The Pharmaceutical Industry Functional Analyst serves as a trusted advisor to pharmaceutical, biotechnology, and Contract Development & Manufacturing Organization (CDMO) customers, providing deep domain expertise in manufacturing operations, quality, regulatory compliance, and digital transformation.
The consultant works closely with customer stakeholders to understand business objectives, operational challenges, and compliance requirements, helping customers identify opportunities for process optimization, manufacturing excellence, digitalization, and business transformation. The role bridges customer needs with technology and business solutions while ensuring alignment with GMP, GxP, FDA, EMA, and industry best practices.
Description of work:
- Serve as a subject matter expert for pharmaceutical, biotechnology, and CDMO manufacturing operations.
- Engage customer stakeholders to understand current business challenges, operational pain points, and strategic objectives.
- Conduct discovery workshops, process assessments, and business requirement gathering sessions with Manufacturing, Quality, Engineering, Validation, Supply Chain, and IT teams.
- Analyze manufacturing and quality processes and recommend practical, compliant, and scalable solutions.
- Translate customer requirements into solution strategies and business transformation roadmaps.
- Support business development teams during customer meetings, solution presentations, proposal development, and technical discussions.
- Provide industry guidance across pharmaceutical and biologics manufacturing processes including:
- Advise customers on manufacturing best practices, process optimization, technology transfer, batch review processes, and operational excellence initiatives.
- Review manufacturing documentation including SOPs, Batch Records, Master Production Records, Validation Documentation, and Quality Procedures.
- Identify opportunities for digitalization, automation, and process improvement initiatives.
- Advise customers on Industry 4.0, Pharma 4.0, manufacturing intelligence, data analytics, artificial intelligence, and smart manufacturing strategies.
- Facilitate business process mapping and gap assessments between current and future-state operations.
- Support development of digital transformation roadmaps aligned with customer business objectives.
- Recommend best practices to improve manufacturing efficiency, right-first-time performance, batch release cycle times, compliance, and productivity.
- Provide guidance on Regulatory Compliance: Understanding of Good Automated Manufacturing Practices (GAMP 5), FDA 21 CFR Part 11, EU Annex 11, and other industry standards for electronic records and computerized systems.
- Support customers in identifying compliance risks and developing mitigation strategies.
- Participate in regulatory readiness assessments, audit preparation, and quality improvement initiatives.
- Drug Substance Manufacturing
- Drug Product Manufacturing
- Upstream Bioprocessing
- Downstream Bioprocessing
- Fill-Finish Operations
- Aseptic Manufacturing
- Cell & Gene Therapy Manufacturing
- Vaccine Manufacturing
Job Knowledge:
- Strong understanding of pharmaceutical, biotechnology, and CDMO manufacturing operations.
- Knowledge of biologics, vaccines, cell and gene therapy, aseptic processing, and fill-finish operations.
- Understanding of manufacturing lifecycle management, process development, technology transfer, and commercial manufacturing.
- Regulatory Compliance: Understanding of Good Automated Manufacturing Practices (GAMP 5), FDA 21 CFR Part 11, EU Annex 11, and other industry standards for electronic records and computerized systems.
- Strong ability to analyze customer business processes and identify optimization opportunities.
- Experience conducting workshops, requirement gathering sessions, and stakeholder interviews.
- Ability to align customer business challenges with practical operational and digital solutions.
- Strong consulting and problem-solving capabilities.
- Excellent presentation and facilitation skills.
- Ability to communicate effectively with executive leadership, manufacturing personnel, quality teams, and technical stakeholders.
- Strong customer-facing consulting experience.
- Knowledge of digital manufacturing technologies such as Manufacturing Execution Systems (MES), Electronic Batch Records (EBR), Laboratory Information Management Systems (LIMS), Enterprise Resource Planning (ERP), Process Historians, SCADA and DCS Systems, Manufacturing Data Analytics Platforms, Artificial Intelligence and Advanced Analytics
Qualifications:
- Bachelor's Degree: Typically, in a relevant field such as Pharmaceutical Engineering, Engineering (e.g., Chemical, Mechanical, or Electrical), Information Technology, or Life Sciences.
- Minimum 5 years of experience within pharmaceutical, biotechnology, biologics, or CDMO environments.
- Demonstrated expertise in pharmaceutical manufacturing operations, quality systems, and regulatory compliance.
- Experience working directly with customers, conducting workshops, and developing business or operational solutions.
- Experience supporting technology transfer, facility startup, process optimization, or manufacturing transformation initiatives.
