ZipRecruiter

Log In

1

Head Of Biotech Cmc Jobs (NOW HIRING)

Regeneron

Head of Regeneron Cell Medicines

Cambridge, MA · On-site

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Identify and evaluate external opportunities (academia, biotech, consortia, platforms) to ... CMC considerations for in vivo modalities (vector design, release testing, stability) versus ex ...

New

Neion Bio

Head of Biologics

New York, NY · On-site

$170K - $230K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

Role Summary We are looking for an exceptional Head of Biologics to lead the selection and development of therapeutic proteins produced using Neion Bio's egg-based biomanufacturing platform. This ...

Neion Bio

Head of Biologics

Manhattan, NY · On-site

$170K - $230K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

Role Summary We are looking for an exceptional Head of Biologics to lead the selection and development of therapeutic proteins produced using Neion Bio's egg-based biomanufacturing platform. This ...

Aspect Biosystems

Head of Quality Assurance

Fremont, CA · On-site

$191 - $202/hr

Biotech Industry Tenure: 10+ years of progressive Quality Assurance leadership experience within a ... Direct experience authoring, reviewing, and approving Quality/CMC sections for regulatory ...

previous page

Showing results 41-60

All JobsHead Of Biotech Cmc Jobs

Head Of Biotech Cmc information

See salary details

$139.5K

$160K

$178K

How much do head of biotech cmc jobs pay per year?

As of Aug 13, 2026, the average yearly pay for head of biotech cmc in the United States is $159,999.00, according to ZipRecruiter salary data. Most workers in this role earn between $150,000.00 and $170,000.00 per year, depending on experience, location, and employer.

What is the difference between Head Of Biotech Cmc vs Biotech Cmc Manager?

AspectHead Of Biotech CmcBiotech Cmc Manager
ResponsibilitiesOversees entire CMC strategy, leads cross-functional teams, and makes high-level decisionsManages day-to-day CMC operations, implements plans, and supervises staff
Experience & CredentialsAdvanced degree (PhD/MSc), extensive industry experience, leadership skillsBachelor's or Master's degree, relevant industry experience, technical expertise
Work EnvironmentStrategic, leadership-focused, often in senior management meetingsOperational, project-focused, in labs or manufacturing settings

The Head Of Biotech Cmc typically holds a senior leadership role, responsible for strategic direction and decision-making, while the Biotech Cmc Manager focuses on managing daily operations and project execution within the biotech CMC department.

What skills and qualifications are needed to thrive as a Head of Biotech CMC?

To thrive as a Head of Biotech CMC (Chemistry, Manufacturing, and Controls), you need deep expertise in biotechnology, pharmaceutical development, and regulatory compliance, often backed by an advanced scientific degree. Familiarity with GMP, quality management systems, and regulatory submission platforms like eCTD is typically required. Exceptional leadership, strategic thinking, and cross-functional communication skills help drive complex projects and align multidisciplinary teams. These competencies are essential to ensure product quality, regulatory approval, and the successful scale-up of biotechnological products.

What are the responsibilities of a Head of Biotech CMC?

A Head of Biotech CMC (Chemistry, Manufacturing, and Controls) oversees the development, manufacturing, and quality control of biotechnological products throughout their lifecycle. They ensure that processes comply with regulatory requirements and meet industry standards for safety and efficacy. Their duties include leading cross-functional teams, managing timelines and budgets, and developing strategies for scale-up and technology transfer. Additionally, they play a key role in interacting with regulatory agencies and facilitating the submission of documentation for product approval.

What challenges does a Head of Biotech CMC face when scaling up production from clinical to commercial stages?

One of the key challenges for a Head of Biotech CMC is ensuring that processes developed at the clinical stage can be effectively and compliantly scaled up for commercial manufacturing. This often involves addressing differences in equipment, maintaining product quality and consistency, and navigating regulatory requirements across multiple regions. Additionally, coordinating cross-functional teams—such as R&D, quality assurance, and supply chain—is essential to resolve technical issues quickly and keep projects on track. Proactive communication and robust risk management strategies are critical for success in this role.
More about Head Of Biotech Cmc jobs

What cities are hiring for Head Of Biotech Cmc jobs?

Cities with the most Head Of Biotech Cmc job openings:

What states have the most Head Of Biotech Cmc jobs?

States with the most job openings for Head Of Biotech Cmc jobs include:

What job categories do people searching Head Of Biotech Cmc jobs look for?

The top searched job categories for Head Of Biotech Cmc jobs are:

Head Of Biotech Cmc jobs near you
Infographic showing various Head Of Biotech Cmc job openings in the United States as of August 2026, with employment types broken down into 5% Internship, 80% Full Time, 5% Part Time, and 10% Contract. Highlights an 71% In-person, and 29% Remote job distribution, with an average salary of $159,999 per year, or $76.9 per hour.

