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Formulation Development Cmc Jobs in Michigan (NOW HIRING)

Formulation Development Cmc information

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?

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.

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.

What job categories do people searching Formulation Development Cmc jobs in Michigan look for?

The top searched job categories for Formulation Development Cmc jobs in Michigan are:

What cities in Michigan are hiring for Formulation Development Cmc jobs?

Cities in Michigan with the most Formulation Development Cmc job openings:

Infographic showing various Formulation Development Cmc job openings in Michigan as of July 2026, with employment types broken down into 2% Locum Tenens, 24% Internship, 58% Full Time, 11% Part Time, 3% Contract, and 2% Summer. Highlights an 92% Physical, 3% Hybrid, and 5% Remote job distribution.

Scientist III - HPLC Chemistry and Molecular Biology - FSP

Parexel

Three Rivers, MI • On-site

Full-time

Retirement, PTO

Re-posted yesterday


Parexel rating

8.2

Company rating: 8.2 out of 10

Based on 13 frontline employees who took The Breakroom Quiz

30th of 73 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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About PAREXEL

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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