... commercial operations. The successful candidate will bring deep expertise in global quality and ... Minimum 8-10 years of experience in pharmaceutical/biotech Quality Assurance, Quality Control, or ...
... commercial operations. The successful candidate will bring deep expertise in global quality and ... Minimum 8-10 years of experience in pharmaceutical/biotech Quality Assurance, Quality Control, or ...
Logistics Specialist
Madison, WI · On-site
$61K - $122K/yr
This position works closely with the lab operations, clinical operations, commercial operations ... Preferred Qualifications * 2+ years of experience in a biotech manufacturing, GMP, and/or ISO13485 ...
Logistics Specialist
Madison, WI · On-site
$61K - $122K/yr
This position works closely with the lab operations, clinical operations, commercial operations ... Preferred Qualifications * 2+ years of experience in a biotech manufacturing, GMP, and/or ISO13485 ...
Logistics Specialist
Madison, WI · On-site
$61K - $122K/yr
This position works closely with the lab operations, clinical operations, commercial operations ... Preferred Qualifications * 2+ years of experience in a biotech manufacturing, GMP, and/or ISO13485 ...
Logistics Specialist
Madison, WI · On-site
$61K - $122K/yr
This position works closely with the lab operations, clinical operations, commercial operations ... Preferred Qualifications * 2+ years of experience in a biotech manufacturing, GMP, and/or ISO13485 ...
Logistics Specialist
Madison, WI · On-site
$61K - $122K/yr
This position works closely with the lab operations, clinical operations, commercial operations ... Preferred Qualifications * 2+ years of experience in a biotech manufacturing, GMP, and/or ISO13485 ...
Logistics Specialist
Madison, WI · On-site
$61K - $122K/yr
This position works closely with the lab operations, clinical operations, commercial operations ... Preferred Qualifications * 2+ years of experience in a biotech manufacturing, GMP, and/or ISO13485 ...
WI · On-site
$275 - $300/hr
Lakefront Biotherapeutics is a global biotech with offices in Belgium, Chicago and San Francisco ... commercial planning, legal operations and AI‑enabled legal tools, and other corporate and ...
WI · On-site
$275 - $300/hr
Lakefront Biotherapeutics is a global biotech with offices in Belgium, Chicago and San Francisco ... commercial planning, legal operations and AI‑enabled legal tools, and other corporate and ...
Director, Global Trade and Operations Strategy
Madison, WI · On-site
$140 - $210/hr
... Commercial, Finance, Tax, and Legal. * Anticipate footprint changes as the business expands ... years biotech/pharma experience; 5+ years in trade compliance, global supply chain operations ...
Director, Global Trade and Operations Strategy
Madison, WI · On-site
$140 - $210/hr
... Commercial, Finance, Tax, and Legal. * Anticipate footprint changes as the business expands ... years biotech/pharma experience; 5+ years in trade compliance, global supply chain operations ...
WI · On-site
$51.21 - $73.97/hr
With the growth of our Quality Operations Team in Ghent, we are looking for new colleagues with a ... Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting ...
WI · On-site
$51.21 - $73.97/hr
With the growth of our Quality Operations Team in Ghent, we are looking for new colleagues with a ... Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting ...
WI · On-site
$120 - $160/hr
... biotechnology, and drug delivery customers. This position is field based, with travel expected to ... commercial, technical, quality, and operations stakeholders. Essential Job Duties and ...
WI · On-site
$197 - $266/hr
Career Category Sales & Marketing Operations Join Amgen's Mission of Serving Patients At Amgen, if ... Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest ...
WI · On-site
$197 - $266/hr
Career Category Sales & Marketing Operations Join Amgen's Mission of Serving Patients At Amgen, if ... Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest ...
Process Development Engineer
Waunakee, WI · On-site
$85 - $125/hr
... commercial manufacturing processes to ensure product quality, process robustness, and operational ... experience in pharmaceutical, biotechnology or CDMO environments is preferred. * Hands-on ...
Process Development Engineer
Waunakee, WI · On-site
$85 - $125/hr
... commercial manufacturing processes to ensure product quality, process robustness, and operational ... experience in pharmaceutical, biotechnology or CDMO environments is preferred. * Hands-on ...
... commercial manufacturing processes to ensure product quality, process robustness, and operational ... experience in pharmaceutical, biotechnology or CDMO environments is preferred. * Hands-on ...
... commercial manufacturing processes to ensure product quality, process robustness, and operational ... experience in pharmaceutical, biotechnology or CDMO environments is preferred. * Hands-on ...
Process Development Engineer
Waunakee, WI · On-site
... commercial manufacturing processes to ensure product quality, process robustness, and operational ... experience in pharmaceutical, biotechnology or CDMO environments is preferred. * Hands-on ...
Process Development Engineer
Waunakee, WI · On-site
... commercial manufacturing processes to ensure product quality, process robustness, and operational ... experience in pharmaceutical, biotechnology or CDMO environments is preferred. * Hands-on ...
Process Development Engineer
Waunakee, WI · On-site
... commercial manufacturing processes to ensure product quality, process robustness, and operational ... experience in pharmaceutical, biotechnology or CDMO environments is preferred. * Hands-on ...
Process Development Engineer
Waunakee, WI · On-site
... commercial manufacturing processes to ensure product quality, process robustness, and operational ... experience in pharmaceutical, biotechnology or CDMO environments is preferred. * Hands-on ...
Manufacturing Technician
$43K - $51K/yr
... commercial production. This hands-on role combines manufacturing, laboratory operations, and ... Associate's degree in Biotechnology or a related field is a plus. Why Apply? * Hands-on experience ...
Quick apply
Manufacturing Technician
$43K - $51K/yr
... commercial production. This hands-on role combines manufacturing, laboratory operations, and ... Associate's degree in Biotechnology or a related field is a plus. Why Apply? * Hands-on experience ...
... across pharma, biotech, and academic research markets. At FUJIFILM Cellular Dynamics, we're ... Commercial Performance: * Own portfolio performance using commercial and operational KPIs, and ...
... across pharma, biotech, and academic research markets. At FUJIFILM Cellular Dynamics, we're ... Commercial Performance: * Own portfolio performance using commercial and operational KPIs, and ...
Director of Product Marketing
Madison, WI · On-site
... biotech, and academic research markets. Company Overview At FUJIFILM Cellular Dynamics, we're ... Commercial Performance: * Own portfolio performance using commercial and operational KPIs, and ...
Director of Product Marketing
Madison, WI · On-site
... biotech, and academic research markets. Company Overview At FUJIFILM Cellular Dynamics, we're ... Commercial Performance: * Own portfolio performance using commercial and operational KPIs, and ...
... biotech, and academic research markets.Company OverviewAt FUJIFILM Cellular Dynamics, we're ... Commercial Performance:Own portfolio performance using commercial and operational KPIs, and ...
... biotech, and academic research markets.Company OverviewAt FUJIFILM Cellular Dynamics, we're ... Commercial Performance:Own portfolio performance using commercial and operational KPIs, and ...
... biotech, and academic research markets. Company Overview At FUJIFILM Cellular Dynamics, we're ... Commercial Performance: * Own portfolio performance using commercial and operational KPIs, and ...
... biotech, and academic research markets. Company Overview At FUJIFILM Cellular Dynamics, we're ... Commercial Performance: * Own portfolio performance using commercial and operational KPIs, and ...
... commercial drug products, to ensure compliance with the principles and guidelines of cGMP. The ... Experience executing GMP quality systems in a pharmaceutical/biotech/medical device environment ...
... commercial drug products, to ensure compliance with the principles and guidelines of cGMP. The ... Experience executing GMP quality systems in a pharmaceutical/biotech/medical device environment ...
... biotechnology regulations. As the regulatory leader for North America, this position serves as the ... Commercial, Innovation, Product Development, Applications, Quality, Operations, and Global ...
... biotechnology regulations. As the regulatory leader for North America, this position serves as the ... Commercial, Innovation, Product Development, Applications, Quality, Operations, and Global ...
Commercial Operations Biotech information
What is commercial operations in biotech?
How does the commercial operations team in biotech typically collaborate with sales, marketing, and supply chain departments?
What are the key skills and qualifications needed to thrive as a commercial operations professional in biotech, and why are they important?
What is the difference between Commercial Operations Biotech vs Sales Representative Biotech?
| Aspect | Commercial Operations Biotech | Sales Representative Biotech |
|---|---|---|
| Primary Focus | Strategic planning, market analysis, and supporting sales teams | Direct sales, client engagement, and product promotion |
| Required Credentials | Bachelor's degree in life sciences, business, or related field; experience in biotech sales or marketing | Bachelor's degree in life sciences or related field; sales experience preferred |
| Work Environment | Office-based, cross-functional teams, corporate settings | Field-based, client meetings, conferences |
| Industry Usage | Common in biotech companies' commercial departments | Common in biotech sales and distribution channels |
Commercial Operations Biotech professionals focus on strategic support, market analysis, and enabling sales teams, while Sales Representatives Biotech engage directly with clients to promote products. Both roles require a background in life sciences, but their daily tasks and work environments differ significantly.
What are the most commonly searched types of Commercial Operations Biotech jobs in Wisconsin?
The most popular types of Commercial Operations Biotech jobs in Wisconsin are:
What are popular job titles related to Commercial Operations Biotech jobs in Wisconsin?
For Commercial Operations Biotech jobs in Wisconsin, the most frequently searched job titles are:
What job categories do people searching Commercial Operations Biotech jobs in Wisconsin look for?
The top searched job categories for Commercial Operations Biotech jobs in Wisconsin are:
What cities in Wisconsin are hiring for Commercial Operations Biotech jobs?
Cities in Wisconsin with the most Commercial Operations Biotech job openings:

Senior Manager, Global Sample Stability and Retains Program
Verona, WI • On-site
Full-time
Posted 22 days ago
Key responsibilities
Establish and manage a compliant global stability and retain sample program across all phases of development and commercial operations.
