Upstream Bioprocessing Jobs in Usa

Previous Pharmaceutical/Biotech experience is mandatory for this role.

MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Project Management, and other Consulting services.

MMR Consulting has offices in Canada, USA, and Australia.

This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of engineers and specialists involved in project management, commissioning and qualification, of equipment, systems and facilities.

This role is for CQV Engineer role to work on the commissioning, qualification, startup of upstream and downstream bioprocess systems/equipment in the biopharmaceutical industry, as well as process equipment in pharma/biotech industries.

The work will require working out of the client’s facilities in San Diego, California.

Responsibilities

• Provide technical guidance into the commissioning, qualification and start-up of various equipment and facilities used in life science manufacturing, such as bioreactors, tanks, CIP, Buffers, Media, Chrom, TFF, washers & autoclaves, centrifuges, etc.
• Lead the development of key qualification deliverables during the project lifecycle to ensure project is well defined, and the action plan to test the system is applicable and relevant.
• Lead qualification processes throughout the project lifecycle such as VPP, Risk Assessments, RTM, DQ, FAT, SAT, IQ, OQ and PQ as appropriate to ensure timely completion and to ensure all quality and engineering specifications are met.
• Prepare protocols, execute protocols, summarize data, resolve deviations, prepare final reports.
• Experience with C&Q of process equipment, utilities, facilities is an asset. Thermal Validation experience is an asset.
• Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates.
• Engage other departments, as required, for design reviews and decisions.
• Travel may be occasionally required for meetings with clients, equipment fabrication vendors or Factory Acceptance Testing (FATs).
• Work may require occasional support over shutdowns or extended hours, specifically during installation and commissioning / validation phases.
• Client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and MMR resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing papers etc.
• Visit construction and installation sites following all site safety requirements.
• Other duties as assigned by client, and/or MMR, based on workload and project requirements.

Qualifications

• 3-6+ years for years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry.
• Engineering or Science degree, preferably in Mechanical, Electrical, Chemical, Biochemical, Electromechanical or a related discipline.
• Excellent written and spoken English is required including the preparation of technical documents in English
• Knowledge of requirements for a cGMP operations, including SOPs, Change Controls, Validation.
• Experience with developing and executing validation projects. Risk-Based Commissioning & Qualification approaches, such as ASTM E-2500 or ISPE ICQ, is considered an asset, but not required.
• Experience with commissioning and qualification of biotech process equipment (upstream or downstream or both), such as some, but not all, of the following: fermentation, bioreactors, downstream purification processes (chromatography, TFF, UF) is required
• Experience with commissioning & qualification of process control systems (i.e. PCS, SCADA, Historians) and building automation systems (i.e. Siemens Insight / Desigo, JCI Metasys) are considered an asset.
• Experience with Qualification or Validation of clean utilities, ISO clean rooms, and Thermal Validation is considered an asset.
• Experience with preparation and execution of URS’s, DQ’s, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs, NCRs, Final Reports.
• Ability to lift 50 lbs.
• Ability to handle multiple projects and work in a fast-paced environment.
• Strong multi-tasking skills

Salary range: 80,000$ -120,000$ based on experience.

Equal Employment Opportunity and Reasonable Accommodations

MMR Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Our hiring decisions are based on merit, qualifications, and business needs. We are committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.

MES (PAS-X) Lead Engineer (Biotech/Pharmaceutical)

Location – Wilson, NC

Aztec Technologies is an engineering and consulting firm providing expertise in the

pharmaceutical and biotechnology industries. Aztec Technologies and Aztec Process Automation

are part of Trinity Consultants Company.

Trinity Consultants, Inc., a leading international EHS, life sciences and environment consulting

services with 1500+ engineers worldwide.

Aztec Technologies provides solutions for Manufacturing Applications:

• Process and Facility Automation

• Project Management

• MES

• Data Analytics

With offices across 3 continents, consulting firm with over 20 years of experience within the

biopharmaceutical and pharmaceuticals industries.

