identification of potential formulation development challenges during the strategy development phase. You will also strategize and oversee product development, ensuring timely milestone achievements and effective formulation experiments.

You will perform and review experiment documentation as per company systems (Electronic Laboratory Notebooks) and write batch plans, protocols, sampling plans, etc. Your responsibilities will also include ensuring robust regulatory strategy for drug products by preparing effective and comprehensive responses to regulatory queries related to formulation development.

To succeed in this role, you must have excellent communication and interpersonal skills, business acumen, and decision-making abilities. Strong analytical and problem-solving skills are essential, as well as the ability to work collaboratively with own team and cross-functional teams.

Requirements
  • Masters or Ph.D. in Pharmacy
  • Minimum 7 years of experience in Formulation Development
Key Skills
  • End-to-end product development and troubleshooting experience
  • Developed Oral Solid dosage forms and delivered 3-4 products overall for regulated markets
  • Theoretical and practical understanding of different stages of formulation research and development
  • Demonstrated theoretical knowledge of commonly used analytical evaluation and characterization tools
  • Broad knowledge of agency requirements like FDA guidelines; cGMP, cGLP, SOPs

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