Humacyte jobs - 47 jobs

DEPARTMENT: Regulatory Affairs COMPANY: Humacyte Inc (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte's initial opportunity, a portfolio of Acellular Tissue Engineered Vessel (ATEVs), is currently approved for use in vascular trauma repair and is in late-stage clinical trials targeting multiple other applications including AV access for hemodialysis and peripheral arterial disease. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte's 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte's 6mm ATEV for urgent arterial repair following extremity vascular trauma also received the RMAT designation. For more information, visit ***************** JOB SUMMARY: The Director of Pharmacovigilance (PV) is responsible for leading global drug safety activities and ensuring compliance with regulatory requirements for adverse event (AE) reporting. This position oversees the integrity of safety data across clinical and post-marketing programs, ensuring timely, accurate submissions to global health authorities and effective signal detection, risk management, and safety evaluation processes. The Director provides strategic leadership for PV operations, collaborates cross-functionally with Regulatory Affairs, Clinical Development, and Data Management teams, and drives continuous improvement of PV systems and procedures to uphold patient safety and regulatory excellence. This role also contributes to medical safety strategy development and supports regulatory submissions, including BLAs and clinical study reports. This full-time position may be performed remotely from any location within the continental U.S. and reports to the Head of Pharmacovigilance and Medical Monitoring. Note: This position requires a Doctor of Medicine (MD). ESSENTIAL FUNCTIONS: Provide PV medical and technical support to one or more clinical project teams to ensure the successful design and execution of Clinical Development Plans. Oversee vendors performing medical review of individual case safety reports (ICSRs) and aggregate safety reports on behalf of the company. Author analyses of similar events (AOSE) and provide medical review and comments for ICSRs. Partner with CROs to ensure safety reporting, tracking, and documentation meet internal SOPs and global regulatory requirements. Lead global pharmacovigilance operations, including case management, vendor oversight, and aggregate reporting. Drive inspection readiness and lead interactions with global health authorities for safety-related audits and inquiries. Contribute for preparation and submission of periodic safety reports (e.g., PBRERs, DSURs, PADERs, Annual Reports, Investigator's Brochures) within required timelines. Contribute to the safety sections of clinical documents such as study protocols, clinical study reports, Investigator's Brochures, and regulatory submissions. Support development, implementation, and evaluation of Risk Management Plans (RMPs) and post-marketing safety studies. Provide medical support for clinical trials, including review of safety queries, eligibility assessments, lab findings, ECGs etc. Collaborate with Data Management and PV vendors to reconcile adverse events between clinical and safety databases. Collaborate in data cleaning and review of Tables, Listings, and Figures (TLFs) before database lock. Work with the Head of Safety to develop medical safety strategies and achieve PV Medical Safety objectives and support regulatory submissions, including BLAs and clinical study reports. Accountable for medical evaluation/interpretation of aggregate data review, signal detection and evaluation activities and ad hoc safety assessments to proactively identify and manage potential safety issues. Organize and contribute to Safety Management Team (SMT) meetings to review and assess study-related safety data, ensuring timely communication of emerging safety concerns. Develop and author responses to PV-related health authority inquiries; represent PV in FDA and other regulatory communications. Author and maintain standard operating procedures (SOPs), Safety Management Plans (SMPs), and safety agreements with partners and CROs. EXPERIENCE & QUALIFICATIONS: MD required, with a minimum of 10 years of relevant pharmacovigilance/drug safety experience in the pharmaceutical or biotechnology industry. Strong scientific and analytical background with an expert understanding of global PV practices and regulatory frameworks. Proficient in validated safety databases and coding dictionaries (MedDRA, WHO Drug). Deep knowledge of U.S. and international PV regulations, GCP, and ICH guidelines. Demonstrated experience authoring and overseeing aggregate safety reports and addressing safety issues proactively. Comprehensive understanding of the end-to-end drug development process. Exceptional written and verbal communication skills with the ability to effectively present complex safety data to diverse audiences. Proven leadership, collaboration, and stakeholder management skills. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and safety data tools. COMPENSATION & BENEFITS HIGHLIGHTS: Stock Options 401k Plan with 4% Match and no Vesting Schedule Medical, Vision and Dental Plans Company Paid Long Term/Short Term Disability Company Paid Life Insurance 23 Days Paid Time Off (PTO) 10 Company Designated Holidays + 2 Floating Holidays Paid Parental Leave Policies ** Please note, Humacyte does not provide U.S. employment sponsorship and does not accept unsolicited resumes from 3 rd party firms and/or agency recruiters. ** The statements in this position profile are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time. Humacyte is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, Humacyte is committed to achieving its business objectives in compliance with all federal, state and local law.

Responsible for working in packaging in order to maintain a steady flow of production. This may involve the following: loading and unloading tubs and moving pallets. Must follow SOP's and any departmental procedures. Recommends improvements and identifies potential problems which could affect the operation both personnel and equipment related. This position reports to the packaging Supervisor and has no direct reports of their own. Salary Range: $20.00 - $21.00 Per Hour Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.Responsibilities PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT * Performs visual inspection of lot numbers, expiration dates, inserts, trays, partitions, over packs, packing and palletizing over packs * Will work on assembly lines with high speed computer-based equipment with HMI applications * Assures that the packaged product meets all [100%] of specifications * Responsible for complying with all SOP's and cGMP's. * Responsible for complying with training. * Maintains a clean and organized work environment and strives to meet daily goals * Makes minor adjustments and assists with changeover and set-up to equipment, as necessary * Performs and documents line clearances before and after the running of each batch. * Assures a safe working environment and wears appropriate safety equipment/apparel at all times as well as alerting the supervisor to unsafe conditions in the department * Performs other duties as assigned * Works overtime as needed REQUIREMENTS * High school diploma or equivalency required * One - Three years of manufacturing/packaging experience * Basic problem solving, mechanical skills required * Good communication skills are necessary * Attention to detail is essential * Ability to lift up to 40 lbs to waist high regularly is required Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

