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CSL Seqirus is a global leader in influenza prevention and the world’s second-largest influenza vaccine provider, operating as a specialized division of CSL Limited. Headquartered in Melbourne, Australia, with major manufacturing hubs in Holly Springs, NC, and Liverpool, UK, the company operates the world’s largest cell-based vaccine facility and serves as a primary partner to governments for global pandemic preparedness. Joining Seqirus now means being part of an agile team committed to developing vaccines that make a meaningful difference worldwide.
Could you be our next Associate Director, Clinical Assay Strategy-Flu? The job is in our Waltham, MA Office. This is a hybrid position and is onsite three days a week. You will report to the Director, Clinical Assay Strategy.
This role is intended for a recognized subject matter expert who understands the scientific, operational, and regulatory evolution of influenza immunogenicity assessment, including HAI, microneutralization (MN), ELLA, and multiplex platforms, and can strategically navigate assay modernization while maintaining regulatory alignment.
You will provide scientific leadership and external oversight of vaccine serology and biomarker assays supporting clinical development programs. This is a strategic, non-laboratory-based role responsible for assay design, validation oversight, regulatory alignment, and vendor governance across global clinical programs.
Influenza Immunology & Assay Strategy
Develop and execute clinical assay strategies for influenza vaccine programs across all phases of clinical development.
Provide expert guidance on HAI assay design, optimization, regulatory expectations, and historical correlates of protection.
Lead strategic implementation and interpretation of microneutralization (MN) assays.
Oversee ELLA, Luminex-based total IgG, subclass, and Fc-effector analyses.
Evaluate and guide adoption of multiplex platforms (e.g., Luminex) for expanded immune profiling.
Lead assay bridging and concordance strategies during platform evolution or vendor transition.
Assess context-of-use and regulatory acceptability of modernized assay platforms.
Clinical Bioanalytical Validation & Regulatory Readiness
Oversee assay qualification, validation, transfer, and lifecycle management aligned with FDA, EMA, ICH, and WHO guidance.
Ensure validation parameters are appropriate for intended clinical endpoints (precision, accuracy, specificity, robustness).
Provide strategic input for label-enabling immunogenicity studies.
Support regulatory submissions with validation documentation and responses to health authority queries.
Anticipate regulatory risks associated with assay modernization in influenza programs.
Externalization & Vendor Oversight
Lead technical evaluation and selection of external bioanalytical laboratories.
Oversee assay transfers ensuring concordance, compliance, and data integrity.
Establish vendor governance frameworks, KPIs, and performance oversight.
Manage complex troubleshooting and scientific escalations with external partners.
Ensure operational excellence across high-throughput influenza clinical serology programs.
Cross-Functional Collaboration
Partner closely with Research, Clinical Development, Regulatory Affairs, Statistics, and CMC teams.
Translate immunological data into strategic development decisions.
Provide scientific leadership in a matrixed environment.
Represent the organization at scientific conferences and regulatory forums.
Qualifications & Experience
Bachelor's in Life Science. PhD preferred in Immunology, Virology, Microbiology, or related Life Sciences discipline preferred.
4+ years of industry experience in vaccine development.
Experience in influenza vaccine required
Demonstrated expertise in HAI and MN assay validation and regulatory positioning.
Experience in ELISA and multiplex immune assay development.
Experience supporting regulatory submissions involving vaccine immunogenicity endpoints.
Proven experience managing outsourced clinical bioanalytical programs.
The expected base salary range for this position at hiring is $179,000 - $212,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.
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About CSL Seqirus
CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
Watch our ‘On the Front Line’ video to learn more about CSL Seqirus
GENERAL SUMMARY
The Director, Commercial and Medical Operations IT Product Manager is a strategic leadership role responsible for driving the vision, roadmap, and delivery of technology platforms that enable operational excellence across commercial and medical domains. This role ensures solutions are innovative, scalable, and compliant, supporting the organization’s transformation and growth. This individual will serve as a key liaison between business stakeholders and I&T teams, ensuring that product strategies align with organizational goals and deliver measurable value. They will lead cross-functional teams, manage product lifecycles, and champion user-centric design and agile methodologies to deliver scalable, high-impact solutions.
