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Cmc In Biotech Jobs in Chicago, IL (NOW HIRING)

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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.

Future opportunities- Join our talent community for Antibody Drug Conjugate Scientists

AbbVie

North Chicago, IL • On-site

Full-time

Posted 20 days ago


AbbVie rating

8.6

Company rating: 8.6 out of 10

Based on 101 frontline employees who took The Breakroom Quiz

16th of 86 rated pharmaceutical


Job description

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

AbbVie (NYSE:ABBV) is a global, research-based biopharmaceutical company formed in 2013, following separation from Abbott. AbbVie combines the focus and passion of a leading-edge biotech with the expertise and capabilities of a long-established pharmaceutical leader, to develop and market advanced therapies that address some of the world's most complex and serious diseases.  AbbVie employs approximately 50,000 people worldwide and markets medicines in more than 170 countries. 

AbbVie Process Chemistry is responsible for the chemical development of AbbVie’s clinical candidates. We are seeking experienced candidates to conduct process research and development of drug conjugates from pre-clinical through clinical development.  

Job Description: 

We are looking for a highly motivated person who can make scientific contributions across synthetic molecule modalities, with a focus on driving the development of drug-conjugate programs from preclinical to late-stage development.   Roles and responsibilities will be commensurate with experience and could range from contributions as an individual member on project teams developing Drug Substance processes to leading cross functional project teams establishing CMC program strategy for clinical assets. The candidate will lead in the development of conjugation chemistry as well as downstream unit operations culminating in drug substance. The candidate will serve as the chemistry representative on the Drug Substance team for drug-conjugate development programs and would be responsible for developing timelines and executing activities required for drug substance. Working with analytical and manufacturing colleagues, the candidate will develop productive collaborations and communications with scientific teams. The role may also have supervisory responsibilities focused on the mentoring and development of direct reports which may be working on aligned or alternate programs. 

Responsibilities: 

  • The candidate will participate on and/or lead activities associated with process development and characterization for new drug conjugates. 

  • Develop and characterize drug-conjugate (and other modalities) processes in the laboratory and translate them to scalable processes. 

  • Participate on and/or lead project teams to enable CMC deliverables (materials, methods, milestones). 

  • Author and review key regulatory documents, laboratory data, technical reports and internal/external presentations and publications. 

  • The position involves multi-disciplinary interactions with organic chemists, analytical chemists, engineers, drug product development, and program management.  The selected candidate will collaborate with and/or lead cross-functional CMC teams to advance pre-clinical and clinical candidates.  

  • The candidate will understand and adhere to corporate standards regarding code of conduct, safety and GXP compliance.  

  • The candidate may supervise one or more direct reports that may be associated with other programs but be fully responsible for their mentorship and career development.  

Qualifications
  • Minimally BS (12+ years); MS (10+ years) or PhD (4+ years) in Chemistry or allied field, with 2+ years of previous work experience in a pharmaceutical laboratory setting. 

  • Experience in drug-conjugate process development is a requirement.  

  • Proven scientific leadership; strong interpersonal and communication skills for facilitating collaborations and a demonstrated ability to lead cross-functional process development teams. 

  • The successful candidate will have a strong understanding of modern organic chemistry, mechanistic theory, control strategy development, and regulatory starting material strategies. 


Additional Information

Multiple times, we have been globally recognized as a "Great Place to Work" and we are proud to provide our employees with the flexibility to maintain a healthy work-life balance. We take our impact on the environment and our communities seriously and therefore focus on giving something back on a regular basis. We are committed to equality, equity, diversity and inclusion (EED&I) – a commitment that is fundamental to us. This includes appreciating different perspectives, creating an inclusive culture and treating all employees with dignity and respect.

At AbbVie, your individual contributions count – help us move mountains together. Be a part of our success, grow with us and accomplish more than you could have imagined. Sounds like the perfect career opportunity for you? We look forward to receiving your application! All you need is a complete CV – we will discuss everything else with you.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html


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About AbbVie

Sourced by ZipRecruiter

AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health, and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube, and LinkedIn.

Industry

Scientific research and development services

Company size

10,000+ Employees

Headquarters location

North Chicago, IL, US

Year founded

2013