... SDS, cIEF, purity/identity assays), and supporting biophysical techniques (DLS, DSC, UV ... Ability to manage complex biologics programs in fast-paced, matrixed environments with strong ...
... SDS, cIEF, purity/identity assays), and supporting biophysical techniques (DLS, DSC, UV ... Ability to manage complex biologics programs in fast-paced, matrixed environments with strong ...
QC Technician I
$19 - $24.25/hr
Perform routine and complex assays with a microbiology focus in accordance with appropriate ... Lab Manager, often involving investigations or method development. * Perform equipment ...
QC Technician I
$19 - $24.25/hr
Perform routine and complex assays with a microbiology focus in accordance with appropriate ... Lab Manager, often involving investigations or method development. * Perform equipment ...
QC Technician I
Lansing, MI · On-site
$19 - $24.25/hr
Perform routine and complex assays with a microbiology focus in accordance with appropriate ... Lab Manager, often involving investigations or method development. * Perform equipment ...
QC Technician I
Lansing, MI · On-site
$19 - $24.25/hr
Perform routine and complex assays with a microbiology focus in accordance with appropriate ... Lab Manager, often involving investigations or method development. * Perform equipment ...
Partner with R&D, Lab Directors, and Clinical Operations to understand technical and scientific ... Sample preparation, assays, and protocols * Data capture, documentation, and validation * Interview ...
Partner with R&D, Lab Directors, and Clinical Operations to understand technical and scientific ... Sample preparation, assays, and protocols * Data capture, documentation, and validation * Interview ...
... managing project teams to achieve goals. Responsibilities * Independently design and execute ... assays for compound characterization, PK/PD and biomarker development * Interact closely with ...
... managing project teams to achieve goals. Responsibilities * Independently design and execute ... assays for compound characterization, PK/PD and biomarker development * Interact closely with ...
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ... Sample management and monitoring of controlled temperature units * Follow all applicable laboratory ...
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ... Sample management and monitoring of controlled temperature units * Follow all applicable laboratory ...
As the Director, Screening and High Content Analysis, you will lead the development and execution ... Develop and optimize imaging assays, phenotypic readouts, and quantitative analysis pipelines
As the Director, Screening and High Content Analysis, you will lead the development and execution ... Develop and optimize imaging assays, phenotypic readouts, and quantitative analysis pipelines
As the Director, Screening and High Content Analysis, you will lead the development and execution ... Develop and optimize imaging assays, phenotypic readouts, and quantitative analysis pipelines
As the Director, Screening and High Content Analysis, you will lead the development and execution ... Develop and optimize imaging assays, phenotypic readouts, and quantitative analysis pipelines
... assays, experimental design, and quantitative analysis to understand the neuronal, glial, and ... Maintain, genotype, and manage transgenic zebrafish lines. * Perform fluorescence screening ...
... assays, experimental design, and quantitative analysis to understand the neuronal, glial, and ... Maintain, genotype, and manage transgenic zebrafish lines. * Perform fluorescence screening ...
Manage daily laboratory operations, including: * Coordinate laboratory supply ordering, inventory ... Participate in the development and optimization of research methods and recommend improvements to ...
Manage daily laboratory operations, including: * Coordinate laboratory supply ordering, inventory ... Participate in the development and optimization of research methods and recommend improvements to ...
To live up to our Always with Purpose employee value proposition, we're putting the development and ... Manage assay exchange process and computation of final assay results * Process all laytime ...
To live up to our Always with Purpose employee value proposition, we're putting the development and ... Manage assay exchange process and computation of final assay results * Process all laytime ...
... assays, experimental design, and quantitative analysis to understand the neuronal, glial, and ... Maintain, genotype, and manage transgenic zebrafish lines. * Perform fluorescence screening ...
... assays, experimental design, and quantitative analysis to understand the neuronal, glial, and ... Maintain, genotype, and manage transgenic zebrafish lines. * Perform fluorescence screening ...
... assays, experimental design, and quantitative analysis to understand the neuronal, glial, and ... Maintain, genotype, and manage transgenic zebrafish lines. * Perform fluorescence screening ...
... assays, experimental design, and quantitative analysis to understand the neuronal, glial, and ... Maintain, genotype, and manage transgenic zebrafish lines. * Perform fluorescence screening ...
Support implementation of laboratory organization, inventory management, and equipment maintenance ... Familiarity with sterile technique and basic cell-based assays * Ability to execute experiments ...
Support implementation of laboratory organization, inventory management, and equipment maintenance ... Familiarity with sterile technique and basic cell-based assays * Ability to execute experiments ...
Scientist III - Analytical Chemist Drug Product - FSP
Three Rivers, MI · On-site
Retirement
PTO
From clinical trials to regulatory, consulting, and market access, every clinical development ... Good organization and project management skills to work on multiple ongoing projects in parallel ...
Scientist III - Analytical Chemist Drug Product - FSP
Three Rivers, MI · On-site
Retirement
PTO
From clinical trials to regulatory, consulting, and market access, every clinical development ... Good organization and project management skills to work on multiple ongoing projects in parallel ...
Research Laboratory Tech Sr
Ann Arbor, MI · On-site
Medical
Dental
Vision
Retirement
Managing lab safety program and compliance with animal protocols * Maintenance of lab equipment ... Experience with PCR assays * Experience with DNA extraction * Knowledge and understanding of ...