This role is accountable not only for technology delivery, but for shaping enterprise-wide business transformation—modernizing operating models, decision-making, and engagement through digital platforms, data, and AI. Success will be measured by measurable improvements in productivity, adoption, compliance, and business outcomes—not output alone.
REPORTING RELATIONSHIP
Reports To: Executive Director, Commercial I&T
Direct Reports: Product Owners, Platform Configuration/Analysts
RESPONSIBILITIES
1) Lead the design and delivery of platforms for revenue management, contracting, pricing, compliance, meetings, training and other operational domains. Ensure seamless integration with enterprise systems and compliance with regulatory requirements. Enable decision intelligence across commercial and medical operations by integrating data, analytics, and workflow platforms that support compliant, scalable execution.
2) Develop and communicate a strategic product vision, integrating digital, data, automation and AI capabilities to future-proof operations. Partner with executive stakeholders to identify opportunities for digital transformation and innovation.
3) Act as a platform steward, accountable for long-term architectural integrity, scalability, and cost efficiency—balancing near-term business needs with enterprise standards and future-state evolution.
4) Manage the full end-to-end product lifecycle, prioritizing features based on business impact, user feedback and emerging technology trends.
5) Ensure robust API integration, adherence to interoperability standards, and implementation of data governance practices to deliver scalable, secure, and compliant solutions.
6) Serve as the primary liaison between business units and IT, translating requirements into actionable, secure, and compliant solutions.
Serve as a senior technology leader embedded with the business units, IT functions, anticipating needs and turning requirements into actionable, secure, and compliant digital products.
7) Own the responsible evaluation, adoption, and scaling of AI and advanced analytics capabilities—partnering with Data, Security, Legal, and business leadership to operationalize AI in compliant, high‑value use cases.
8) Develop and manage strategic relationships with external technology and managed services partners to ensure seamless integration, compliance, and innovation across platforms
9) Own product financials including vendor strategy, run vs. grow investment decisions, total cost of ownership, and value realization tracking in partnership with Finance and Procurement.
10) Build and develop agile, cross-functional teams, fostering a culture of innovation, accountability, and continuous learning
11) Define and evolve delivery models (product-aligned teams, DevOps, vendor/partner orchestration) to improve speed, quality, and accountability across global teams.
12) Establish and monitor key performance indicators (KPIs) to measure product performance, business impact, and regulatory compliance.
13) Ensure platforms meet global regulatory, privacy, and cybersecurity standards.
14) Stay ahead of industry trends, regulatory changes, technology innovations, proactively adapting strategies.
15) Drive continuous improvement, operational excellence, and change management initiatives.
16) Serve as a trusted advisor to executive leadership, shaping strategic decisions through data-driven insights, tradeoff analysis, and forward-looking recommendations.
JOB SPECIFICATIONS
Education
• Bachelor’s or advanced degree in Computer Science, Engineering, Information Systems, or related field.
Experience
• 10+ years experience in product management, application development or digital transformation
• 4+ years in leadership roles.
• Proven success delivering enterprise technology solutions in global, matrixed, and regulated environments.
• Pharma/Biotech or similarly regulated environment experience preferred.
Additional Comments
Skills Required:
• Expertise in agile methodologies, SDLC, cloud platforms, AI/ML, data analytics, and cybersecurity.
• Exceptional communication, strategic thinking, and stakeholder management skills
• Expertise with cloud-based ecosystems (AWS, Azure) and advanced analytics tools for insights-driven operations.
Working Conditions
• Understands complex problems to collaborate and explore alternative solutions.
• Ability to make decisions which have significant impact on the immediate work unit and monitor impact outside immediate work unit.
• Fast paced environment with frequent interruptions
• Proven track record of delivering enterprise technology solutions in complex, matrixed environments.
• Excellent communication, strategic thinking, and problem-solving skills.
