ZipRecruiter

Log In

1

Cmc Jobs in Manchester, MI (NOW HIRING)

All JobsCmc JobsCmc Jobs in Manchester, MI

Cmc information

See Manchester, MI salary details

$12

$28

$61

How much do cmc jobs pay per hour?

As of Aug 31, 2026, the average hourly pay for cmc in Manchester, MI is $28.84, according to ZipRecruiter salary data. Most workers in this role earn between $17.74 and $33.75 per hour, depending on experience, location, and employer.

What is a CMC?

CMC stands for Chemistry, Manufacturing, and Controls. CMC professionals are responsible for ensuring that pharmaceutical products are developed, manufactured, and controlled in compliance with regulatory standards. Their work includes overseeing formulation development, analytical testing, process validation, and documentation required for regulatory submissions. CMC experts play a critical role in bringing safe and effective drugs to market by ensuring product quality and consistency throughout the development and manufacturing process.

What are some common challenges faced by a CMC professional when coordinating between R&D, manufacturing, and regulatory teams?

CMC professionals often encounter challenges in aligning the timelines and priorities of R&D, manufacturing, and regulatory teams. Ensuring that product development meets both regulatory requirements and manufacturing feasibility can require extensive cross-functional communication and problem-solving. Additionally, adapting to evolving regulatory guidelines and integrating feedback from multiple stakeholders demands strong project management skills. Overcoming these challenges is essential for maintaining project momentum and ensuring successful product submissions.

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

To thrive as a CMC professional, you need expertise in pharmaceutical sciences, regulatory requirements, and process development, typically supported by a degree in chemistry, pharmacy, or a related field. Familiarity with regulatory submission systems, analytical tools, and quality management software is essential. Strong project management, attention to detail, and effective communication are vital soft skills for coordinating cross-functional teams and ensuring compliance. These skills and qualities are critical to guarantee the safety, efficacy, and regulatory approval of pharmaceutical products.

What is the difference between CMC vs Regulatory Affairs Specialist?

AspectCMCRegulatory Affairs Specialist
Required CredentialsBachelor's degree in life sciences, chemistry, or pharmacy; often additional certifications in pharmaceutical sciencesBachelor's degree in life sciences, pharmacy, or related field; certifications in regulatory affairs are common
Work EnvironmentLaboratories, manufacturing sites, and R&D departments within pharmaceutical companiesRegulatory agencies, pharmaceutical companies, and consulting firms
Industry UsageFocuses on drug development, manufacturing, and quality documentationFocuses on compliance, submissions, and communication with regulatory bodies

While both CMC and Regulatory Affairs Specialists work within the pharmaceutical industry, CMC professionals primarily handle the chemistry, manufacturing, and control aspects of drug development. Regulatory Affairs Specialists focus on ensuring compliance with regulations and managing submissions to authorities. Both roles often collaborate but serve distinct functions in bringing a drug to market.

Cmc jobs near you
Infographic showing various Cmc job openings in Manchester, MI as of August 2026, with employment types broken down into 1% As Needed, 75% Full Time, 20% Part Time, and 4% Contract. Highlights an 90% Physical, 3% Hybrid, and 7% Remote job distribution, with an average salary of $59,996 per year, or $28.8 per hour.

Principal Scientist - Bioseparation & Analytical Development

Ann Arbor, MI • On-site

Element Materials Technology
Manufacturing • 10K+ employees

7.3

Company rating: 7.3 out of 10

Based on 43 frontline employees who took The Breakroom Quiz

74th of 120 rated laboratories

Good employer

Paid breaks

Respectful managers

Learn more about Element Materials Technologyexternal

Full-time

Re-posted 24 days ago

Job description

Overview

Element Ann Arbor is currently seeking a highly experienced Principal Scientist - Bioseparation to lead and execute advanced analytical method development, characterization, and validation of large molecule therapeutics across discovery, development, and late-stage CMC. This is an onsite, laboratory-based role with significant hands-on responsibility in bioseparation sciences, supporting a broad range of biologics modalities including proteins and recombinant proteins, peptides and peptide-drug conjugates, monoclonal antibodies (mAbs) and biosimilars, antibody-drug conjugates (ADCs), mRNA therapeutics, DNA constructs (including plasmid DNA and oligonucleotides), viral vectors, and other complex or emerging modalities such as fusion proteins, multispecifics, and engineered biologics.

