API/DP Quality by Design Principal Scientist, Right First Time Program Office

This colleague will represent the Right First Time Program Office in partnership with Co-Development Teams across PharmSci & PGS, to technically define and lead both the product Risk Assessment processes (e.g., Right First Time) and Product Knowledge Management deliverables (e.g., PUP) throughout the Co-Dev lifecycle.

Key accountabilities include:

• Represent the Right First Time PO to lead cross functional co-development teams in the conducting of risk assessments and the development of process understanding plans via the i-Center.
• Comfortable discussing and advising colleagues with implementing the scientific deliverables underpinning Quality by Design drug development
• Lead the RFT process across a range of technologies including the recent expansion into FAST and PCMM
• Increasingly support a range of customized RFT processes based on appreciation of key project attributes (eg volume, complexity, CoG, development speed)
• Ensure consistent execution of established tools to enable colleagues across WRD to capture, retain and leverage process understanding for both internal sites and CMOs.
• Support key continuous improvement activities associated with RFT including the conducting of Co-Dev Lessons Learned

ROLE RESPONSIBILITIES

• As an RFT lead technical facilitator, partner with line subject matter experts in the generation of key content to drive the RFT process for projects e.g. flow diagrams, cause and effect matrices and failure mode & effects analysis templates.
• Apply own technical knowledge & experience to allow effective proactive facilitation of API & DP risk assessments.
• Be effective at technically leading multiple co-development teams working at various sites globally in the WRD and PGS network as well as Contract Manufacturing Organizations (CMOs).
• Partner with and provide technical recommendations to project teams to support process robustness assessments.
• Provide training and coaching in effective use of the RFT tools as needed, including (PUP, i-Center, GDMS, etc.).
• Develop and deliver training materials based on their underpinning scientific principles for all process tools and ensure that all training materials undergo continuous improvement
• Drive the continuous improvement of knowledge management processes and tools to enable rapid access to data and knowledge over the entire product lifecycle that underpin a broad range of technical Co-Dev RFT deliverables
• Enhance and implement a cross co-development Lessons Learned culture by facilitating Lessons Learned sessions and ensuring implementation of the high value lessons through a cross-functional LL Council.

BASIC QUALIFICATIONS

• Bachelor's Degree with 12+ years of experience or Master's Degree with 9+ years of experience or PhD with 4+ years of experience with a degree in a science, engineering or technology discipline required.
• Excellent project management capabilities and communication skills throughout all levels of the organization is required.
• Demonstrated capability to take informal leadership role in working team environment.
• Proven ability to implement system improvements into work processes

PREFERRED QUALIFICATIONS

• 6-10 years' in the biopharmaceutical industry preferred.
• Minimum of 2 years' experience working directly with multiple pharmaceutical sites preferred.
• Pfizer knowledge management practices would be beneficial
• Strong team working and interpersonal skills, ability to communicate effectively with R&D and Manufacturing stakeholders .
• Practical experience in participating in risk assessments strongly preferred.
• Any experience of leading/conducting risk orientated discussions would be a plus.
• Experience with Informatics and/or programming would be a plus.
• Experience creating webpages and use of file sharing programs, e.g. SharePoint is also a plus.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Some business travel may be required (5-10%) to other Global Pfizer sites

Additional Job Information

• Last Date to Apply: May 28, 2021
• Eligible for Employee Referral Bonus

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