This position follows a hybrid work model, with an expectation to be onsite at our Salt Lake City or Raleigh office 2-3 days per week. The purpose of this job is to maintain and establish growth of the current service agreement base and create new business opportunities through conversion of service expirations to sold service contracts leading to increased revenues for the company. The Senior Service Solutions representative is directly responsible for (a) training and mentoring new representatives (b) monitoring their work and helping them understand and correct errors (c) achieving the territory sales goals and maintaining existing customers within a territory as defined by bio Merieux. Conducts telemarketing activities contacting customers who do not have service contracts, and sells the value of our contract offerings. Primary Responsibilities Articulate service contract value proposition and quote Service Contract offerings to customers. Drive new business revenue by quoting and converting service expirations into sold service agreements. Quote and execute renewals to maintain existing customer business. Minimize lost service agreement business. Identify opportunities to aggregate multiple instruments for a customer on an agreement and assist to close, working with the Service CAMs where applicable. Manage pipeline to ensure timing of closes matches Monthly Forecast & Quarterly Business Plan. Monitor monthly sales as reported for accuracy and adjust action plans to account for shortages towards goal. Work closely with sales, support, marketing and customers to ensure attainment of customer delight. Perform all work in compliance with company policy and within the guidelines of the bio Merieux, Inc. Quality System. Establish and maintain communications with sales, field service (internal and external), marketing, and customers to ensure attainment of customer satisfaction through programs and policies that are being developed consistent with customer needs and desires. Maintain customer records in Service Agreements database on a daily basis for all accounts in their territory. Submit a complete and accurate Bookings Package (including Billing Cover Sheet, Quote and PO) to Finance on a timely basis while assisting Finance in administering contract entitlements as needed. Assist customer and internal teams with resolving billing disputes as needed. Support audits by maintaining and updating customer data as needed. Provide technical expertise/assistance in product line as required in sales process. Support and/or deliver key sales presentations/demonstrations where required for selling Service. Communicate with customers on service contract issues where required. Oversee refresh of all departmental training materials on tools and processes and deliver to new hires. Creates new material as required. On board and mentor new hires for, at a minimum, the first 6 months, checking all customer quotes for accuracy. Help new teammates to understand their errors and equip them with the knowledge/tools to avoid similar errors. Share best practices on sales pipeline and workload management with team members. Model best practices and be shadowed by new team members in customer calls and other reviews. Coach team mates on how to present the value of bio Merieux services to the customer and assist team management in developing related tools and presentations for Service Sales, Field Sales and Field Service. Work closely with team management and serve as "subject matter expert" to identify, develop and test new process and tool improvements. Support team mgmt and Service Sales by taking responsibility and accountability for projects and reports as required. Collaborate with Canadian and other regions as required to promote Service Sales best practices. Education and Experience High School Diploma or equivalent required B.S. in Business, Microbiology, or another related science preferred 4 years of experience in service sales and/or telemarketing required Familiarity with computerized information management systems (SAP and SalesForce is preferred). Thorough understanding of Service Sales tools and processes. Knowledge, Skills, and Abilities Understanding the Business Business acumen to understand how a business operates and how to make it successful. Intellectual Horsepower Critical thinking, using logic and reason to analyze information and make decisions in the workplace. Manage and meet competing deadlines, requiring careful prioritization and time management to ensure all tasks are completed on time. Detail orientation to complete tasks without errors and produce high-quality work. Maintaining Focus Priority setting that align with business objectives Getting Organized Organizing work and resources efficiently to ensure smooth operations Planning objectives and strategies to achieve them within a set timeline Practicing time management to allocate tasks, balance priorities, and meet deadlines efficiently Getting Work Done Through Others Managing and measuring work by tracking progress, performance, and goal achievement using metrics and KPIs. Informing others by sharing clear, timely information to ensure alignment. Managing Work Processes Collect and analyze data to drive informed decision-making to improve performance and identify issues Dealing with Complex Situations Communicates instructions clearly and effectively Focusing on the Bottom Line Action Oriented: Takes action even when facing challenges Perseverance: Demonstrates perseverance and a focus on outcomes Drive for Results: Drive for Results while successfully removing barriers Being Organizationally Savvy Ability to work cross-functionally allowing for better collaboration and communication when working across teams to achieve shared objectives Ability to cooperate with others at all levels including leadership Communicating Effectively Written Communications - including the ability to communicate technical data in written form Effective verbal communication skills Relating Skills Easily accessible and open to communication Effectively navigate social interactions in the workplace Build and maintain positive, productive interactions with colleagues Developing and Inspiring Others Reach mutually beneficial agreements through effective communication and compromise Managing Diverse Relationships Fosters a culture of inclusiveness among all team members Acting with Honor and Being Open Consistently uphold and reflects the core ethical principles and values that bio Merieux promotes Maintain composure by having the skill of staying calm, focused, and professional in high-pressure or stressful situations. Actively and attentively listen to others, ensuring a clear understanding of their messages, needs, and concerns. Emotional intelligence by having the ability to recognize, understand, and manage one's own emotions, as well as the emotions of others. Working Conditions and Physical Requirements Ability to remain in stationary position, often standing, for prolonged periods. Ability to ascend/descend stairs, ladders, ramps, and the like. Domestic travel required 5% The estimated wage range for this role is between $27.00 and $41.25/hour. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bio Merieux's bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate's experience and will be presented in writing at the time of the offer.In addition, bio Merieux offers a competitive Total Rewards package that may include: A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options Company-Provided Life and Accidental Death Insurance Short and Long-Term Disability Insurance Retirement Plan including a generous non-discretionary employer contribution and employer match. Adoption Assistance Wellness Programs Employee Assistance Program Commuter Benefits Various voluntary benefit offerings Discount programs Parental leaves #LI-US#biojobs Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bio Merieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bio Merieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site or contact us at [emailprotected]. BioMerieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant's identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMerieux's or its affiliates' application process by contacting us via telephone at , by email at [emailprotected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

