ZipRecruiter

Log In

1

Analytical Method Development Jobs in Michigan (NOW HIRING)

Trinseo LLC

Analytical Technician

Midland, MI · On-site

Aid in new method development for new analytical test methods as required by the business. * Associates degree (or equivalent coursework) in technical curriculum (preferably chemistry, engineering ...

Trinseo

Analytical Technician

Midland, MI · On-site

Aid in new method development for new analytical test methods as required by the business. Qualifications * Associates degree (or equivalent coursework) in technical curriculum (preferably chemistry ...

Trinseo

Analytical Technician

Midland, MI · On-site

Aid in new method development for new analytical test methods as required by the business. Qualifications * Associates degree (or equivalent coursework) in technical curriculum (preferably chemistry ...

Dupont

Analytical Chemist

Auburn Hills, MI · On-site

Develop, optimize, validate, and troubleshoot analytical methods to support R&D, manufacturing, quality, and regulatory needs * Maintain instrument performance, calibration, and data integrity ...

ALS

National Technical Manager

Holland, MI · On-site

Works together with the National Quality Manager to make decisions regarding approaches to systems and protocols that pertain to analytical method development, documentation, validation, acceptance ...

Cayman Chemical Company

QC Chemist, GMP

Ann Arbor, MI · On-site

Independently perform GC and HPLC method development and qualification activities for new projects in compliance with GMP requirements. * Perform analytical testing to support method validation ...

Cayman

QC Chemist, GMP

Ann Arbor, MI · On-site

Independently perform GC and HPLC method development and qualification activities for new projects in compliance with GMP requirements. * Perform analytical testing to support method validation ...

next page

Showing results 1-20

All JobsAnalytical Method Development JobsAnalytical Method Development Jobs in Michigan

Analytical Method Development information

What are the key skills and qualifications needed to thrive in the Analytical Method Development position, and why are they important?

To excel in Analytical Method Development, a strong background in chemistry, analytical techniques, and statistical analysis is typically required, often supported by a relevant science degree. Familiarity with laboratory instrumentation such as HPLC, GC, MS, and validation protocols, as well as experience with software like Empower or ChemStation, is highly valued. Attention to detail, problem-solving, and effective communication are crucial soft skills for this role. These competencies are vital to ensure robust method development, regulatory compliance, and effective teamwork in a laboratory setting.

What does a typical day look like for someone working in Analytical Method Development?

A typical day involves designing, executing, and optimizing analytical experiments to develop new testing methods or improve existing ones, often using advanced laboratory instruments. You may also analyze data, document results, troubleshoot instrument or methodological issues, and collaborate with scientists, quality assurance, and production teams. Regular tasks include preparing reports for regulatory submissions, participating in team meetings to discuss progress and challenges, and maintaining rigorous documentation standards. The role balances independent technical work with teamwork and cross-departmental communication to ensure methods meet performance, accuracy, and compliance standards.

What is an Analytical Method Development job?

An Analytical Method Development job involves designing, optimizing, and validating methods for analyzing pharmaceutical, chemical, or biological samples. Professionals in this role ensure accurate, reliable, and reproducible results by developing techniques like chromatography, spectroscopy, or titration. They collaborate with research, quality control, and regulatory teams to comply with industry standards and guidelines. This role is critical in drug development, manufacturing, and ensuring product quality and safety.

What are the most commonly searched types of Analytical Method Development jobs in Michigan? The most popular types of Analytical Method Development jobs in Michigan are:
Analytical Method Development jobs near you
Principal Scientist - Bioseparation & Analytical Development

Principal Scientist - Bioseparation & Analytical Development

Element Materials Technology

Ann Arbor, MI • On-site

Other

Re-posted 2 days ago

Element Materials Technology rating

7.6

Company rating: 7.6 out of 10

Based on 42 frontline employees who took The Breakroom Quiz

53rd of 103 rated laboratories

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 techniques
    Strong 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
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.

What Element Materials Technology employees say

Pay

Benefits

Hours and flexibility

Workplace

Get the full story on Breakroom

Apply