Note: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin, or other legally protected classifications.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
The Director, Field Engagement IT Product Manager is a visionary leader responsible for shaping and executing the strategy for enterprise-scale technology platforms that drive commercial and medical field effectiveness and engagement. This role bridges business and technology, ensuring solutions deliver measurable value, support digital transformation, and remain agile in a rapidly evolving biopharma landscape. They will lead cross-functional teams, manage product lifecycles, and champion user-centric design and agile methodologies to deliver scalable, high-impact solutions.
This role is accountable not only for technology delivery, but for shaping enterprise-wide business transformation—modernizing operating models, decision-making, and engagement through digital platforms, data, and AI. Success will be measured by measurable improvements in productivity, adoption, compliance, and business outcomes—not output alone.
REPORTING RELATIONSHIP
Reports To: Executive Director, Commercial I&T
Direct Reports: Product Owners, Platform Configuration/Analysts
RESPONSIBILITIES
1) Lead the design, delivery, and continuous improvement of platforms and solutions optimizing field experience and productivity through integrated CRM, engagement data, and analytics capabilities – balancing simplicity, compliance
and effectiveness.
2) Define and communicate a forward-looking product vision and roadmap, leveraging AI, automation, and advanced analytics to unlock new business opportunities. Partner with executive stakeholders to identify opportunities for
digital transformation and innovation.
3) Act as a platform steward, accountable for long-term architectural integrity, scalability, and cost efficiency—balancing near-term business needs with enterprise standards and future-state evolution.
4) Manage the full end-to-end product lifecycle, prioritizing features based on business impact, user feedback and emerging technology trends.
5) Ensure robust API integration, adherence to interoperability standards, and implementation of data governance practices to deliver scalable, secure, and compliant solutions.
6) Serve as a senior technology leader embedded with the business units, IT functions, anticipating needs and turning requirements into actionable, secure, and compliant digital products.
7) Own the responsible evaluation, adoption, and scaling of AI and advanced analytics capabilities—partnering with Data, Security, Legal, and business leadership to operationalize AI in compliant, high‑value use cases.
8) Develop and manage strategic relationships with external technology and managed services partners to ensure seamless integration, compliance, and innovation across platforms
9) Own product financials including vendor strategy, run vs. grow investment decisions, total cost of ownership, and value realization tracking in partnership with Finance and Procurement.
10) Build and mentor high-performing, cross-functional teams, championing agile, DevOps, and user centric design practices
11) Define and evolve delivery models (product-aligned teams, DevOps, vendor/partner orchestration) to improve speed, quality, and accountability across global teams.
12) Establish and monitor key performance indicators (KPIs) to measure product success, business impact, user adoption, and regulatory compliance.
13) Ensure platforms meet global regulatory, privacy, and cybersecurity standards.
14) Stay ahead of industry trends, regulatory changes, technology innovations, proactively adapting strategies.
15) Drive continuous improvement, operational excellence, and change management initiatives.
16) Serve as a trusted advisor to executive leadership, shaping strategic decisions through data-driven insights, tradeoff analysis, and forward-looking recommendations.
JOB SPECIFICATIONS
Education
• Bachelor’s or advanced degree in Computer Science, Engineering, Information Systems, or related field.
Experience
• 10+ years experience in product management, application development or digital transformation
• 4+ years in leadership roles.
• Proven success delivering enterprise technology solutions in global, matrixed, and regulated
environments.
• Pharma/Biotech or similarly regulated environment experience preferred.
Additional Comments
Skills Required:
• Expertise in agile methodologies, SDLC, cloud platforms, AI/ML, data analytics, and cybersecurity.
• Exceptional communication, strategic thinking, and stakeholder management skills
• Expertise with cloud-based ecosystems (AWS, Azure) and advanced analytics tools for insights-driven engagement.
• Deep understanding of enterprise CRM and engagement platforms in regulated environments (ie., Veeva and Salesforce)
Working Conditions
• Understands complex problems to collaborate and explore alternative solutions.
• Ability to make decisions which have significant impact on the immediate work unit and monitor impact outside immediate work unit.
• Fast paced environment with frequent interruptions
• Proven track record of delivering enterprise technology solutions in complex, matrixed environments.
• Excellent communication, strategic thinking, and problem-solving skills.