The successful candidate will work with a group of engineers involved in the design, automation,

commissioning and start-up of various processes, systems, and facilities. A combination of

strong technical aptitude, automation engineering skills and technical writing are the desired skill

set. This is an outstanding opportunity to join our growing team and to work in the Life Sciences

space that will enhance professional opportunities!

Candidates need to be local or willing to relocate to the areas of operation where we have open

opportunities for immediate hire in the Wilson, NC area:

Key Responsibilities:

• Own MES configuration management for PAS-X, including:
• Manufacturing Batch Records (MBRs)
• Material management
• Equipment and timer management
• Label management
• Lead MES design, configuration, testing, and troubleshooting
• Act as technical interface between MES, DCS (DeltaV), ERP, LIMS, and other shop-floor systems
• Support MBR migration from a legacy site
• Ensure alignment with site and global MES standards
• Support risk assessments and GMP compliance activities
• Provide hands-on troubleshooting and technical support during execution
• Develop and maintain MES technical documentation
• Collaborate closely with IT, Manufacturing, Quality, and Engineering teams

Required Qualifications

• 8+ years experience in pharmaceutical or biopharmaceutical manufacturing environments
• Strong hands-on experience with MES platforms, preferably Werum PAS-X
• Proven experience with MBR design and execution
• Solid understanding of GMP manufacturing processes
• Experience integrating MES with DCS (DeltaV) and enterprise systems
• Strong analytical, troubleshooting, and problem-solving skills
• Bachelor’s degree in Engineering, IT, Science, or related discipline

Preferred / Nice-to-Have Skills

• Programming experience: .NET, SQL / PL-SQL, Java
• Experience with OPC servers/clients
• Knowledge of 21 CFR Part 11 and EU GMP Annex 11
• Process knowledge across:
• Upstream
• Downstream
• Bioprocess support functions
• Ability to communicate effectively with both technical and non-technical stakeholders

Ideal Candidate Profile:

• Senior-level PAS-X MES SME
• Strong on-site presence and ownership mindset
• Comfortable operating as Owner’s Rep, not a junior configurator
• Deep pharma/biotech automation background
• Able to bridge Manufacturing, IT, Automation, and Quality

Previous Pharmaceutical/Biotech experience is mandatory for this role

MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Project Management, and Validation.

MMR Consulting has offices in Canada, USA, and Australia.

This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of engineers involved in the design, commissioning & qualification, start-up and project management of various processes, systems, and facilities. The ideal candidate should possess leadership skills to lead teams of intermediate & junior engineers.

This role is for Sr. CQV Engineer will require to work on the validation of upstream and downstream bioprocess systems/equipment in the biopharmaceutical industry, as well as process equipment in pharma/biotech industries. The ideal candidate should possess leadership skills to lead teams of intermediate & junior engineers.

The work will require working out of client’s facilities, which are typically in the Greater Denver/Boulder Colorado & surrounding areas.

Responsibilities

• Provide technical guidance in the commissioning, qualification and start-up of various pharmaceutical / biopharmaceutical cGMP process equipment, utilities & facilities.
• Lead the development (for example, write test cases) of key qualification deliverables such as DQ, FAT, SAT, IQ, OQ and PQ during the project lifecycle.
• Able to perform field execution of qualification test cases and protocols.
• Support development of Project Validation Plans (PVPs) to ensure the action plan to test the system is applicable and relevant.
• Lead qualification processes throughout the project lifecycle to ensure timely completion and to ensure all quality and engineering specifications are met.
• Possess knowledge of relevant regulatory requirements and industry best practices on all or any of the following – Process equipment, clean utilities, automation systems, laboratory equipment, building & facilities
• Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, and provide updates.
• Engage other departments, as required, in the design reviews and decisions.
• Travel may be occasionally required for meetings with equipment fabrication vendors or Factory Acceptance Testing (FATs).
• Work may require occasional support over shutdowns or extended hours, specifically during installation, construction, commissioning, qualification, and validation phases.
• Visit construction and installation sites, wearing necessary safety PPE.
• You may be involved with other aspects such as client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and MMR resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing papers etc.
• Supervise contractors during critical testing of system and equipment.
• Other duties as assigned by client, and/or MMR, based on workload and project requirements.
• As this position requires working on client sites, you will need to comply with the client’s safety rules including mandatory vaccination policies for COVID-19, where applicable
• Lead/Mentor a team of validation engineers/specialists.

