Job Title: Project Manager (New Product Introduction (NPI) Tech Transfer Lead) Duration: 12 Months (Potential extension) Location: Remote Working Schedule: Standard Working Hours 8-5PM
New Product Introduction (NPI) Tech Transfer Lead Drug Substance Manufacturing
Position Summary We are seeking a highly capable Senior Project Manager to lead complex technology transfer and commercialization programs across the Drug Substance (DS) Manufacturing network. This role combines pharmaceutical drug substance manufacturing expertise, exceptional project management, strategic thinking, digital innovation, and hands-on execution.
The successful candidate will lead the transfer of drug substance manufacturing processes across external manufacturing sites, drive cross-functional execution, manage technical and operational risks, and ensure the reliable delivery of clinical and commercial supply. The role will also champion digital innovation by using data analytics, automation, and digital tools to improve transfer effectiveness, program visibility, proactive risk management, and data-driven decision-making across the manufacturing network.
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.
Key Responsibilities Technology Transfer & New Product Introduction (NPI)
Lead complex new product introduction and technology transfer activities for drug substance manufacturing, including new launches and programs transferring into CDMO networks, from development through commercial implementation.
Serve as the primary program lead, coordinating across Process Development, Quality, Regulatory, Supply Chain, Validation, Engineering, Procurement, and Contract Manufacturing Organizations (CMOs/CDMOs).
Develop and execute comprehensive technology transfer strategies, integrated plans, schedules, and governance frameworks.
Drive stage-gate deliverables and maintain alignment with program milestones, budgets, and business objectives.
Facilitate issue resolution and timely decision-making to maintain project schedules.
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 strategies.
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 and proactively implement mitigation strategies before they become issues.
Facilitate global meetings, decision forums, and technical reviews.
Digital Strategy, Data Analytics & Operational Excellence
Develop and maintain executive dashboards, KPIs, and reporting tools to improve visibility into transfer readiness, milestones, risks, and performance.
Partner with cross-functional teams to implement digital solutions that improve technology transfer execution and manufacturing performance.
Use tools such as Power BI, Tableau, Smartsheet, Jira, SAP, Veeva, LIMS, MES, and other data visualization platforms to improve operational effectiveness.
Analyze process and manufacturing data to identify trends, predict risks, monitor transfer readiness, and improve cycle times.
Drive standardization and automation across technology transfer processes, governance, reporting, and performance metrics.
Promote data integrity, governance, and compliance while improving access to manufacturing and project information.
Education Bachelor's degree in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, Biotechnology, or a related scientific discipline.
Experience
At least 2 years of direct experience in peptide drug substance manufacturing.
Strong understanding of cGMP manufacturing and global regulatory requirements.
At least 2 years of experience leading complex, cross-functional projects involving integrated project schedules, risk registers, executive communications, and external CMOs.
Proven track record of managing multiple technology transfers and manufacturing programs simultaneously.
At least 2 years of experience using data visualization, project management, and AI-enabled tools.
Preferred Qualifications
Direct experience with peptide manufacturing.
Master's degree or PhD in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, Biotechnology, or a related scientific discipline.
Experience developing dashboards and analytics tools using Power BI, Tableau, Spotfire, or equivalent platforms.
Experience using digital tools for project management, manufacturing operations, and technology transfer execution.
Experience implementing data-driven process improvements and operational excellence initiatives.
Familiarity with AI-enabled business processes, predictive analytics, and digital manufacturing technologies.
Strong analytical skills and the ability to translate complex data into actionable business decisions.
Strong technical understanding of pharmaceutical manufacturing, commercialization, and cGMP requirements.
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
Top 3 Must Have Skill Sets:
Project Management
Drug Substance Manufacturing
Power BI
Day to Day Responsibilities:
Technology Transfer & New Product Introduction (NPI)
Lead complex new product introduction and technology transfer activities for drug substance manufacturing, including new launches and programs transferring into CDMO networks, from development through commercial implementation.
Serve as the primary program lead, coordinating across Process Development, Quality, Regulatory, Supply Chain, Validation, Engineering, Procurement, and Contract Manufacturing Organizations (CMOs/CDMOs).
Develop and execute comprehensive technology transfer strategies, integrated plans, schedules, and governance frameworks.
Drive stage-gate deliverables and maintain alignment with program milestones, budgets, and business objectives.
Facilitate issue resolution and timely decision-making to maintain project schedules.
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 strategies.
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 and proactively implement mitigation strategies before they become issues.
Facilitate global meetings, decision forums, and technical reviews.
Digital Strategy, Data Analytics & Operational Excellence
Develop and maintain executive dashboards, KPIs, and reporting tools to improve visibility into transfer readiness, milestones, risks, and performance.
Partner with cross-functional teams to implement digital solutions that improve technology transfer execution and manufacturing performance.
Use tools such as Power BI, Tableau, Smartsheet, Jira, SAP, Veeva, LIMS, MES, and other data visualization platforms to improve operational effectiveness.
Analyze process and manufacturing data to identify trends, predict risks, monitor transfer readiness, and improve cycle times.
Drive standardization and automation across technology transfer processes, governance, reporting, and performance metrics.
Promote data integrity, governance, and compliance while improving access to manufacturing and project information.
Possible Extension: Yes
Red Flags:
Little to no PM experience
Prior role as Executive VP or Director
short term work durations
Interview Process:
One phone screening and one virtual interview
Applicant Notices & Disclaimers
For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's pay range is $44.26/hr - $56.22/hr.