Job SummaryThe Manager, Contract Manufacturing is responsible for managing key customer accounts, supporting financial performance, and driving the successful execution of contract manufacturing initiatives across assigned U.S. facilities. This role partners closely with executive leadership, customers, and cross-functional teams to advance new business opportunities, optimize manufacturing strategies, and ensure alignment with commercial and operational objectives. The incumbent oversees forecasting, budgeting, project planning, and pricing strategies while ensuring projects are executed on time, within scope, and to profitability targets. They lead negotiations, facilitate business reviews, enhance customer relationships, and serve as the primary liaison between customers and internal production units. The role plays a key part in shaping strategic manufacturing plans, expanding capabilities (including fill/finish operations), and supporting long-term growth and operational excellence for Fresenius Kabi Contract Manufacturing.Responsibilities Manage key accounts for assigned customer(s), including organizing regular business review meetings. Hold profit and loss accountability for contract manufacturing operations at a specific site. Oversee forecasting and budgeting for both existing and new business initiatives. Develop and deliver high-quality presentations for internal and external stakeholders, including business reviews, budget discussions, and executive updates. Support strategic projects to implement new contract manufacturing opportunities within U.S. facilities, enhancing internal manufacturing capabilities and capacity. Prepare, analyze, and manage customer quotations, pricing models, and negotiation strategies to secure competitive and profitable agreements. Collaborate with Fresenius Kabi's executive leadership on evaluating and advancing new contract manufacturing ventures. Lead cross-functional teams to address customer requests, drive project outcomes, and ensure operational excellence. Develop comprehensive project plans for both new development and ongoing maintenance initiatives. Manage project timelines, budgets, resources, and performance metrics to ensure successful implementation of contract manufacturing projects. Serve as a primary liaison between customers and internal Production Units (PUs), coordinating resources and aligning priorities to achieve project milestones. Determine pricing strategies and margin structures for contract-manufactured products by analyzing cost inputs provided. Support contract and pricing negotiations with new and existing customers by preparing analysis, coordinating cross-functional input, and partnering with legal counsel and plant representatives. Support the Business Development team, with emphasis on opportunities related to pre-filled syringe fill/finish operations. Coordinate customer meetings and site visits, ensuring alignment across functional departments and delivering a customer-focused experience. Support the local Senior Leadership Team (SLT) in managing ongoing contract manufacturing operations and contributing to the strategic planning of production units. Represent Fresenius Kabi Contract Manufacturing at industry conferences, trade shows, and exhibitions to promote capabilities, network, and advance business development. Completes all training requirements, including all department-specific, compliance training, etc. Participates in any and all reasonable work activities as assigned by management. All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities. RE Manage key accounts for assigned customer(s), including organizing regular business review meetings. Hold profit and loss accountability for contract manufacturing operations at a specific site. Oversee forecasting and budgeting for both existing and new business initiatives. Develop and deliver high-quality presentations for internal and external stakeholders, including business reviews, budget discussions, and executive updates. Support strategic projects to implement new contract manufacturing opportunities within U.S. facilities, enhancing internal manufacturing capabilities and capacity. Prepare, analyze, and manage customer quotations, pricing models, and negotiation strategies to secure competitive and profitable agreements. Collaborate with Fresenius Kabi's executive leadership on evaluating and advancing new contract manufacturing ventures. Lead cross-functional teams to address customer requests, drive project outcomes, and ensure operational excellence. Develop comprehensive project plans for both new development and ongoing maintenance initiatives. Manage project timelines, budgets, resources, and performance metrics to ensure successful implementation of contract manufacturing projects. Serve as a primary liaison between customers and internal Production Units (PUs), coordinating resources and aligning priorities to achieve project milestones. Determine pricing strategies and margin structures for contract-manufactured products by analyzing cost inputs provided. Support contract and pricing negotiations with new and existing customers by preparing analysis, coordinating cross-functional input, and partnering with legal counsel and plant representatives. Support the Business Development team, with emphasis on opportunities related to pre-filled syringe fill/finish operations. Coordinate customer meetings and site visits, ensuring alignment across functional departments and delivering a customer-focused experience. Support the local Senior Leadership Team (SLT) in managing ongoing contract manufacturing operations and contributing to the strategic planning of production units. Represent Fresenius Kabi Contract Manufacturing at industry conferences, trade shows, and exhibitions to promote capabilities, network, and advance business development. Completes all training requirements, including all department-specific, compliance training, etc. Participates in any and all reasonable work activities as assigned by management. All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities. REQUIREMENTS Bachelor's degree (with a preference for science, pharmaceutical, or engineering disciplines); Advanced degree is a plus. 5+ years of relevant experience specifically in project management or transfer projects in pharmaceutical industry or related industry (with technical transfer experience strongly preferred). Experience with pre-filled syringe fill/finish technologies is highly desirable. Thorough understanding of relevant technologies and contract manufacturing services and must be able to rapidly establish credibility with clients and executive stakeholders. Exceptional communication skills and meticulous attention to detail are essential, as this position is customer-facing. Intermediate to advanced skillset with Microsoft Office (Excel, Word, PowerPoint, Project and Visio), familiarity with planning tools (SAP/IBP), CRM tools (SalesForce.com), and other database concepts. Highly self-driven, capable of working independently and collaboratively in dynamic conditions. Must demonstrate proactive management, drive collaboration, and be a positive team leader. Demonstrated ability to influence others, work collaboratively within cross-functional projects, and drive change management. Able to manage and prioritize multiple complex projects with demonstrated time management skills. Exceptional attention to detail. Solid interpersonal and effective communication skills (verbal and written). Strong team player that is solution-oriented and can build influential relationships with both internal department and external customers. Exercise sound business judgment, confidentiality, and discretion in business relationships. Strong presentation skills accompanied with exceptional interpersonal and communication skills (verbal and written). Able to manage and prioritize multiple complex projects with demonstrated time management skills. Demonstrated ability to prioritize and execute tasks in a fast-paced dynamic environment. Ability to travel both domestically and internationally to attend meetings/trainings/programs/customer visits (approximately 10%) and is based on business need (via public transportation: air/auto); may require overnight travel. Ability to work flexible hours and weekends to meet business/customer needs Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job SummaryThe Digital Marketing Specialist - Cell & Gene Therapy (CGT) Technologies leads the development and execution of integrated digital marketing strategies that drive audience engagement, brand equity, and commercial success. This role partners with cross-functional teams and external agencies to deliver innovative, compliant, and personalized content across all digital channels, leveraging advanced analytics and industry best practices to optimize performance and achieve strategic business objectives. *Position may be worked remotely, with willingness and ability to travel to Lake Zurich, IL to engage with cross-functional teams. This position is unable to offer sponsorship either now or in the future Base Salary Range: $80,000-85,000 Final pay determinations will depend on various factors, including, but not limited to experience level, education level, knowledge, skills, and abilities.Responsibilities Design and execute integrated digital marketing campaigns to assist commercial business in the digital space. Assist in the development of digital content for web, LinkedIn, email, and other digital channels to drive engagement. Follow promotional review and approval processes, as well as distribution guidelines, to ensure efficiency and compliance across digital marketing activities. Manage digital calendar and oversee execution of digital campaigns to ensure timely distribution aligned with key commercial milestones. Collect performance analytics using analytics tools to measure effectiveness and reports insights to key stakeholders to support data-driven future optimization strategies. Implement ongoing web optimization techniques to improve web performance. Job Requirements Bachelor's degree required. 3+ years of digital marketing experience with a focus on digital campaign management, analytics, and optimization. Knowledge of web analytics, such as SEO/SEM, AEO, and GEO. Experience with the following digital platforms: Adobe Experience Manager, Adobe Analytics, Salesforce Applications, and Veeva. Proficient with Microsoft Office Suite of software. Ability to travel up to 15 percent for customer engagements, team engagements, and conferences, as well as willingness and ability to travel to Lake Zurich, IL to engage with cross-functional teams Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

