Associate Consultant - CMC Development & Analytics

Associate Consultant, CMC Development & Analytics

ZS is looking to hire a Decision Analytics Associate Consultant in its Supply Chain and Manufacturing practice with experience in pharmaceutical CMC development, process science, biologics manufacturing, and tech transfer. The primary responsibility of this role is to support client engagements in the pharmaceutical CMC development area, with a focus on helping clients solve business and technical challenges across drug development, manufacturing, analytics, and technology‑enabled transformation.

This role will work with clients and ZS teams to address questions related to drug substance and drug product development, process development, tech transfer, process validation, future lab operating models, and CMC data analytics. The ideal candidate has industry experience working with biologics; small‑molecule experience is also acceptable. Cell and gene therapy experience is not required for this role. The Associate Consultant will bring a process scientist mindset, strong communication skills, and some consulting experience, including the ability to right‑size deliverables, work effectively with clients, and translate technical concepts into clear business recommendations.

• Apply CMC, process science, and analytical skills to solve client questions related to pharmaceutical development, manufacturing, tech transfer, process validation, and regulatory readiness.
• Support client engagements focused on biologics manufacturing and development; small molecule experience is also relevant.
• Work collaboratively with clients to understand business needs, technical requirements, available data sources, and decision‑making priorities.
• Analyze data from CMC, manufacturing, quality, regulatory, and development systems to generate actionable insights.
• Support projects involving drug substance, drug product, process development, formulation, analytical chemistry, tech transfer, process validation, and related CMC functions.
• Help clients think through future lab setups, lab operating models, digital lab capabilities, and ways to accelerate drug development.
• Contribute to the design of future‑state CMC and lab operating models, including processes, roles, systems, data flows, and technology enablement.
• Translate scientific, manufacturing, and analytical findings into clear recommendations for client stakeholders.
• Communicate results with an emphasis on answering the client’s business question, not just explaining the analytical process.
• Right‑size deliverables based on client needs, project scope, timeline, and stakeholder expectations.
• Support project planning, workstream execution, deliverable development, and day‑to‑day client engagement.
• Build expertise across CMC analytics, biologics development, process science, pharmaceutical manufacturing, and digital transformation topics.
• Upskill on new CMC concepts, therapeutic modalities, analytics methods, and emerging technologies relevant to client challenges.
• Contribute to ZS’s Supply Chain and Manufacturing practice development through knowledge assets, reusable tools, and thought leadership.

• Bachelor’s or master’s degree in Chemical Engineering, Biochemical Engineering, Mechanical Engineering, Materials Engineering, Chemistry, Biotechnology, Pharmaceutical Sciences, or a related technical discipline;
  PhD may substitute for work experience.
• At least 2.5 years of relevant pharmaceutical or biopharmaceutical CMC experience, preferably with biologics; small‑molecule experience is also acceptable.
• Hands‑on experience in at least one CMC function, such as process development, process engineering, process chemistry, formulation, analytical chemistry, drug substance manufacturing, or drug product manufacturing.
• Strong process science foundation, including understanding of unit operations, process characterization, scale‑up, tech transfer, process validation, manufacturing readiness, QbD, CQAs, CPPs, and control strategy.
• Familiarity with CMC regulatory milestones, submission requirements, and systems such as ELN, LIMS, ERP, LCM, PLM, MES, or related platforms.
• Experience using data analytics, modeling,…