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Global Program Manager
4 months ago
Biocon Biologics is a fully integrated pure play biosimilars organization globally committed towards transforming patient lives through innovative and inclusive healthcare solutions. It is engaged in developing high-quality, affordable biosimilars aimed at expanding patient access to cutting-edge class of therapies across the world. Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led-global biopharmaceuticals company and India's first publicly listed biotech enterprise. Biocon Biologics has one of the largest biosimilars portfolios, a wide global footprint, state-of-the-art manufacturing facilities, world-class R&D ecosystem, and high quality & compliance standards, enabling it to fulfil unmet needs of patients across the globe. With the scientific capabilities, scale of manufacturing, large product pipeline, strong talent pool and expertise in developing and commercializing biologics, the company aims to serve 5 million patients through its biosimilar and reach USD 1 billion revenue mark in FY22.
Role/Job Description:
- Program Manager - Launch Management (Biologics) Global Markets
Primary responsibilities include but are not limited to the below
- Lead global launch management activities for all Biologics programs (Developed (US, EU, Swiss, CANZ, Japan) and ROW markets)
- Liaise with key stakeholders involved in the launch preparation including SCM, Program Management, Commercial, Quality, Manufacturing and others
- As a single point of contact take complete ownership of the launch Management; Ensure Artwork development & Procurement, readiness of Commercial BMR to support Drug Substance, Drug Product manufacturing, BPR and DR readiness to support packaging and dispatch of the Finished products across manufacturing sites as per the launch plan
- Liaise with development teams, regulatory and program managers to keep track of post approval variations, in terms of process modifications, reagent changes, site changes, scale changes etc.; as part of life cycle management impacting commercial launch and re-supplies
- Provide regular updates and communications to key stakeholders and management on progress and deliverables
- Draft, publish and track integrated project plans in Microsoft project and or other similar tools
- Identify risk, mitigation paths and ensure timely escalations of events impacting product launch timelines
- Strive continuously to bring in efficiency and improvement in launch management practices to remove bottlenecks and redundancies
- Set up weekly review with Internal and external stakeholders to track, monitor and report the status of the launches across projects
- Participate in joint governance forums (JDC, JQC) to discuss and escalate issues which are impacting commercial launches
- Lead preparation for biweekly calls and monthly reports to Senior Management and Portfolio Committees
- Manage all expectations of Senior Management and business needs
Technical / Functional Skills:
- Total Experience - 14+ years
- Bio-pharmaceutical/ Pharmaceutical Supply chain & Pharmaceutical Launch Management (Small molecules or Biologics)
- Bio-pharmaceutical/ Pharmaceutical Project Management Experience (at least 3+ years)
- Proficiency in Microsoft Project and Project management tools (at least 3-4 years)
- PMP certified desired but not necessary
- Basic knowledge in SAP
- Prior experience in R&D / Reg Affairs / Manufacturing / QA (optional)
Behavioral / Management / Other Skills:
- Team player as it involves managing a big team involving senior leadership
- Excellent written and oral communication skills
- Good articulation skills
- Willing to take larger responsibilities
Biocon Biologics is an Equal Opportunity, EEO / Affirmative Action Employer committed to excellence through diversity. All qualified applicants will receive consideration for employment without regard to, and no employee shall be discriminated against because of their race, color, religion, age, sex (including pregnancy), national origin, disability, genetic information, status as a protected veteran or any other characteristic protected by applicable federal, state or local law.
