Anil Sebastian

CORE COMPETENCIES, QUALIFICATIONS AND SKILLS
• 7+ years of industry experience in process development for biologics; 7+ years of post-doctoral research experience in developing clinical wound healing prototype; technical and management experience in both industry and academics.
• Experience as the lead in designing and setting up process development labs for biologics; identifying the infrastructure and utilities for novel biologics, biosimilars and mRNA therapeutics development.
• Technical expertise in upstream process development (UPD) and overall understanding of other process development functions. Management experience in process development departments.
• Experience in implementing novel platform processes as per ICH guidelines for cell line development (CLD) in the industry; Subject Matter Expert (SME) in Regulatory affairs of CLD.
• Experience in customer proposals as a SME for complex protein development and Technology Transfer; represented Lonza Biologics in several international conferences.
• Business development experience for biosimilars and mRNA therapeutics.
• Experience as the lead in setting up human tissue wound healing research group and lab in the University of Manchester in accordance with Health and Safety Executive (HSE) and Human Tissue Act regulations.
• Led and managed cross-functional strategic project teams in the industry aimed for continuous improvement and innovation in product development.
• Track record of operational excellence in team management, leadership in scientific and strategic projects.
• Experience in authoring scientific publications, patents and grants to support financial and commercial aspects of research.
WORK EXPERIENCE
November 2021 – Present: Senior Group Leader, Upstream Process Development, Accord Biopharma London, Accord Healthcare, Harrow, UK.
• Setting up of process development laboratories for novel biologics and biosimilars in Accord Biopharma London and Lambda Therapeutics (Ahmedabad, India):
o Lead for designing and executing the layout of UPD labs, also responsible for designing downstream purification, analytical, bioanalytical and formulation labs. This was in accordance with Medicines and Healthcare products Regulatory Authority (MHRA) and HSE requirements.
o Liaised with Procurement, Finance, Information Technology, Engineering, Quality Assurance and equipment vendors to identify appropriate infrastructure/equipment/automation and utilities for procuring and installing the equipment.
• mRNA therapeutics development:
o Lead of the organisation for mRNA therapeutics development. Designed process development labs for product development.
o Currently liaising with Scientific and Medical Affairs, Intellectual Property rights and Regulatory Affairs teams for identifying biological targets for development.
o Also involved in business development for in-licensing opportunities, partnering with CDMOs for product development and identifying suitable collaborations with universities and research organisations.
• Recruitment and people management:
o Responsible for recruiting group leaders and technical staff to different departments within process development.
o Currently managing the UPD team, also deputising the head of process development in managing the other process development departments.
• Finance management:
o Responsible for finance (CAPEX & OPEX) in process development departments.
o Expenditures for building work, equipment purchase, and technical lab activities were raised and received approval in several stages.
o Currently liaising with finance department on a weekly basis for tracking expenses.
• Business development:
o Involved in the business team for prioritising development of biosimilars aimed for the UK market.
o Had discussions with MHRA for Phase III waiver for a few Biosimilars.
o Performed technical due diligence on vendors/3rd party organisations for in-licensing technology or products.
• Technical competency:
o Technical SME in upstream process development which includes next generation automation platforms, protein engineering, cell line construction and development, optimisation and evaluation of cell line in bioreactors and ambr systems.
o Introducing Artificial Intelligence and Digitalisation in unit operations of UPD.
o Lead for tech transfer in UPD, however involved in tech transfer for several aspects of process development.
o Responsible for deliverables from all process development departments.
o In addition to technical documentation, experience in authoring equipment and utility qualification reports, safety documentation, Genetically Modified Organisms notification forms, trade effluent consent forms etc.
o Quality Assurance lead of the department, leading investigations and implementing required CAPAs.
Accomplishments
• Set up process development labs for novel biologics and biosimilars in both Accord Healthcare and Lambda therapeutics.
• Strategically aligned with Senior management on project plans/deliverables for Process Development departments for the next 3 years.
• Designed and implemented Quality management systems in R&D.
• Expanded Full Time head counts in process development department from 2 to 16 within an year, however planned for a total of 34 FTEs by the end of March 2023
• Successful in grant applications to Royal Society Industry Fellowship Scheme and Wellcome Leap R3 program for mRNA product development.
• Developed business cases for 3 x biosimilars for in-licensing them.
• Performed due diligence of several products on Chemistry, Manufacturing & Control (CMC) activities for product development, before in-licensing them.
• Identified biological targets for mRNA therapeutics development.