Qualifications

• 12+ years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry.
• Previous experience in the pharmaceutical / biotech industry, with knowledge of requirements for cGMP operations.
• Validation experience such as cleaning validation, thermal validation, mixing studies, process validation, computer systems validation is an asset but not required.
• Experience with developing and executing validation projects to Risk-Based Commissioning & Qualification approaches, such as ASTM E-2500 or ISPE ICQ, is considered an asset, but not required.
• Experience with commissioning & qualification of process control systems (i.e. PCS, SCADA, Historians) and building automation systems are considered an asset.
• Experience with commissioning and qualifications of biotech process equipment, such as some, but not all, of the following: fermentation, bioreactors, downstream purification processes (chromatography, TFF, UF), CIP systems, Buffer systems, Clean Utilities would be an asset.
• Experience with Qualification or Validation of clean utilities and ISO clean rooms.
• Experience with preparation and execution of URS’s, DQ’s, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs
• Lead teams of Validation staff, manage staff priorities, provide mentorship/oversight, help staff resolve issues. Leadership is considered an asset but not required.
• Possess leadership skills, and be able to take initiative to lead projects, involving multiple stakeholders, departments, and varying complexities.
• Possess mentorship skills, to coach and develop junior and intermediate employees.
• Engineering degree, preferably in Mechanical, Electrical or Chemical.
• Travel may be required on occasion.
• Ability to handle multiple projects and work in a fast-paced environment.
• Strong multi-tasking skills
• Ability to lift 50 lbs.

Compensation: 90,000$ - 115,000$ based on experience.

Equal Employment Opportunity and Reasonable Accommodations

MMR Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Our hiring decisions are based on merit, qualifications, and business needs. We are committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.

Manufacturing Associate

Location: Novato, CA

Assignment: 6-Month Contract

Pay Rate: $28–$32.20/hour (depending on shift)

Schedule

Alternating Saturdays and Sunday–Tuesday, 6:00 PM – 7:00 AM

About the Role

We are seeking a motivated Manufacturing Associate to support large-scale bioprocess operations in a cGMP-regulated manufacturing environment. This role plays an important part in ensuring the consistent production of high-quality biologic therapeutics used to treat rare diseases.

The Manufacturing Associate will assist with production activities including buffer and media preparation, equipment operation, and supporting cell culture and purification processes. This position is ideal for candidates who enjoy hands-on laboratory work, following structured procedures, and contributing to a collaborative production team.

Key Responsibilities

Operate large-scale equipment supporting cell culture and purification operations

Prepare buffer and media solutions for manufacturing batches

Support biopharmaceutical production processes including tangential flow filtration, chromatography, and formulation

Follow Standard Operating Procedures (SOPs) and document work in accordance with Good Documentation Practices (GDP) and regulatory guidelines

Identify, troubleshoot, and escalate process issues when necessary

Assist with equipment setup, cleaning, and maintenance activities

Support continuous improvement initiatives and process updates within the manufacturing team

Education and Qualifications

Bachelor's degree in Biology, Biochemistry, Biotechnology, Chemical Engineering, or a related scientific field

OR

Associate's degree or biotechnology certificate with 2+ years of experience in biotech manufacturing or another regulated industry

Preferred Qualifications

Experience working in a GMP or regulated laboratory/manufacturing environment

Familiarity with bioprocess techniques such as chromatography, filtration, or buffer preparation

Strong attention to detail and ability to follow detailed procedures

Comfort working in a team-based, fast-paced manufacturing environment

Additional Information

Candidates must be comfortable working overnight shifts and flexible schedules as required by production needs.

