VP, Manufacturing & Technical Operations - Project Farma

VP, Manufacturing & Technical Operations - Project Farma at PerkinElmer

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VP, Manufacturing & Technical Operations - Project Farma

Raleigh, North Carolina | Albany, New York | Annapolis, Maryland | Atlanta, Georgia | Augusta, Maine | Austin, Texas | Boston, Massachusetts | Carson City, Nevada | Columbia, South Carolina | Columbus, Ohio | Concord, New Hampshire | Remote

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Responsibilities

Location Raleigh, North Carolina US Job ID REQ-057340

This is a full-time salaried position withProject Farma, a PerkinElmer company. The successful candidate will reside in one of Project Farma's primary markets and be willing to travel domestically to meet client project requests.

• Market locations include but are not limited to: Boston, Philadelphia, DMV, Northern New Jersey, Chicago, Indianapolis, Columbus, St Louis, Kansas City, Raleigh-Durham, Houston, Dallas, Boulder, Portland, San Fransisco, San Diego, and Los Angeles.

Project Farma's purpose is to improve patient lives by accelerating the delivery of life-changing therapies. We accomplish this through the successful execution of high-quality life sciences projects across the full project lifecycle. Project Farma (PF) team members collaborate with cross-functional teams to build trusted client relationships, deliver an exceptional customer experience, and contribute to business growth by identifying opportunities and applying data-driven insights to support project planning, cost, schedule, and performance management.

This role contributes to organizational success by supporting financial performance, operational efficiency, and continuous improvement, while also investing in people through mentorship, knowledge sharing, and professional development. All team members are expected to embody Project Farma's values by being curious, personable, and unselfish, while maintaining a strong commitment to a Patient Focused and People First mindset.

This role provides executive leadership for a major function, discipline, or business area, with accountability for strategy, performance, talent, and outcomes. Depending on the role, this position may also serve as a highly skilled subject matter expert, providing deep functional, technical, or industry expertise that shapes decision-making, standards, and strategic direction. It partners closely with executive peers to drive growth, scalability, and alignment with enterprise goals while fostering a high-performance, values-driven culture.

The Manufacturing & Technical Operations Practice Area Lead (PAL) is responsible for leading a team and overseeing the execution of work aligned to project, client, and business objectives. This role balances people leadership with operational accountability, including coaching, performance management, resource planning, and ensuring high-quality delivery within defined scope, timelines, and budget. This position is a senior individual contributor and cross-functional leader responsible for driving complex, high-impact programs across pharmaceutical manufacturing, process development, and supply chain functions. This role serves as the central coordinator and strategic integrator for technical initiatives spanning drug substance and drug product operations, technology transfers, regulatory submissions support, and continuous improvement programs.

The ideal candidate brings deep pharmaceutical technical knowledge, exceptional program management discipline, and the ability to influence without authority across a matrixed organization.

