Managing Director - Biologic Pharmaceuticals
atIntellipro Group
About the role
The Managing Director is the business leader Biologics Pharma, responsible for the development and execution of Business's strategy and annual Plan, and for all industrial, quality, regulatory, commercial, financial and human resources operations of the Company. Reporting to the Board of Directors, the Managing Director has full accountability for all functions, all site activities and approximately 140 employees at the across the business.
Key responsibilities
Define, propose to the Board and execute vision, mission and multi-year strategy; prepare the annual Business Plan and budget for Board approval and deliver approved targets; report performance, risks and corrective actions to quarterly Board meetings and Annual General Meetings
- Ensure reliable, on-time and cost-efficient manufacturing of each drug profile as Contract Manufacturing Organisation for a pharmaceutical originator and of own products; secure supply of product bulk, diluent, components and consumables; manage inventory, cold chain and distribution
- Act as the ultimate site management authority for the Pharmaceutical Quality System; guarantee that all operations comply with Thai FDA GMP, PIC/S / EU GMP, WHO and other applicable standards; chair Management Reviews; ensure timely closure of audit and inspection observations
- Lead preparation to become an EU / UK, TGA, WHO-prequalified and US FDA-ready drug product site; own the US FDA readiness programme; ensure maintenance of manufacturing licences, product licences and variations with Thai FDA
- Grow and diversify revenue: deliver the vaccine technology transfer through validation, registration, manufacturing licence and commercialisation; secure importation and market launch; identify, evaluate and propose new products, in-licensing and CMO opportunities
- Ensure the financial health and sustainability of the Company: P&L, cash and working-capital management, cost of goods and under-absorption control, CAPEX prioritisation and ROI, accurate and timely financial statements, statutory audit, tax and BOI / NVI privilege compliance
- Lead, unite and develop the Management Committee; define a clear organisation with roles, decision rights and accountability; secure recruitment of key vacancies; build succession plans for critical and retiring positions; develop a leadership pipeline and manage compensation, performance and engagement
- Prepare and present Board and Shareholders' meetings; implement Board resolutions; maintain transparent, balanced relationships with the three shareholders; ensure compliance with the Joint Venture Agreement, Articles of Association, Thai company law and related obligations
- Sponsor and steer the site project portfolio (compliance plan, technology transfers, capacity extension, serialisation and IT systems, energy / solar farm, HSE upgrades) with clear scope, budget, schedule and risk management
- Ensure a safe workplace and full compliance with Thai labour, industrial estate, environmental and safety legislation; sponsor the HSE management system; ensure business continuity and crisis management including product recall
Key Qualifications
- Degree (or equivalent) in Pharmacy, Life Sciences, Biotechnology, Chemical / Industrial Engineering, Medicine or a related scientific discipline
- MBA or postgraduate qualification in business administration, finance or general management strongly preferred
- Minimum 15 years in the pharmaceutical, vaccine or biologics industry, of which at least 7 years in senior leadership of a manufacturing site or business unit with full P&L accountability
- Direct experience hosting and successfully closing regulatory inspections and customer audits (Thai FDA, PIC/S members such as EMA / MHRA / TGA, WHO Prequalification; US FDA experience a strong asset)
- Financial management experience: annual budget and 5-year business plan preparation, cost of goods and under-absorption management, CAPEX justification, cash management, dividend policy and reporting to a Board and shareholders
- Understanding of regulatory strategy for multi-market registration (ASEAN, Australia, EU / UK, US) and of the requirements a drug product site must meet to support a BLA / MAA
- Strong stakeholder management with the Board of Directors, shareholders, Thai authorities, customers, suppliers and consultants
- Ability to develop people: coaching of managers, succession planning, talent retention and leadership development
- Change leadership: capacity to move the organisation from a local-standard manufacturer to an internationally inspected (EU / TGA / WHO / US FDA) site while balancing agility, cost and workload
- High integrity, ethics and compliance awareness; role model for quality culture and data integrity
- Thai national or long-term Thailand resident with excellent understanding of Thai business, public-sector and regulatory culture; fluent in Thai and in English (written and spoken)
- Structured, financially rigorous, results-oriented, resilient under pressure, and comfortable operating in a small company with limited resources and high expectations
Company EA Licence: 22C1076
EA License No : R1106634
Experience required
- 1 years
Salary
- 300,000 - 400,000 THB, Negotiable
Job function
- Senior Management
Job type
- Full-time
Company overview
Intellipro Group is headquartered in San Jose, California, and provides IT services and human resources solutions, including recruitment, across the Americas and Asia Pacific. Intellipro hires management and business roles in Bangkok.