Develop, review, and approve stability protocols and study designs, and ensure timely execution of stability studies.
Oversee stability data trending, statistical analysis, and support regulatory submissions related to stability and retains.
Job description
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
The Senior Manager will lead the Global Sample Stability and Retains Program within the Quality Control unit in the Quality organization, based on site at the Arrowhead Verona site. This role is responsible for the strategic design, implementation, and oversight of stability programs, global retain sample management, and reference standard lifecycle management across all phases of development and commercial operations. The successful candidate will bring deep expertise in global quality and regulatory requirements (FDA, EMA, MHRA, PMDA, TGA, Health Canada, and other applicable health authorities) for stability and retain management and will lead a team responsible for ensuring compliant, audit-ready stability, retains, and reference standard operations across Arrowhead's global network of internal sites, CMOs, and CTLs.
Responsibilities
- Establish and manage a compliant global stability and retain sample program (raw materials, drug substance, drug product, and finished goods) per US 21 CFR 211.170, EU GMP Annex 19, and other applicable regional regulations (UK MHRA, Japan PMDA, Australia TGA, etc.), including defined sample quantities, storage conditions, retention periods, and inventory/chain-of-custody/disposition management, coordinated with international distribution and regulatory affairs for country-specific requirements.
- Develop, review, and approve stability protocols, study designs, and commitments per ICH Q1A(R2), Q1E, Q5C, and regional guidance; ensure all stability studies (long-term, accelerated, intermediate, in-use, photostability, thermal cycling, transportation/excursion) are executed on schedule across internal labs and external CMOs/CTLs.
- Oversee stability data trending and statistical analysis (regression, pooling, out-of-trend evaluation) to support shelf-life/retest date determination and justifications for regulatory filings (INDs, NDAs, BLAs, MAAs, and global equivalents), including leading shelf-life extension activities (protocol development, data packages, statistical justification, and coordination with Regulatory Affairs for submissions).
- Support annual product stability reviews, APQR/PQR, and stability commitment tracking; manage stability chamber qualification, monitoring, and excursion investigations with Facilities/Engineering.
- Own the end-to-end reference standard lifecycle program - selection, qualification, characterization, stability monitoring, inventory, and distribution across internal sites, CMOs, and CTLs - including qualification protocols/reports with acceptance criteria and traceability to primary/compendial standards, and timely requalification/replacement ahead of expiry (including bridging studies between lots).
- Support regulatory submissions and health authority information requests related to stability and retains.
- Directly manage, mentor, and develop a team of stability and retain professionals, including hiring, performance management, training, and career development.
- Other duties as assigned
Requirements
- Bachelor's degree in Chemistry, Pharmaceutical Sciences, Biology, or a related scientific discipline required; advanced degree (MS) preferred.
- Minimum 8-10 years of experience in pharmaceutical/biotech Quality Assurance, Quality Control, or CMC, with significant direct experience in global stability program management and retain sample management.
- Minimum 3-5 years of people management experience, with demonstrated ability to lead, develop, and grow a team.
- Experience supporting both clinical (IND-stage) and global commercial products preferred.
- Prior experience with RNAi, oligonucleotide, biologics, or complex/novel modality products is a plus
- Expert working knowledge of global stability and retains regulations and guidance, including US FDA 21 CFR 211, EU GMP Annex 19, ICH Q1A(R2)/Q1E/Q5C, UK MHRA, Japan PMDA, Australia TGA, and Health Canada requirements.
Preferred:
- Masters of Science Degree in Chemistry, Pharmaceutical Sciences, Biology, or a related scientific discipline
- Strong understanding of stability study design, statistical trending, shelf-life extrapolation, and regulatory submission requirements.
- Demonstrated experience managing global retain sample programs across multiple markets and distribution channels.
- Experience hosting and supporting regulatory inspections (FDA, EMA, MHRA, PMDA, TGA) and third-party audits.
- Hands-on experience using LIMS (Laboratory Information Management System) for stability sample scheduling, pull-point tracking, test result entry, and stability data trending; experience configuring or administering stability modules within a LIMS strongly preferred.
- Demonstrated experience with data trending techniques (e.g., linear regression, pooling analysis, out-of-trend/out-of-specification evaluation) used to support shelf-life determination and shelf-life extension justifications.
- Demonstrated experience managing reference standard lifecycle activities, including selection, qualification, stability monitoring, inventory management, and global distribution.
- Strong project management skills with the ability to manage multiple studies, timelines, and priorities simultaneously.
- Excellent written and verbal communication skills; experience authoring SOPs, technical reports, and regulatory documentation.
- Demonstrated leadership, coaching, and team-building skills.
- Ability to work effectively in a fast-paced, growing biopharmaceutical environment with evolving priorities.
Wisconsin pay range
$140,000-$160,000 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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About Arrowhead Pharmaceuticals
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
201 - 500 Employees
Headquarters location
Pasadena, CA, US
Year founded
1989