Associate Consultant - CMC Development & Analytics
ZS Associates · San Francisco, United States · 3mo ago
ZS is a place where passion changes lives. As a management consulting and technology firm focused on improving life and how we live it, we transform ideas into impact by bringing together data, science, technology and human ingenuity to deliver better outcomes for all. Here you’ll work side-by-side with a powerful collective of thinkers and experts shaping life-changing solutions for patients, caregivers and consumers, worldwide. ZSers drive impact by bringing a client-first mentality to each and every engagement. We partner collaboratively with our clients to develop custom solutions and technology products that create value and deliver company results across critical areas of their business. Bring your curiosity for learning, bold ideas, courage and passion to drive life-changing impact to ZS.
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.
What You’ll Do: In this role, you will...
- 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.
What You’ll Bring
- 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, reporting, visualization, AI-enabled tools, or technology solutions to generate insights and accelerate CMC development.
- Some consulting or client-facing experience, including working with clients, right-sizing deliverables, managing stakeholder expectations, and communicating recommendations clearly.
- Strong communication, problem-solving, attention to detail, teamwork, ownership, adaptability, and client-first mindset.
- Fluency in English
- Client-first mentality
- Intense work ethic
- Collaborative spirit and problem-solving approach
How you’ll grow:
- Cross-functional skills development & custom learning pathways
- Milestone training programs aligned to career progression opportunities
- Internal mobility paths that empower growth via s-curves, individual contribution and role expansions
Perks & Benefits:
At ZS, your growth matters. We offer a comprehensive total rewards package that supports your health and well‑being, financial future, time away, and professional development. With robust skills‑building programs, multiple career progression paths, internal mobility, and a deeply collaborative culture, you’ll have the opportunity to do meaningful work, expand your capabilities, and thrive as part of a global community. For details on total rewards in United States, visit ZS US office locations | Where we work | ZS.
Hybrid working model:
We are committed to giving our employees a flexible and connected way of working. A flexible and connected ZS allows us to combine work from home and on-site presence at clients/ZS offices for the majority of our week. The magic of ZS culture and innovation thrives in both planned and spontaneous face-to-face connections.
Travel:
Travel is a requirement at ZS for client facing ZSers; business needs of your project and client are the priority. While some projects may be local, all client-facing ZSers should be prepared to travel as needed. Travel provides opportunities to strengthen client relationships, gain diverse experiences, and enhance professional growth by working in different environments and cultures.
Considering applying?
At ZS, we honor the visible and invisible elements of our identities, personal experiences, and belief systems—the ones that comprise us as individuals, shape who we are, and make us unique. We believe your personal interests, identities, and desire to learn are integral to your success here. We are committed to building a team that reflects a broad variety of backgrounds, perspectives, and experiences. Learn more about our inclusion and belonging efforts and the networks ZS supports to assist our ZSers in cultivating community spaces and obtaining the resources they need to thrive.
If you’re eager to grow, contribute, and bring your unique self to our work, we encourage you to apply.
ZS is an equal opportunity employer and is committed to providing equal employment and advancement opportunities without regard to any class protected by applicable law.
Work Authorization:
This position is not eligible for visa sponsorship. Candidates must have authorization to work in the United States that does not now or in the future require employer sponsorship.
To complete your application:
An on-line application, including a full set of transcripts (official or unofficial), is required to be considered.
NO AGENCY CALLS, PLEASE.
Find Out More At:
www.zs.com
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.
What You’ll Do: In this role, you will...
- 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.
What You’ll Bring
- 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, reporting, visualization, AI-enabled tools, or technology solutions to generate insights and accelerate CMC development.
- Some consulting or client-facing experience, including working with clients, right-sizing deliverables, managing stakeholder expectations, and communicating recommendations clearly.
- Strong communication, problem-solving, attention to detail, teamwork, ownership, adaptability, and client-first mindset.
- Fluency in English
- Client-first mentality
- Intense work ethic
- Collaborative spirit and problem-solving approach
How you’ll grow:
- Cross-functional skills development & custom learning pathways
- Milestone training programs aligned to career progression opportunities
- Internal mobility paths that empower growth via s-curves, individual contribution and role expansions
Perks & Benefits:
At ZS, your growth matters. We offer a comprehensive total rewards package that supports your health and well‑being, financial future, time away, and professional development. With robust skills‑building programs, multiple career progression paths, internal mobility, and a deeply collaborative culture, you’ll have the opportunity to do meaningful work, expand your capabilities, and thrive as part of a global community. For details on total rewards in United States, visit ZS US office locations | Where we work | ZS.
Hybrid working model:
We are committed to giving our employees a flexible and connected way of working. A flexible and connected ZS allows us to combine work from home and on-site presence at clients/ZS offices for the majority of our week. The magic of ZS culture and innovation thrives in both planned and spontaneous face-to-face connections.
Travel:
Travel is a requirement at ZS for client facing ZSers; business needs of your project and client are the priority. While some projects may be local, all client-facing ZSers should be prepared to travel as needed. Travel provides opportunities to strengthen client relationships, gain diverse experiences, and enhance professional growth by working in different environments and cultures.
Considering applying?
At ZS, we honor the visible and invisible elements of our identities, personal experiences, and belief systems—the ones that comprise us as individuals, shape who we are, and make us unique. We believe your personal interests, identities, and desire to learn are integral to your success here. We are committed to building a team that reflects a broad variety of backgrounds, perspectives, and experiences. Learn more about our inclusion and belonging efforts and the networks ZS supports to assist our ZSers in cultivating community spaces and obtaining the resources they need to thrive.
If you’re eager to grow, contribute, and bring your unique self to our work, we encourage you to apply.
ZS is an equal opportunity employer and is committed to providing equal employment and advancement opportunities without regard to any class protected by applicable law.
Work Authorization:
This position is not eligible for visa sponsorship. Candidates must have authorization to work in the United States that does not now or in the future require employer sponsorship.
To complete your application:
An on-line application, including a full set of transcripts (official or unofficial), is required to be considered.
NO AGENCY CALLS, PLEASE.
Find Out More At:
www.zs.com