Manufacturing & Tech Ops - Senior Manager

PerkinElmer; Quinte West; On-site; CAD 206,721 - 225,003; Full time

Job summary

Project Farma, a PerkinElmer company, is seeking a Senior Manager in Manufacturing & Tech Ops to lead teams and oversee work aligned to project, client, and business goals in Trenton, NJ with remote options.

The role emphasizes coaching, performance management, resource planning, and ensuring high-quality delivery within scope, timelines, and budget, with opportunities to scale and improve organizational effectiveness across multiple projects.

Qualifications

• 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).
• 7-13+ years of experience in engineering or operations within pharmaceutical, biotech, or regulated manufacturing environments.
• Demonstrated experience leading cross-functional programs or clinical and/or commercial technology transfer projects in a GMP environment.
• Strong understanding of pharmaceutical development and manufacturing processes (biologics, small molecules, 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).
• Experience applying continuous improvement tools and methods.
• 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
• Travel: Willingness to travel as required for client project assignments.

Responsibilities

• Lead or Support 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 elevate risks and issues.
• Own stage-gate processes and governance deliverables, ensuring milestones are met on time, within scope, and aligned to regulatory commitments.
• Coordinate or work with 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, development of staff awareness of CPP and 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.
• Development of manufacturing batch records, SOPs or validation protocols as required.
• Perform operational readiness assessments that fully evaluate equipment suitability and reliability, facility fit and finish, material workflow, supply chain planning, training materials and programs, quality and compliance, sampling plans, area risk assessments and PPE/gowning requirements, cleaning procedures and frequency, tier communication plans, warehouse operations and operational planning that incorporates planned downtime for necessary asset maintenance and repair.
• Support the primary point of contact and program communicator in their efforts to align with senior leadership, cross-functional partners, and external collaborators or CDMOs.
• Drive alignment across stakeholders with competing priorities; facilitate trade-off discussions and decision-making.
• Prepare and deliver high-quality program status reports, executive briefings, and governance committee presentations.
• Support the development and deployment of program management frameworks, tools, and best practices across the organization.
• 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

Skills

Team leadership

Program management

Cross-functional collaboration

GMP knowledge

Regulatory compliance

Communication

Education

Bachelor’s Degree in Life Science or Engineering

Tools

MS Project

Smartsheet

Veeva Vault

Job description

Manufacturing & Tech Ops - Senior Manager

Trenton, New Jersey | Remote

Location Trenton, New Jersey US

Job ID REQ-058107

This is a full-time salaried position with Project 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.

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.

The Manufacturing & Tech Ops - Manager/Senior Manager is responsible for leading teams 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. At more senior levels, this role provides experienced leadership and operational oversight across multiple projects or functional areas, with accountability for team performance, talent development, and consistent execution of business priorities, while partnering with senior leaders to drive continuous improvement, scalability, and organizational effectiveness.

Key Responsibilities

• Lead or Support 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 elevate risks and issues.
• Own stage-gate processes and governance deliverables, ensuring milestones are met on time, within scope, and aligned to regulatory commitments.
• Coordinate or work with 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, development of 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.
• Development of manufacturing batch records, SOPs or validation protocols as required.
• Perform operational readiness assessments that fully evaluate equipment suitability and reliability, facility fit and finish, material workflow, supply chain planning, training materials and programs, quality and compliance, sampling plans, area risk assessments and personnel PPE/gowning requirements, cleaning procedures and frequency, tier communication plans, warehouse operations and operational planning that incorporates planned downtime for necessary asset maintenance and repair.
• Support the primary point of contact and program communicator in their efforts to align with senior leadership, cross-functional partners, and external collaborators or CDMOs.
• Drive alignment across stakeholders with competing priorities; facilitate trade-off discussions and decision-making.
• Prepare and deliver high-quality program status reports, executive briefings, and governance committee presentations.
• Support the development and deployment of program management frameworks, tools, and best practices across the organization.
• 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

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).
• 7-13+ years of experience in engineering or operations within pharmaceutical, biotech, or regulated manufacturing environments.
• Demonstrated experience leading cross-functional programs or clinical and/or commercial technology transfer projects in a GMP environment.
• Strong understanding of pharmaceutical development and manufacturing processes (biologics, small molecules, 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).
• Experience applying continuous improvement tools and methods.
• 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
• Travel: Willingness to travel as required for client project assignments.

Other Preferred

• Certification in First Aid or CPR,
• Familiarity with ISO standards and FDA audit processes.
• Experience supporting equipment qualification (IQ/OQ/PQ).
• Experience with aseptic processing is a plus
• 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.

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 $(147,000) to $(160,000). 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.

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.

PerkinElmer is proud to be an equal opportunity workplace and is an affirmative action employer. PerkinElmer is committed to equal employment opportunity without regard to unlawful considerations of race, color, ancestry, religion, sex, national origin, sexual orientation, disability, age, veteran status or other characteristics protected by law.

To learn more about equal employment opportunity protections, please view the available EEO is the Law, EEO is the Law Supplement, and Pay Transparency Non-Discrimination Provision documents.

Please note that PerkinElmer is an E-Verify Employer in the United States. Additional information about E-Verify can be reviewed here.

Accessibility

PerkinElmer is committed to providing reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. If you have a disability and need assistance with any part of the hiring process or have questions about our workplace accessibility, please email us at [e-mail].