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Vaxcyte

Associate Director, Regulatory CMC

San Carlos, CA · On-site +1

$180K - $210K/yr

Provides regulatory CMC guidance to various cross-functional teams and ensures all applicable ... Minimum 10 years of experience working in vaccine or biotech industry, or in a related field, or ...

Altimmune

CMC Director, Regulatory Affairs

Gaithersburg, MD · On-site

$162K - $213K/yr

S/Ph.D. degree in chemistry, pharmaceutical science, engineering or related discipline is preferred with a minimum of 5-10 years regulatory CMC or CMC-related experience in the biotech/pharma ...

Altimmune

CMC Director, Regulatory Affairs

Gaithersburg, MD · Remote

$153K - $202K/yr

S/Ph.D. degree in chemistry, pharmaceutical science, engineering or related discipline is preferred with a minimum of 5-10 years regulatory CMC or CMC-related experience in the biotech/pharma ...

GenScript/ProBio

CMC Analytical Scientist

Hopewell, NJ · On-site

$80K - $110K/yr

HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence ... Collaborate closely with other teams in CMC and coordinate cross-functional activities to support ...

GenScript/ProBio

CMC Analytical Scientist

Pennington, NJ · On-site

$80K - $110K/yr

HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence ... Collaborate closely with other teams in CMC and coordinate cross-functional activities to support ...

GenScript/ProBio

CMC Analytical Scientist

Pennington, NJ · On-site

$80K - $110K/yr

HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence ... Collaborate closely with other teams in CMC and coordinate cross-functional activities to support ...

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How much do cmc biotech jobs pay per hour?

As of Jun 12, 2026, the average hourly pay for cmc biotech in the United States is $28.94, according to ZipRecruiter salary data. Most workers in this role earn between $21.39 and $33.41 per hour, depending on experience, location, and employer.

What jobs will no longer exist in 2030?

In 2030, roles in manual manufacturing, data entry, and routine administrative tasks are expected to decline due to automation and AI advancements. Jobs requiring repetitive tasks or basic skills may be replaced by machines or software, while roles involving complex decision-making and creativity are likely to persist.

What are CMC Biotech professionals?

CMC Biotech professionals specialize in Chemistry, Manufacturing, and Controls (CMC) within the biotechnology industry. They are responsible for developing, manufacturing, and ensuring the quality and regulatory compliance of biopharmaceutical products from early development through commercialization. Their work includes process development, scale-up, analytical testing, and creating documentation for regulatory submissions. CMC experts play a crucial role in bringing safe and effective biotech therapies to market.

What are some common challenges faced by CMC Biotech professionals when working cross-functionally with other departments?

CMC (Chemistry, Manufacturing, and Controls) Biotech professionals often collaborate closely with teams in research, quality assurance, regulatory affairs, and production. A common challenge is aligning timelines and expectations across departments, as regulatory requirements and quality standards may evolve during product development. Effective communication and proactive project management are crucial to ensure that all teams are aligned, especially when handling complex data or responding to regulatory feedback. Building strong cross-functional relationships and maintaining flexibility can help CMC professionals successfully navigate these challenges.

What are the big 4 in biotech?

The 'Big 4' in biotech typically refers to the four largest pharmaceutical and biotech companies: Johnson & Johnson, Roche, Pfizer, and Novartis. These companies lead the industry in research, development, and market share, often requiring biotech professionals to have strong knowledge of drug development, regulatory processes, and laboratory skills.

What is a CMC in biotech?

In biotech, CMC stands for Chemistry, Manufacturing, and Controls, which refers to the detailed documentation and processes involved in developing, producing, and ensuring the quality of a biopharmaceutical product. CMC professionals are responsible for regulatory compliance, process validation, and quality assurance to meet industry standards and facilitate product approval.

What is the highest paying job in biotech?

In biotech, senior executive roles such as Chief Scientific Officer (CSO) or Vice President of Research typically have the highest salaries, often exceeding $200,000 annually. These positions require extensive experience, advanced degrees, and leadership skills, and they oversee research and development strategies within biotech companies.

What are the key skills and qualifications needed to thrive as a CMC (Chemistry, Manufacturing, and Controls) Biotech professional, and why are they important?

