Aravind Sukumaran

• Led CDMO startup facility 4 x2K scale Single use multiproduct facility ahead of timelines for startup and on time delivery for Client engineering runs
• Managed EHS department as Interim lead with heavy influence on Proactive Safety measures for the site
• Responsible for setting Global KPIs for the site in partnership with Site Lead from Laupheim, Germany Site
• Created a sustainable results driven Tiered process and enhanced supportive leadership and cascade for SLT members and the organization
• Lead member in HOP (Human and Organizational Performance) initiative for the site
• Site strategy deployment and lead for projects -Finance, Quality and Operations, Tech transfer and Attrition rate reduction initiatives
• Influenced Site by providing significant process improvements in short time -Red to green metrics influence on Batch Release, Safety and quality metrics such as Investigation closure and CAPA metrics
• Created an outstanding Operational Execution Plan for Batch readiness from Operations and support functions standpoint to ensure success of client project which also resulted in headcount reduction
• Involved in several technical proposals and presentations to prospective clients in partnerships with Business Development colleagues.
• Core SLT member for partnership with Business Development to identify, select new clients including assistance and oversight on due diligence efforts, audits, site visits, and person in plant for drug substance manufacturing campaigns.
• Involved in P&L for the site and robust recovery plan

• Led the Drug Substance (DS) manufacturing operation according to site production/supply plan, quality systems and regulatory requirements- Oversight of 110 members of team in a highly dynamic and fast paced environment-24 x 7 rotation shifts (4 shifts) and Oversight of 3rd shift Facilities group- 21 members
• Member of Site leadership Team (SLT)- 5 years
• Strategic plan for Equipment Utilization in liaison with Engineering for multiproduct facility
• Delivered a major turnaround of Mammalian multiproduct two-line operation with over 50 % green team in less than 4 months- Superior results setting a strong foundation for future of the Site.
• 100% Overall Success Rate- historical best figures for Prevnar DS in 2019 and 2021
• Continuous Improvement initiatives resulting in 4 million $ in savings
• Owned the development of colleagues and management of the site organization and governance structures, performance, metrics
• Foster network collaboration between sites, support functions and Business units- Prevenar Product Team- Andover Site Representative
• Development of clear strategic path for operations team and connection to site strategies and goals
• Oversee Manufacturing department preparation for internal and external audits including training of SMEs for the front room, representing the manufacturing function and managing audit responses
• Implement and Sustain site programs such as IMEx and Ownership of assigned IMEx elements at the site level (Over 6 years’ experience in Integrated Manufacturing Excellence – generation of DS operating standards, Deployment, Maturity, Certification and Sustaining IMEX), Tier 3 (SLT) Structured Gemba (SG) Element Owner.
• Delivered two major DS certifications for IMEX as well as influenced Leadership Ecosystem deployment for the site, IMEX Champion for Drug Substance Ecosystem (Multiple Operations Group)
• Member of Executive Integrated business planning for 0–24-month supply planning for the site.
• Coaching and mentoring across the site (Site Size -950 ) via Structured Gemba and conversations to improve various functional groups (ecosystems)
• People Development –Agility and flexibility-Co-op, Internship program in Ops, Mass Bio and MCC Apprentice Program (Talent attraction), Afghan Refugee leadership initiative, Capability Building- Technical and leadership expertise (Talent Retention)
• Delivered several strategic initiatives such as Reliability of Equipment for the asset, strategic planning for platform process equipment, yield improvement projects, built high performing Tier 1 Process Centric Teams, Process robustness initiatives and Cadence improvement to increase capacity.

• Technical Manager for Andover Production operations for Polysaccharides Manufacturing (Prevenar 13) leading a dynamic team of Scientists/Engineers involved in Several process robustness investigations, yield issues and contamination investigations etc.
• Lead for Asset Leadership Team on technical support , Engineering Projects , project prioritization, and point of contact in decision making for batch related issues. Prevenar product team representative for the site
• Provided strategic direction to departmental heads regarding Process Robustness Initiatives and Equipment related issues

• Managed a team of 10 engineers, delegating tasks and monitoring progress to ensure support for Operations as well as support on RFT goal
• ·Accountable for the management of all engineering, validation and maintenance (EVM) deliverables (Team size 20) on the assigned asset equipment and systems for the entire life cycle of the asset -both upstream and downstream processes and production support (Media and Buffer prep). Deliverables include process engineering, validation /qualification, performance, maintenance, reliability, and safety aspects of the asset for each phase of the life cycle.

• Process Engineering lead for Polysaccharides sustaining support and capital projects
• Successful implementation of several process engineering projects such as new transfer paths, Steam-In-Place (SIP) automation, new jumper design and Clean-in-Place (CIP) design for target equipment
• Design of agitators and new tanks including procurement, design, P&ID updates, FAT and commissioning work and project delivery under tight timelines.
• Startup Project Lead (Team of 7 members) for startup validation activities associated with the Prevnar project (Pneumococcal Vaccine). Team lead for purification equipment validation, cleaning validation, changeover Shut down Activities (Spray Ball Coverage Testing, SIP) and Decommissioning activities for Suites I-IV in the Andover Manufacturing Facility.

NOTE: Multiple promotions Since 2005 from Engineer III to Engineer IV, Senior Engineer I and Senior Engineer II

• Developed validation protocols for process equipment and systems.
• Authored and executed qualification protocols for clean utilities, HVAC, and manufacturing processes.
• Commissioning and Qualification of Equipments (Startup plant) such as Autoclaves, Spray Dryers, Lyophilizers, Liquid Nitrogen Immersion Device, CIP, Vibratory Sieves, and Clean Steam generators.
• Validation of large-scale Biotech manufacturing equipment’s and utilities (Startupplant, State of the Art, Biotech facility utilizing Distributed Control Systems) in the Production Building facility (Manufacture of Enbrel). Team lead for Validation (20 consultants)

• Assisted in the design, development and testing of various engineering projects.
• Developed P&IDs for the Site and worked on several I&C projects

• Validation of Chambers, Sterilizers, Depyro Ovens and equipment in Medical Imaging facility

• Calculus Teaching Assistant for Undergrad students

• Production Supervisor managing 40 people including Process and Maintenance