Technology Transfer Lead, Pfizer Parenteral Center of Excellence

ROLE SUMMARY

Provides technical leadership and is a main point of contact representing Pfizer Parenteral Center of Excellence (PCoE) with Pfizer sites that manufacture parenteral injectables and external CMOs (Contract Manufacturing Organizations). The role is involved in the collaborative development of products for PCoE and works directly to provide guidance for Pfizer and CMO groups that are supporting PCoE PharmSci products. Focused on global product development through commercial launch.

This individual must be able to work in a collaborative environment and must be able to effectively communicate to both internal and external customers. To be successful, the position must interface effectively with analytical, formulation, microbiology, device, regulatory, operations, quality and other essential functions. The role oversees and manages the tech transfer process of sterile injectable (includes solutions, lyophilized products)and other pharmaceutical dosage forms (includes solutions, suspensions, emulsions, etc.) and must have a fundamental understanding of cGMP, sterile operations, etc.

The individual will be expected to provide detailed technical, process understanding and expertise in support of complex technical investigations, process troubleshooting, technical transfer, scale up, as well as batch manufacturing (demonstration/engineering/registration/process validation/initial commercial batches). The individual will be instrumental in facilitating project and technical ownership to PGS (Pfizer Global Supply) prior to PV (Process Validation)/commercial batch manufacturing.

The individual will be expected to leverage collaboration across multiple groups and competing priorities and should have extensive understanding and experience dealing with large technical group of engineers, scientist and technicians in large multi-product contract manufacturing facilities. The role should be knowledgeable of the documentation necessary for tech transfer of new products, including tech transfer plans and risk assessments.

The position resides in the GPPD (Global Parenteral Product Development) organization and is responsible for Right First Time (RFT) processes and knowledge management for the HBU portfolio as part of global "codevelopment" project teams. Using principles of Quality Risk Management (QRM) and sound science, the individual will help facilitate the design and the development of manufacturing processes at key milestones.

ROLES & RESPONSIBILITIES

• Participate in cross-functional teams, within PCoE and manufacturing sites, in the evaluation and implementation of novel manufacturing technology and processes in commercial processes that increase process robustness and promote a culture of innovation and continuous improvement.
  
• Author, review, and/or approve site technology transfer documents such as tech transfer plans, risk assessments, study protocols, reports, batch records, sampling protocols, CAPAs, change controls, standard operating and business procedures, policy and instructions, etc.
  
• Facilitates the RFT risk assessment process by coordinating with subject matter experts to assist in the generation of key content to support the RFT and knowledge management processes for projects.
  
• Prepare, distribute & present project and portfolio status reports to project team members and management.
  
• Contribute to regulatory filings, as required, including reviewing and authoring CTD sections and peer review of submissions.
  
• Requires detailed knowledge of technology transfer and scale up. Must be capable of assessing challenges and able to provide technical support to resolve the technical issues during the manufacturing.
  
• Able to trouble shoot/recommend the solutions to resolve the technical issues with manufacturing equipment.
  
• Able to handle multiple projects simultaneously at different CMOs and internal manufacturing sites. Responsible for working with global R & D groups in optimizing/establishing process parameters (with commercial processes in mind) within the design space to evaluate/implement opportunities for process improvements.
  
• Requires understanding of scientific principles, operational aspects of production equipment, automation control systems, processing requirements and any related procedural requirements with emphasis on sterile injectable pharmaceutical dosage forms.
  

BASIC QUALIFICATIONS

• B.S. and 10 years, Ph.D. + 4 years, or M.S. + 6 years of relevant pharmaceutical development and/or manufacturing experience.
  
• Detail and planning oriented.
  
• Able to work autonomously and demonstrate strong oral and written communication skills.
  

PREFERRED QUALIFICATIONS

• Working knowledge of project management concepts and tools.
  
• Digital competency for process mapping tools/software (Visio, etc.) and other process capability based tools/software (MiniTab, etc.)
  
• Experience in process development and pharmaceutical manufacturing.
  

PHYSICAL/MENTAL REQUIREMENTS

• Working environment mostly involves normal office environment.
  
• Occasionally, laboratory and manufacturing working environment where procedures, PPE (personal protective equipment) or protective apparel/devices may be needed to address noise, dust, fumes, safety hazards, etc.
  
• May need to enter and participate actively in manufacturing areas to support tech transfer, scale up, or various aspects of the drug development process which would involve long periods of standing.
  

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Colleague will work standard 1st shift work schedule, however, additional hours outside of this (including weekends) are required frequently to support conference calls with international groups and oversight of engineering and exhibit batches.
  
• Some travel will be required to, albeit limited to not more than 5-10% in a given year.
  

Other Job Details:

• Eligible for Relocation Package: yes
• Eligible for Employee Referral Bonus: yes

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