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• Bachelor's Degree in computer science or engineering
  
• 5+ years of work experience in in Workday, Integrations and API integration
  

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• Hands on work experience with Workday
  
• Experience with Workday Projects (preferably implementation experience)
  
• Able to write XSLT scripting both XSLT2.0/XSLT 3.0
  
• Hands on experience on Workday Studio
  
• Hands on experience in API integration either SOAP or Rest
  
• Hands on experience on PECI/WECI/PICOF and Core Connectors
  
• Understanding of Payroll data and Experience on US payroll and Global Payroll
  
• Ability to resolve issues/troubleshoot application in a high-pressure & time critical environment
  
• Experience using ITSM Service now tool
  
• Self-motivated to initiate actions and be responsible for consequent decisions.
  
• Good programming and debugging skills.
  
• Strong analytical, design thinking and problem solving skills.
  
• Strong written/verbal communications skills.
  
• Good team player and interpersonal skills.
  

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• Hands on experience on ADO ( Azure Devops) .
  
• Exposure to Agile practices ( Scrum /Kanban) .
  
• Understanding of ITIL Process guidelines, with specific focus on Service Operations and Incident Management.
  
• Functional Knowledge of HR in finance business.
  
• ServiceNow Development
  

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• Resolve incidents/failures and ensure closure within the SLAs
  
• Development of New Integrations within HR Workstream
  
• Collaborate with business partners on new and ongoing Workday Projects
  
• Efficiently Debug issues in case of Production Failure
  
• Participate in root cause analysis and provide solution/work around for HR cases
  
• Debug issues , incidents and provide solutions for the same through hands on development
  
• Proactively identify & implement opportunities to increase efficiency through automation & process efficiencies
  
• Participate in engineering efforts for ETL solutions i.e. system design , build, deployment, best practices and testing
  
• Create well documented change requests and follow up for approvals
  
• Communicate with global stakeholders, other IT teams, and business areas
  
• Provide Level 3 Support during the time of Production Failures
  
• Should be flexible for upskilling in different skill sets
  
• Work with upstream and downstream application teams for any risks or potential issues
  

PRODUCT MANAGER

Ann Arbor, MI

Are You Ready to Help Shape the Voice and Vision of Zomedica?

At Zomedica, marketing is more than campaigns — it’s about strategy and product leadership. We’re looking for a product manager with a creative mindset to own the product roadmap and long-term vision, help drive adoption, and increase product demand for our growing portfolio of animal health solutions.

In this role, you’ll focus on upstream product management to shape how products are positioned, launched, and supported in the market. If you thrive at the intersection of creativity and business strategy, this is your opportunity to make a lasting mark.

What’s in It for You?

• Product Leadership – Play a hands-on role in product launches, market positioning, and lifecycle management.
• Career-Defining Growth – Expand your expertise in both marketing and product management within a fast-growing, innovative company.
• Cross-Functional Impact – Collaborate with sales, R&D, and leadership to align go-to-market strategies and drive adoption.

Are You Ready?

We believe in bold ideas, fresh perspectives, and building products that make a real difference in animal health. If you’re ready to combine your marketing expertise with product leadership and play a critical role in shaping Zomedica’s future, we’d love to hear from you.

In this role, you will contribute to the long-term vision, strategy, and roadmap for assigned product portfolios, working closely with the sales organization to increase product demand and drive sales. This role is responsible for upstream product management to drive product positioning and provide sales process support.

