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Cmc In Biotech Jobs (NOW HIRING)

Legend Biotech US

Manager, Regulatory CMC

Somerset, NJ · Hybrid

Legend Biotech is seeking a Manager, Regulatory CMC as part of the Regulatory Affairs team based in Somerset, NJ. Role Overview This position will support the development and execution of global CMC ...

Legend Biotech US

Manager, Regulatory CMC

Somerset, NJ · On-site

Legend Biotech is seeking a Manager, Regulatory CMC as part of the Regulatory Affairs team based in ... Somerset, NJ. Role Overview This position will support the development and execution of global CMC ...

Legend Biotech USA, Inc.

$193K - $254K/yr

RequirementsAdvanced degree in life sciences, biotechnology, pharmaceutical sciences, engineering ... Strong CMC technical background is required. Ability to critically evaluate data from a broad range ...

New

Atomic

Drug CMC Lead

$150K - $215K/yr

... CMC strategy in biotech/pharmaceutical settings. * Expertise in formulation development, analytical method development/validation, stability programs, GMP manufacturing, and quality compliance.

Legend Biotech USA, Inc.

Legend Biotech is seeking a Manager, Regulatory CMC as part of the Regulatory Affairs team based in ... Somerset, NJ. Role OverviewThis position will support the development and execution of global CMC ...

Legend Biotech USA

NJ · On-site

$125K - $155K/yr

About GenScript Founded in 2002 in New Jersey, GenScript Biotech Corporation accelerates innovation ... Experience and service in Early Discovery, Platform Development, or CMC within biopharma or top ...

BrainChild Bio, Inc.

Director, CMC Quality Position Summary BrainChild Bio is seeking an experienced Director, CMC ... BrainChild Bio is a clinical-stage biotechnology company leading the field in the development of ...

BrainChild Bio

Director, CMC Quality

$190K - $210K/yr

Director, CMC Quality Position Summary BrainChild Bio is seeking an experienced Director, CMC ... BrainChild Bio is a clinical-stage biotechnology company leading the field in the development of ...

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Cmc In Biotech information

What is the difference between Cmc In Biotech vs Formulation Scientist?

AspectCmc In BiotechFormulation Scientist
Required CredentialsBachelor's or Master's in Life Sciences, Good Manufacturing Practice (GMP) knowledgeBachelor's or Master's in Pharmacy, Chemistry, or related field; GMP experience
Work EnvironmentLaboratories, manufacturing facilities, regulatory settingsLaboratories, R&D departments, manufacturing units
Employer & Industry UsageBiotech companies, pharmaceutical firms, contract manufacturing organizationsPharmaceutical companies, biotech firms, contract labs

While both roles operate within the biotech and pharmaceutical industries, Cmc In Biotech focuses on Chemistry, Manufacturing, and Controls documentation and regulatory compliance, whereas Formulation Scientists primarily develop and optimize drug formulations. Cmc In Biotech professionals ensure regulatory submissions are complete, while Formulation Scientists work on creating effective drug delivery systems. Both roles often collaborate but serve distinct functions within the product development pipeline.

What is a CMC in biotech position?

A CMC (Chemistry, Manufacturing, and Controls) position in biotech involves overseeing the development, manufacturing, and quality control of biopharmaceutical products. Professionals in this role ensure that products meet regulatory standards and are produced consistently, often requiring knowledge of GMP (Good Manufacturing Practice) and regulatory guidelines.

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 CMC in biotech?

In biotech, CMC stands for Chemistry, Manufacturing, and Controls, which refers to the detailed documentation and processes ensuring the quality, safety, and efficacy of a biotech product throughout development and production. Professionals in this field often work on regulatory submissions, quality assurance, and process validation to meet industry standards.
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Infographic showing various Cmc In Biotech job openings in the United States as of September 2026, with employment types broken down into 4% As Needed, 89% Full Time, 2% Part Time, and 5% Contract. Highlights an 78% Physical, 4% Hybrid, and 18% Remote job distribution.

Associate Director, CMC Statistician

San Carlos, CA • On-site

Vaxcyte
Biotechnology Research and Development • 51 - 200 employees
Learn more about Vaxcyteexternal

Full-time

Re-posted 13 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
Equal Opportunity
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.
Recruitment Fraud Notice
Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent Vaxcyte in recruitment activities. Vaxcyte has an established recruitment process for all positions prior to issuing an offer for employment and we will never extend unsolicited employment offers or ask candidates to provide financial or sensitive personal information as part of the application process. All legitimate communication from Vaxcyte will come from an official @vaxcyte.com email address. Qualified and interested candidates should apply to current openings at vaxcyte.com/careers.
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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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