Director, CMC - Small Molecule Chemistry

Pathos

New York, NY • On-site

$210K - $250K/yr

Full-time

Posted 3 days ago

New

Job description

Drug development shouldn't be guesswork, not when patients are waiting.
Pathos is building a next-generation biotech with AI at the core. Not as a feature, but as the operating system for how medicines get developed. We believe most drugs don't fail because the science was wrong. They fail because they were tested in the wrong patients, with the wrong assumptions, in trials that couldn't answer the real question: who benefits, and why?
Pathos exists to change that. We're building the largest foundation model in oncology and pairing it with proprietary AI systems, deep oncology expertise, and 200+ petabytes of multimodal data linked to patient outcomes, so we can make development decisions with more precision, much earlier.
This is not theoretical. We're well-capitalized and have the leadership to build a generational company. We invest in and advance our own clinical-stage programs, using our AI platform to sharpen trial design, patient selection and biomarker strategy. So therapies reach the patients most likely to benefit, sooner.
How We Build
Pathos does not operate like a traditional biotech. There is no middle management. There are no layers of approval. The company is designed, from the ground up, around small teams of 2-4 subject matter experts who each command hundreds of AI agents to do the work that used to require dozens of people.
Everyone builds. Everyone ships. Every function at Pathos - from clinical execution to asset selection to the foundation model itself - runs on this model. Our product velocity delivers meaningful outcomes in hours instead of weeks. This is not a future aspiration. It is how we operate today.
The people who thrive here are operators: deep experts who can specify what needs to happen, orchestrate AI agents to execute at scale, and make high-judgment calls that compound over time. If you have spent your career building and shipping AI systems at scale, this is the environment where that experience becomes a superpower.
About the Role
We are seeking a Director, CMC - Small Molecule Chemistry to lead the chemistry, manufacturing, and controls strategy for our small-molecule oncology programs. This individual will own drug substance and drug product development - from early clinical supply through late-stage development - ensuring phase-appropriate quality, robust processes, and regulatory-ready documentation. This is a foundational hire on the Pathos CMC/Technical Operations team. You will help build and scale the chemistry, manufacturing, and controls function from an early stage, partnering with the Head of CMC and working with Research, Clinical, Regulatory, and Quality colleagues in a fast-moving, resource-conscious environment. You are equally comfortable rolling up your sleeves on technical detail and operating strategically across a portfolio.
What You Will Do
CMC Strategy & Program Leadership
  • Expert in Synthetic, Organic or Medicinal Chemistry of Oncology Compounds and comfortable building phase-appropriate end-to-end CMC strategy
  • Define and execute the end-to-end small-molecule CMC strategy for one or more oncology programs, spanning drug substance (API) and drug product.
  • Serve as the CMC program lead and single point of accountability, representing CMC on cross-functional program teams alongside Research, Clinical, Regulatory, and Quality.
  • Translate program goals and timelines into phase-appropriate development plans, budgets, and risk-mitigation strategies.

Process & Analytical Development
  • Direct route scouting, synthetic route selection, and process development for APIs, applying deep synthetic and organic chemistry expertise to deliver scalable, cost-effective, and controllable processes.
  • Oversee drug product formulation and process development, including solid oral and other dosage forms appropriate to oncology indications.
  • Guide analytical method development, qualification/validation, specifications setting, impurity and genotoxic impurity control strategies, and stability programs.
  • Apply QbD and risk-based principles to build robust control strategies and process understanding.

External Manufacturing & Supply
  • Select, manage, and technically oversee CDMOs/CMOs for API and drug product manufacture, tech transfer, and scale-up.
  • Ensure timely, phase-appropriate clinical supply (Phase 1-3) and lead process performance and validation activities to support late-stage development and eventual commercialization.
  • Author and review batch records, development reports, and technical transfer packages; troubleshoot process and analytical issues.

Regulatory & Quality
  • Author and review CMC sections of regulatory filings (IND, IMPD, briefing documents, and later NDA/MAA modules) and support health-authority interactions.
  • Partner with Quality to ensure GMP compliance, manage deviations and change control, and support internal and external audits.

Who You Are
Required Qualifications
  • Ph.D. in Synthetic Organic Chemistry, Medicinal Chemistry, or a closely related field (or an M.S./B.S. with commensurate additional experience).
  • 8-10+ years of pharmaceutical/biotech CMC experience with demonstrated depth in synthetic, organic, or medicinal chemistry.
  • Direct experience in oncology drug development.
  • Proven track record across the full development lifecycle: phase-appropriate development for Phase 1-3 as well as hands-on experience with late-stage development.
  • Experience in BOTH a small/emerging biotech and a large pharma environment, with the versatility to operate effectively in each.
  • Deep, hands-on knowledge of API route design and process development, drug product formulation, analytical development, impurity control, and stability.
  • Demonstrated success managing CDMOs/CMOs and leading technical transfer and scale-up.
  • Strong command of ICH, FDA, and EMA CMC guidance and phase-appropriate GMP expectations, with experience authoring CMC regulatory submissions.

Preferred Qualifications
  • Experience taking a small-molecule oncology asset through pivotal/late-stage development and toward registration.
  • Familiarity with high-potency (HPAPI/OEB) handling and containment relevant to oncology compounds.
  • Experience with continuous manufacturing, complex/novel formulations, or drug-device combinations.
  • Comfort operating in a data- and technology-forward organization; interest in leveraging AI/ML to accelerate CMC decision-making.

What Success Looks Like
  • Reliable, phase-appropriate clinical supply that never gates the clinical program.
  • Robust, well-understood processes and control strategies that de-risk the path to late-stage development.
  • Clean, defensible CMC regulatory submissions and successful health-authority interactions.

Location
This is a hybrid role, requiring 3 days per week onsite, in our NYC Headquarters.
The pay range for this role is:
210,000 - 250,000 USD per year (New York Office - ACLS East Tower)

Apply