Responsibilities will include:

1. Develop and execute go-to market strategies and tactical plans for assigned product portfolios.
2. Define the product roadmap, including creating and maintaining marketing materials and developing communication strategies.
3. Serve as the product lead in new product development and product support teams.
4. Recommend scope of present and future product lines.
5. Gain competitive intelligence to understand the market and customer needs to grow the business.
6. Provide competitive market and product information and voice-of-customer inputs to product development and marketing teams.
7. Recommend product pricing by utilizing market research, production and sales costs, and anticipating volume.
8. Collaborate with the sales team to drive sales through regular customer visits, both virtually and on-site, and in the field making sales calls with account managers.
9. Translate market trends into a compelling product direction and vision.
10. Translate product features into tangible benefits that meet customer needs.
11. Serve as customer and user champion to ensure that product interface, features, and experience reflect voice-of-customer input, market needs, and corporate delivery objectives.

Job requirements and skills:

• Bachelor’s Degree in a related discipline; education or background in Engineering, Biotechnology, or other scientific / technical field preferred.
• 7+ years of related experience in product management / animal health / medical device marketing, with experience in capital marketing, and demonstrated success in launching new products.
• Excellent written and verbal communication skills, with strong influencing skills to gain commitment and support for decisions.
• Proven ability to work effectively cross-functionally and with all levels with an organization.
• Must be organized, with proven ability to manage multiple priorities and meet deadlines.
• Solid analytical and critical thinking skills; attention to detail balanced with the ability to see the big picture.
• Experience with digital marketing platforms and CRM tools a plus.
• Ability to travel up to ~25%.

Zomedica offers excellent compensation and incentives, a competitive benefits package with medical insurance, employer-paid dental / vision / disability / life insurance, a 401k plan with a Company match, generous PTO and paid holidays, a collaborative work environment, and great growth potential. As part of the Zomedica team, you will have the unique opportunity to share in the Company's success. Join our growing team of talent dedicated to advancing care for the pets we love! Zomedica is an equal opportunity employer.

Palantir builds the world's leading software for data-driven decisions and operations. By bringing the right data to the people who need it, our platforms empower our partners to develop lifesaving drugs, forecast supply chain disruptions, locate missing children, and more.

As a Corporate Accounting Analyst, you will partner closely with the upstream operational and international accounting teams. You will be responsible for helping the Corporate Accounting team close the books monthly as well as build out related internal controls, automation, and process improvements. We value problem solvers who are not satisfied with the status quo, and who are energized by opportunities to improve the efficiency and accuracy of existing processes.

• Partner with upstream and downstream teams to perform flux analysis as part of the month-end close process and advise on accounting for related transactions.
• Assist in month-end close activities related to payroll, prepaids, credit cards, accruals, and other transactions for both US and international subsidiaries.
• Prepare monthly reconciliation for balance sheet accounts, working with business partners to obtain support for any reconciling items.
• Implement and document improvements to facilitate growth, scalability, and improved compliance.
• Provide support to internal and external auditors during quarterly and year-end reviews relating to financial statement audits, including preparation of supporting documentation.
• Opportunity to take on additional progressive responsibilities.

• A highly analytical and innovative approach to problem-solving, with a demonstrated track record of process improvement.
• Ability to work both independently and as part of a team, with excellent communication and interpersonal skills. Experience partnering with international teams is a plus.
• Strong attention to detail and organizational skills; able to maintain accuracy in work products and multitask in a fast-paced, dynamic environment.
• NetSuite and Coupa experience is a plus.

• 3+ years of accounting or finance experience, with at least 2 years of general corporate accounting experience (expertise with public accounting preferred).
• Degree in Accounting, Finance, or a related field.
• Basic understanding of general ledger accounting and financial reporting.

The estimated salary range for this position is estimated to be $85,000 - $120,000/year. Total compensation for this position may also include restricted stock units, sign-on bonus, and other potential future incentives. Further note that total compensation for this position will be determined by each individual's relevant qualifications, work experience, skills, and other factors. This estimate excludes the value of any potential sign-on bonus; the value of any benefits offered; and the potential future value of any long-term incentives.

Our benefits aim to promote health and wellbeing across all areas of Palantirians' lives. We work to continuously improve our offerings and listen to our community as we design and update them. The list below details our available benefits and some of the perks that can be enjoyed as an employee of Palantir Technologies.

