Company Description:

With over 78 years of experience, Bioplus Life Sciences is a pharmaceutical company based in Bengaluru. We focus on advanced Biotechnology and have programs in late-stage clinical phases for global unmet needs. Our pipeline includes pre-clinical programs and blockbuster Novel therapeutics, with a strong emphasis on R&D and Clinical Development.

We are delighted to invite you to explore an opportunity of learning, contributing and discovering science and medicine with us as part of our global research team. Bioplus Life Sciences and its affiliate Theialife Inc, USA & Akeso Biopharma, Singapore have a novel portfolio of first in class and best in class novel therapeutics in discovery stage to Phase 3 clinical stage.

Theialife is currently building a global leadership team in Boston, as a prerequisite to list on NASDAQ.

Our lead molecule ND 10 for early onset paediatric myopia control will be applying for EU Marketing Authorization in Q1-2025 and US FDA pre submission meeting NDA meeting also in Q1-2025.

As you are probably familiar with the drug discovery journey you will appreciate that is the culmination of 18 years of effort, perseverance, and devotion to a single-minded goal of creating a global biopharmaceutical company. The myopia drug opportunity is itself over USD 20 billion and there is no other therapeutic in clinical development except Atropine which has had efficacy endpoint issues. We are adding new large manufacturing capability including a 2-million-liter microbial fermentation bio foundry and significant dosage form capacity.

By 2030 we intend to be amongst the World’s top 5 Ophthalmology innovation led global companies.

To support, build and develop our pipeline we are looking to add Scientists, Doctors and Engineers and Technical People to our team of likeminded dedicated science warriors who have devoted their lives to pursue excellence and contribute to finding medical solutions for significant global unmet medical needs.

POSITION SUMMARY:

Bioplus seeks a seasoned Manager Engineering & Maintenance (API) to oversee engineering operations at its Hosur-based API manufacturing facility. This role involves leading a team of 30+ professionals to ensure optimal performance of large-scale fermentation, chemical manufacturing, and utilities across a 16-acre campus with 250,000+ liters of installed capacity. The candidate will ensure compliance with US FDA, UK MHRA, and cGMP standards while driving innovation in process design, equipment reliability, and infrastructure development.

KEY RESPONSIBILITIES:

Team Leadership & Strategy

• Lead engineering and maintenance teams to achieve plant operational goals, including preventive/predictive maintenance, breakdown management, and spare parts inventory
• Develop and implement asset lifecycle management strategies for reactors, fermenters, HVAC, chilling plants, air compressors, and effluent treatment systems

Compliance & Regulatory Oversight

• Ensure adherence to cGMP, US FDA, and UK MHRA guidelines during audits, validations, and daily operations
• Maintain documentation for equipment calibration, maintenance activities, and change controls using tools like SAP or Track Wise.

Project Management & Process Engineering

• Oversee CAPEX projects, including design, procurement, installation, and commissioning of new equipment (e.g., reactors, steam systems, diesel generators)
• Optimize utilities (brine plants, chilling systems) and drive energy conservation initiatives to reduce operational costs
• Collaborate with Project Management consultants for the brown field and green field projects
• Track record of handling at least 5 to 7 brown field or green field projects

Infrastructure & Utilities Management

• Manage civil/structural engineering projects, HVAC systems, and utilities (steam, compressed air, power distribution)
• Ensure efficient operation of effluent treatment plants (ETP/MEE) and environmental compliance

Safety & Collaboration

• Enforce EHS protocols, including LOTO, PPE, and risk assessments, to maintain a zero-incident workplace.
• Collaborate with cross-functional teams (Quality, R&D, Dosage Manufacturing) to support facility expansion and technology transfers.

QUALIFICATIONS & EXPERIENCE

• Education: B.Tech / M.Tech (Mechanical / Chemical Engineering)
• Experience: 10+ years in pharmaceutical/biopharmaceutical API plants, with 5+ years in leadership roles.

Technical Skills:

• Expertise in fermentation, chemical reactors, utilities, and effluent management
• Proficiency in reliability-centered maintenance (RCM), root cause analysis (RCA), and lean methodologies
• Familiarity with CAD, STADD Pro, SAP, and CMMS tools
• Expertise in Civil, Structural (CS), also Mechanical, Electrical, and Piping (MEP) work
• Regulatory Knowledge: Direct experience with US FDA/MHRA audits and validation protocols.

WHAT WE OFFER

• Opportunities for professional development and career growth.
• A collaborative and innovative work environment.

WHY JOIN BIOPLUS?

Bioplus offers a unique opportunity to make a significant impact on global healthcare by shaping the commercial success of novel, life-changing therapies. As part of our team, you’ll collaborate with passionate professionals committed to improving patient outcomes worldwide.

EQUAL EMPLOYMENT OPPORTUNITY (EEO) POLICY:

Career opportunities at Bioplus are provided without discrimination on the basis of race, sex/gender, religion/caste/creed, social or ethnic origin, colour, age, differently abled (including physical medical conditions), sexual orientation, domestic partnership status, gender identity or expression, marital status, ancestry, genetic information or any other reason prohibited by laws in India.

REFERENCE: https://bioplus.in / https://theialife.com

For further information, contact:

Hemant Patel, DGM – Human Resources

Email: recruitment@bioplus.in