AM Mgr Sr Mgr - F&D Project Management with Pharma Co, Mumbai
Naukri.com
Mumbai
9d ago
source : Naukri.com

Client Company : I

Job Location : Fort / Nariman Point, Mumbai, Maharashtra

Numbers of Positions : 1

Asst. Manager - Projects Management

Markets : USA

Profile : Projects Management for Pharma Formulation Products Development

Products : Solid / Liquid / Semi-Solid / Parenterals / Ophthalmic Pharmaceutical Products.

Job Profile :

  • Overall the incumbent will be responsible for planning and direction of Project Management activities and client-sponsored projects.
  • job will include performing a number of duties outlined below, but not limited to, with minimal or no supervision :
  • Ensuring functional and compliant Project Management department by efficient planning and managing complex R&D projects from inception to launch, execution of 505(b)2, Generic first to file;
  • first to market; clinically and logistically challenging projects.

  • Ensuring collaboration among R&D, Clinical Development, Production and Cross Functional Teams (CFTs) to enable timely project delivery.
  • Define and implement a robust project review mechanism to address escalations and mitigate risks.
  • Manage co-development projects with multi-national partners
  • Provide digital dashboards to senior management to track the status of deliverables (filings and milestones)
  • Collaborate with business to showcase R&D capabilities to potential partners for co-development projects.
  • Prepare and manage annual budgets.
  • Representing the Project Department in meetings with FDA & corporate project reviews.
  • Staying updated with recent practices and trends in the generic pharmaceutical industries and project management tools.
  • Providing scientific and technical guidance to management on new project management models and suggests alternatives.
  • Ability to effectively manage multiple projects, duties and assignments.
  • Any other task assigned to you by the company officers and / or designated management staff from time-to-time.
  • Client Company : II

    Job Location : Andheri East, Mumbai

    Numbers of Positions : 1

    Manager / Sr. Manager - Projects Management

    Markets : USA

    Products : Topical formulations like creams, oils, gels, solutions, lotions

    Job Profile :

  • ANDA project management
  • Overseeing Companys special projects (ANDAs) for the US market
  • End to end execution of ANDA (Para I Para IV) / IND projects 505( b1) 505(b2) from timely procurements, managing development timelines, bio study slots, co-
  • ordinating with the manufacturing plant for exhibit batch schedules and monitor regulatory teams activities for dossier compilation and determine filing dates.

  • Host weekly round of discussions and fortnightly project reviews to track ongoing activities.
  • Evaluate potential bottlenecks during project execution and monitor day to day activities.
  • Compilation of budgetary estimates and project plans for monitoring timelines.
  • Budget reconciliation and man-day consumption tracking to analyze overall project profitability.Overseeing Companys special projects (ANDAs) for the US market.
  • Identification of new products in various therapy areas which a company can take up for development & manufacturing.
  • Evaluate the products with respect to their Market potential, NPV & IRR values, API challenges, Regulatory challenges, Developmental challenges, Manufacturing challenges
  • Initiation of the product development in R & D and tracking of its progress until the dossier is filed. Provide technical inputs wherever necessary.
  • Managing Projects within all Key PMP knowledge Areasi.e Feasibility Assesment, Project Scope, Business case, Project Budget, Timelines, Risk analysis, Planning, Execution , role out communication plan, Project Control till Project Closures.
  • Projecting Timelines : Formulation Development (Qbd Design),Method Developments, Deformulation, DOE, D+EStudies, Stability studies, E&L Studies, Product Development report , Technology Transfer, Exhibit Batches planning, Packaging & Labelling, Dossier Filing etc.
  • Driving the development of the product by co-ordinating with R & D, regulatory affairs and marketing.
  • Communication to various regulatory consultant for FDA Correspondence and Pre IND Meetings
  • CRO / CMO / CDMO identification and liaison with them for the development and / or commercial manufacturing of the products.
  • Price Negotiations, finalizing commercial proposals and Master Service Agreements defining the mode of Alliance.

  • Key account Management of partnered Projects.
  • Overseeing supply chain activities and commercial launches in regulated markets.
  • Salary : INR 10,00,000 - 20,00,000 P.A.

    Employment Type : Permanent Job, Full Time

    Keyskills

    project management pmp Project Coordinator Program Management Portfolio Management Strategic Planning Project Tracking

    Desired Candidate Profile

    Client Company : I

  • M.Pharm / MBA (Pharma / Projects Management) / PGD (Projects Management) with 6-8 years of demonstrated industry and project management experience, preferably with generics in handling complex R&D projects from inception to launch, execution of 505(b)2 ;
  • other alternate approaches for regulated markets with emphasis on respiratory and topical dosage forms.

  • Ability to work with cross functional teams and develop good working relationships within and outside the department.
  • Strong Project management skills.
  • Excellent leadership skills interacting with senior leaders and team across.
  • Experience working in a global organization where stakeholders and project team members are geographically dispersed.
  • Well experience on using Microsoft Projects.
  • Should have excellent communication skills with good spoken and written English.
  • Client Company : II

  • Candidate should have M.Sc / B.Pharm / M.Pharm + MBA with 8+ yrs experience in Projects Management / Business Development for R&D / Formulation Development Projects for Regulated markets.
  • Candidates from CRO would be first choice.
  • Should have Good understanding of product development life cycle for Liquid Oral / Topical / Semi Solid Oral Formulations.
  • Should have understanding of preparing and review of finished product specification, product development report, master documents like Stability protocol, agreements, project costing, risk assessment and mitigation strategy etc.
  • Experience of direct contact with clients by telephone and face-to-face meetings.
  • Should have excellent communication skills with good spoken and written English.
  • UG : B.Pharma - Pharmacy

    PG : M.Pharma - Pharmacy, MS / M.Sc(Science) - Any Specialization

    Doctorate : Doctorate Not Required

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