Employees (and their eligible dependents) can enroll in medical, dental, and vision insurance as well as voluntary life insurance. Employees are automatically covered by Palantir's basic life, AD&D, and disability insurance. Commuter benefits. Take what you need paid time off, not accrual based. 2 weeks paid time off built into the end of each year (subject to team and business needs). 10 paid holidays throughout the calendar year. Supportive leave of absence program including time off for military service and medical events. Paid leave for new parents and subsidized back-up care for all parents. Fertility and family building benefits including but not limited to adoption, surrogacy, and preservation. Stipend to help with expenses that come with a new child. Employees can enroll in Palantir's 401k plan.

We accept applications on an ongoing basis. We want every Palantirian to achieve their best outcomes, that's why we celebrate individuals' strengths, skills, and interests, from your first interview to your longterm growth, rather than rely on traditional career ladders. Paying attention to the needs of our community enables us to optimize our opportunities to grow and helps ensure many pathways to success at Palantir. Promoting health and well-being across all areas of Palantirians' lives is just one of the ways we're investing in our community. Learn more at Palantir's Life at Palantir. Our offerings may vary by region.

In keeping consistent with Palantir's values and culture, we believe employees are \"better together\" and in-person work affords the opportunity for more creative outcomes. Therefore, we encourage employees to work from our offices to foster connectivity and innovation. Many teams do offer hybrid options (WFH a day or two a week), allowing our employees to strike the right trade-off for their personal productivity. Based on business need, there are a few roles that allow for \"Remote\" work on an exceptional basis. If you are applying for one of these roles, you must work from the state in which you are employed. If the posting is specified as Onsite, you are required to work from an office.

Palantir values excellence regardless of background. We are proud to be an Equal Opportunity Employer for all, including but not limited to Veterans and those with disabilities. Palantir is committed to making the application and hiring process accessible to everyone and will provide a reasonable accommodation for those living with a disability. If you need an accommodation for the application or hiring process, please reach out to and let us know how we can help.

SAP PRA/JVA SME – Strategic Roadmap Delivery

Are you an SAP expert ready to shape the future of Oil & Gas operations? We're seeking a SAP PRA/JVA SME to lead RAPID Discovery and drive strategic roadmap delivery.

This role offers the chance to work at the intersection of Oil & Gas industry expertise and cutting‐edge S/4 HANA and RISE implementations. You'll collaborate with stakeholders to define processes, optimize systems, and ensure seamless integration across upstream operations.

Bring your knowledge of SAP PRA/JVA and help transform business outcomes. Prior experience in Oil & Gas, S/4 HANA, and RISE is essential. Exposure to Upstream O&G environments is a strong plus. This is your opportunity to make a measurable impact in a high‐visibility role.

Apply today and join us in delivering innovation and strategic excellence in Oil & Gas.

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• Plan and execute assigned on-site experiments in support of Process Development activities and project goals.
  
• Select appropriate experimental methods and techniques based on project requirements.
  
• Analyze and interpret experimental data, evaluate data quality, and identify anomalous results.
  
• Recommend alternative approaches, research new methods and techniques, and proactively consult senior team members to resolve technical challenges.
  
• Participate in group meetings and present experimental results, data interpretation, and conclusions.
  
• Demonstrate strong verbal communication and interpersonal skills, including the ability to clearly explain experimental processes and outcomes.
  
• Work collaboratively with a team-oriented, problem-solving mindset.
  
• Consistently follow safety practices; ability to work with highly potent compounds upon appropriate training.
  

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• Bachelor's or higher degree in Chemical Engineering, Biochemical Engineering, Biochemistry, Chemistry, or a related scientific discipline.
  
• Prior experience in biologics purification, with emphasis on conjugation, tangential flow filtration (UF/DF), and filtration.
  
• Experience with analytical techniques such as SEC/HPLC, capillary electrophoresis (reducing/non-reducing), and HCP testing is beneficial but not required.
  
• Knowledge of cGMPs, technology transfer, and bioprocess scale-up.
  
