Manufacturing & Tech Ops - Senior Director

Manufacturing & Tech Ops - Senior Director at PerkinElmer

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Manufacturing & Tech Ops - Senior Director

Raleigh, North Carolina

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Responsibilities

Location Raleigh, North Carolina US Job ID REQ-057413

This is a full-time salaried position with Project Farma, a PerkinElmer company. The successful candidate will reside in the one of Project Farmas primary market locations and be willing to travel domestically to meet client project requests.

Project Farmas 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 Farmas values by being curious, personable, and unselfish, while maintaining a strong commitment to a Patient Focused and People First mindset.

The Manufacturing & Tech Ops Director / Senior Director is a deeply experienced individual responsible for supporting project execution through technical contribution, analysis, and problem-solving with limited guidance. May serve as project technical operations lead or project lead / manager. This role applies intermediate to advanced technical expertise on more than one subject to solve complex problems, contributes meaningfully to project outcomes, and demonstrates increased independence in executing assigned work. Directors are expected to build foundational skills, apply Project Farma methodologies, and deliver high-quality work products while collaborating across disciplines. This role requires sound judgment, effective prioritization, within established project frameworks, and continued growth toward greater ownership and technical proficiency. The Director is responsible for leading a project 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.

The Manufacturing & Tech Ops Director / Senior Director is a senior, client-facing consulting leader responsible for delivering and growing high-value technical initiatives spanning drug substance and drug product operations, technology transfers, regulatory submissions support, and continuous improvement programs.

The role is expected to be fully billable, with some amount of time as assigned by leadership allocated as needed to support business development, especially on land and expand opportunities. 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

• Maintain high billable utilization consistent with senior consulting expectations.
• Travel as required to support client projects, executive workshops, tech transfers and client-facing activities.
• Act as project sponsor or senior engagement lead, guiding scope, approach, and client communication.
• Manage end-to-end program management for complex technical operations initiatives including new product introductions, technology transfers, process validations, and facility fit assessments.
• Coordinate cross-functional workstreams across Manufacturing, Process Development, Quality, Regulatory Affairs, Supply Chain, and Engineering.
• 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.
• 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.
• Lead or contribute to proposal development, scope definition, pricing input, and client presentations.
• Actively contribute to PFs reputation as a leader in manufacturing and technical operations consulting.
• Represent the firm at industry forums, conferences, webinars, and professional societies (e.g., ISPE, PDA).
• Collaborate with Regional VPs, Client Engagement, and Client Solutions teams to align resources with strategic client needs.
• Contribute to firmwide initiatives where manufacturing and tech operations expertise is required.
• 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 Ezperience

• Bachelors 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).
• 13-20+ years of experience in operations management within pharmaceutical, biotech, or regulated manufacturing environments.
• Demonstrated success delivering and advising on complex, 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.
• Willingness and ability to travel regularly in support of project delivery and client needs.
• Previous experience in development and presentation of thought leadership including conference presentations, white papers, published papers, etc.

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 $170,000 - $195,000. 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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