• Job Description

  Req#: 4892990

  
  ROLE SUMMARY
  
  • Lead the PSSM SI development team for Sterile Injectable products for globally regulated markets.
  • By working with the PSSM SI Innovation team, support design and testing of potential future sterile injectable products for development.
  • Oversee and ensure API and Commodity sourcing activities to enable the portfolio.
  • Oversee and ensure successful execution of all Tech Transfer to commercial manufacturing sites and teams, under the Co-Development model.
  • In collaboration with GTE, provide support for select Sterile Injectable products, life cycle management of on-market products, as requested.
  • As a key member of the PSSM SI Leadership team, represent the organization on any number of internal and external initiatives within PSSM.
  • Work broadly within PSSM organization to ensure best practices in Formulation (Drug Product Design, DPD), Analytical (ARD), Microbiology (ARD) and Extractables & Leachables (ARD), and API (Chemical R&D, CRD) activities use the latest scientific best practices.
  • Support the creation and delivery of digital predictive sciences and informatics by working with PSSM Data Sciences and PSSM SI organizations.
  
  ROLE RESPONSIBILITIES
  
  • Lead the product development team at IITMRP Chennai – Formulation, Analytical, API Sourcing/Testing, Ideation Proof-of-Concept Testing, and Microbiology teams – for the development of pipeline sterile injectable products. Extractable and Leachable (E&L) activities are within scope of analytical activities.
  • Promote a culture of innovation and compliance, with focus on execution. Develop a high-performing team.
  • Benchmark performance against other Pfizer R&D locations, as well as competing Indian companies.
  • Lead and guide the product development of pharmaceutical dosage forms for various regulated and emerging markets with experience in guiding injectable product development.
  • Manage product development time-lines and to ensure regulatory filings as per the business plan.
  • Manage the technical transfer of the product from the development site to global sites within the network. Co-ordination to ensure smooth technology transfers from laboratory scale to commercial scale.
  • Collaborate with the GTE (formulation, analytical and packaging development teams) to ensure smooth execution of exhibit and commercial batches. Collaborate with PGS in the Pfizer co-development model for development and launch of new products.
  • Interface with commercial to characterize product strategy, and finalize the product pipeline and time-lines.
  • Build relationship with manufacturing sites, and coordinate with various site functions, to ensure aligned product development, smooth transfer of technology and execution of exhibit batches.
  • Provide support to investigation of incident/referred market complaints, as required.
  • Ensure effective implementation of safety systems and procedures within the function and active participation for implementation of the same in the premises.
  
  Opportunity Identification
  • Identify and/or guide regulatory strategy for product applications or response to queries, when necessary.
  • Develop product formulation strategy to circumvent existing Intellectual Property, in alignment with advise from IP Counsel.
  • Identify opportunities for generation of new Intellectual Property for Pfizer, during the course of product development.
  
  Team and Leadership Development
  • Build quality and compliance mindset within the development teams. Own quality as part of the business. Partner with Quality/Compliance function, and ensure inspection-readiness at all times.
  • Hire and develop talent within PharmSci teams. Develop leaders within, and provide for adequate succession. Mitigate risk of attrition.
  • Equip IKKT R&D laboratories with appropriate technology, equipment and instrument, to facilitate world-class development capabilities.
  • Provide leadership for business initiatives in R&D. Network and collaborate across global locations.
  
  Project Planning and Execution
  • Lead detail planning, and execution to maintain endorsed timelines.
  • Apply latest development approaches, and best-in-class work processes for efficient use of resources, and optimal development timelines.
  
  Communication Skills
  • Ensures effective, accurate, and timely communication of program information to meet the needs of the co-development team and stakeholders
  • Supports development of project level goals that contribute to the overall goals of the business and monitors progress against these goals.
  • Establish connections with global development centers.
  • Support operation of the Chennai R&D site, as needed.
  Ability to Influence and Motivate
  • Role requires leadership influence
  • Influence the allied functions at site (like Instrumentation, Quality, Facilities/GWS, GTE etc.) for optimal operation of the site.
  • Clarifies project deliverables/workload to enable partner lines to assess resource needs, raise gaps, and partner with team leadership to resolve.
  
  QUALIFICATIONS
  
  
  BASIC QUALIFICATIONS
  • Minimum 15 years’ experience in the Pharmaceutical industry, with extensive experience in development of parenterals. Previous roles must include leadership of development teams – both formulation and analytical – including broad range of product portfolio (anti-infectives, oncolytics, potent compounds, controlled substances etc.).
  • Experience in developing complex SI products, alternative formulations and drug-device combination products desired
  • Experience or exposure to support of on-market products desired. Experience in a multi-national company preferred.
  • Familiarity with Project Management principles desired, with exposure to matrixed organizational structure.
  •
  • Understands all aspects of product development including formulation, process, analytical, microbiological, bioassay, extractables & leachables (E&L) development requirements from product inception through product launch.
  • Demonstrated influencing and negotiating skills. High awareness of personal limits and a willingness to proactively consult others to ensure quality of judgement
  • Exposure to project governance preferred.
  • Experience working in multi-disciplinary teams as well as working independently in ambiguous situations/assignments, gathering input from colleagues and management to address issues
  • Familiarity with planning, scheduling, and forecasting.
  • Requires excellent English oral and written communication skills. And the ability to understand and convey scientific information to varied audience.
  
  PREFERRED QUALIFICATIONS
  • PhD in Pharmaceutical Sciences, Pharmaceutics, or Chemistry preferred. Master degree can be acceptable, provided accompanied by appropriate development and leadership experience.Strong leadership, negotiation, interpersonal, and facilitation skills.
  • Familiarity with project management tools and techniques (such as developing integrated project plans, critical path management, project change control, project risk management, and decision analysis).
  • Proven ability to succeed in a fast-paced, challenging and complex environment.

  Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

  Research and Development

  #LI-PFE

• About the company

  At Pfizer we know that great things happen anywhere people come together with one shared goal. And the greatest rewards are sometimes where you least expect them. The future of medicine is happening at Pfizer.

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