The Clinical Applications Specialist I (CAS I) provides product applications and technical support to internal and external customers for the diagnostic test systems marketed by bio Merieux including but not limited to training, troubleshooting, and consultation. This product knowledge is used to support sales growth through delivering exceptional technical support. Manages the complaint handling process to ensure the timely, accurate resolution of customer complaints and will also coordinate efforts with other internal and field support teams to provide world-class support for all customers. Promotes teamwork and cooperation, removes barriers to productivity, and creates an enthusiastic/positive work environment. Primary Duties Prioritize answering customer inquiries, both internal and external, per established guidelines and document in the enterprise resource planning (ERP) system. Provide world class customer support with consistent follow up, deliver product education, troubleshooting, and resolutions to ensure customer satisfaction. Responsible for initiating, managing, and resolving customer complaints and suggestions. Will also determine if a complaint needs to be escalated for further investigation requiring the expertise of other departments. Perform on-call duties as needed to provide 24-hour technical support to customers. Support existing customers with additional training and technical assistance as needed or as product enhancements are launched that require additional training or implementation. Manage product returns when applicable. Maintain competency of bio Merieux products and procedures that are job specific and assist with implementation of new products. Participate in revenue generation initiatives which include the promotion of value-added projects and services. Establish and maintain enterprise resource planning (ERP) certification. Meets quality plan standards and all departmental key performance indicators (KPIs). Perform all work in compliance with company quality procedures and standards. Performs other duties as assigned. Qualifications Required Education, Training and Experience Bachelor degree in a biological science and 2+ years of Clinical Microbiology laboratory or Molecular Biology experience required. or AAS degree in a biological science and 4+ years of Clinical Microbiology laboratory or Molecular Biology experience accepted. Preferred Education, Training and Experience Medical device industry experience a plus. Customer facing experience preferred. Networking or LIS/LIMS experience preferred. Knowledge, Skills, and Abilities Consistently upholds and reflects the core ethical principles and values that bio Merieux promotes. Skilled in MS Office tools to include but not limited to Outlook, Teams, Word, and Excel Intermediate: applies skills independently in most situations; handles moderately complex tasks with occasional guidance Ability to work cross-functionally allowing for better collaboration and communication when working across teams to achieve shared objectives Ability to cooperate with others at all levels including leadership Thriving in a fast-paced environment by managing tasks, multitasking, and adapting quickly to maintain productivity. Effective written and verbal communication skills Knowledge of bio Merieux products and Salesforce is a plus. Working Conditions and Physical Requirements Ability to remain in stationary position, often standing, for prolonged periods Total travel: 15% -Domestic travel required: 10% /International travel required: 5% The estimated salary range for this role is between $72,100 - $84,600. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bio Merieux's bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate's experience and will be presented in writing at the time of the offer.In addition, bio Merieux offers a competitive Total Rewards package that may include: A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options Company-Provided Life and Accidental Death Insurance Short and Long-Term Disability Insurance Retirement Plan including a generous non-discretionary employer contribution and employer match. Adoption Assistance Wellness Programs Employee Assistance Program Commuter Benefits Various voluntary benefit offerings Discount programs Parental leaves #LI-US#biojobs Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bio Merieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bio Merieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site or contact us at [emailprotected]. BioMerieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant's identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMerieux's or its affiliates' application process by contacting us via telephone at , by email at [emailprotected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

Job SummaryResponsible for the accurate weighing, checking and verification when mixing specific chemical compounds for product formulation. Performs monitoring of mixing and ancillary support equipment throughout formulation and filling and executes calibrations and preventive maintenance activities. Routinely complies with cGMP's, departmental SOP's and company policies and maintains accurate documentation for each batch manufactured. Hourly Range: $20.49-$30.21 Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.Responsibilities Performs set-up, operation and monitoring of tanks and mixing equipment for product formulation. Including the use of valves, motors, shafts, heating and cooling lines, gas bubbling, sparging and blanketing Weighs out and mixes precise amounts of chemicals according to specific formulas and monitors (verifies) product output from mixing operations. Responsible for the correct storage of raw materials (i.e. temperature requirements, nitrogen blanketing and moisture sensitive). Calibrates and operates all formulation-related equipment (such as scales, pH meters, tanks, graduates, and pots etc.). Performs operations necessary to adjust pH of product before releasing to production lines. Cleans and sanitizes equipment and chemical containers used in the product formulation process in accordance with SOP's. Performs daily, weekly and monthly department cleaning and fogging; Perform sanitization and operation of the WFI heat exchanger Completes documents accurately when recording batch compounding, consumption of raw materials and cleaning activities. Initiates work orders to maintain equipment and facilitates continuous improvement. Strictly adheres to SOP's, cGMP's, safety requirements and company policies. Assists in the training of new employees and completes training on procedures in scheduled time frame. Performs pfault testing on glass lined tanks. Perform accurate sampling of formulation and filling, hold time studies, taking dissolution samples, pressure readings and completing additional paperwork for products in development. Performs other duties and responsibilities as directed by supervision. job activities here in order of relevance to the job Requirements: Must have 2 years minimum of experience working in pharmaceutical or related manufacturing environment. Heavy lifting is required. Must be willing to work overtime when necessary. Must be trained and qualified in Personal Protective Equipment [PPE], i.e. respirators. Must have good attention to detail, basic problem solving, communication and good documentation skills. Mechanical troubleshooting ability a plus. Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

