NPI Project Manager
Aditi Consulting
3 days ago
Contract
Remote
United States
$50 - $53 USD hourly
Payrate: $50.00 - $53.00/hr.
Summary:
We are seeking a highly capable individual 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.
Responsibilities
Qualifications
Skills
Pay Transparency: The typical base pay for this role across the U.S. is: $50.00 - $53.00 /hour. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.
Consent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. These communications may include information about potential opportunities and information. Message and data rates may apply. Message frequency may vary.
You represent and warrant that the email address(es) and/or telephone number(s) you provided to us belong to you and that you are permitted to receive calls, text (SMS) messages, and/or emails at these contacts. You also acknowledge and agree to Aditi Consulting LLC’s use of AI technology during the sourcing process, including calls from an AI Voice Recruiter. AI is used solely to gather data and does not replace human-based decision-making in employment decisions. Calls may be recorded.
Consent is not a condition of purchasing any property, goods, or services. You may revoke your consent at any time by replying “STOP” to messages or by contacting privacy@aditiconsulting.com.
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our .
#AditiConsulting
# 26 - 05758
Summary:
We are seeking a highly capable individual 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.
Responsibilities
- 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.
- 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.
- 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.
Qualifications
- Bachelor's degree in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, Biotechnology, or a related scientific discipline.
- 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.
Skills
- 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.
Pay Transparency: The typical base pay for this role across the U.S. is: $50.00 - $53.00 /hour. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.
Consent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. These communications may include information about potential opportunities and information. Message and data rates may apply. Message frequency may vary.
You represent and warrant that the email address(es) and/or telephone number(s) you provided to us belong to you and that you are permitted to receive calls, text (SMS) messages, and/or emails at these contacts. You also acknowledge and agree to Aditi Consulting LLC’s use of AI technology during the sourcing process, including calls from an AI Voice Recruiter. AI is used solely to gather data and does not replace human-based decision-making in employment decisions. Calls may be recorded.
Consent is not a condition of purchasing any property, goods, or services. You may revoke your consent at any time by replying “STOP” to messages or by contacting privacy@aditiconsulting.com.
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our .
#AditiConsulting
# 26 - 05758