May 2016 – October 2021: Group Leader, Cell Culture Development, Lonza Biologics PLC, Slough, UK.
Started as a Senior Scientist, later promoted to Lead Scientist and Supervisor and then to Group Leader
Responsibilities
• Team management:
o Responsible for managing a team of 8 members with diverse skill sets, followed Kaizen, Gemba and Hoshin events (operational excellence tools for continuous improvement) for effective management.
o Department planner for resources based on work-load and head count.
• Strategic project management:
o Led an innovation and strategic project adopting six sigma methodology for process improvement with global reach.
o Implemented state-of-the-art infrastructure for CLD with next generation laboratory automation which reduced product development timelines and man days.
o Led Cell Line Construction (CLC) Governance and Cell Line Instability investigation team (cross-functional) for global Lonza sites.
o Department lead for complex protein development and implementing strategies alongside working with other process development departments.
• Profitability management:
o Tracked and investigated variances (Right First Time Matrix) in customer projects for all departments within process development.
• Customer deliverables management:
o Tracked the progress of deliverables (On Time In Full and Schedule Adherence Matrix) in customer projects within the department on a monthly basis; updates were provided to the wider site meetings.
• Regulatory Affairs:
o Review documents for Investigational New Drug (IND) and Biological License Application (BLA) submission as an SME in CLD; also point of contact for Regulatory bodies on CLD queries.
• Recruitment:
o Manager for co-ordinating customer/internal lab tours in the department and involved in recruitment to the department.
• Technical competency:
o Automation platforms and experimental methodologies for cell line construction, development and optimisation. Management reviewer for UPD reports.
o Technology transfer experience from customers and other Lonza sites.
Accomplishments
• Led the team to implement next generation state-of-the-art CLD automation platform in Slough site; designed workflows for this novel platform and helped in commercialising the platform. This will be eventually implemented in global Lonza sites.
• Member of the team which successfully reduced timeline (Gene to IND) for complex protein development as part of continuous improvement. This platform has been commercialised, enabling Future Clinical Manufacturing.
• Identified potential causes for cell line instability in Lonza’s platform cell lines; worked towards mitigations as well as integrating new technologies to improve host cell line offerings in Lonza’s commercial pipeline.
• Led and mentored Science Leads on 35+ CLD stages for complex protein development and customer proposals; reviewed 25+ IND documents and several others for BLA submission.
• Delivered talks on advancements in complex protein development of Lonza Biologics in several international conferences.
September 2008 – May 2016: Post-Doctoral Research Associate, Plastic and Reconstructive Surgery Research group, School of Medical and Human Sciences, University of Manchester, UK.
Started as a Honorary Research Associate and then appointed as Research Associate
Responsibilities
• Research group and lab set up:
o Initiated a research group on electrical stimulation and human tissue wound healing in the University.
o Technical lab was designed with state-of-the-art automation platforms.
• Research work:
o Identified trends and adapted ideas from relevant/current research, recruited staff, provided technical training, authored publications, patents and proposals for funding bodies.
• Regulatory Affairs:
o Responsible for ensuring studies are scientifically robust and meet the current Regulatory guidance (Human Tissue Act 2004, Environmental Health and Safety regulations).
• Collaborations:
o Developed collaborations with other departments and research groups, industries, academics and hospitals.
Accomplishments
• Set up the biological research group on electrical stimulation and human cutaneous wound healing in The University of Manchester.
• Developed a potential prototype for electrically stimulating human skin for wound healing and helped in identifying suitable funding sources for commercialising this prototype.
• Provided leadership to a team of direct reports (students, technicians, PhDs, Post-Doctoral members).
• Helped in raising £2.75 M for 5 years from investors and hedge funding sources for the research.
• Authored and published 20 peer-reviewed research articles including 2 in Nature Publication Group as the first author.
• Nominated for Young Investigator’s Award in joint European and American wound healing society meeting (October, 2015) and nominated twice for International Young Investigators Award by European Tissue Repair Society meetings (October, 2013 and September, 2011) as part of the research.
October 2007 – December 2007: Research Associate, Intercytex ltd, Manchester, UK.
• Investigated the role of alternative biologicals/methods for trypsin and serum in mammalian tissue culture. Automation development for maintenance of cell culture was undertaken in this project. Novel alternative products (for the same objective) were assessed to demonstrate acceptable level of safety and clinical feasibility.
EDUCATION
2005 – 2008: PhD in Mammalian tissue engineering (Recreating hematon (bone marrow tissue) in vitro), School of Chemical Engineering and Analytical Sciences, The University of Manchester, UK.
2004 – 2005: MSc in Biotechnology (First class with distinction), The University of Manchester, School of Chemical Engineering and Analytical Sciences, UK.
2002 – 2004: MSc in Biotechnology (First class with distinction), Loyola College (autonomous), The University of Madras, Chennai, India.
1999 – 2002: BSc in Chemistry (First class with distinction), St. Berchmans’ College, Mahatma Gandhi University, Kerala, India.

ACADEMIC ACHIEVEMENTS
• Awarded Overseas Research Scholarship in 2005 by the “Secretary of State for Education and Skills”, UK, for international research students.
• Awarded Chemical Engineering Departmental Scholarship in 2005 for PhD in School of Chemical Engineering and Analytical Sciences, The University of Manchester, UK.
• Second rank in MSc dissertation from Loyola College (autonomous), University of Madras, India.
• Received C. T. Thevercaud Award for obtaining first rank in BSc Chemistry from St. Berchmans’ College, Mahatma Gandhi University, Kerala, India.