The Quality Engineering Intern will be responsible for supporting the Quality Engineering department while providing assistance to the QA/QC Project Manager for the completion and validation of QC Projects. Over the course of the internship, they will complete an internship project that includes the review and analysis of established processes to devise an optimized process flow for the identification, segregation and investigation of non-conforming materials, and adverse events. Storyboards and training materials will be created as project deliverables to provide uniform training and instruction for all stakeholders. Responsibilities: Support the maintenance of MDSAP and ISO certification at the site by completing project objectives related to continuous improvement (CI) and QA/QC project initiatives. Work with representatives from several departments to gather and perform data analysis for quality engineering studies Work with SMEs and QE representatives to create workable solutions to implement CI and QA/QC project actions Create process flow diagrams (as appropriate) to aid in communication and information sharing Perform walkthroughs of the manufacturing areas as part of quality engineering data gathering and QA/QC project initiatives Document project objectives and progress in both written and electronic formats Capture CI and QA/QC project deliverables and outcomes in final presentation. Performs other duties as assigned. Education, Skills, & Experience: Must be currently enrolled in a degree program at a recognized institution of higher learning Upcoming Junior level or higher Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bio Merieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bio Merieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site or contact us at [emailprotected]. BioMerieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant's identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMerieux's or its affiliates' application process by contacting us via telephone at , by email at [emailprotected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

Execute assigned Continuous Improvement, Cost of Goods reduction, and efficiency oriented tasks to support Manufacturing schedule adherence and Engineering project work. Ensure required Engineering support is available for the manufacture and packaging of the BacT/ALERT product line to meet or exceed production targets and quality. Support SAP Master Data review for raw materials in supply chain Primary Duties: 1. Support Engineering operations and BACT/ALERT Manufacturing , Observe and Evaluate BACT/ALERT processes 2 Support Reliability Engineering initiatives, Evaluate equipment reliability through data analysis, perform spare parts criticality assessments to support inventory requirements 3. Support new product development and other projects 4. Participate in continuous improvement initiatives as required(Gemba walks, Kaizen events, etc) by exploring opportunities and evaluate OEE results, analyze data and seek improvements . 5. Observe and evaluate in process scrap and act to improve as required 6. Provide technical documents and results, formal evaluation of results with SMEs 7. Author, support and execute technical reports 8. Actively participate in team meetings 9. Support SAP revision, manufacturing process orders, DHR review and other Supply chain activities/processes as required 10. Support Supply chain improvement efforts and service delivery 11. Interacts and support Maintenance, Management, Quality, Engineering and other support groups as needed 12. Works as a troubleshooter to identify barriers and obstacles that could impede progress in production processes 13. Execute assigned tasks, communicates proposed changes as needed and completion of projects timely. 14. Perform all work in compliance with company quality procedures and standards. 15. Performs other duties as assigned. Education, Skills and Experience: High School Diploma, GED or equivalent required Must currently be a Sophomore level equivalent or higher in a technical discipline(Engineering or Life Sciences). Strong technical writing skills and communication skills, Knowledgeable in cGMP and Engineering principles Previous professional work experience preferred Flexibility, being highly adaptable and resilient to thrive in a dynamic work environment. Manage and meet competing deadlines, requiring careful prioritization and time management to ensure all tasks are completed on time. Thriving in a fast-paced environment by managing tasks, multitasking, and adapting quickly to maintain productivity. Practicing time management to allocate tasks, balance priorities, and meet deadlines efficiently Informing others by sharing clear, timely information to ensure alignment. Collect and analyze data to drive informed decision-making to improve performance and identify issues Perseverance: Demonstrates perseverance and a focus on outcomes Ability to work cross-functionally allowing for better collaboration and communication when working across teams to achieve shared objectives Written Communications - including the ability to communicate technical data in written form Build and maintain positive, productive interactions with colleagues Participate in a way that enhances team performance and cohesion. Actively and attentively listen to others, ensuring a clear understanding of their messages, needs, and concerns. Working Conditions and Physical Requirements: Ability to remain in stationary position, often standing, for prolonged periods. Ability to ascend/descend stairs, ladders, ramps, and the like. Ability to wear PPE correctly most of the day. The pay for this role is $22.00. In addition, bio Merieux offers a competitive Total Rewards package thatmayinclude (dependent upon hours worked):*A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options*Company-Provided Life and Accidental Death Insurance*Short and Long-Term Disability Insurance*Retirement Plan including a generous non-discretionary employer contribution and employer match.*Adoption Assistance*Wellness Programs*Employee Assistance Program*Commuter Benefits*Various voluntary benefit offerings*Discount programs*Parental leaves Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bio Merieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bio Merieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site or contact us at [emailprotected]. BioMerieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant's identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMerieux's or its affiliates' application process by contacting us via telephone at , by email at [emailprotected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

The Industry Field IT Specialist II is a critical technical contributor responsible for implementing and supporting bio Merieux middleware and instrument software solutions across varied customer environments. This mid-level field role requires solid experience with IT systems and a collaborative approach to ensure seamless integration with Laboratory Information Management Systems (LIMS) and secure connectivity. The specialist will lead system configuration, deploy remote support tools, and manage software updates and cybersecurity compliance. Success in this role demands proactive troubleshooting, strong communication skills, and the ability to juggle multiple customer-facing projects in a dynamic setting. Primary Duties Coordinates internal and external technical teams to successfully deliver IT implementation projects and solutions for customers. Conducts the setup and installation of software and middleware at customer sites or data centers, ensuring systems are properly networked and fully functional. Integrates company solutions with customer Laboratory Information Management Systems (LIMS) by managing communication, consulting technical resources, and performing the scope of work. Troubleshoots and resolves system issues both remotely and onsite to maintain optimal performance. Responds promptly to all field IT service requests, ensuring timely and effective resolution within assigned projects or regions. Collaborates with customers to identify system-related challenges, research solutions, and implement corrective actions. Maintains strong customer relationships by proactively addressing issues to ensure satisfaction and reliability. Provides customers with information about available systems, options, and consumables, and coordinate with sales teams to support ordering. Obtains and maintains CRM certification to support service investigations and documentation. Supports revenue growth by promoting value-added projects, products, and services. Manages Field IT projects by meeting milestones, deadlines, and requirements while keeping stakeholders informed of progress or changes. Completes detailed service reports and checklists for every customer interaction to accurately capture system, customer, or test-related issues. Provides on-site and remote technical assistance to internal customers (Sales, Field Applications, Field Service, Technical Support Center) via correspondence, phone and in person as appropriate to diagnose difficult connectivity problems as required. Provides field training and orientation for new hires as required in all areas of troubleshooting and installation of solutions as needed. Perform all work in compliance with company quality procedures and standards. Performs other duties as assigned. Education & Training Bachelor's Degree in computer networking, cybersecurity or related field required Experience Requirements 2+ years of professional related experience as it relates to: LIMS interfacing, networking support, servers, software applications, hardware, middleware, computers, and operating systems End-User support required; systems marketed by bio Merieux a plus. Industrial Microbiology or related field preferred Knowledge, Skills & Abilities Functional skills including critical thinking, adaptability, time management, communication, problem-solving and digital literacy. Technical learning aptitude to quickly understand and acquire new technical knowledge and skills. Effective and efficient problem analysis that leads to high-quality decisions. Analyze data and make decisions/recommendations, using data to guide decision-making and provide suggestions for improvement. Understand complex information and interpret it accurately, often requiring critical thinking and analysis to grasp the full picture. Planning objectives and strategies to achieve them within a set timeline Organizing work and resources efficiently to ensure smooth operations Troubleshooting issues to identify and resolve problems efficiently Demonstrates assertiveness and confidence in the face of a challenge Ability to work cross-functionally allowing for better collaboration and communication when working across teams to achieve shared objectives Effective Presentation Skills - including the ability to present technical data Written Communications - including the ability to communicate technical data in written form Effective verbal communication skills Maintain composure by having the skill of staying calm, focused, and professional in high-pressure or stressful situations. Working Conditions & Physical Requirements Ability to remain in stationary position, often standing, for prolonged periods. Ability to ascend/descend stairs, ladders, ramps, and the like. Ability to wear PPE correctly most of the day. Ability to adjust or move objects up to 50 pounds in all directions. Domestic Travel: 60% International Travel: 5% The estimated salary range for this role is between $89,500 - $111,100. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bio Merieux's bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate's experience and will be presented in writing at the time of the offer.In addition, bio Merieux offers a competitive Total Rewards package that may include: A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options Company-Provided Life and Accidental Death Insurance Short and Long-Term Disability Insurance Retirement Plan including a generous non-discretionary employer contribution and employer match. Adoption Assistance Wellness Programs Employee Assistance Program Commuter Benefits Various voluntary benefit offerings Discount programs Parental leaves #LI-US#biojobs Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bio Merieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bio Merieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site or contact us at [emailprotected]. BioMerieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant's identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMerieux's or its affiliates' application process by contacting us via telephone at , by email at [emailprotected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

Come Be Part of a Mission that Matters! Neogen Corporation is seeking a Technical Services Field Technician to join our team. In this field-based role, you'll be responsible for providing on-site and remote technical support for Neogen equipment, including Soleris and MLS II, MDS, LX1, LX25 and APNG systems. You'll work closely with customers to deliver preventive maintenance, installations, and troubleshooting while effectively relaying customer feedback to internal teams. This position requires strong communication skills, a proactive approach to problem-solving, and the ability to travel extensively. This role follows a field-based model and requires travel up to 80% of the time. Hours: Full-time, core business hours with travel flexibility Travel: Up to 80% domestic travel Essential Duties and Responsibilities: Provide on-site and phone-based technical support for Neogen instruments (Soleris, MLS II, and other equipment) Schedule and coordinate all on-site customer visits, including maintenance, installations, and technical support Prepare customer quotes for service and maintenance work Develop weekly travel itineraries and share with management Document all customer interactions and service outcomes in Salesforce Troubleshoot and resolve equipment issues, coordinating with technical service and lab support as needed Partner with the Field Trainer to coordinate equipment installations Communicate customer feedback to sales, marketing, technical service, and product management teams Support marketing efforts and promote new products while on customer visits Participate in post-installation customer follow-ups and ongoing engagement Maintain high standards of diplomacy, tact, and professionalism when working with internal teams and clients Education and Experience: Degree or comparable experience needed. 1-3 years of technical support or field service experience preferred Previous role involving travel is strongly preferred Experience working in a customer-facing technical role is a plus Skills and Competencies: Strong analytical and problem-solving skills Clear verbal and written communication Ability to multi-task and manage multiple priorities Excellent customer service and interpersonal skills Team player with a proactive, solutions-oriented mindset Computer Skills: Proficiency with Microsoft Word, Excel, and Outlook Experience with Salesforce or other CRM systems preferred Please press Apply to submit your application. WHO IS NEOGEN: From farm to fork, we offer solutions to enhance the quality, quantity and safety of the global food supply. Our food safety diagnostics are used within farming operations to the production facilities of most of the world's best-known food companies. Neogen's solutions are critical to the health and well-being of our customers' operations - and in turn their consumers. What we do matters! Neogen's culture combines stability with a deep believe in providing professional and personal growth. Our Pillars of Trust - the principles which guide our everyday decision-making, include Openness, Honesty, Credibility, Respect, and Service. It's the belief in these characteristics that provide a consistent, happy and healthy work environment for our employees.

