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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 Washington as of June 2026, with employment types broken down into 75% Full Time, 15% Part Time, 5% Temporary, and 5% Contract. Highlights an 85% Physical, 2% Hybrid, and 13% Remote job distribution.

Associate Director, External Operations, Cell Therapy - External Supply Management

AstraZeneca GmbH

Gaithersburg, MD • On-site

$115 - $173/hr

Other

Medical, Dental, Vision, Retirement, PTO

This job post has expired today. Applications are no longer accepted.

Job description

The Associate Director, External Operations, Cell Therapy – External Supply Management

Leads external manufacturing partner operations. These operations span a network of CDMOs and external partners supporting cell therapy across autologous, allogeneic, in vivo, and new platforms. Creates operational governance, tech transfer, batch execution, investigations, and risk management to meet supply, quality, and cost targets. Supports programs across development, clinical, scale‑up, validations, launch readiness, and commercialization as portfolio evolves. Partners cross‑functionally with CMC Product Leadership, Process Development, Quality, Regulatory, Procurement, and Finance to ensure external supply.

Role based in Gaithersburg, MD and reports to the Head of External Supply - Cell Therapy Products.

You will
  • Lead daily operational management of assigned CDMOs/external manufacturing partners to ensure performance against supply, quality, and cost targets.
  • Guide execution across tech transfer, manufacturing, release, delivery, issue resolution, deviations, investigations.
  • Be a primary operational interface across technical operations, Quality, Supply Chain, Regulatory, CMC, Program management, finance, procurement and legal.
  • Lead change management implementation at external partners following CMC Product Strategy. Oversee/coordinate change control, impact assessment, and implementation plan.
  • Establish and run partner governance, including business reviews, escalation pathways, performance monitoring and action tracking.
  • Translate program needs and demand plans into executable external supply plans and clear partner priorities.
  • Build and maintain accountable relationships with external partners while on execution, quality, timeline, cost and supply reliability.
  • Support negotiations and content of contracts such as MSAs, SOWs, Change Orders and other commercial agreements to ensure they reflect operational scope, supply requirements, governance, milestones and cost of goods optimization. Manage supplier's performance against the contract deliverables.
  • Oversee budget input to Program Budgets and monitor spend against budgets.
  • Promote continuous improvements of external operations processes, scorecards and way of working across the network.
  • Ensure end‑to‑end integration of physical and financial flows in SAP across CDMO operations covering master data, subcontracting, batch status/release, GR/IR, variance and WIP settlement, and KPI reporting.
You have
  • Bachelor's degree in engineering, life sciences or related discipline is required; advanced degree preferred.
  • Minimum 8+ years' experience in biotech, pharma or advanced therapy GMP operations.
  • Experience applying lean, structural and continuous improvement to deliver more efficient and reliable operations.
  • Cross‑functional leadership, communication, and stakeholder management.
  • Experience working in and with multiple geographies and achieve success through collaboration.
  • Experience applying digital, analytics and AI‑enabled workflows to improve visibility, workflow efficiency and operational execution.
Desired skills
  • Experience in SAP and inventory to COGS.
  • At least 2 years of experience in cell and gene therapy including management of CDMOs and external suppliers.

The annual base pay for this position ranges from $115K to $173K. Our positions offer eligibility for multiple incentives an opportunity to receive short‑term incentive bonuses, equity‑based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Date Posted: 26-Jun-2026

Closing Date: 09-Jul-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

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