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What are some typical challenges a Head of CMC faces when overseeing cross-functional development teams in pharmaceutical manufacturing?

As the Head of CMC (Chemistry, Manufacturing, and Controls), one common challenge is coordinating efforts between R&D, regulatory, quality assurance, and manufacturing teams to ensure alignment on timelines and compliance standards. Balancing innovative process development with strict regulatory requirements and managing resource constraints are also frequent hurdles. Effective communication and proactive project management are essential to navigate shifting priorities, address technical issues quickly, and keep all teams focused on delivering high-quality products within set deadlines.

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

AspectHead Of CmcCmc Manager
ResponsibilitiesOversees entire CMC development, strategy, and regulatory compliance at a senior levelManages day-to-day CMC activities, ensuring project milestones and quality standards are met
Required CredentialsAdvanced degree in life sciences, extensive industry experience, leadership skillsBachelor's or Master's in related field, relevant industry experience
Work EnvironmentStrategic planning, cross-department collaboration, senior management meetingsOperational tasks, project management, team supervision

The Head Of Cmc typically holds a senior leadership role, focusing on strategic oversight and regulatory compliance, while the Cmc Manager handles daily operational activities. Both roles require relevant industry experience, but the Head Of Cmc's responsibilities are broader and more strategic.

What are the roles and responsibilities of a Head of CMC?

A Head of CMC (Chemistry, Manufacturing, and Controls) oversees all aspects of the drug development process related to manufacturing and quality. They are responsible for ensuring that pharmaceutical products are developed, manufactured, and controlled according to regulatory standards. This role involves leading cross-functional teams, managing relationships with external partners, and ensuring timely submission of regulatory documents. The Head of CMC also plays a key role in problem-solving, process optimization, and maintaining compliance throughout the product lifecycle.

What are the key skills and qualifications needed to thrive as a Head of CMC, and why are they important?

To thrive as a Head of CMC (Chemistry, Manufacturing, and Controls), you need deep expertise in pharmaceutical development, regulatory requirements, and process optimization, typically supported by an advanced degree in chemistry, pharmacy, or a related field. Experience with quality management systems, regulatory submissions (e.g., IND, NDA, BLA), and industry-standard software such as LIMS or ERP platforms is essential. Strong leadership, strategic thinking, and cross-functional communication skills distinguish top performers in this role. These capabilities are critical for ensuring product quality, regulatory compliance, and the successful advancement of drug candidates through the development pipeline.
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Head Of Cmc jobs near you
Infographic showing various Head Of Cmc job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 80% Full Time, 16% Part Time, 1% Temporary, 1% Contract, and 1% Nights. Highlights an 95% Physical, 1% Hybrid, and 4% Remote job distribution.

Director, Analytical Development (Flow Cytometry & Method Validation)

Orca Bio

Sacramento, CA

$175K - $215K/yr

Full-time

Re-posted 22 days ago

Job description

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
 
We have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.

Summary:

In this Sacramento-based role, reporting into our VP/Head of CMC, you will lead the design, development, validation, and lifecycle management of analytical methods supporting cell therapy programs. This role will provide strategic and technical leadership with a strong emphasis on advanced flow cytometry, method validation, and cell-based assays. The ideal candidate brings deep expertise in cell therapy analytics, a proven track record in regulatory submissions, and demonstrated success in building and leading high-performing scientific teams.

Responsibilities

Leadership & Strategy

  • Provide scientific and operational leadership for the Analytical Development function supporting cell therapy programs.
  • Build, mentor, and lead a team of scientists specializing in flow cytometry, cell-based assays, and analytical characterization.
  • Define and execute analytical strategies aligned with program, regulatory, and commercialization timelines.
  • Collaborate cross-functionally with Process Development, Manufacturing, Regulatory Affairs, QC, and Clinical teams.
  • Develop methods related to raw material testing and microbial release tests.

Flow Cytometry & Cell Therapy Expertise

  • Lead the development, optimization, and qualification of multiparametric flow cytometry assays for cell identity, purity, potency, and phenotypic characterization.
  • Establish standardized panels, controls, and gating strategies for complex cell therapy products (e.g., CAR-T, TCR-T, stem cell-derived therapies).
  • Drive innovation in high-dimensional cytometry and data analysis approaches.

Analytical Method Development & Validation

  • Oversee development, qualification, transfer, and ICH-compliant validation of analytical methods.
  • Ensure assays meet regulatory expectations for precision, accuracy, specificity, robustness, and stability.
  • Lead comparability studies, reference standard programs, and method lifecycle management.
  • Establish an efficient strategy for method validation and transfer.

Regulatory & Compliance

  • Author and review analytical sections of IND, BLA, and other regulatory submissions.
  • Serve as a technical subject matter expert during regulatory agency interactions.
  • Ensure compliance with cGMP, GLP, and regulatory guidelines.

Operational Excellence

  • Drive continuous improvement in assay robustness, throughput, and scalability.
  • Manage budgets, timelines, and resource allocation across multiple programs.
  • Oversee technology transfer to Quality Control laboratories.
Required Qualifications

Education & Experience

  • Ph.D. in Immunology, Cell Biology, Analytical Chemistry, or related field required
  • Minimum 10+ years of industry experience in biotech or pharma
  • 8+ years’ experience in experience in cell therapy analytical development (e.g., CAR-T, gene-modified cells, stem cells)
  • MSc degree acceptable with 15+ years of relevant experience

Technical Expertise

  • Deep expertise in flow cytometry assay development (multicolor panels, intracellular staining, rare cell detection, functional assays)
  • Strong background in analytical method validation (ICH Q2 and regulatory expectations)
  • Experience with cell-based potency assays
  • Familiarity with advanced cytometry technologies (e.g., spectral cytometry, CyTOF) is a plus
  • Strong understanding of CMC development for biologics and cell therapies

Leadership Skills

  • Proven experience leading and developing high-performing teams
  • Strong project management and cross-functional leadership skills
  • Ability to influence stakeholders at all organizational levels
  • Strategic thinking and scientific rigor
  • Strong communication and presentation skills
  • Results-driven with a focus on quality and compliance
  • Ability to manage complexity in a fast-paced environment
Preferred Qualifications
  • Experience supporting late-stage clinical programs or commercial products
  • Prior experience interacting with FDA/EMA regulatory agencies
  • Experience in data analysis tools (FlowJo or equivalent)
  • Knowledge of automation and digital data systems in analytical labs
The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
 
Who we are
 
We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
 
We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
 
We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
 
We maintain a start-up culture of camaraderie and leadership by example, regardless of title.
 
We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
 
Notice to staffing firms
 
Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.