Sr. Manager, PGS New Product Modelling

Role Summary

The heightened new product launch and acceleration activity in PGS has made it a necessity for an enhanced infrastructure (work processes, systems, and dedicated focus) within PGS for the modelling of both physical capacity as well as head count equivalents (HCEs).  The Sr Mgr, PGS New Product Modelling  (NPM) is a pivotal position in the definition and implementation of the required infrastructure across PGS (all modalities).  While this position will be within the Launch Excellence group, it will work hand in hand across the Operational Units (Bios, SM, ES) as well as key enablers (i.e. analytical/QC, GT&E MSAT, etc.), and will feed new product information into the LRVF (Long Range Volume Forecast) owned by Network Performance.

The Sr Mgr, PGS New Product Modelling Associate (NPM) will help analyze / codify PGS activities (including HCEs) by modality (SM, Vx, Mab, GTx), as well as key strategic RSM/RM for new modalities where current commercial sources are not yet established.  This modelling work will be integrated in the  Op Plan cycle  leveraging systems (RAPID, Planisware), learnings and practices (standard offerings) from WRD/PharmSci, however, making fit for purpose for PGS use (not yet fully leveraging these systems in PGS new products).

The primary focus of this new position is to define the work process across PGS (both annual Op Cycle, and PGS standard offerings), and partner groups (i.e. PPM, MedSci, PDA, Procurement, etc) and propose required PGS organization constructs needed to support going forward implementation and continued enhancement (both internal to LaunchX and broader PGS, including Network Design & Performance).  Statistical analyses (Monte Carlo) will be used for both capacity and HCE planning purposes.

Finally, this role will support New Modalities activities for the mRNA platform, and other platforms as they are developed.  This may include working on high uncertainty level components (such as the RM / plasmid / DS needs) and developing appropriate strategies for continued manufacturing, progression to GMP status (as needed) and commercialization.  Further work may include capital, capacity planning, and cost of goods analyses as may be called for. Project management activities (incl. meeting organization / minutes/ timeline analyses / etc.) will also be involved.

The heightened new product launch and acceleration activity in PGS has made it a necessity for an enhanced infrastructure (work processes, systems, and dedicated focus) within PGS for the modelling of both physical capacity as well as head count equivalents (HCEs).  The Sr Mgr, PGS New Product Modelling  (NPM) is a pivotal position in the definition and implementation of the required infrastructure across PGS (all modalities).  While this position will be within the Launch Excellence group, it will work hand in hand across the Operational Units (Bios, SM, ES) as well as key enablers (i.e. analytical/QC, GT&E MSAT, etc.), and will feed new product information into the LRVF (Long Range Volume Forecast) owned by Network Performance.

The Sr Mgr, PGS New Product Modelling Associate (NPM) will help analyze / codify PGS activities (including HCEs) by modality (SM, Vx, Mab, GTx), as well as key strategic RSM/RM for new modalities where current commercial sources are not yet established.  This modelling work will be integrated in the  Op Plan cycle  leveraging systems (RAPID, Planisware), learnings and practices (standard offerings) from WRD/PharmSci, however, making fit for purpose for PGS use (not yet fully leveraging these systems in PGS new products).

The primary focus of this new position is to define the work process across PGS (both annual Op Cycle, and PGS standard offerings), and partner groups (i.e. PPM, MedSci, PDA, Procurement, etc) and propose required PGS organization constructs needed to support going forward implementation and continued enhancement (both internal to LaunchX and broader PGS, including Network Design & Performance).  Statistical analyses (Monte Carlo) will be used for both capacity and HCE planning purposes.

Finally, this role will support New Modalities activities for the mRNA platform, and other platforms as they are developed.  This may include working on high uncertainty level components (such as the RM / plasmid / DS needs) and developing appropriate strategies for continued manufacturing, progression to GMP status (as needed) and commercialization.  Further work may include capital, capacity planning, and cost of goods analyses as may be called for. Project management activities (incl. meeting organization / minutes/ timeline analyses / etc.) will also be involved.

Role Responsibilities

Enhance PGS Framework for New Product HCE activity in Planisware/RAPID

• Analyze and refine Standard Offerings (buckets of activity) for PGS NP work during pre-licensure development, launch and global expansion (align w/ co-dev model).  Continued enhancement based on feedback loop (actuals)
• Refine work process with OpU tech transfer leads for HCEs
• Support PGS implementation strategy for Activity Tracker (methodology for capturing & analyzing PGS actuals)
• Scenario planning as needed (i.e. BD/M&A activity, new technology/continuous processing, major project accelerations, etc.)
• Establish and drive continuous improvement on HCE efficiency and forecast accuracy of Standard Offerings

Partner with Network Performance to Establish & Manage “PGS New Product Op Plan Cycle” – aligned with overall Op Plan cycle managed by PDA/PPM for GDP, PBG and WRD

• Refine time based work process within PGS.  Support process for HCEs forecasting.  Support process for capacity (owned by Network Performance) by providing new product volumes prior to transition into site based/Network Performance models)
• Integrate into PGS annual budget process (as needed/appropriate)

Partner with Sites/OpU’s & Network Performance on PGS Capacity Modelling for New Products (capacity by modality, across modalities)

• Establish and maintain models used for New Product models.  Maintain interfaces and integrate into “PGS NP Op Plan cycle” (timescale)
• Drive harmonization of process and communication models across modalities (SM/LM / GTX / NM)

• Scenario planning as needed (i.e. BD/M&A activity, new technology/continuous processing, major project accelerations, etc.)
   

Partner with PGS Finance & OpUs on early stage complex project COGS Modelling for New Products

• Support harmonization of process and R&R across PGS by phase of project & modality, including interfaces and handoff points to co-dev leaders and sites
• Establish “database” and benchmarking to be supportive of early valuation and development efforts (Op Plan, BD, etc.)

Provide New Product Modelling Support to Business Development activities (i.e. HCEs, capacity, COGS)

• Scenario planning as needed

Provide Project Management support to support New Modalities projects (as needed)

• Take leaderships roles, as required, to handle urgent project needs (such as allocation of key RMs / integration of supply chain requirements).  Work with SMEs at sites / vendors to minimize potential disruptions.  Define and develop new team structures to enable success.

• Develop ideas and lead/co-lead complex projects across business units.
• Develop and manage plans including monitoring progress independently.
• Continuously improve the resource management capabilities through the delivery of robust business tools, processes and data.
• Work with leadership to define and implement appropriate measures and set operational and quality performance targets in line with Pfizer's vision and goals.
• Interpret internal and external business challenges and apply technical interpretation to meet business needs independently.
• Collaborate with and mentor colleagues on best practices in systems and information management.
• Help others take appropriate risks based on division's objectives.
• Build trust and credibility with stakeholders and peers.

Qualifications

Must-Have

• 7+ years experience in pharmaceutical development and manufacturing.

  Preferred experience with both large and small molecule

• Strong analytical capabilities with experience in modeling complex situations

Nice-to-Have

• Experience in New Product Development
• Experience in Small molecule and Large molecule / Vaccines manufacturing technologies and/or operations

 
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment.  As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations.  These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure.  Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act.  Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government.  If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.  Pfizer is an E-Verify employer.

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