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 Specialist(QA/QC) 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 & Technical Ownership

·       Own the CMC strategy across development and commercial products, ensuring alignment with regulatory and business objectives

·       Define and maintain product specifications, control strategies, and critical quality attributes (CQAs)

·       Ensure scientific and technical robustness of formulation, manufacturing processes, and analytical approaches

2. External Manufacturing (CMO) Technical Oversight

·      Serve as the technical lead for CMOs, providing guidance on manufacturing processes and product requirements

·      Support technology transfer activities, including process knowledge transfer and scale-up

·      Monitor process performance and support process optimization and troubleshooting

·      Ensure manufacturing processes are consistent, reproducible, and scalable

3. Analytical & Control Strategy

·      Define and maintain analytical strategies and specifications for raw materials, intermediates, and finished products

·      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 and complex quality issues

4. Process Validation & Lifecycle Management

·      Lead or support process validation strategies and execution with CMOs

·      Ensure lifecycle management of processes, including continued process verification (CPV)

·      Maintain oversight of critical process parameters(CPPs) and process performance trends

·      Design and author stability study protocols, including definition of acceptance criteria and test strategies

5. Regulatory CMC Support

·      Prepare and review CMC sections of regulatory submissions (e.g., IND, NDA, variations)

·      Ensure alignment between manufacturing processes, analytical methods, and regulatory filings

·      Support responses to regulatory queries and inspections related to CMC topics

6. Change Management (Technical Assessment)

·      Assess technical impact of changes to manufacturing processes, analytical methods, materials, and suppliers

·      Provide scientific justification and risk assessment to support change control decisions

·      Ensure changes are appropriately evaluated for product quality and regulatory impact

7. Product Lifecycle & Continuous Improvement

·      Monitor process and product performance data to identify opportunities for improvement

·      Drive continuous improvement initiatives related to manufacturing robustness, yield, and quality

·      Support Product Quality Reviews (PQR) with technical insights and recommendations

8. Cross-functional Collaboration

·      Partner closely with Quality (QA/QC) to ensure alignment between technical decisions and GMP requirements

·      Work with Regulatory Affairs, Supply Chain, and R&D to support product development and commercialization

·      Interface with external advisors (CMC and QA) for complex technical or strategic decisions

Qualifications

·      Degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related discipline (advanced degree preferred)

·      3–8 years of experience in pharmaceutical/biotech CMC, process development, or technical operations

·      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

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