Manufacturing & Tech Ops - Senior Manager
PerkinElmer · Trenton, NJ · Yesterday
ManagementFull-time
About the role
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.
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 escalate risks and issues.
- Own stage-gate processes and governance deliverables, ensuring milestones are met on time, within scope, and aligned to regulatory commitments.
- Career Development
- Develop 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.
Requirements
- 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.
- Travel: Willingness to travel as required for client project assignments.
Qualifications
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