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:

The General Manager – Quality Control (API) will lead and oversee all Quality Control (QC) operations for Bioplus’ API manufacturing plant and research center at Hosur. This senior leadership role is responsible
for ensuring that all laboratory operations, testing, and data management meet global regulatory standards (US FDA, EU GMP, UK MHRA, 21 CFR, GLP, GMP). The ideal candidate will have at least 15 years of experience managing globally accredited pharmaceutical laboratories, with deep expertise in analytical
instrumentation, wet chemistry, microbiology, and regulatory compliance.

KEY RESPONSIBILITIES:

• Lead, manage, and develop the QC team to ensure efficient and compliant laboratory operations for raw materials, intermediates, finished APIs, and research samples
• Oversee all analytical and microbiological testing, ensuring strict adherence to global GMP, GLP, and
  21 CFR Part 11 guidelines 
• Ensure the qualification, calibration, and maintenance of laboratory instruments (HPLC, GC, FTIR,
  UV-Vis, dissolution testers, etc.) and the integrity of all laboratory data
• Supervise the design, review, and approval of analytical methods, validation protocols, and
  stability studies in accordance with regulatory requirements Oversee wet chemistry and
• microbiological analyses, ensuring compliance with pharmacopeial and
  in-house specifications 
• Ensure timely and accurate release of materials and products by reviewing and approving analytical results and QC documentation
• Ensure Quality Control Management of Sampling and testing
• Ensure and supervise the calibration of all lab equipment
• Lead the laboratory’s preparedness for global regulatory inspections and customer audits,
  including direct interaction with auditors and timely response to observations
• Develop, implement, and continuously improve Standard Operating Procedures (SOPs) and laboratory best practices
• Ensure robust data integrity, audit trail review, and compliance with electronic data
  management systems 
• Drive continuous improvement initiatives in laboratory efficiency, safety, and compliance
• Collaborate with cross-functional teams (QA, Production, R&D, Regulatory Affairs,
  Warehouse) to support product development, technology transfer, and troubleshooting
• Mentor and train QC staff on technical skills, regulatory updates, and best practices in laboratory
  operations
• Oversee laboratory investigations, OOS/OOT management, deviations, CAPA, and change controls
• Manage laboratory budgets, resource allocation, and procurement of consumables and equipment

QUALIFICATIONS & EXPERIENCE

• Master’s degree or Ph.D. in Chemistry, Pharmaceutical Sciences, or a related discipline
• Minimum 15 years of progressive experience in Quality Control management within globally accredited laboratories for pharmaceutical APIs and drug evaluation
• Deep expertise in analytical instrumentation, wet chemistry, and microbiological techniques
• Strong knowledge of global GMP, GLP, and 21 CFR Part 11 compliance requirements
• Demonstrated ability to lead teams through international regulatory inspections (US FDA, EU GMP, UK MHRA)
• Excellent leadership, communication, and interpersonal skills
• Strong analytical and problem-solving abilities
• Experience with electronic laboratory management systems and data integrity practices

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://www.theialife.com
For further information contact:
Hemant Patel, DGM – Human Resources
Email: recruitment@bioplus.in