US Quality Network, Transfer & New Product Commercialization Lead

MSD

Millsboro (DE)

Hybrid

USD 142,000 - 224,000

Full time

7 days ago

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Job summary

MSD is seeking an Associate Director to lead the Quality Network, Transfer and NPC in our United States operations. You will shape the quality strategy across late development through commercialization, managing biomaterial transfers and the analytical handover to ATS.

The role requires a strong track record in biologics quality, regulatory compliance, and cross-functional leadership to drive risk reduction and lifecycle support for NPC programs.

Qualifications

Bachelor’s degree in chemistry, Pharmacy, Biology, Veterinary, or related scientific discipline.
Minimum 7+ years experience in Pharmaceutical Industry with Biological products, including site-based Operations manufacturing or Quality.
Proven knowledge and understanding of USDA, EU GMP regulations, guidelines, and expectations in their application in daily operations.
MPS or continuous improvement certification (green belt minimum preferably).
Strong communication and influencing abilities.
Proven ability to manage complex projects.
Strong ability to initiate and drive change within complex organizations.

Responsibilities

Accountable for the development, execution, and implementation of the Quality strategy including Product Quality analytical strategy for NPC’s and transfers across the value chain.
Provide quality leadership from late development through commercialization, inspection readiness, launch, and lifecycle management.
Participate in increasingly complex strategy evaluations, managing overall project management/technological transfer and analytical transfer/transfer of biomaterials.
Drive Quality network strategy development and implementation.
Develop and implement an optimal quality and testing strategy delivering minimized CAPEX, maximized asset utilization, and strategic usage of analytical platforms and knowledge.
Ensure optimal usage of workforce and analytical knowledge base, developing Quality positions for filings & launches.
Drive efficiency and reliability, program level quality risk & performance, minimizing risk, and ensuring business continuity and reliability.
Support the timely execution of network activities and NPC’s.
Ensure successful handover to ATS for the analytical transfer/transfer of biomaterials.
Develop and oversee compliance to all network and transfer quality activities and NPC’s impacting Animal Health.
Develop and present quality business cases for strategic-related actions.
Lead activities from quality strategy to transfer execution by StS/ATS and report progress to governance bodies.
Work closely with Sr Specialists Network Transfer.
Apply Animal Health Quality Manual /Quality Standards guidance for Animal Health projects; design, implement, and maintain GMP and Animal Health Quality Standards during transfers and NPC’s.
Manage and ensure milestone delivery and prioritization of complex transfer Quality projects regarding Quality Assurance Release processes and Quality systems.
Partner with other global support functions such as Global Transfer teams, Global Supply chain, Bioprocess Technology Solutions, R&D, Aseptic Process Solutions, Global Regulatory Affairs, and others as appropriate.
Support and ensure collaboration and exchange of preferred cGMP practices across the network.

Skills

Biologics

Biopharmaceutical Industry

CMC Biologics

Commercialization

Manufacturing

Pharmaceutical Industry

Process Efficiency Improvements

Project Management

Quality Leadership

Quality Operations

Quality Strategy

Technology Transfer

Vaccine Manufacturing

Education

Bachelor’s degree in chemistry, Pharmacy, Biology, Veterinary, or related scientific discipline

Job description

Job Description

As the Quality Network, Transfer and New Product Commercialization (NPC) Lead you are accountable for the development, execution and implementation of the Quality strategy including Product Quality analytical strategy for NPC’s and transfers across the value chain. Provides quality leadership from late development through commercialization, inspection readiness, launch, and lifecycle management. This multifaceted role includes participating in increasingly complex strategy evaluations, where Science & Technology (StS) is responsible for overall project management/technological transfer and Analytical Technology Solutions (ATS) is responsible for the analytical transfer/transfer of biomaterials.

As a member of the Excellence Quality Team, the Associate Director drives Quality network strategy development and implementation:

Responsibilities.

Accountable for the development, execution, and implementation of the Quality strategy including Product Quality analytical strategy for NPC’s and transfers across the value chain.
Provide quality leadership from late development through commercialization, inspection readiness, launch, and lifecycle management.
Participate in increasingly complex strategy evaluations, managing overall project management/technological transfer and analytical transfer/transfer of biomaterials.
Drive Quality network strategy development and implementation.
Develop and implement an optimal quality and testing strategy delivering minimized CAPEX, maximized asset utilization, and strategic usage of analytical platforms and knowledge.
Ensure optimal usage of workforce and analytical knowledge base, developing Quality positions for filings & launches.
Drive efficiency and reliability, program level quality risk & performance, minimizing risk, and ensuring business continuity and reliability.
Support the timely execution of network activities and NPC’s.
Ensure successful handover to ATS for the analytical transfer/transfer of biomaterials.
Develop and oversee compliance to all network and transfer quality activities and NPC’s impacting Animal Health.
Develop and present quality business cases for strategic-related actions.
Lead activities from quality strategy to transfer execution by StS/ATS and report progress to governance bodies.
Work closely with Sr Specialists Network Transfer.
Apply Animal Health Quality Manual /Quality Standards guidance for Animal Health projects; design, implement, and maintain GMP and Animal Health Quality Standards during transfers and NPC’s.
Manage and ensure milestone delivery and prioritization of complex transfer Quality projects regarding Quality Assurance Release processes and Quality systems.
Partner with other global support functions such as Global Transfer teams, Global Supply chain, Bioprocess Technology Solutions, R&D, Aseptic Process Solutions, Global Regulatory Affairs, and others as appropriate.
Support and ensure collaboration and exchange of preferred cGMP practices across the network.

Qualifications

Required

Bachelor’s degree in chemistry, Pharmacy, Biology, Veterinary, or related scientific discipline.
Minimum 7+ years experience in Pharmaceutical Industry with Biological products, including site-based Operations manufacturing or Quality.
Proven knowledge and understanding of USDA, EU GMP regulations, guidelines, and expectations in their application in daily operations.
MPS or continuous improvement certification (green belt minimum preferably).
Strong communication and influencing abilities.
Proven ability to manage complex projects.
Strong ability to initiate and drive change within complex organizations.
Learning ability: autodidactic, actively learning new concepts, applying in practice, and training others.
Effective communication skills to different target groups (technicians, management, and peers) and across boundaries.
Task-oriented leadership: ability to drive project sponsorship and gain support and resources.
Focus on results: drives results based on strategy and customer needs.
Self-reflection: actively looking for feedback and translating this to personal development actions.
Broader understanding of complex (Animal Health) Quality Operations.
Self-motivated, self-sufficient, inclusive.

Required Skills:

Biologics, Biopharmaceutical Industry, CMC Biologics, Commercialization, Manufacturing, Pharmaceutical Industry, Process Efficiency Improvements, Project Management, Quality Leadership, Quality Operations, Quality Strategy, Technology Transfer, Vaccine Manufacturing

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

San Francisco Residents Only:

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

The salary range for this role is

$142,400.00 - $224,100.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

25%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License: