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Analytical Development Biotech Jobs in Michigan (NOW HIRING)

... and development. We specialize in control and disease-state biospecimens, including human and ... The successful candidate will bring deep ADP WorkforceNow expertise, strong analytical skills, and ...

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... in biotech, pharmaceutical organizations or consultancies with demonstrated success in pre-launch ... S. * Proficiency in RWD study design and analysis, and patient outcome measure development.

... analyses, and implementation of mitigation strategies throughout product development. * Lead human ... Experience in the medical device, pharmaceutical, biotechnology, or other regulated manufacturing ...

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Business analysis and project management proficiency. * Strong verbal and written communication ... development, support, or architecture experience. * Experience in Animal Health, Pharma, Biotech ...

We support the pharmaceutical, biotech, and medical device industries with our proven, scientific ... Preparation of study protocols and development of Statistical Analysis Plans and Statistical ...

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Analytical Development Biotech information

What are some typical challenges faced by analytical development professionals in the biotech industry?

Analytical Development professionals in biotech often encounter challenges such as developing robust methods for novel biologics, ensuring regulatory compliance, and adapting to rapid technological changes. They frequently work within cross-functional teams, collaborating closely with research, manufacturing, and quality assurance groups to optimize assay performance and troubleshoot issues. Staying current with evolving regulatory standards and balancing project timelines with method validation requirements are also common aspects of the role.

What is analytical development in the pharmaceutical industry?

Analytical development in the pharmaceutical industry involves creating and validating methods to accurately measure the quality, purity, and potency of drug substances and products. For an Analytical Development Biotech, this includes designing assays, optimizing analytical techniques like HPLC or mass spectrometry, and ensuring compliance with regulatory standards such as GMP and ICH guidelines.

What is the difference between Analytical Development Biotech vs Quality Control Analyst?

AspectAnalytical Development BiotechQuality Control Analyst
CredentialsBachelor's/Master's in Life Sciences, Chemistry, or related fieldsBachelor's in Chemistry, Biology, or related fields; often requires GMP training
Work EnvironmentResearch labs, development departments, collaborative teamsQuality labs, manufacturing facilities, compliance-focused settings
Industry UsageDeveloping and optimizing analytical methods for biotech productsTesting and ensuring product quality and compliance with standards

Analytical Development Biotech focuses on creating and refining analytical methods during product development, while Quality Control Analysts primarily test products to ensure they meet quality standards. Both roles require similar educational backgrounds and work in laboratory settings, but their core responsibilities differ in the product lifecycle.

What is analytical development in biotech?

Analytical Development in biotech refers to the process of designing, developing, and validating methods to analyze biological products, such as proteins, antibodies, or cell therapies, during various stages of drug development and manufacturing. These methods are essential for ensuring the safety, quality, potency, and purity of biotechnological products. Professionals in this field work closely with research, production, and regulatory teams to ensure that analytical methods meet industry standards and comply with regulatory requirements. Analytical Development is a critical part of bringing new biopharmaceutical products from the lab to the market.

What are the key skills and qualifications needed to thrive as an analytical development biotech professional?

To thrive as an Analytical Development Biotech professional, you need a strong background in analytical chemistry, biochemistry, or a related field, typically supported by at least a bachelor's or master's degree. Familiarity with analytical instrumentation such as HPLC, GC, mass spectrometry, and relevant quality systems like GMP or ICH guidelines is crucial. Strong problem-solving, attention to detail, and effective communication are important soft skills for collaborating across multidisciplinary teams. These competencies ensure accurate data generation, regulatory compliance, and successful development of biotechnological products.

What are popular job titles related to Analytical Development Biotech jobs in Michigan?

For Analytical Development Biotech jobs in Michigan, the most frequently searched job titles are:

Principal Product Engineer - Electronics

North Star Staffing Solutions

Livonia, MI

Full-time

Re-posted 14 days ago


Job description

Company Description

North Star Staffing Solutions is a full lifecycle recruiting company for clients based nationwide. We specialize in placing experienced candidates in industries such as Accounting/Banking, Finance, Manufacturing, IT, Aerospace, Agriculture/Environmental, Biotech and Pharmaceutical, Automotive, Construction, Engineering, Healthcare, Hospitality, Legal, Restaurant/Food Services, Sales/Marketing, and Telecommunications.

Job Description

The engineer will work in the Body Control Systems (BCS) organization designing and developing Automotive Switches, Steering Column Control Modules, and Steering Angle Sensors. This role will entail working in a matrix organization interfacing with mechanical engineering, software engineering, suppliers, purchasing, manufacturing, test engineering and sales as well as,

  • Supporting all phases of the product development life cycle.
  • Daily technical design and support of automotive switches, steering column control modules and steering angle sensors.
  • Generate schematics, BOMs and layouts
  • Analysis of circuit and system performance
  • Develop circuit and system test plans and processes
  • Work with TRW technical sub-suppliers
  • Support customer quotations
  • Customer and system requirements analysis
  • Worst case analysis
  • Interface control documents
  • DFMEAs
Qualifications
  • Minimum 10 years experience with state of the art, automotive real time micro-controller based systems.
  • Experience working in product development with a preferred focus on electronics and module design.
  • Strong analytical background for detailed circuit design, experience with 8 / 16 / 32 bit microcontrollers, safety critical tolerant design, and electronic test / debugging.
  • Experience with computer aided schematic capture preferably Mentor Graphics DxDesigner.
  • Experience with circuit simulation tools, preferably Mentor Graphics System Vision.
  • Experience with design analysis and modeling tools to perform electronics worst case circuit design analysis. Knowledge of laboratory tools for performing product analysis and testing.
  • Knowledge of automotive electronics manufacturing processes preferred.
  • Experience with micro controller based systems
  • Mentor Graphics or other schematic capture tools
  • Switches background/Spanish speaking is a plus!
Additional Information

If you meet the requirements of this unique opportunity, we encourage you to explore how you can make a difference by applying now. 

Contact: Jennifer LauÂ