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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?

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?

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 Iowa? For Cmc In Biotech jobs in Iowa, the most frequently searched job titles are:
What job categories do people searching Cmc In Biotech jobs in Iowa look for? The top searched job categories for Cmc In Biotech jobs in Iowa are:
Cmc In Biotech jobs near you

Senior Director, Mid-Atlantic CMC

WuXi Biologics Group

Atlantic, IA • On-site

$160 - $274/hr

Other

Posted 7 days ago

Job description

Job Title– Senior Director, Mid-Atlantic CMC

Work Location - United States (Remote)

Summary: Opportunity for Director through the Executive level, depending upon experience. Leads the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical team, and business development team. The incumbent will also participate in business development activities such as visiting existing or new clients and promoting WuXi Biologic’s services at conferences/trade shows.

Responsibilities
  • Provide technical and portfolio leadership to support IND and BLA, enabling CMC activities.
  • Collaborate with CMC functional areas to ensure the successful execution of various CMC projects and the delivery of results on time and within budget.
  • Provide strategic thinking and technical guidance for the project teams, in product development and manufacturing strategy.
  • Lead CMC projects with a good understanding of potential technical challenges and meeting the regulatory requirements and ICH’s guidelines.
  • Serve as the center of solution and decision maker for technical issues.
  • Coordinate efforts and facilitate communication to ensure alignment between WuXi Biologics and clients.
  • Work with a high-performance team to ensure the best quality services, IP, and EHS compliance.
  • Support corporate business development to enhance the current service offering and develop new clients.
Qualifications
  • PhD in Biochemistry, Molecular Biology, Biochemical/Chemical Engineering or related discipline.
  • Technical experience at large pharma or biotech companies.
  • Minimum of 8‑20 years of relevant pharmaceutical or biotech industry experience in cell line development, CMC process development, analytical sciences, and/or GMP manufacturing.
  • Demonstrates a good understanding of the pharmaceutical industry and large molecule drug development.
  • Working knowledge and understanding of current regulations and industry trends for large molecule and Antibody‑Drug‑Conjugate (ADC) product development, manufacture, and testing.
  • Biologics manufacturing experience.
  • Ability to effectively work across all levels, functions, sites, and companies.
  • Excellent verbal and written communication skills in both English and Chinese.
  • Strong and effective project management, problem‑solving, and interpersonal skills with a proven track record working cross‑functionally across a wide variety of technical, business, and operational areas.
  • Experience in writing regulatory documents and submissions and the ability to work on multiple CMC projects simultaneously.
  • Experience in a CRO or CMO is preferred but not required.
  • Self‑starter, self‑motivated, and highly flexible in a home‑based position with about 10‑15% travel.
  • Organized and detail‑oriented.

The pay range for this job opportunity ranges from $160,000 - $274,000

The job description does not intend to list all the duties and responsibilities assigned to this position. An employee holding this position would be required to perform other job‑related duties/responsibilities based on their expertise and the company's business needs.

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