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 General Manager – API Process Design Engineering (Fermantation) to lead process innovation and technical operations at its Hosur-based API manufacturing facility. This role demands a strategic leader with 20+ years of experience in biopharmaceutical API process design, scale-up, and automation, ensuring compliance with US FDA and EU GMP standards. The candidate will oversee equipment qualification, material transfer systems, and utilities design while driving operational excellence across a facility serving global markets.

KEY RESPONSIBILITIES:

Process Design & Scale-Up Leadership

• Spearhead end-to-end process design for fermentation and chemical synthesis units, including reactor systems, piping networks, and utilities (steam, chilling plants, effluent management)
• Optimize scale-up strategies for API production, leveraging tools like DynoChem and PAT for process modeling and critical quality attribute (CQA) monitoring
• Lead equipment selection, qualification (IQ/OQ/PQ), and lifecycle management for fermenters, reactors, and automation systems

Regulatory Compliance & Automation

• Ensure adherence to US FDA, EU GMP, and ICH guidelines during process validation, tech transfers, and audits
• Implement process automation solutions (DCS/SCADA) and digital tools (PAT, lab automation) to enhance efficiency and data integrity.

Cross-Functional Collaboration

• Partner with R&D, Quality, and Supply Chain to align process designs with production schedules and regulatory filings
• Support technology transfers from lab to plant, resolving scale-up challenges and ensuring seamless commercialization.

Team & Project Management

• Mentor a multidisciplinary team of engineers and technicians in process design, safety protocols, and lean methodologies
• Manage CAPEX projects, including greenfield expansions and utility upgrades, within budget and timelines

QUALIFICATIONS & EXPERIENCE

• Education: Bachelor / Master (Chemical Engineering)
• Experience: 20+ years in API/biopharmaceutical manufacturing, with expertise in process design, equipment qualification, and automation
• Technical Skills: Proficiency in process simulation software (DynoChem, VISMIX) and CAD tools
• In-depth knowledge of cGMP, US FDA/EU audits, and validation protocols (IQ/OQ/PQ)
• Hands-on experience with solvent recovery, crystallization, and effluent treatment systems

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