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Cmc Analytical Lead Jobs (NOW HIRING)

Merck & Co.

Analytical testing is critical to the assessment of vaccine product quality, potency, purity ... CMC-Regulatory. The lead will be responsible for coordinating the activities of their direct ...

Atomic

Drug CMC Lead

$150K - $215K/yr

Manage analytical method development, validation and qualification for release and stability ... Lead development and execution of CMC strategy to support IND and eventual NDA submission. * Define ...

Celcuity Inc.

$230K - $240K/yr

Lead analytical development and material characterization for existing and new compounds ... Author and review analytical CMC sections and relevant bioanalytical components for IND through NDA ...

Iambic Therapeutics, Inc

$224K - $310K/yr

... CMC. This leadership role will provide scientific, strategic, and operational oversight of ... The individual will lead phase-appropriate analytical strategies for drug substance and drug ...

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Cmc Analytical Lead information

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$29.5K

$100.7K

$193.5K

How much do cmc analytical lead jobs pay per year?

As of Sep 14, 2026, the average yearly pay for cmc analytical lead in the United States is $100,673.00, according to ZipRecruiter salary data. Most workers in this role earn between $67,500.00 and $125,000.00 per year, depending on experience, location, and employer.

What is a CMC Analytical Lead?

A CMC Analytical Lead is a professional responsible for overseeing the analytical strategy and testing of pharmaceutical products throughout their development and manufacturing process. CMC stands for Chemistry, Manufacturing, and Controls, which involves ensuring that drug substances and products meet regulatory and quality standards. The Analytical Lead manages method development, validation, and transfer, coordinates between laboratories and regulatory authorities, and supports submissions for drug approval. This role requires strong scientific knowledge, project management skills, and the ability to collaborate across multidisciplinary teams.

What are the key skills and qualifications needed to thrive as a CMC Analytical Lead?

To thrive as a CMC Analytical Lead, you need a strong background in analytical chemistry, pharmaceutical sciences, and regulatory guidelines, often supported by an advanced degree in a related field. Familiarity with analytical techniques (such as HPLC, GC, and spectroscopy), data management systems, and knowledge of ICH/FDA regulations are essential, along with experience in method development and validation. Excellent project management, leadership, and cross-functional communication skills help drive collaboration and problem-solving across teams. These skills are crucial for ensuring product quality, regulatory compliance, and the successful development and commercialization of pharmaceutical products.

How does a CMC Analytical Lead typically collaborate with cross-functional teams during drug development projects?

As a CMC Analytical Lead, you will frequently collaborate with formulation scientists, process development teams, regulatory affairs, and quality assurance professionals. Your primary responsibility is to ensure robust analytical strategies are in place to support product development, from early stages through commercialization. This involves coordinating method development, validation, and transfer activities, as well as providing technical input during regulatory submissions. Strong communication and organizational skills are essential, as you will often lead meetings and serve as the analytical point of contact for various stakeholders.

What are popular job titles related to Cmc Analytical Lead jobs?

For Cmc Analytical Lead jobs, the most frequently searched job titles are:

Senior Manager, GMP Investigational Quality

Manhattan, NY • On-site

Scorpion Therapeutics
51 - 200 employees
Learn more about Scorpion Therapeuticsexternal

Other

Posted 15 days ago

Job description

The Role:

Responsible for GMP Quality oversight and lot review/release activities supporting early and late-stage phase investigational programs, including drug substance, drug product, and clinical finished goods manufactured, packaged, labeled, stored, and distributed by Contract Manufacturing Organizations (CMOs) and other external partners. Ensure compliance with cGMPs, Syndax Quality Systems, and applicable regulatory requirements.

Key Responsibilities:
  • Support GMP quality oversight for early phase programs (review/approval of master batch records, executed batch records, CoAs, specifications, method qualification protocols/reports, and source documentation).
  • Support clinical finished goods release (packaging/labeling records, label proofs, expiry/retest, temperature excursion documentation, product release/QP release support).
  • Coordinate with external manufacturers, CDMOs, contract labs, and packaging/labeling vendors and internal partners.
  • Manage deviations, investigations, CAPAs, change controls, OOS/OOT events, complaints, and other quality events (focus on patient safety, data integrity, and supply continuity).
  • Lead quality investigations; drive root cause, CAPA development, and effectiveness verification.
  • Partner with CMC, Analytical Development, Supply Chain, Clinical Operations, Regulatory Affairs, and external partners to identify GMP risks and resolve quality issues.
  • Identify/mitigate GMP compliance risks, quality system gaps, and process improvement opportunities.
  • Author/review/approve GMP quality documents (deviations, change controls, CAPAs, SOPs, quality agreements as applicable).
  • Maintain clear communication of quality risks, open issues, and release readiness.
Desired Experience/Education and Personal Attributes:
  • BS in a scientific field (required).
  • 5+ years in pharma/biotech with GMP Quality experience supporting CMOs and clinical-stage development.
  • Early phase GMP oversight experience for drug substance/drug product/clinical finished goods.
  • Experience reviewing/approving GMP documentation (MBRs/EBRs, clinical packaging/labeling records, CoAs, method qualification).
  • Experience with clinical labeling/packaging, release, expiry/retest, temperature excursions, and QP release.
  • Experience managing deviations/investigations/CAPAs/OOS-OOT/complaints and product impact assessments.
  • Cross-functional experience (CMC, Analytical Development, Supply Chain, Clinical Operations, Regulatory Affairs, vendors).
  • Strong technical writing; clear verbal/written communication.
  • Judgment, project management, and ability to manage multiple priorities in fast-paced outsourced/hybrid environments.
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