Research Laboratory Tech Sr
Ann Arbor, MI · On-site
Medical
Dental
Vision
Retirement
Managing lab safety program and compliance with animal protocols * Maintenance of lab equipment ... Experience with PCR assays * Experience with DNA extraction * Knowledge and understanding of ...
Cell & Molecular Scientist
$33.25 - $41.75/hr
Medical
Dental
Vision
Retirement
PTO
... the development of safe and effective therapies and products . Everything we do is designed to ... Responsibilities may include project management, troubleshooting technical issues and adherence to ...
Cell & Molecular Scientist
$33.25 - $41.75/hr
Medical
Dental
Vision
Retirement
PTO
... the development of safe and effective therapies and products . Everything we do is designed to ... Responsibilities may include project management, troubleshooting technical issues and adherence to ...
Cell & Molecular Scientist
Kalamazoo, MI · On-site
$33.25 - $41.75/hr
Medical
Dental
Vision
Retirement
PTO
... the development of safe and effective therapies and products . Everything we do is designed to ... Responsibilities may include project management, troubleshooting technical issues and adherence to ...
Cell & Molecular Scientist
Kalamazoo, MI · On-site
$33.25 - $41.75/hr
Medical
Dental
Vision
Retirement
PTO
... the development of safe and effective therapies and products . Everything we do is designed to ... Responsibilities may include project management, troubleshooting technical issues and adherence to ...
Medical Technologist (PRN)
Big Rapids, MI · On-site
The technologist assists the laboratory manager in maintaining an efficient and effective ... Performs assigned technical assays according to established procedures and report tests after ...
Medical Technologist (PRN)
Big Rapids, MI · On-site
The technologist assists the laboratory manager in maintaining an efficient and effective ... Performs assigned technical assays according to established procedures and report tests after ...
Medical Laboratory Technician
Holland, MI · On-site
The technician assists the laboratory manager in maintaining an efficient and effective laboratory ... Essential Duties and Responsibilities 1. Performs assigned technical assays according to ...
Medical Laboratory Technician
Holland, MI · On-site
The technician assists the laboratory manager in maintaining an efficient and effective laboratory ... Essential Duties and Responsibilities 1. Performs assigned technical assays according to ...
Assay Development Manager information
What are some common challenges faced by an assay development manager during the early stages of a new project?
One of the main challenges Assay Development Managers encounter in the early phases of a project is balancing the need for high sensitivity and specificity with practicality and scalability. They often need to troubleshoot unexpected assay variability, optimize protocols, and ensure the reproducibility of results under tight deadlines. Additionally, coordinating input from cross-functional teams—such as R&D scientists, quality assurance, and regulatory affairs—can present logistical hurdles. Effective communication and project management skills are essential to navigate these complexities and drive the project forward.
What is an assay development manager?
An Assay Development Manager is a scientific professional responsible for leading the design, development, validation, and optimization of laboratory assays, which are tests used to measure the presence or amount of a substance in biological samples. They manage teams of scientists and collaborate closely with research, quality, and regulatory departments to ensure assays meet scientific and regulatory requirements. Their work is vital in fields such as biotechnology, pharmaceuticals, and diagnostics, supporting drug discovery, disease diagnosis, and product development.
What is the difference between Assay Development Manager vs Laboratory Supervisor?
| Aspect | Assay Development Manager | Laboratory Supervisor |
|---|---|---|
| Credentials | Bachelor's/Master's in Life Sciences, relevant certifications | Bachelor's in Life Sciences or related field, relevant certifications |
| Work Environment | Research labs, biotech or pharma companies | Laboratories, clinical or research settings |
| Employer & Industry | Biotech, pharmaceutical, diagnostics | Research institutions, hospitals, biotech |
| Primary Focus | Designing and optimizing assays, project management | Overseeing daily lab operations, staff supervision |
The Assay Development Manager focuses on designing, developing, and optimizing assays, often managing projects and teams. In contrast, the Laboratory Supervisor oversees daily lab operations and staff, ensuring smooth workflow. Both roles require relevant scientific credentials and work in similar environments, but their core responsibilities differ significantly.
What are the key skills and qualifications needed to thrive as an assay development manager?
To thrive as an Assay Development Manager, you need a strong background in molecular biology, biochemistry, or a related field, typically with an advanced degree and experience in assay design and validation. Familiarity with laboratory automation, data analysis software, and quality management systems is essential, along with relevant certifications like GLP or ISO standards. Strong project management, leadership, and communication skills help drive cross-functional teams and ensure effective collaboration. These competencies are crucial for delivering reliable assays that meet scientific, regulatory, and business objectives.
What are popular job titles related to Assay Development Manager jobs in Michigan?
For Assay Development Manager jobs in Michigan, the most frequently searched job titles are:
What job categories do people searching Assay Development Manager jobs in Michigan look for?
The top searched job categories for Assay Development Manager jobs in Michigan are:
What cities in Michigan are hiring for Assay Development Manager jobs?
Cities in Michigan with the most Assay Development Manager job openings:
Principal Scientist - Bioseparation & Analytical Development
Ann Arbor, MI • On-site
Other
Re-posted 18 days ago
Element Materials Technology rating
7.3
Based on 43 frontline employees who took The Breakroom Quiz
76th of 120 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
Skills / Qualifications
Physical Demands:
#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.
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
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About Element Materials Technology
Sourced by ZipRecruiter
Industry
Manufacturing and medical equipment and supplies manufacturing
Company size
10,000+ Employees
Headquarters location
Huntington Beach, CA, US