• Strong technical writing skills.
  
• Ability to work effectively in cross-functional and multidisciplinary teams.
  
• Working knowledge of downstream process development, including centrifugation, normal and tangential flow filtration, chromatography operations, and virus clearance, with hands-on experience in several areas expected.
  
• Experience with multiple biologic modalities (e.g., monoclonal antibodies, bispecifics, fusion proteins, antibody-drug conjugates, virus particles) and expression systems (microbial and mammalian) is a plus.
  
• Ability to design and execute purification experiments with increasing independence to support process definition, optimization, and characterization.
  
• Collaborate with Technical Operations during technology transfer from process development to GMP manufacturing, including on-floor support, troubleshooting, and identification of process and equipment improvements.
  
• Contribute to regulatory filings, process validation, and characterization reports.
  
• Self-motivated, well-organized, and intellectually curious, with interest in scientific literature and conferences.
  

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• BS degree in a relevant scientific discipline with 2+ years of relevant experience, OR
  
• MS degree in a relevant scientific discipline with 0+ years of relevant experience
  

Our client is a globally recognized European leader in bioprocess technologies, specializing in precision-engineered analytical lab equipment and control systems for the life sciences sector. With operations spanning approximately 80 countries and a long-standing heritage, they serve leading research institutions, pharmaceutical companies, and industrial biotech firms worldwide.

Our client is seeking a Director of Operations to lead the day-to-day operational performance of their U.S. assembly site with full accountability for safety, quality, delivery, cost, and people performance. The successful candidate will translate global operational strategies into effective local execution, build scalable manufacturing infrastructure, and establish processes that support aggressive growth targets in the North American market while maintaining the precision and compliance standards synonymous with the company's Swiss engineering heritage.

The ideal candidate is an accomplished operational leader with deep expertise in precision manufacturing or engineered products, proven success managing site-level operations with P&L accountability, and the ability to excel in a matrix organization with international reporting structures. This role offers a unique opportunity to shape operational capabilities for a growing North American operation while leveraging the resources, expertise, and reputation of an established global organization.

Key Responsibilities:

• Direct all production activities, material flow, production planning, purchasing, logistics, and supply chain operations to ensure efficient and compliant delivery of biotechnology instrumentation
• Execute corporate operations strategies, standards, and KPIs at the site level; establish performance targets and implement monitoring systems to drive on-time delivery, customer satisfaction, and optimal resource utilization
• Manage site-level budget, cost control, and operational results; identify and implement cost-reduction strategies and margin improvement opportunities without compromising quality
• Oversee purchasing, procurement, vendor management, inventory control, and warehousing operations to ensure material availability, favorable commercial terms, and supply chain efficiency
• Develop, maintain, and continuously improve manufacturing documentation, SOPs, and process controls in alignment with quality systems and regulatory requirements (ISO, OSHA)
• Serve as primary North American operational liaison with Swiss headquarters on manufacturing standards, quality requirements, technology transfer initiatives, and process improvements
• Lead capacity planning, facility infrastructure projects, and continuous improvement programs to support business scaling and operational excellence

Key Qualifications:

• Bachelor's degree in Engineering, Operations Management, Industrial Engineering, or related field required; Master's degree or MBA preferred
• Minimum 8–10 years of progressive leadership experience in operations, assembly, or plant management, preferably in industrial, engineered products, or precision instrumentation environments
• Proven track record managing site-level operations with full accountability for safety, quality, delivery, cost, and people performance
• Strong knowledge of OSHA regulations, EHS requirements, and U.S. labor law in manufacturing settings
• Hands-on experience with Lean Manufacturing, Operational Excellence, continuous improvement methodologies, and data-driven decision-making
• Proficiency with SAP or similar ERP systems strongly preferred; solid understanding of supply chain management, vendor management, and warehousing in precision manufacturing environments
• Experience working in matrix organizations with international reporting lines; familiarity with European mid-sized company culture highly beneficial.