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Cmc Small Molecules Jobs in Michigan (NOW HIRING)

Cmc Small Molecules information

What is CMC Small Molecules?

CMC Small Molecules refers to the Chemistry, Manufacturing, and Controls (CMC) activities involved in the development and production of small molecule drugs. These are low molecular weight compounds, typically developed as medicines for a wide range of diseases. CMC encompasses the processes for ensuring that these drugs are manufactured consistently, safely, and to high-quality standards, including formulation, testing, stability, and compliance with regulatory guidelines. Professionals working in CMC Small Molecules are critical to bringing new pharmaceutical products from the laboratory to the market.

What skills and qualifications are needed to thrive as a CMC Small Molecules professional?

To thrive as a CMC Small Molecules professional, you need a strong background in chemistry, pharmaceutical sciences, and regulatory guidelines, usually supported by an advanced degree in a scientific discipline. Familiarity with analytical instrumentation, GMP manufacturing processes, and regulatory submission systems (such as eCTD) is crucial. Strong project management, problem-solving abilities, and effective cross-functional communication help individuals excel in this field. These skills ensure the successful development, scale-up, and regulatory approval of safe and effective small molecule pharmaceuticals.

What are the main challenges faced by CMC Small Molecules professionals during drug development projects?

CMC Small Molecules professionals often encounter challenges such as ensuring consistent product quality across different manufacturing scales, meeting strict regulatory requirements, and managing tight project timelines. Collaboration with cross-functional teams—including analytical, formulation, and regulatory groups—is essential for aligning on specifications and resolving technical issues. Staying adaptable and detail-oriented helps address unexpected process or analytical hurdles, which are common in the development and scale-up of small molecule therapeutics.

What is the difference between Cmc Small Molecules vs CMC Formulation Scientist?

AspectCmc Small MoleculesCMC Formulation Scientist
Required CredentialsBachelor's or Master's in Chemistry, Pharmaceutical Sciences, or related fields; GMP knowledgeBachelor's or Master's in Pharmaceutical Sciences, Chemistry, or related fields; formulation expertise
Work EnvironmentLaboratories, manufacturing facilities, R&D settingsLaboratories, formulation development labs, production environments
Employer & Industry UsagePharmaceutical companies, biotech firms, contract research organizationsPharmaceutical companies, biotech firms, contract manufacturing organizations

While both roles involve working within the pharmaceutical industry and require similar educational backgrounds, Cmc Small Molecules focuses on the development and manufacturing of small molecule drugs, emphasizing chemistry and process development. In contrast, CMC Formulation Scientists specialize in creating drug formulations, ensuring stability and delivery. Both roles are essential in bringing new drugs to market but differ in their specific focus areas and daily responsibilities.

What are popular job titles related to Cmc Small Molecules jobs in Michigan?

For Cmc Small Molecules jobs in Michigan, the most frequently searched job titles are:

What cities in Michigan are hiring for Cmc Small Molecules jobs?

Cities in Michigan with the most Cmc Small Molecules job openings:

Scientist III - HPLC Chemistry and Molecular Biology - FSP

Parexel

Three Rivers, MI • On-site

Full-time

Retirement, PTO

Re-posted 21 days ago


Key responsibilities

  • Support high-throughput, pre-formulation, pre-qualification, robustness, and admixture testing

  • Analyze samples through reporting of results and documentation following appropriate methods, protocols, and procedures

  • Manage samples and monitor controlled temperature units


Parexel rating

8.2

Company rating: 8.2 out of 10

Based on 13 frontline employees who took The Breakroom Quiz

35th of 75 rated research


Job description

When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

We are looking for a Scientist III - HPLC (High Performance Liquid Chromatography) and Molecular Biology to work as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients located in Rahway, NJ. This position offers full benefits, sick time, 401K, paid holidays, and paid time off. This role does not offer sponsorship.

Responsibilities

  • Support of high-throughput, pre-formulation, pre-qualification, robustness, and admixture testing

  • Analysis of samples through reporting of results and documentation following appropriate methods, protocols, and procedures

  • Sample management and monitoring of controlled temperature units

  • Follow all applicable laboratory safety and hygiene procedures

Qualifications - B.S. or M.S. in Chemistry, Chemical Engineering, Biochemistry, Biology or similar life sciences and relevant years of experience in analytical chemistry or biologics testing laboratory:

  • Scientist 3 - B.S. with 3 to 5 years of experience; M.S. with 1 to 2 years of experience

Required Skills and Experience

  • Must have separations experience for large molecules or plate-based assay experience*

  • Experience in analyzing biologics including monoclonal antibodies and/or other therapeutic proteins using at least one of the following techniques*:

    • HPLC / UPLC

    • Protein A Titer, SEC, IEX, AEX, CEX, or HIC

    • Electrophoretic methods CE-SDS and/or cIEF

    • ELISA (HCP, proA) and binding potency assay

    • qPCR and basic molecular biology techniques

    • High-throughput liquid handling system, e.g., Tecan, Bravo, etc.

Significant experience with the separation of small molecules, including hand-on instrumental experience and a demonstrated understanding of fundamental concepts and practices of separations science and chromatographic techniques will be considered in place of experience with large molecules

  • Basic instrument troubleshooting

  • Ability to follow complicated scientific protocols / procedures

  • Making accurate reagent preparations (dilutions / solutions / buffers / mobile phases)

  • Ability and willingness to train in molecular biology, immunoassay and analytical chemistry techniques

  • Proficient with Microsoft Office Applications (Outlook, Excel, Word, PowerPoint, Teams, etc.)

  • Excellent communication (oral and written) and attention to detail

Desired Skills and Experience

  • Familiarity with compendial testing such as UV 280, pH, and Physical Observations

  • Good documentation practices and use of electronic laboratory notebooks (ELNs)

  • Knowledge of LIMS and Empower

  • Sample submission and sample management

  • Monitoring of controlled temperature units

  • Experience with Biosafety Level 2 cabinets/hoods

About Parexel

Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies.

For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement.

Come join us!

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EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.


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PAREXEL logo

About PAREXEL

Sourced by ZipRecruiter

Bring your Data Management expertise to Parexel's Strategic Partnerships. Although we work globally, each partnership we form is deeply personal. We are as dedicated to every aspect of our client's product development as they are - and work closely with client teams in true partnership to understand both challenges and opportunities. At Parexel we are focused on meeting customer and patient needs through collaborative partnership so that we get treatments into the hands of patients who need them most.

Industry

Pharmaceutical and medicine manufacturing

Company size

10,000+ Employees

Headquarters location

Waltham, MA, US

Year founded

1983