Senior Formulation Development Project Leader

2 weeks ago

Bikaner, Rajasthan, India beBeeTechnicalTransfer Full time ₹ 21,25,000 - ₹ 23,75,000
Project Manager Job Description

This role is responsible for managing and coordinating Technology Transfer projects, tasks, schedules, status and project reporting to stakeholders independently.

The ideal candidate will have experience in project management with prior experience in formulation development of solid oral dosage forms, parenteral dosage forms, liquid dosage forms, topical dosage forms, nasal spray (protein and peptide delivery system/complex parenteral dosage forms will be an added advantage).

The project manager will facilitate communication within and outside the project team, facilitate problem-solving & decision-making with respect to project deliverables and meeting timelines/tasks/'requests from project teams and other cross-functional departments.

The project manager will also be responsible for following up with team members to ensure timely deliverables (e.g., major milestones, cost and scope), focus on proactive planning to manage risk, remove barriers and meet goals, establish project plan baselines and document assumptions.

Additionally, the project manager will fully understand business cases including competitive landscape, regulatory/clinical requirements, IP landscape and other potential external factors which may derail the project, prepare draft agendas, meeting minutes, presentations for project related meetings to varied stakeholders, including governance boards.

Qualifications and Requirements
  • Qualification: M. Pharmacy or B. Pharmacy with MBA.
  • Experience: At least 9 years of experience in Project Management with prior experience in Formulation Development of solid oral dosage forms, Parenteral dosage form, Liquid dosage form, Topical dosage form, Nasal spray (Protein and Peptide Delivery System/Complex Parenteral Dosage forms will be added advantage)
  • Should have thorough knowledge of generic drug development cycle including 505(B2), complex generics, peptides, various regulatory guidelines, (ICH, ANVISA, USFDA, EMA) and regulations (GMP, GCP, GLP etc.)
  • Should have thorough understanding of eCTD dossier modules and various regulatory filing pathways for EU, US, CA, PMDA, LATAM etc.
  • Should have knowledge of EPM / MSP software and expert in Microsoft excel and power point presentations.
Benefits

We offer a dynamic work environment that fosters collaboration and growth opportunities. Our company recognizes and rewards hard work and dedication through competitive compensation packages and employee rewards programs.

Why Join Us?

Our company offers exciting challenges, a supportive environment, career development opportunities, and a fun and inclusive culture. If you're ready to take the next step in your career and join a business committed to delivering high-quality products and services, then we want to hear from you.

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