Projects Manager

Role & responsibilities

• Identify the steps/stages for the projects based on what is the objective of the project.
• Projects of responsibility will include all Internal development, site transfer, third-party CMO Out licensed and in licensed (Partnership), and launch projects intended for the US market.
• Identify the (SPOCs) in each department for this project. And ensure the outcome of each SPOC is clearly defined.
• Prepare timelines for projects based on feedback from SPOC on activities to be undertaken by respective departments.
• Lead projects from requirements definition through deployment, identifying schedules, scopes, budget estimations, and implementation plans, including risk mitigation.
• Hold monthly pipeline products meetings with all cross-functional teams to ensure a unified understanding of project priorities, responsibilities, and goal dates.
• Act as an intermediary between external manufacturing partners, Marketing partners (Out licensed products) and internal stakeholders.
• Responsible for monitoring the progress of a project versus the approval assumption and raising flags when things are off course. Is also responsible for recommending stopping a project if the initial assumptions have changed so much that the ROI is compromised (or negative).
• Ensure primarily through SPOCs.
• For all new projects, ensure the CDA, business case (PIDF), terms sheet, supply agreements and quality agreements are initiated and/or in place.
• Create and route trade dress proposals for internal feedback and approval.
• Ensure arrival of API, raw materials, tooling, columns, reference stands/impurities for project initiation.
• Coordinate with regulatory and internal teams on document compilation for new and supplemental ANDA submissions.
• Coordinate with marketing and supply chain teams for forecasts, purchase orders and, launch quantity finalization.
• Coordinate with potential and current API vendors for product specifications, product samples, product lead times and, availability.
• Coordinate with third party packaging sites for quotes, feasibility and, lead times.

• Coordinate internal resources and third parties/vendors for the flawless execution of projects.
• Suggest to add/delete product due to cost/price/ equipment requirements or timelines.
• Interact with QC, and QA to ensure a prior understanding of the project
• Ensure timely completion of the project as per target.
• Establish and maintain processes for managing scope during the project lifecycle, setting quality and performance standards, and assessing risks.
• Perform quality checks on the final output and report.
• Own and develop relationships with partners, working with them to optimize and enhance our integration.
• Strong knowledge of injectable drug formulations, including aseptic processing, lyophilization, and sterilization techniques.
• Minimum [8] years of experience in handling injectable projects, preferably in a pharmaceutical environment.
• Familiarity with regulatory guidelines such as ICH, WHO GMP, and country-specific pharmacopoeias.

Key Skills:

• Strong project management skills with the ability to multitask.
• Excellent communication and team coordination abilities.
• Problem-solving and analytical thinking.
• Proficiency in relevant software tools for project tracking and documentation.

• Advanced knowledge of Microsoft Excel.
• General understanding of the Pharmaceutical Value chain and formulation development and production (US Market)
• Organizational and time management skills
• Good communication and interpersonal skills
• Additional marketing certifications are a plus
• Existing knowledge in the pharma industry of managing customer/CMO relationships is added advantage.
• Strong knowledge of injectable drug formulations

Preferred candidate profile

Looking forward for candidates only for Pharma industry, Non Pharma Pls dont apply

Perks and benefits