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Formulation Development Cmc information

What is the role of CMC in drug development?

In formulation development, CMC (Chemistry, Manufacturing, and Controls) ensures the quality, safety, and efficacy of a drug by establishing manufacturing processes, quality standards, and regulatory documentation. Formulation scientists and CMC teams collaborate to develop stable, scalable drug products that meet regulatory requirements throughout development and commercialization.

What is the salary of formulation R&D?

The salary for a Formulation Development CMC professional typically ranges from $70,000 to $130,000 annually, depending on experience, education, and location. Entry-level roles may start lower, while senior positions with specialized skills or certifications can earn higher salaries. Compensation often includes benefits such as health insurance and bonuses.

What is the highest paying job in pharmaceuticals?

In pharmaceuticals, senior roles such as Vice President of Research and Development or Chief Scientific Officer typically have the highest salaries, often exceeding several hundred thousand dollars annually. These positions require extensive experience, advanced degrees, and leadership skills, and they oversee drug development, regulatory strategies, and company innovation.

What is the difference between Formulation Development Cmc vs Formulation Scientist?

AspectFormulation Development CmcFormulation Scientist
CredentialsBachelor's or Master's in Pharmacy, Chemistry, or related fields; industry certificationsBachelor's or Master's in Pharmaceutical Sciences, Chemistry, or related fields
Work EnvironmentPharmaceutical or biotech R&D labs, manufacturing settingsResearch labs, development facilities, pharmaceutical companies
Industry UsageRegulatory submissions, product development, manufacturing supportFormulation research, experimental design, product optimization

Formulation Development Cmc focuses on developing formulations suitable for regulatory approval and manufacturing, often involving documentation and compliance. Formulation Scientists primarily conduct research and experiments to create and optimize formulations. While both roles require similar educational backgrounds and work in related environments, Cmc roles emphasize regulatory and manufacturing aspects, whereas Scientists focus on experimental research and innovation.

Is formulation part of CMC?

In formulation development roles within CMC (Chemistry, Manufacturing, and Controls), formulation is a core component, involving the design and optimization of drug formulations to ensure stability, efficacy, and manufacturability. These professionals work with analytical tools, quality standards, and regulatory requirements to develop suitable formulations for clinical and commercial products.

What is Formulation Development CMC?

Formulation Development CMC (Chemistry, Manufacturing, and Controls) refers to the process of designing and optimizing the composition of a drug product, ensuring it is safe, effective, and stable for patient use. This role involves selecting appropriate excipients, developing the manufacturing process, and generating the data required to support regulatory submissions. CMC professionals collaborate with research, quality, and regulatory teams to ensure that the drug product meets all necessary standards throughout its lifecycle.

What are the key skills and qualifications needed to thrive as a Formulation Development CMC specialist, and why are they important?

To thrive as a Formulation Development CMC specialist, you need expertise in pharmaceutical sciences, chemistry, and regulatory guidelines, often supported by an advanced degree in a relevant field. Familiarity with analytical techniques, formulation equipment, and regulatory submission systems like eCTD is crucial. Strong problem-solving skills, attention to detail, and effective collaboration are essential soft skills in this role. These competencies ensure the successful development, optimization, and regulatory approval of safe and effective pharmaceutical products.

What are some typical challenges faced by professionals in Formulation Development CMC, and how are they addressed?

Professionals in Formulation Development CMC often encounter challenges such as ensuring formulation stability, meeting regulatory requirements, and scaling up from laboratory to manufacturing. Addressing these challenges requires close collaboration with analytical, regulatory, and manufacturing teams, as well as staying current with evolving guidelines. Effective project management, rigorous experimental design, and proactive risk assessment are key strategies to successfully navigate these complexities and ensure timely progress of drug development projects.
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Formulation Development Cmc jobs near you
Scientist I / II, tLNP Formulation