Key Responsibilities

• Lead end-to-end program management for complex technical operations initiatives including new product introductions, technology transfers, process validations, and facility fit assessments.
• Develop integrated program plans, critical path analyses, risk registers, and resource plans; proactively identify and escalate risks and issues.
• Own stage-gate processes and governance deliverables, ensuring milestones are met on time, within scope, and aligned to regulatory commitments.
• Coordinate cross-functional workstreams across Manufacturing, Process Development, Quality, Regulatory Affairs, Supply Chain, and Engineering.
• Partner with technical subject matter experts to translate scientific and process requirements into executable operational plans and develop staff awareness of critical process parameters (CPP) and critical quality attributes (CQA).
• Support technology transfer activities from development into GMP manufacturing, including documentation, gap assessments, and readiness reviews.
• Facilitate resolution of technical, operational, and quality issues that arise during operations, startup or shutdown of manufacturing equipment.
• Develop manufacturing batch records, SOPs, validation protocols, and regulatory filing sections as required.
• Represent operations in regulatory audits, including defense of process control strategy and executed batch records.
• Perform comprehensive operational readiness assessments to confirm that manufacturing areas, equipment, processes, materials, personnel, and support systems are prepared for safe, compliant, and reliable GMP operations. Areas of assessment include equipment readiness and reliability; facility fit and finish; material flow and warehouse operations; supply chain planning; training readiness; quality and compliance controls; sampling plans; area risk assessments; PPE/gowning requirements; cleaning procedures and frequency; tier communication processes; and operational plans that account for preventive maintenance, corrective maintenance, calibration, repairs, and other planned downtime needs.
• Serve as the primary point of contact and program communicator for senior leadership, cross-functional partners, and external collaborators or CDMOs.
• Prepare and deliver high-quality program status reports, executive briefings, and governance committee presentations.
• Drive alignment across stakeholders with competing priorities; facilitate trade-off discussions and decision-making.
• Champion operational excellence and lean principles within technical operations, identifying opportunities to improve efficiency, quality, and cycle time.
• Support the development and deployment of program management frameworks, tools, and best practices across the organization.
• Contribute to capacity planning, portfolio prioritization, and resource management processes.
• Lead, coach, and develop a team of technical professionals to deliver high‑quality work aligned with project, client, and business objectives.
• Provide day‑to‑day people leadership, including onboarding, training, mentorship, and ongoing skills development, to build a strong and capable technical team.
• Set clear performance expectations and provide regular feedback, coaching, and guidance to support individual growth and accountability.
• Other duties as assigned.

Attributes for Success

• Technical Delivery: Applies advanced technical knowledge and professional expertise.
• Innovation & Continuous Improvement: Seeks better ways, adapts to change and champions new ideas.
• Customer Focus & Professionalism: Represents PF with consistent professionalism, appropriate escalation and respect for internal stakeholders, even during high-stress delivery situations.
• Integrity & Humility: Demonstrates self-awareness and puts PF mission above ego.
• Collaboration & Communication: Communicates clearly and proactively and drives transparent alignment with clients.
• Project Execution: Delivers reliably, manages priorities and drives for high-quality outcomes.
• Growth Mindset: Shows openness to new ideas, feedback, and change.

Experience Required

• Bachelor's Degree in Life Science, Engineering, or related discipline (OR a combination of equivalent work experience in capital project engineering, pharma cGMP facility start-up, CapEx/OpEx project management and/or comparable military experience).
• 20+ years of experience in operations management within pharmaceutical, biotech, or regulated manufacturing environments.
• Demonstrated experience leading cross-functional programs or technology transfer projects in a GMP environment.
• Strong understanding of pharmaceutical development and manufacturing processes (biologics, small molecule, or both).
• Ability to interpret technical documentation and engineering drawings.
• Working knowledge of cGMP regulations (FDA 21 CFR Parts 210/211, ICH guidelines, EMA requirements).
• Exceptional organizational, communication, and stakeholder management skills.
• Proven ability to manage multiple priorities and drive results in a fast-paced, matrixed environment.
• Experience leading teams.

Other Preferred

• Familiarity with ISO standards and FDA audit processes.
• Experience supporting equipment qualification (IQ/OQ/PQ).
• Experience with aseptic processing is a plus.
• Experience with CDMOs and external manufacturing partner management.
• Familiarity with regulatory submission processes (IND, BLA, NDA, MAA).
• Proficiency with program management tools (e.g., MS Project, Smartsheet, Veeva Vault).
• Six Sigma, Lean, or other continuous improvement certification.
• Manufacturing startup, ramp-up, or remediation experience.
• Operational excellence / reliability / OEE improvement experience.
• Experience supporting client-facing consulting engagements.
• Experience developing technical teams, delivery standards, or reusable frameworks.

Project Farma is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.

Applicants must be authorized to work in the United States on a full-time basis. We will not sponsor applicants for current or future work visas for this position. This position may require significant travel to support project and business needs. We cannot employ anyone with an invalid driver's license.

The annual compensation range for this full-time position is $200,000 - 250,000. The final base pay offered to the successful candidate will be determined by factors including internal equity, work location, as well as individual qualifications, such as job-related skills, experience, and relevant education or training.

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PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.

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