Specialist in Pharmaceutical Product Development

1 week ago

Hyderabad Secunderabad Telangana, India beBeeFormulation Full time ₹ 15,00,000 - ₹ 20,00,000
Job Title: Formulation Scientist

We are seeking an experienced Specialist to develop product formulations, ensure successful pilot and pivotal bio studies, scale up and exhibit, respond to deficiencies with proper justification. Ensuring the successful development of a robust stable formula and process from bench scale to commercial level is essential.

Roles & Responsibilities
  • Review and analyze data, collaborating with the strategy design team to prioritize product criticality and plan preformulation studies. Coordinate with the preformulation team to strategize reverse engineering studies for comprehensive characterization.
  • Evaluate available information and consult with experts to devise contingency strategies, ensuring proactive identification of potential formulation development challenges during the strategy development phase.
  • Strategize and oversee product development, ensuring timely milestone achievements and effective formulation experiments. Coordinate daily analysis plans with the analytical team, proactively addressing potential challenges and ensuring resource availability. Facilitate pilot and exhibit batch processes, collaborate on process optimization trials, and contribute to PDR and filing preparation for the development of a robust and stable bioequivalent drug product.
  • Perform and review experiment documentation as per company systems (ELN). Write batch plans, protocols, sampling plans etc.
  • Ensure robust regulatory strategy for drug products by preparing effective and comprehensive response to regulatory queries related to formulation development.
  • Facilitate laboratory and equipment maintenance and implementation of company safety standards by Preparing and reviewing Standard Operating Procedure (SOP) pertaining to the function.
  • Provide guidance to develop formulation capabilities within the team.

Qualifications

Educational qualification: Masters/Ph.D in pharma

Minimum work experience: 7 years of experience in formulation development

Skills & Attributes

Technical Skills

  • Experience in end-to-end product development and troubleshooting.
  • Developed oral solid dosage forms and delivered 3-4 products overall for regulated markets.
  • Good theoretical and practical understanding of different stages of formulation research and development.
  • Demonstrates theoretical knowledge of commonly used analytical evaluation and characterization tools.
  • Basic understanding of engineering principles & process controls related to equipment and process scale ups.
  • Knowledge of agency requirements like Food Drug Approval (FDA) guidelines; Current Good Manufacturing process (cGMP), Current Good Laboratory Practice (cGLP), Standard Operating Procedures (SOPs).
  • Complete understanding on 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.
  • Committed to Learning & Coaching the team.

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