As part of the Analytical Production Securitization Industrialization team in the Engineering and Industrialization department, the Associate Process Scientist will perform projects to support the manufacturing of BACT/ALERT Culture Media products. Within this role the Associate Process Scientist will be required to interface with Manufacturing, Quality Control, Quality Assurance / Validation, R&D, Purchasing, Supply Chain, and other functions as required in order to ensure successful project achievements to facilitate quality production that meets on-time customer demands. The position will primarily operate as project lead on multiple projects that will ensure cost savings and raw material securitization initiatives. This position directly impacts delivering lower cost BACT/ALERT product by lowering upstream raw material costs while ensuring supply chain continuity and supporting Quality Control and Operations functions to manufacture quality product. Primary Duties: 1. Analyzes chemical and/or biologically derived raw materials for secondary/alternate sourcing projects for site securitization and/or cost savings initiatives. 2. Executes hands on laboratory testing at the bench scale, within final product, and through large scale validation activities. 3. Management of multiple projects will be required, whereby assessments are generated to assess interim progress and effectiveness. 5. Executes project leadership is necessary in order to guide timelines, adjust expectations, and collaborate cross-functionally. 6. Perform all work in compliance with company quality procedures and standards. 7. Performs other duties as assigned. Education, skills and experience: * • B.S. in Biochemistry or closely related field required with 2 years of experience in a regulated industry required * Or in lieu of a Bachelor's degree, 6 years of experience in a regulated industry, will be accepted * M.S. in Biochemistry or closely related field preferred * Engineering/science role within medical device/diagnostic or pharmaceutical preferred * Project Management experience preferred * Experience working in a cGMP environment preferred * FDA regulated cGMP industry experience preferred * Functional skills including critical thinking, adaptability, time management, communication, problem-solving and digital literacy. * Manage and meet competing deadlines, requiring careful prioritization and time management to ensure all tasks are completed on time. * Troubleshooting issues to identify and resolve problems efficiently * Solution oriented in the face of conflict * Drive for Results: Drive for Results while successfully removing barriers * Ability to work cross-functionally allowing for better collaboration and communication when working across teams to achieve shared objectives * Written Communications - including the ability to communicate technical data in written form

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers. About the role: Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a plasma donor screener and perform phlebotomy to support plasma center operations. How you will contribute: * You will answer phones, and greet and focus on our donors, while ensuring the safety of donors and our team. * You will screen new and repeat donors and take and record donor vital signs and finger stick results. * You will use our Donor Information System, prepare donor charts, maintain accurate records, and coordinate donor compensation. * You will help identify operational opportunities for continuous improvement and initiate changes to center processes using company approved procedures. * You will be there for our donors, which includes working a variety of shifts, Saturdays and Sundays, and holidays. What you bring to Takeda: * High school diploma or equivalent * Ability to walk and/or stand for the entire work shift * Will work evenings, weekends, and holidays * Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees * Ability to lift to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs. * Fine motor coordination, depth perception, and ability to hear equipment from a distance * Because of potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear * 1 or more years minimum experience working in a customer or patient facing role is helpful What Takeda can offer you: Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program to include retirement benefits, medical/dental, family leave, disability insurance and more, all in a fast-paced, friendly environment. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world. BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - NC - Greensboro U.S. Starting Hourly Wage: $16.00 The starting hourly wage reflects the actual starting rate for this position. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations USA - NC - Greensboro Worker Type Employee Worker Sub-Type Regular Time Type Part time Job Exempt No

Job SummaryThe Engineering Project Manager leads and coordinates cross-functional projects to ensure delivery on time, within scope, and on budget. The role requires a balance of technical knowledge, structured project management, and leadership skills to plan, organize, and execute projects while maintaining clear communication with stakeholders.Responsibilities Project Management Plan, structure, and execute projects from initiation to completion, ensuring timelines, resources, and deliverables are aligned. Apply project management methodologies to ensure effective execution and risk management. Define clear project goals, milestones, and timelines, and implement structure from the start. Technical Leadership Leverage knowledge of product properties (aseptic, TS, bags, syringes, etc.), manufacturing technologies, and pharma execution strategies. Support design reviews, qualification activities, and technical decision-making. Drive structured problem solving and simplify complex challenges into actionable steps. Business & Financial Management Oversee project budgets, ensure cost control, and deliver within approved financial parameters. Monitor and report on project performance to stakeholders, including senior leadership. Team Leadership & Collaboration Motivate, guide, and align cross-functional teams while managing conflicts and facilitating decision-making. Communicate clearly and transparently with all stakeholders, including internal teams, customers, and senior leadership teams (SLT). Ensure every voice is heard and considered in the decision-making process. Continuous Improvement Encourage team self-reflection and learning, fostering a culture of continuous improvement. Identify and implement process enhancements to improve efficiency and effectiveness. Travel Expecting 20-30% travel based on projects All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities. Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers. Phlebotomist About the role: Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a plasma donor screener and perform phlebotomy to support plasma center operations. How you will contribute: * You will greet donors as they enter and exit the donor floor. * You will perform venipuncture of donors and programming of plasmapheresis machine. * You will monitor donors during the donation process and manage donor reactions. * You will perform all tasks required for the setup, verification, operation, and troubleshooting of plasmapheresis equipment within scope of training. * You will install, prime, and disconnect disposable sets on the plasmapheresis machines * You will stock supplies, break down empty cartons and assist with proper disposal. * You will take and record donor pulse, blood pressure, and temperature measures and monitor electronic donor questionnaire system. * You will perform finger sticks, test sample, and record other donor measures to include hematocrit, total protein, and weight. * You will enter donor information into the Donor Information System (DIS). * You will coordinate donors to donor floor and compensate donors using the Debit Card system. * You will support the center management team in identifying operational opportunities for continuous improvement, initiating changes to center processes through use of company approved procedures including 5S, Value Stream Mapping and Kaizen. What you bring to Takeda: * High school diploma or equivalent * Ability to walk and/or stand for the entire work shift * Will work evenings, weekends, and holidays * Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees * Ability to lift to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs. * Fine motor coordination, depth perception, and ability to hear equipment from a distance * Because of potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear * 1 or more years minimum experience working in a customer or patient facing role is helpful What Takeda can offer you: Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program to include retirement benefits, medical/dental, family leave, disability insurance and more, all in a fast-paced, friendly environment. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world. BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - NC - Fayetteville - Morgan U.S. Starting Hourly Wage: $18.00 The starting hourly wage reflects the actual starting rate for this position. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations USA - NC - Fayetteville - Morgan Worker Type Employee Worker Sub-Type Regular Time Type Part time Job Exempt No

