... CMC/Manufacturing; define readiness and execute in QC * Oversee instrument lifecycle (URS inputs ... pharma/biotech), including 3+ years of people management experience * Strong hands-on ...
... CMC/Manufacturing; define readiness and execute in QC * Oversee instrument lifecycle (URS inputs ... pharma/biotech), including 3+ years of people management experience * Strong hands-on ...
... CMC/Manufacturing; define readiness and execute in QC * Oversee instrument lifecycle (URS inputs ... pharma/biotech), including 3+ years of people management experience * Strong hands-on ...
... CMC/Manufacturing; define readiness and execute in QC * Oversee instrument lifecycle (URS inputs ... pharma/biotech), including 3+ years of people management experience * Strong hands-on ...
Cmc In Biotech information
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 regulations, process development, and analytical techniques.
What is the difference between Cmc In Biotech vs Formulation Scientist?
| Aspect | Cmc In Biotech | Formulation Scientist |
|---|---|---|
| Required Credentials | Bachelor's or Master's in Life Sciences, Good Manufacturing Practice (GMP) knowledge | Bachelor's or Master's in Pharmacy, Chemistry, or related field; GMP experience |
| Work Environment | Laboratories, manufacturing facilities, regulatory settings | Laboratories, R&D departments, manufacturing units |
| Employer & Industry Usage | Biotech companies, pharmaceutical firms, contract manufacturing organizations | Pharmaceutical 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?
In biotech, CMC stands for Chemistry, Manufacturing, and Controls, which refers to the detailed documentation and processes involved in developing and producing a pharmaceutical product. CMC professionals ensure that manufacturing processes meet quality standards and regulatory requirements, often working with laboratory analysis, process validation, and compliance documentation.
What is the CMC department in biotech?
The CMC (Chemistry, Manufacturing, and Controls) department in biotech is responsible for developing, manufacturing, and ensuring the quality of biopharmaceutical products. It involves activities such as process development, validation, regulatory documentation, and quality control to ensure products meet safety and efficacy standards.
What are popular job titles related to Cmc In Biotech jobs in Utah? For Cmc In Biotech jobs in Utah, the most frequently searched job titles are:
What job categories do people searching Cmc In Biotech jobs in Utah look for? The top searched job categories for Cmc In Biotech jobs in Utah are:
- Director Of Regulatory Affairs
- Associate Director Biopharma Pharmaceutical
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- Senior Director Of Regulatory Affairs
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What cities in Utah are hiring for Cmc In Biotech jobs? Cities in Utah with the most Cmc In Biotech job openings:
Full-time
Medical, Retirement
Re-posted 12 days ago
Job description
Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients.
We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.
The Senior Manager, QC Chemistry will serve as both a technical and people leader within the QC Chemistry group, overseeing up to 5 chemists responsible for analytical testing of biologics and related materials. This individual will ensure the delivery of safe, compliant, and on-time analytical results at scale. This is a hands-on leadership role with routine lab work (approximately 40-60%, workload-dependent) required to support critical testing, troubleshooting, and method lifecycle activities.
The ideal candidate will play a key role in supporting both clinical and commercial readiness by ensuring phase-appropriate method performance, data integrity, and operational excellence across all testing activities, with a strong emphasis on chromatography-based methods.
Key Accountabilities/Core Job Responsibilities:
Qualifications/Skills:
Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers
This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.
Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.
Salt Lake City Drug Testing Policy
We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.
The Senior Manager, QC Chemistry will serve as both a technical and people leader within the QC Chemistry group, overseeing up to 5 chemists responsible for analytical testing of biologics and related materials. This individual will ensure the delivery of safe, compliant, and on-time analytical results at scale. This is a hands-on leadership role with routine lab work (approximately 40-60%, workload-dependent) required to support critical testing, troubleshooting, and method lifecycle activities.
The ideal candidate will play a key role in supporting both clinical and commercial readiness by ensuring phase-appropriate method performance, data integrity, and operational excellence across all testing activities, with a strong emphasis on chromatography-based methods.
Key Accountabilities/Core Job Responsibilities:
- Lead and develop QC Chemistry team; set priorities, build schedules, run tier huddles, and ensure coverage/cross-training
- Hands-on (~50%) lab leader supporting chromatography testing, troubleshooting, record approvals, and bench mentoring
- Own analytical method lifecycle (readiness, validation/verification/transfer); author/review protocols, reports, and change control
- Serve as QC SME for HPLC/UPLC and core analytical techniques (e.g., UV/Vis); support biologics assays (e.g., CE-SDS, icIEF, potency) as needed
- Ensure GMP/ALCOA+ data integrity & GDP; review/approve ELN/LIMS entries; maintain audit readiness and responses
- Lead OOT/OOS/deviation investigations, root cause, and CAPAs; verify effectiveness and drive timely closure
- Act as QC lead for method transfers, coordinating with AD/CMC/Manufacturing; define readiness and execute in QC
- Oversee instrument lifecycle (URS inputs, IOQ/PQ, calibration/PM, training, release-to-use) with ENG/vendors
- Drive operations & KPIs (TAT, investigation cycle time, schedule adherence); standardize SOPs/templates and oversee routine QC testing, stability, and sample management
- Lead direct report(s) through goal setting, development planning, training compliance, and ongoing performance feedback
Qualifications/Skills:
- Typically requires a BS in Chemistry, Biochemistry, or related field and 8+ years of GMP QC experience (pharma/biotech), including 3+ years of people management experience
- Strong hands-on chromatography experience (HPLC/UPLC required)
- Prior experience leading or mentoring small teams
- Experience with analytical method validation, transfer, and troubleshooting
- Strong knowledge of GMP, data integrity (ALCOA+), and QC documentation practices
- Experience with OOS/OOT investigations, root cause analysis, and CAPAs
- Familiarity with CDS/ELN/LIMS systems (e.g., Empower, OpenLab)
- Biologics analytical experience (e.g., CE-SDS, icIEF, potency) is a plus, not required
- Ability to work onsite in Salt Lake City, UT with occasional off-shift support
Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers
This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.
Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.
Salt Lake City Drug Testing Policy
About Denali Therapeutics
Sourced by ZipRecruiter
Industry
Scientific research and development services
Company size
201 - 500 Employees
Headquarters location
San Francisco, CA, US
Year founded
2013