Note: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin, or other legally protected classifications.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
This position is fully on-site in Owensboro, KY.
The Engineering Technician supports UniFirst’s mission of operational excellence by driving process improvements, maintaining accurate labor standards, and supporting incentive-based pay systems. This role partners closely with Production, Accounting, and Engineering teams to identify inefficiencies, improve cost performance, and enhance workflows in a high-volume, high-variation environment. The ideal candidate will have strong analytical skills, a continuous improvement mindset, and the ability to thrive in a dynamic distribution setting.
Responsibilities:
- Assist with the Development and maintenance of engineered labor standards using time studies, work measurement, and process observations.
- Validate standards through work sampling, spot pace rating, and statistical analysis.
- Maintain labor data in Labor Management Systems and ensure accurate reflection of process changes.
- Support incentive pay accuracy by validating standards and assisting in the rollout and ongoing calibration of productivity expectations.
- Provide training, documentation, and guidance to Distribution Center managers on labor standards and LMS reporting.
- Collaborate with Production and Engineering teams to assess current manufacturing and distribution practices.
- Design, redesign, and optimize layouts, workflows, and tools to enhance throughput, ergonomics, and space utilization.
- Support site-level 5S initiatives to improve floor space, visual controls, and product flow.
- Assist with space and capacity analysis using CAD tools and layout modeling.
- Perform value stream mapping, root cause analysis, and time studies to identify and eliminate waste.
- Document standard work and partner with operations to implement improvements that align with Lean Manufacturing and Safety principles.
- Support specific CI (Continuous Improvement) projects in coordination with front-line leadership and cross-functional teams.
- Analyze production data for trends, bottlenecks, and improvement opportunities.
- Assist the Accounting department in understanding cost variances related to labor, throughput, and material usage.
- Recommend and justify process changes with measurable savings in cost, time, or resources.
- Support cost-reduction initiatives by optimizing labor, materials, and process design.
- Develop clear documentation of procedures, methods, and training materials in partnership with Operations, Training, and HR.
- Maintain and distribute updated SOPs, labor metrics, and individual performance reports.
- Serve as a technical resource for onboarding, training, and reinforcing best practices in engineered standards and workflow design.
Qualifications
Requirements:
- Bachelor’s degree in Industrial Engineering, Engineering Technology, or related field (or Associate degree with relevant experience).
- 0–2 years of experience in industrial/process engineering, labor standards, or manufacturing/distribution environments.
- Proficient in Microsoft Office (Excel, Word, Teams); experience with Excel modeling and pivot tables preferred.
- Experience with stopwatch time studies, standard data systems, and performance rating methods.
- Familiar with Lean Manufacturing, ergonomics, safety regulations, and 5S methodology.
- Basic to intermediate skills in AutoCAD or similar layout design tools.
- Strong analytical, documentation, and communication skills.
Benefits & Perks:
401K with Company Match, Profit Sharing, Health Insurance, Employee Assistance Program, Life Insurance, Paid Time Off, Tuition Reimbursement, 30% Employee Discount, Employee Referral Bonuses.
UniFirst is an international leader in garment & Uniform services industry. We currently employ over 14,000 team partners who serve 300,000 business customer locations throughout the U.S., Canada, and Europe.
We were included in the top 10 of Selling Power magazine’s “Best Companies to Sell For” list and recognized on Forbes magazine’s “Platinum 400 – Best Big Companies” list. As an 80-year old company focused on annual growth, there’s never been a better time to join our team.
UniFirst is an equal opportunity employer. We do not discriminate in hiring or employment against any individual on the basis of race, color, gender, national origin, ancestry, religion, physical or mental disability, age, veteran status, sexual orientation, gender identity or expression, marital status, pregnancy, citizenship, or any other factor protected by anti-discrimination laws.
If you need accommodation for any part of the application process because of a medical condition or disability, please send an e-mail to TalentAcquisition@unifirst.com or call 800-347-7888 to let us know the nature of your request.
UniFirst Recruiters and/or representatives will not ask job seekers to provide personal financial information when submitting a job application. Please be vigilant as such requests for information may be fraudulent.
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