Senior Formulation Development Specialist

3 days ago

Hyderabad Secunderabad Telangana, India beBeeFormulation Full time

Our organization seeks an accomplished specialist in formulation development to contribute to product formulation, ensure successful pilot and pivotal bio study execution, scale-up, and showcase. The chosen candidate will guarantee the development of robust, stable formulas and processes for given products from bench scale to commercial level.

Key Responsibilities:

  • We are looking for a Specialist who will review and analyze data, collaborate with the Strategy design team to prioritize product criticality, and plan preformulation studies. Coordination with the preformulation team will be necessary to strategize reverse engineering studies for comprehensive characterization.
  • The selected individual 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.
  • This role involves strategizing and overseeing product development, ensuring timely milestone achievements and effective formulation experiments. Daily analysis plans coordination with the Analytical team, proactively addressing potential challenges, and ensuring resource availability is crucial.
  • We require a specialist who can perform and review experiment documentation as per company systems (ELN), write Batch plans, protocols, sampling plans, etc.
  • The ideal candidate will ensure a robust regulatory strategy for drug products by preparing effective and comprehensive responses to regulatory queries related to formulation development.
  • Facilitating laboratory and equipment maintenance and implementation of company safety standards by preparing and reviewing Standard Operating Procedure (SOP) pertaining to the function is essential.
  • This position involves providing guidance to develop formulation capabilities within the team.

Requirements

Educational Qualification: Masters/Ph.D in pharma

Minimum Work Experience: 7 years of experience in formulation development

Skills and Attributes:

Technical 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 knowledge of analytical evaluation and characterization tools.
  • Brief understanding of engineering principles & process controls related to equipment and process scale-ups.
  • Awareness of agency requirements like FDA guidelines; cGMP, cGLP, SOPs.
  • Comprehensive understanding of prerequisites of preclinical/clinical studies, sourcing, analytical data interpretation, and regulatory aspects Intellectual Property (IP) laws and patents; developmental quality aspects.

Behavioral Skills

  • Excellent communication and interpersonal skills.
  • Business Acumen & Decision Making
  • Strong analytical and problem-solving abilities.
  • Performance-oriented and good at building, leveraging relationships.
  • Ability to work collaboratively with own team and cross-functional teams.
  • Commitment to learning & coaching the team.

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