Scientist I / II, tLNP Formulation

AbbVie

North Chicago, IL • On-site

$78K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 20 days ago

AbbVie rating

8.6

Company rating: 8.6 out of 10

Based on 98 frontline employees who took The Breakroom Quiz

13th of 73 rated pharmaceutical

Job description

Company Description
About AbbVie
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.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
About the Team
The Targeted Lipid Nanoparticle (tLNP) drug product development group within AbbVie's tLNP CMC team is committed to advancing clinical-stage tLNP assets from First-in-Human (FIH) through Phase 2. The team collaborates across biologics discovery, CMC partners, Clinical Operations, Regulatory Affairs, Quality Assurance, and external manufacturing to support development and commercialization of tLNP products. Key focus areas include establishing robust formulation and process development capabilities, leading critical CMC activities for pipeline programs, devising formulation development strategies, conducting stability evaluations, optimizing clinical in-use strategies, developing innovative product presentations, implementing stage-based quality risk management, and driving scientific initiatives to ensure the strong development of current and future tLNP programs.
Purpose
AbbVie is seeking a highly motivated Scientist I/II to support the development of early-stage targeted Lipid Nanoparticle (tLNP) assets within AbbVie's pipeline. The successful candidate will contribute to formulation and process development activities through hands-on laboratory experimentation, data analysis, and scientific problem solving. This role will work closely with cross-functional teams including analytical sciences, process development, manufacturing, and subject matter experts to advance tLNP drug product development from early research through clinical enablement.
Responsibilities
  • Design, execute, and interpret formulation and process development experiments to support tLNP drug product development.
  • Conduct formulation screening studies evaluating variables such as pH, buffer systems, cryoprotectants, surfactants, antioxidants, and other excipients to improve stability and performance of tLNP formulations.
  • Support process development activities including formulation preparation, sterile filtration, freeze-thaw evaluations, lyophilization development, and other drug product unit operations.
  • Generate high-quality experimental data and perform scientific analysis to support formulation and process optimization efforts.
  • Apply statistical tools and Design of Experiments (DoE) approaches, with appropriate guidance, to evaluate formulation and process variables.
  • Characterize tLNP formulations using relevant analytical and biophysical techniques and collaborate with analytical teams to interpret results.
  • Support technology transfer, scale-up activities, and manufacturing readiness assessments by providing laboratory process knowledge and technical documentation.
  • Evaluate formulation stability under various storage and stress conditions and contribute to development of clinical in-use strategies.
  • Maintain detailed and accurate documentation of experimental procedures, results, and conclusions in electronic laboratory notebooks, technical reports, and presentations.
  • Effectively communicate scientific findings and recommendations within project teams and cross-functional meetings.
  • Continuously identify opportunities to improve laboratory methods, workflows, and scientific understanding.
  • Maintain compliance with safety, quality, and good research practices while ensuring high laboratory productivity.

Qualifications
  • Scientist I: BS in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, Biotechnology, Chemistry, Biochemistry, Bioengineering, or a related scientific discipline with typically 5+ years of relevant industry experience, or MS with typically 2+ years of relevant industry experience. PhDs need not apply.
  • Scientist II: BS in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, Biotechnology, Chemistry, Biochemistry, Bioengineering, or a related scientific discipline with typically 7+ years of relevant industry experience, or MS with typically 5+ years of relevant industry experience. PhDs need not apply.
  • Fundamental understanding of drug product formulation principles, protein biochemistry, stability, and analytical characterization.
  • Demonstrated ability to independently execute experiments, analyze data, troubleshoot technical challenges, and communicate scientific findings.
  • Experience with formulation development, process development, or characterization of biologics, nanoparticles, or related drug delivery systems.
  • Knowledge of laboratory experimental design, data analysis, and scientific documentation practices.
  • Strong written and verbal communication skills and ability to work effectively in multidisciplinary teams.
  • Ability to manage multiple priorities and deliver high-quality results within project timelines.

Preferred
  • Hands-on experience with mRNA, lipid nanoparticles (LNPs), targeted LNP systems, biologics, or advanced drug delivery platforms.
  • Experience evaluating formulation stability and stress conditions, including freeze-thaw and frozen-state storage.
  • Familiarity with formulation characterization techniques including Dynamic Light Scattering (DLS), Nanoparticle Tracking Analysis (NTA), Differential Scanning Calorimetry (DSC), Microflow Imaging (MFI), chromatography methods (SEC, RP-HPLC, IEX), and UV-Vis spectroscopy.
  • Experience performing LNP characterization assays such as particle size analysis, encapsulation efficiency measurements, and ligand-targeting assessments.
  • Working knowledge of sterile drug product operations including filtration, aseptic processing, lyophilization, and fill-finish development.
  • Experience supporting technology transfer, process scale-up, or manufacturing activities.
  • Familiarity with statistical software and Design of Experiments (DoE) methodologies.
  • Understanding of relevant ICH, cGMP, and pharmaceutical development principles.

Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this roleat the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on manyfactors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
  • This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount isearned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that areallocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolutediscretion, consistent with applicable law.
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

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