Offer summary

Qualifications:

15+ years of CMC experience in biologics, particularly antibodies and bispecifics., Strong technical CMC expertise with proven FIH/IND filing experience., Experience managing external manufacturing organizations, especially in China., Ability to work remotely and independently across time zones..

Key responsibilities:

Lead all technical CMC activities for FIH trials.

Manage external manufacturing partnerships, including Chinese CMOs.

Provide regulatory CMC expertise across technical writing, IND strategy, and agency interactions.

Provide strategic advice on CMC operations with a business-minded approach.

The global Life Sciences industry is dominant in today’s world. Drug development processes are progressing faster than ever before. The need for vaccines, treatments and medical devices continues to grow at an exponential rate to ensure treatment for disease reaches those it needs to. That means for Barrington James, we grow at the same speed. With 14 global offices specialising in niche areas of the Life Science industry, we are ready to support our growing group of clients in sourcing the most, senior, specialist and rare candidates to join them. ‘We Invest In Our People’ through training and development, through meritocratic progression, and through unrivalled commission structures, shareholder and bonus schemes. Barrington James Board & Executive Partners Barrington James is your global and award- winning Life Science Executive recruitment partner. With combined experience of over 100 years, our Executive Search team has access to the deepest pharmaceutical networks. Our primary focus is to understand and address the business challenges and hiring needs of our clients through a range of bespoke services, including Executive Search, Project Management, Market Research, Mapping Practice and Reference Check Insights.

Job description

Job Description

We are currently looking for a technical CMC consultant to support an early phase biotech on a part-time basis. The consultant will drive CMC activities into FIH; this is a critical role brought drive key CMC changes when hitting the clinic, managing international manufacturing relationships and support preparation for First-in-Human (FIH) studies and IND filings.

Responsibilities:

- Lead all technical CMC activities for FIH trials.
- Manage external manufacturing partnerships, including Chinese CMOs.
- Provide regulatory CMC expertise across technical writing, IND strategy, and agency interactions.
- Provide strategic advice on CMC operations with a business-minded approach, balancing technical rigor with entrepreneurial flexibility.

Requirements:

- 15+ years of CMC experience in biologics, particularly antibodies and bispecifics.
- Strong technical CMC expertise, with proven FIH/IND filing experience.
- Experience managing external manufacturing organizations (CMOs), especially in China.
- Ability to work remotely and independently, across time zones.
- Strong business mindset, able to combine bureaucratic attention to regulatory detail with commercial pragmatism.
- Prior experience working with small biotech and big pharma is highly desired.

Required profile