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Contract Method Validation Jobs in Wisconsin (NOW HIRING)

MicroPrecision

Manager, Business Development SS

Delavan, WI · On-site

$90K - $120K/yr

An Upfront Contract : Is This the Right Fit? We are looking for a hunter who thrives working with ... We are looking for a professional who uses a structured sales methodology to uncover true business ...

Microprecision

Manager, Business Development SS

Delavan, WI · On-site

$90K - $120K/yr

An Upfront Contract : Is This the Right Fit? We are looking for a hunter who thrives working with ... We are looking for a professional who uses a structured sales methodology to uncover true business ...

Cadence Inc

Quality Assurance Engineer II

Sturgeon Bay, WI · On-site

$69K - $89K/yr

As a Quality Engineer II for a Contract Medical Device Manufacturing Organization, you will be ... validation methods to ensure reliable manufacturing processes and products. This role analyzes data ...

Actalent

Hardware Test Engineer

Waukesha, WI · Hybrid

$75 - $90/hr

Strong understanding of verification, validation, and qualification testing methodologies for ... Job Type & Location This is a Contract to Hire position based out of Waukesha, WI. Pay and Benefits ...

Vaiticka Solution LLC

UX Designer

Waukesha, WI · On-site

Contract As a UX Designer, you will be a part of an Agile team to build healthcare applications and ... Use participatory design methods (e.g., paper prototyping, co-creation sessions, card sorting) to ...

IO Datasphere

Project Manager

Madison, WI · On-site

Continuously improving the Project Methodology · Providing input into Project Management Best ... Contract: 1+ years Skills Required: · 3-5 years - Project Management knowledge and experience · 3 ...

Malcolm Drilling

Project Manager

Mukwonago, WI · On-site

Negotiate construction contracts (with help from our legal team). * Prepare project submittals ... Basic understanding of construction methods and practices. * Ability to travel to various job sites ...

Malcolm Drilling

Project Manager

Mukwonago, WI · On-site

Negotiate construction contracts (with help from our legal team). * Prepare project submittals ... Basic understanding of construction methods and practices. * Ability to travel to various job sites ...

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Showing results 21-40

All JobsContract Method Validation JobsContract Method Validation Jobs in Wisconsin

Contract Method Validation information

What is the difference between Contract Method Validation vs Analytical Method Validation?

AspectContract Method ValidationAnalytical Method Validation
PurposeValidates that a contracted method meets specific requirements for a particular project or clientEnsures an analytical method is accurate, reliable, and reproducible for testing purposes
ScopeTypically project-specific, focusing on methods used under contractual agreementsBroader, covering method development, validation, and routine testing
CredentialsOften requires validation expertise, GMP knowledge, and industry-specific certificationsRequires analytical chemistry knowledge, validation experience, and relevant certifications
Work EnvironmentPharmaceutical, biotech, or manufacturing settings with client-specific projectsLaboratories performing routine testing and method development in similar industries

Contract Method Validation focuses on validating methods for specific client projects, while Analytical Method Validation ensures the overall reliability of testing methods used routinely in laboratories. Both roles require similar credentials and work in related environments, but their scope and purpose differ.

What cities in Wisconsin are hiring for Contract Method Validation jobs?

Cities in Wisconsin with the most Contract Method Validation job openings:

Contract Method Validation jobs near you

Senior Scientist II, Discovery Analytical Chemistry

Arrowhead Pharmaceuticals

Madison, WI • On-site

$92K - $126K/yr

Full-time

Re-posted 3 days ago

Job description

Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.
Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
Arrowhead is seeking a highly motivated and experienced Senior Scientist on Analytical Chemistry to lead analytical method development, characterization, and testing activities supporting pharmaceutical development programs. This role will be responsible for developing and qualifying analytical methods, overseeing analytical activities performed at contract development and manufacturing organizations (CDMOs), and authoring analytical sections of regulatory submissions. The successful candidate will serve as a technical expert in Antibody oligo conjugate (AOC) drug characterization and will collaborate closely with Process Development, Manufacturing, Quality, Regulatory Affairs, and external partners.
Responsibilities
  • Design, develop, optimize, qualify, and transfer analytical methods to support development and manufacturing activities.
  • Lead analytical characterization studies for drug substances, intermediates, and related materials.
  • Develop and execute analytical strategies to assess product identity, purity, potency, impurities, and stability.
  • Interpret analytical data, investigate trends, and provide scientific recommendations to project teams.
  • Support method lifecycle management, troubleshooting, and continuous improvement activities.
  • Provide scientific and technical oversight of analytical development, testing, method qualification, and transfer activities conducted at CDMOs.
  • Review protocols, reports, deviations, investigations, and technical documents generated by external partners.
  • Monitor project timelines, deliverables, and analytical performance to ensure project objectives are achieved.
  • Serve as the primary analytical subject matter expert during interactions with CDMOs and contract testing laboratories.
  • Collaborate with Process Development, Manufacturing, Quality Control, Quality Assurance, Regulatory Affairs, and CMC teams to support program milestones.
  • Contribute to analytical control strategy development and product specification setting.
  • Present analytical findings and recommendations to internal teams and management.
  • Author and review analytical sections of regulatory submissions, including INDs, IMPDs, CTAs, BLAs, and other global regulatory filings.
  • Support responses to regulatory agency questions and inspections.
  • Ensure analytical activities comply with applicable GMP, ICH, FDA, EMA, and other regulatory requirements.
  • Participate in quality investigations, change controls, risk assessments, and CAPA activities as needed.

Requirements
  • PhD in analytical chemistry or close related fields with 5+ years pharmaceutical relevant industry experience; or M.S. with 8+ years of relevant industry experience; or B.S. with 10+ years of relevant industry experience.
  • Extensive knowledge of Oligo, mAb, ADC or AOC-related analytical techniques and applications.
  • Demonstrated expertise with chromatographic methods, including HPLC, UHPLC, and related analytical platforms.
  • Experience with GMP-regulated analytical development and testing environments.
  • Strong understanding of method transfer, validation, and lifecycle management principles.
  • Experience authoring analytical CMC documentation for regulatory submissions.
  • Strong scientific problem-solving and troubleshooting skills.
  • Excellent technical writing and communication abilities.
  • Ability to manage multiple projects in a fast-paced environment.
  • Strong organizational skills and attention to detail.
  • Effective collaborator with demonstrated ability to influence cross-functional teams and external partners.

Preferred
  • Hands-on Experience with Size Exclusion Chromatography coupled with Multi-Angle Light Scattering (SEC-MALS) is preferred but not necessary.
  • Experience supporting biologics, oligonucleotides, ADC, AOC or other complex modalities.
  • Prior experience managing external laboratories and CDMOs.
  • Familiarity with ICH guidelines and global regulatory expectations.

Wisconsin pay range
$130,000-$150,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
Candidates must have current, valid authorization to work in the country where this role is located.
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