Project Manager Senior

Job Title: Senior Project Manager

Location: Fully Remote

Working Schedule: Standard Working Hours 8-5 PM

Top 3 Must Have Skill Sets: * NPI * Peptide Manufacturing * Digital Strategy

Position Overview: We are seeking a highly capable Senior Project Manager to lead complex technology transfer and commercialization programs within the Peptide Drug Substance (DS) Manufacturing network. This role requires a unique combination of deep peptide manufacturing expertise, exceptional project management skills, strategic thinking, digital innovation and hands-on execution.

The successful candidate will serve as a key leader responsible for transferring peptide manufacturing processes across external manufacturing sites, driving cross-functional execution, managing technical and operational risks, and ensuring successful delivery of clinical and commercial supply. In addition, this individual will champion digital innovation by leveraging data analytics, automation, and digital tools to enhance technology transfer effectiveness, improve program visibility, enable proactive risk management, and drive data-driven decision making across the manufacturing network. The candidate will play a critical role in advancing digital capabilities that increase operational efficiency, accelerate execution, and support continuous improvement throughout the product lifecycle.

The successful candidate must be equally comfortable leading complex technology transfers, managing manufacturing operations, analyzing data, and implementing digital solutions that improve execution across the network.

Basic Qualifications: Doctorate degree and 3 years of experience OR Masters degree and 5 years of experience OR Bachelors degree and 7 years of experience OR Associates degree and 12 years of experience OR High school diploma / GED and 14 years of experience

Day to Day Responsibilities:

Technology Transfer & New Product Introduction (NPI)

* Lead complex peptide drug substance manufacturing new product introduction technology transfer activities for new launches or programs tech transferring into CDMO programs from development through commercial implementation.

* Serve as the primary program lead coordinating with Process Development, Quality, Regulatory, Supply Chain, Validation, Engineering, Procurement, and Contract Manufacturing Organizations (CMOs/CDMOs).

* Develop and execute comprehensive technology transfer strategies, plans, schedules, and governance frameworks.

* Drive stage-gate deliverables and ensure alignment with program milestones, budgets, and business objectives.

* Facilitate issue resolution and rapid decision-making to maintain project timelines.

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Manufacturing Specialist

* Ensure accuracy and completion of data entries and/or tasks for budget development, monitoring, and reporting; contract inputs and requirements, confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc.

* Own Deviations (Major/Minor). Maintain and monitor systems to ensure all deviations received are appropriately investigated and concluded per the company's quality standards and procedures. Optimize deviation management, corrective and preventive actions effectiveness to prevent reoccurring events.

* Own SICAR, CAPA, CAPA EV and more complex change control records.

* Report contract site performance metrics to site lead, identify improvement opportunities for site performance, continuous improvement and standardization of performance tools used by the Work Center Teams (WCT)

* Oversight and reporting of procurement/payment of invoices

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Program & Project Management

* Lead multiple high-priority technology transfer projects simultaneously.

* Build and maintain integrated project plans with clear deliverables, critical path activities, dependencies, risks, and mitigation plans.

* Establish governance structures and provide executive-level updates on project status, risks, decisions, and resource requirements.

* Drive accountability across cross-functional teams and contract sites to ensure delivery against commitments.

* Anticipate risks before they become issues and proactively implement mitigation strategies.

* Facilitate global meetings, decision forums, and technical reviews.

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Digital Strategy, Data Analytics & Operational Excellence

* Develop and maintain executive dashboards, KPIs, and reporting tools to improve visibility of transfer readiness, milestones, risks, and performance.

* Partner with cross functional teams to implement digital solutions that improve technology transfer execution and manufacturing performance.

* Utilize tools such as Power BI, Tableau, Smartsheet, Jira, SAP, Veeva, LIMS, MES, and data visualization platforms to improve operational effectiveness.

* Leverage process and manufacturing data to identify trends, predict risks, monitor transfer readiness, and improve cycle times.

* Drive standardization and automation of technology transfer processes, governance, reporting, and performance metrics.

* Promote data integrity, governance, and compliance while improving accessibility of manufacturing and project information.

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Operational Excellence & Continuous Improvement

* Identify opportunities to improve technology transfer effectiveness, governance, standardization, and execution.

* Implement best practices and lessons learned across multiple transfer programs.

* Develop tools, dashboards, and metrics to improve visibility to project performance and risk.

* Drive continuous improvement initiatives that enhance cycle times, manufacturing readiness, and overall program success.

Possible Extension: Yes

Red Flags:

* Short durations per company

* No Pharma manufacturing operations experience

* No mention of digital innovations, use of Project Management tools and platforms

Interview Process: 1 Phone Screening & 2 Virtual Interviews