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 GM / AVP – Global Business Development (CDMO) to lead global expansion for its API (fermentation, strain engineering, organic chemistry) and oral solid dosage form (OSD) CDMO services. This role requires a strategic leader with 15+ years of experience in pharmaceutical business development, P&L management, and global market penetration. The candidate will drive client acquisition across the US, EU, Asia, Middle East, and ANZ, leveraging technical expertise in API and finished drug manufacturing while representing Bioplus at key industry forums like CPHI Europe, CDMO Live, and DCAT.

KEY RESPONSIBILITIES:

• Direct site preparedness for FDA, EU, MHRA, and TGA audits, including mock inspections, documentation reviews, and gap assessments
• Lead cross-functional teams during regulatory inspections, ensuring timely resolution of observations and CAPA implementation
• Maintain compliance with 21 CFR Part 11, 210/211, and ICH guidelines across all sites

Quality Systems & Policy Standardization

• Develop and harmonize corporate quality policies (SOPs, QMS) to align with global regulatory expectations.
• Oversee electronic quality management systems (eQMS) like TrackWise for deviations, change controls, and CAPA tracking.
• Conduct periodic quality reviews (PQRs) and management review meetings to ensure continuous improvement.
• Monitor and report on key quality metrics, driving continuous improvement initiatives and harmonization of quality systems across the site

Cross-Functional Collaboration

• Partner with site QA/QC teams to standardize validation protocols (process, cleaning) and stability testing programs
• Liaise with R&D, Manufacturing, and Supply Chain to resolve quality risks and ensure compliance during tech transfers

Team & Project Management

• Design training programs on GMP/GLP updates, inspection readiness, and root cause analysis methodologies.

Supplier & Risk Management

• Implement risk-based vendor qualification programs, including audits and quality agreements.
• Monitor supplier performance and address non-conformances through systematic problem-solving

QUALIFICATIONS

• Education: Bachelor or Master degree in Pharmacy / Chemistry / Life Sciences
• Experience: 15+ years in pharmaceutical QA, including 5+ years in corporate QA leadership roles across multiple sites

Regulatory Expertise:

• Proven success in 3+ FDA/EU/MHRA/TGA audits (zero critical observations preferred).
• In-depth knowledge of data integrity (ALCOA+), Process Validation (Stage 3), and ICH Q10

Skills:

• Proficiency in eQMS tools (Track Wise, Master Control) and audit management software.
• Exceptional communication skills for interfacing with global auditors and senior leadership.

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