15 days old

Director of Continuous API Development and Manufacturing

Pfizer Inc.
Groton, Connecticut 06340
  • Job Type
    Employee
  • Job Status
    Full Time
  • Shift
    1st Shift

We are seeking a manager to lead chemical engineering capability for small molecule active pharmaceutical ingredient (API) continuous development and manufacturing within Chemical Research and Development (CRD) in Groton. The successful candidate will play a leading role in the development of Pfizer’s Flexible API Supply Technology (FAST) strategy.  Pfizer are investing significantly in FAST to deliver continuous development and manufacturing approaches to small molecule (API) candidates in our portfolio.  They will lead engineering resources towards the development of a suite of continuous technologies and integration with automation, process analytical technologies and manufacturing facility requirements.  They will drive portfolio application to enhance speed, quality and flexibility in API development and manufacturing from early candidate selection through to commercial supply. 

CRD, as part of Worldwide R&D in Pharmaceutical Sciences, is responsible for the development of process technology for the production of API. CRD managers engage in all facets of development from small scale synthesis in support of medicinal chemistry programs, to the development of the commercial synthetic route and transfer into commercial supply. CRD managers partner with manufacturing specialists for API synthesis in kilo-lab and pilot plant facilities, as well as provide oversight for technology transfer to Pfizer manufacturing sites and third-party facilities. 

The successful candidate will join the Technology API group as a manager and group leader of the FAST engineers.  They will provide oversight, engineering expertise and accountability for the development of continuous API platforms.  They will manage existing FAST engineers and will develop the team through workforce planning, goal setting, performance management and individual development planning. They will collaborate with managers and scientists from across Medicinal Design, Pharm Sci Small Molecule and Pfizer Global Supply to evolve FAST strategy and evolve our change management plan towards the introduction of continuous technologies.    They will be accountable for developing FAST platforms through early prototyping, development of industry standardized modules and application to the portfolio from early development through to commercial manufacturing.  They will drive our ability to develop integrated continuous unit operations for API development and manufacture, ensuring strong partnership with experts in PAT, automation and control.  They will be a strong people manager with a proven ability to drive performance and personal development of direct line reports.  They will be strong matrix leaders, able to bring diverse teams together in order to deliver complex tasks.     

 

Role Responsibilities;

 

Critical Thinking

 

  • Sets goals, objectives and priorities for the development of FAST platforms, including plug flow reactors, continuous stirred tank reactors, liquid-liquid extraction, heterogeneous catalysis and continuous crystallization. Drives rapid prototyping of technologies towards modular skid mounted technologies for application to clinical and commercial manufacturing. 
  • Provides technical and functional expertise within CRD, ensuring sound chemical engineering principles are applied in the development of FAST platforms.
  • Leverages technical and functional expertise from PSSM, Medicinal Design and PGS to ensure effective development of FAST platforms, suitable for use from early development through to commercial manufacturing.
  • Considered a subject matter expert in chemical engineering. 
  • Takes appropriate business risks to achieve desired results, ensuring safety and project delivery at all stages of development.   Guides direct reports on acceptable levels of risk-taking.
  • Develops solutions to manage evolution of batch to continuous, including hybrid options, with appropriate levels of modularity and effective evolution of supply chain.

 

Leadership

  • Collaborates across Pharm Sci Small Molecule, Medicinal Design and Pfizer Global Supply (PGS) to deliver a cohesive continuous strategy. 
  • Manages and leads a team of chemical engineers, including automation and mechanical engineering experts. within the Technology API group.  Will grow the team through workforce planning while ensuring budgetary targets are met for expense and capital.
  • Has direct accountability for setting direction, deploying resources, and leading pay, performance, goal setting, and development discussions for the FAST engineers.
  • Leads matrix teams across PSSM, Medicinal Design and PGS in order to ensure alignment and learning towards the development of FAST platforms.
  • Uses knowledge of industry, customer requirements and general business environment to adapt and implement strategic actions for the effective delivery of FAST platforms.
  • Develops and exhibits a high level of business knowledge and understanding of PGS in order to meet customer requirements for continuous development and manufacturing of small molecule API.
  • Champions innovation to drive a change from traditional batch processing to continuous processing.
  • Assesses CRD talent needs and identifies talent within the organization to ensure bench strength for critical roles within the FAST engineering team.

 

Communication

  • Actively shares knowledge across PSSM, Medicinal Design and PGS to ensure effective design and execution.  Actively shares pre-competitive knowledge with key peer pharma partners in order to develop industry standardized and sustainable platforms.
  • Contributes to the development of organizational knowledge management processes/systems to ensure global learning across our ecosystem.
  • Ensures decisions are supported by the FAST Alignment Team.
  • Contributes to the evolution of FAST strategy, including authoring of white papers and presentation and communication to the FAST Alignment Team and Portfolio Delivery Team. 
  • Contributes to an open communication environment to ensure the knowledge and expertise of the FAST team is leveraged.

 

Relocation support available

Requirements

Basic Qualifications

BS Chemical Engineering with 14 years experience, or MS Chemical engineer with a minimum of 12 years relevant pharmaceutical Chemical engineering experience in small molecule API or PhD Chemical Engineer with a minimum of 9 years relevant pharmaceutical chemical engineering experience in small molecule API.  Experience in the development and application of continuous platforms and supervising others.

An expert in chemical engineering principles with a proven track record of chemical engineering solutions for small molecule API.  An expert in process design, modelling, science of scale, quality by design and equipment design.  An expert in small molecule API development and manufacturing. 

Prior management experience required.

 

Preferred Technical Skills

An expert in continuous development and manufacturing of small molecule API. 

Ability to perform complex tasks with appropriate mental agility, including mathematical calculations and complex data analysis.

Will be required to occasionally travel internationally (0-10%) to support team goals.

Categories

Posted: 2020-09-11 Expires: 2020-10-11

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Director of Continuous API Development and Manufacturing

Pfizer Inc.
Groton, Connecticut 06340

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