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 Pharma seeks an experienced AGM – Production (Dosage Forms) to lead oral solid dosage (OSD) manufacturing operations at our UK MHRA- and EU GMP-certified facility. The role demands expertise in global regulatory compliance (US FDA, UK MHRA, EU, TGA), technical mastery of OSD processes, and proven leadership in managing cross-functional teams within a high-compliance environment.

KEY RESPONSIBILITIES:

Operational & Technical Management

• Oversee end-to-end production of tablets, effervescent tablets, hard-shell capsules, and sachets, ensuring adherence to batch records, SOPs, and yield targets
• Optimize manufacturing processes (granulation, compression, coating, encapsulation, blistering) to meet productivity and quality goals
• Troubleshoot equipment/process deviations (e.g., tablet hardness, dissolution failures) and implement corrective actions
• Drive operational excellence across the facility by optimizing capacity utilization, implementing lean practices, and leading initiatives to enhance productivity and efficiency in OSD manufacturing
• Stay abreast of emerging equipment and processing technologies relevant to OSD manufacturing, including identifying and evaluating potential manufacturers and vendors for continuous process improvement
• Coordinate with engineering teams for preventive maintenance, calibration, and validation of equipment (e.g., tablet presses, capsule fillers)

Regulatory Compliance & Audits

• Ensure strict compliance with cGMP, OSHA EHS, and global guidelines (US FDA 21 CFR Part 211, EU Annex 1, ICH Q10)
• Lead preparation and execution of regulatory audits (US FDA, UK MHRA, EU, TGA), including documentation review and floor readiness
• Address audit observations (483s, findings) through robust CAPA systems and ensure timely closure.

Team Leadership

• Manage a team of 50+ personnel, including shift supervisors, operators, and technicians
• Conduct training on GMP, safety protocols, and new technologies (e.g., continuous manufacturing)
• Foster a culture of operational excellence through Lean Six Sigma, TPM, and Kaizen initiatives.

Documentation & Reporting

• Review and approve batch manufacturing records, deviation reports, and change controls
• Maintain compliance with data integrity standards (ALCOA+ principles) across electronic and paper-based systems

EHS & Sustainability

• Enforce OSHA-compliant safety practices (PPE, chemical handling, waste management)
• Drive energy-efficient practices to reduce environmental impact.

QUALIFICATIONS

• Education: Master’s in Pharmacy (M.Pharm) mandatory
• Experience: 15+ years in OSD manufacturing, including 5+ years in leadership roles at FDA/EU-approved sites

Technical Skills:

• Expertise in OSD unit operations (fluid bed drying, compression, film coating)
• Proficiency in SAP/ERP systems and production metrics (OEE, cycle time)
• Regulatory Exposure: Direct involvement in ≥2 successful US FDA/EU/MHRA/TGA audits

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