To thrive as a CMC Biotech professional, you need a strong background in biochemistry, molecular biology, regulatory affairs, and process development, often supported by an advanced degree in life sciences or chemical engineering. Familiarity with regulatory submission tools (such as eCTD), quality management systems, and analytical instrumentation is critical. Strong project management, attention to detail, and cross-functional communication skills help ensure effective collaboration and compliance. These competencies are essential for developing safe, effective biotech products while meeting stringent regulatory standards.
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What states have the most Cmc Biotech jobs? States with the most job openings for Cmc Biotech jobs include:
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Cmc Biotech jobs near you
Infographic showing various Cmc Biotech job openings in the United States as of June 2026, with employment types broken down into 1% As Needed, 74% Full Time, 3% Part Time, 21% Contract, and 1% Nights. Highlights an 82% Physical, 3% Hybrid, and 15% Remote job distribution, with an average salary of $60,196 per year, or $28.9 per hour.
Associate Director, CMC Statistician

Associate Director, CMC Statistician

Vaxcyte

San Carlos, CA • On-site

Full-time

Posted 8 days ago

Job description

Join our Mission to Protect Humankind!
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.
WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:
*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
*MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.
Summary:
Vaxcyte is looking for an energetic and talented individual to join Vaxcyte's Global Analytical organization as Associate Director, CMC Statistician. The position will be an integral part of the Vaccine Specification Working Group (VSWG), providing statistical leadership for specification setting and Justification of Specifications (JOS) across late-stage development, PPQ, BLA readiness, and commercial lifecycle management. This individual will collaborate with Process Development, MSAT, Stability, Quality, Regulatory Affairs, Manufacturing, and external partners to develop statistically sound, patient-centric, and regulatory-ready approaches. The ideal candidate will bring deep CMC statistics experience in biotech/pharma, excellent technical writing and communication skills, and a practical, data-driven approach to cross-functional decision making.
Essential Functions:
  • Serve as the CMC statistical lead for the VSWG, supporting specification-setting strategy for drug substance, drug product, intermediates, raw materials, release testing, stability testing, and in-process testing.
  • Develop statistical strategies for specification and JOS using clinical experience, manufacturing experience, stability behavior, analytical variability, assay capability, and process capability.
  • Design and execute statistical analyses such as confidence intervals, prediction intervals, tolerance intervals, regression, ANOVA, DOE, equivalence testing, trend analysis, control charts, and Cpk/process capability analyses.
  • Provide statistical input to late-stage development, PPQ, BLA/MAA preparation, health authority responses, commercial readiness, and specification lifecycle management.
  • Author and review statistical sections of specification and JOS documents, CMC technical reports, regulatory submission sections, and briefing materials.
  • Assess analytical method performance and method lifecycle changes, including precision, transfer/bridging, comparability, and impact of analytical variability on specification decisions.
  • Partner with Process Development, MSAT, Stability, QA, RA, Manufacturing, and external partners to align statistical rationale with CMC control strategy and regulatory expectations.
  • Support PPQ, APR, and CPV activities by evaluating process consistency, state of control, trends, internal control limits, and capability relative to proposed or registered specifications.
  • Translate complex statistical concepts into clear recommendations for cross-functional teams, senior leaders, and non-statistical stakeholders; support audits, inspections, and health authority interactions as needed.

Requirements:
MS or PhD in Statistics, Biostatistics, Applied Statistics, Mathematics, Data Science, or a related quantitative discipline with 10+ years of experience in the pharmaceutical or biotechnology industry. Other combinations of education and/or experience may be considered.
  • Significant hands-on experience in CMC statistics, including specification setting, JOS preparation, analytical method evaluation, stability analysis, process validation, PPQ, CPV, and/or commercial manufacturing support.
  • Demonstrated experience supporting BLA, MAA, IND, or major health authority submissions and responses; BLA experience strongly preferred.
  • Strong understanding of late-stage and commercial specification-setting principles, including clinical relevance, patient-centric justification, manufacturing experience, analytical capability, stability data, and lifecycle considerations.
  • Experience with vaccines, biologics, complex modalities, multivalent products, conjugates, or adjuvanted products is strongly preferred.
  • Strong expertise in statistical methods used in CMC and analytical development, including regression, ANOVA, DOE, equivalence testing, tolerance/prediction intervals, control charts, process capability, and stability/shelf-life modeling.
  • Proficiency with statistical software such as R, SAS, JMP, Python, Minitab, or equivalent tools.
  • Comprehensive understanding of relevant regulatory expectations and guidance, including FDA, EU, WHO, and ICH principles applicable to biologics/vaccines, specifications, analytical methods, validation, stability, and lifecycle management.
  • Significant experience authoring technical and regulatory-ready documents, including statistical reports, JOS sections, protocols, validation reports, SOPs, and CMC submission content.
  • Excellent communication and interpersonal skills, both written and verbal; able to explain complex statistical concepts clearly and influence cross-functional decisions in a fast-paced environment.
  • Strong strategic and analytical decision-making skills; able to navigate ambiguity, prioritize across competing demands, and implement practical, phase-appropriate, and compliant approaches.
  • Self-starter with proven project management capability and the ability to work independently in a remote, matrixed, and highly collaborative environment.

Reports to: Senior Director, Global Analytical Lead - Commercial Readiness and Analytical Strategy
Location: San Carlos, CA
Work Arrangement: Remote
Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $170,000 - $198,000
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
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About Vaxcyte

Sourced by ZipRecruiter

Industry

Biotechnology research and development

Company size

51 - 200 Employees

Headquarters location

San Carlos, CA, US

Year founded

2013

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