Location: Singapore
Moleac is a biopharmaceutical company focused on addressing unmet medical needs by bringing innovative products to patients worldwide. With a dynamic, fast-paced, and mission-driven environment, Moleac is committed to improving health outcomes and delivering quality through excellence in our global operations.
We are seeking a CMC Lead to own the technical and scientific aspects of product development and commercial manufacturing, working closely with CMOs, analytical laboratories, and internal stakeholders in an international environment.
This is a key role in shaping CMC strategy within a lean, high-impact organization, building strong internal expertise to ensure that product quality is built on sound science, robust processes, and well-controlled analytical strategies.
The CMC lead is responsible for ensuring that manufacturing processes, analytical methods, and product specifications are scientifically justified, scalable, and aligned with regulatory expectations.
You will partner closely with the Quality team to ensure that technical excellence and GMP compliance are jointly achieved, while leveraging guidance from senior CMC and QA advisors.
ESSENTIAL DUTIES & RESPONSIBILITIES
1. CMC Strategy & Asset Lead
- Define and drive end-to-end CMC strategy across investigational and commercial products
- Ensure alignment of CMC activities with regulatory, clinical, and business objectives
- Establish and maintain control strategy, CQAs, and product specifications
- Act as the technical subject matter expert (SME) for manufacturing related matters
2. Technology Transfer & CMO Technical Oversight
- Lead and coordinate technology transfer activities to CMOs and manufacturing sites
- Provide technical oversight and scientific input into process validation strategies and execution
- Ensure processes are scalable, reproducible, and well understood
- Monitor process performance and support process optimization and troubleshooting
3. Analytical & Control Strategy
- Define and maintain analytical and control strategies
- Ensure analytical methods are fit-for-purpose, validated, and aligned with regulatory expectations
- Provide technical interpretation of analytical data, trends, and atypical results
- Support investigations involving OOS/OOT results, product complaints and complex quality issues
5. Regulatory CMC Support
- Prepare and review CMC sections of regulatory submissions (e.g., IND, NDA, variations)
- Ensure technical consistency between development, manufacturing, and regulatory filings
- Provide scientific input to health authority queries and inspections
6. Change Management (Technical Assessment)
- Provide technical evaluation and risk assessment for changes
- Assess impact on product quality, process performance, and regulatory filings
QUALIFICATIONS
- Degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related discipline (advanced degree preferred)
- 3–5 years of experience in pharmaceutical/biotech CMC, process development, or QC
- Experience working with CMOs and outsourced manufacturing models is highly preferred
- Strong understanding of ICH guidelines, GMP, and CMC regulatory requirements
Key Competencies
- Strong technical depth in pharmaceutical development and manufacturing processes
- Ability to connect scientific principles with practical manufacturing realities
- Experience in analytical methods, specifications, and control strategies
- Strong problem-solving skills in process or analytical investigations
- Ability to work cross-functionally and influence external partners
- Ability to read technical documents in Mandarin and communicate effectively with CMOs located in China
Success Profile for This Role
- Acts as the technical owner of products, ensuring they are manufacturable, consistent, and scalable
- Brings scientific rigor to decision-making, especially in ambiguous or complex situations
- Works seamlessly with QA to ensure both compliance and technical excellence
- Effectively leverages external partners and advisors to strengthen internal capabilities