Responsibilities
  • Lead development, optimization, and troubleshooting of bioseparation-based analytical methods supporting biologics across discovery, development, and late-stage CMC, including orthogonal analytical strategies for comprehensive characterization
  • Perform hands-on execution and technical leadership across a broad range of modalities, including proteins and recombinant proteins, peptides and peptide-drug conjugates, monoclonal antibodies (mAbs) and biosimilars, antibody-drug conjugates (ADCs), mRNA therapeutics, DNA/plasmid DNA/oligonucleotides, viral vectors, and emerging complex biologics (fusion proteins, multispecifics, engineered constructs)
  • Apply deep expertise in chromatography platforms (HPLC/UPLC/UHPLC, SEC, IEX, HIC, RP-HPLC, affinity chromatography), mass spectrometry (LC-MS/MS, high-resolution MS, SEC-MALS, native MS, MAM workflows, glycan/PTM characterization), capillary electrophoresis (CE-SDS, cIEF, purity/identity assays), and supporting biophysical techniques (DLS, DSC, UV/fluorescence, MALS, CD, FTIR)
  • Lead analytical strategy for complex biologics programs, including method development, qualification, validation, transfer, comparability, stability, forced degradation, and full characterization studies
  • Ensure development of robust GMP-compliant methods aligned with ICH Q2/Q6, USP, EP, and GMP requirements, and support regulatory submissions (IND, BLA, IMPD) with high-quality analytical data packages
  • Drive innovation in analytical science, including implementation of MAM workflows, high-throughput LC-MS platforms, automated bioseparation methods, and evaluation of emerging technologies in biologics characterization
  • Provide scientific leadership and mentorship to junior scientists, including troubleshooting complex bioseparation and mass spectrometry challenges and establishing best practices in analytical development and execution
Skills / Qualifications
  • BS in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field required; Master's degree or higher preferred, but not required.
  • Extensive industry experience in biologics analytical development is highly desirable
  • 8-15+ years of experience in biopharmaceutical or CRO analytical development with strong hands-on expertise in bioseparation of large molecules
  • Deep technical expertise across analytical platforms, including LC/UPLC/SEC/IEX/HIC/RP chromatography, LC-MS and high-resolution mass spectrometry, CE-SDS, cIEF, SEC-MALS, and complementary biophysical techniquesStrong scientific knowledge of protein structure and higher-order structure, monoclonal antibodies and biosimilars, antibody-drug conjugates (ADCs), engineered biologics, and nucleic acid-based therapeutics (mRNA, DNA, oligonucleotides)
  • Demonstrated experience in comparability, stability studies, and degradation pathway analysis for complex biologics
  • Preferred experience includes CRO or client-facing analytical project execution, MAM workflows, advanced LC-MS analytics, glycan mapping and PTM quantification, and automation/high-throughput analytical systems
  • Strong scientific writing capability with experience supporting regulatory documentation and submissions
  • Proven ability to execute in onsite laboratory environments with strong hands-on bioseparation and multi-platform analytical integration skills
  • Ability to manage complex biologics programs in fast-paced, matrixed environments with strong problem-solving and scientific reasoning capabilities
  • Effective communicator across scientific, regulatory, and operational stakeholders

Physical Demands:

  • Frequency of required physical force: Minimum (moderate)
  • Lifting requirements: lifting <50 lbs. often and >50 lbs. on occasion
  • Ability to stand on feet for long periods of time
  • Ability to lift 50+lbs periodically

#LI-TK1

Company Overview

Element is one of the fastest growing testing, inspection and certification businesses in the world. Globally we have more than 9,000 brilliant minds operating from 270 sites across 30 countries. Together we share an ambitious purpose to 'Make tomorrow safer than today'.

When failure in use is not an option, we help customers make certain that their products, materials, processes and services are safe, compliant and fit for purpose. From early R&D, through complex regulatory approvals and into production, our global laboratory network of scientists, engineers, and technologists support customers to achieve assurance over product quality, sustainable outcomes, and market access.

While we are proud of our global reach, working at Element feels like being part of a smaller company. We empower you to take charge of your career, and reward excellence and integrity with growth and development.

Industries across the world depend on our care, attention to detail and the absolute accuracy of our work. The role we have to play in creating a safer world is much bigger than our organization.

Diversity Statement

At Element, we always take pride in putting our people first. We are an equal opportunity employer that recognizes diversity and inclusion as fundamental to our Vision of becoming "the world's most trusted testing partner".

All suitably qualified candidates will receive consideration for employment on the basis of objective work related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws or other characteristics in accordance with the applicable governing laws.

Employment Type: OTHER

What Element Materials Technology employees say

Pay

Benefits

Hours and flexibility

Workplace

Get the full story on Breakroom

Apply