The Human Resources Administrator is responsible for providing comprehensive administrative support to the Human Resources function, serving as the first point of contact for employees, and promoting a positive and engaging workplace culture. This role ensures the efficient delivery of HR operation services, supports employee lifecycle processes including but not limited to onboarding, engagement, training, offboarding, HR compliance, HR communications, reporting and analytics, compliance day to day workday activities and special projects. Hourly Range: $25.00-$30.00 Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage. Responsibilities * Serve as the first point of contact for employees seeking HR assistance/Employee Support Center, providing timely and accurate responses and escalating complex matters as needed. * Coordinate locker assignments, shoe/eyeglass/eye exam voucher programs, and other employee related benefits or services. * Coordinate the end-to-end onboarding process including, new hire documentation, HRIS entry, and coordinating orientation schedules, check-in meetings etc. Responsible for delivering New Hire Orientation presentation to ensure new employees are properly introduced to company policies, culture, and procedures. Partner with hiring managers to ensure smooth integration of new employees. Coordinate the end-to-end offboarding process, including termination checklists and documentation, exit interviews, system access removal, and timely processing of final pay and benefits. Provides data analytics to HR business partners to enable proactive continuous improvement. * Process employee changes in HRIS such as but not limited to promotions, compensation changes, data changes, transfers, cost center changes, terminations, etc. * Generate and schedule reports to support compliance, workforce planning, and leadership decision making. * Conduct regular audits as assigned to ensure accuracy, consistency, and compliance with policies and regulations. * Monitor HRIS data integrity and ensure compliance with record-keeping and other requirements. * Prepare regular and ad-hoc HR reports including headcount, turnover, new hires, exits, and other workforce metrics. * Create and maintain reporting templates and distribute reports to stakeholders. * Support compliance reporting and other required submissions. * Collect, track, and perform basic analysis of HR metrics; summarize findings to highlight trends. * Ensure HR processes and documentation comply with federal, state, and local employment laws and regulations. * Conduct audits of employee records, documentation, and HR practices. * Support internal and external audits by preparing documentation and responding to inquiries. * Draft, edit, and distribute HR communications including announcements, policy updates, and engagement messages. * Maintain and update HR intranet content, employee policies and work instructions, and other HR related resources. * Write and revise HR documents as needed. * Prepare, proof, and distribute HR-related correspondence including offer letters, compensation letters, employment verification, and other employment-related documents. * Maintain accurate and organized HR files (electronic and physical). * Process departmental mail and ensure timely distribution of HR-related correspondence. * Support HR leadership in process improvements and employee experience initiatives. * Participate in special projects and cross-functional initiatives as assigned. Ensure compliance with federal and state posting requirements by monitoring and updating workplace posters. * Track and update job description revisions and maintain accurate HR documentation. * Supports employee engagement activities, events, recognition programs, and support communication strategies to increase awareness and participation Launch and track 90-day evaluations and extensions. * Compile and submit exempt overtime reports. * Coordinate bereavement flowers and charitable contributions as appropriate. Prepare and process purchase orders (POs) for HR expenses. * Support HR communications, including employee announcements and engagement initiatives. * May perform full-cycle recruitment activities including posting positions, sourcing candidates, screening applications, coordinating interviews, supporting selection, and managing the offer process. Requirements: * High school diploma with two or more years of related experience; Bachelor's degree in human resources, business administration, or related field and minimum of 1+ years of experience in human resources, preferably in an administrative or generalist role. * Experience with HRIS platforms a plus (e.g., Workday, or similar platform). * Strong written and verbal communication skills, with the ability to draft professional human resources documents and communications, deliver training sessions, and effectively engage with employees and leaders at all levels of the organization. * Basic analysis skills with the ability to review data, identify trends, and prepare summary findings. * Knowledge of employment laws and compliance requirements, * Excellent interpersonal, communication (including public speaking), and customer service skills. * Highly organized with the ability to manage multiple priorities and maintain attention to detail. * Demonstrated ability to handle sensitive information with discretion and maintain confidentiality. * Proficient in Microsoft Office Suite, including Word, Excel, PowerPoint, and Outlook. * Must be able to take ownership of processes, tasks, and projects assigned, ensuring completion with accuracy and accountability. Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers. About BioLife Plasma Services Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a Medical Support Specialist (Plasma Center Nurse) to support plasma center operations. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. About the role: Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will determine donor eligibility to donate plasma, management of donor adverse events, review of laboratory test results, and donor notification of unsuitable test results. The Medical Support Specialist (Plasma Center Nurse) works under the guidance of the Center Manager (or Assistant Manager as applicable) for operational guidance and under the management of the Center Physician for medical issues. The Medical Support Specialist will be familiar with regulations of the plasma collection industry or a manufacturing environment. The Medical Support Specialist follows guidance provided by BioLife Medical Affairs and provides center level support of environmental, health and safety (EHS). How you will contribute You will determine donor eligibility; to include, proper management of informed consent, AIDS education and confidential self-exclusion, medical history interview and acceptance requirements, physical examination, blood testing, and reviewing Serological Protein Electrophoresis (SPE). You will evaluate donor reaction(s), which occurs at the facility as outlined in the SOPs. Follow applicable SOPs for medical emergencies including the development of Center Physician's standing orders and donor transport to emergency care facilities. You will refer to the Center Physician or Medical Affairs (as applicable) when in need of providing unacceptable findings to donors, or guidance concerning medical or technical issues, including donor safety and eligibility. You will support the Hepatitis B and Seasonal Flu vaccination programs for employees as applicable. You will manage employee incidents and determine whether further evaluation is required by occupational health/ER. Refer to EHS guidance regarding employee incidents. You can be a Pandemic Coordinator when authorized by EHS and support investigations associated with pandemic threats within the local community as indicated by EHS or Medical Affairs. What you bring to Takeda: High school diploma or equivalent to including graduate equivalent of a recognized educational nursing program with state requirements Currently licensed or certified in the state where responsibilities will be assigned: LPN or LVN Current Cardiopulmonary Resuscitation (CPR) and AED certification Fulfill state requirements (in state of licensure) for basic IV therapy Satisfactorily complete the FDA approved training requirements for BioLife Medical Support Specialist Two years in a clinical or hospital setting What Takeda can offer you: Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program to include medical/dental, paid time off and retirement benefits, all in a fast-paced, friendly environment. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to bring Better Health and a Brighter Future to people around the world. BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - NC - Fayetteville - Morgan U.S. Hourly Wage Range: $25.00 - $34.38 The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations USA - NC - Fayetteville - Morgan Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt No

The Global Clinical System Engineer II is responsible for end-to-end product ownership and contributing to worldwide serviceability throughout the entire product lifecycle-from successful launches to effective obsolescence management. This role combines complaint handling process, investigation management, technical support excellence including coaching, and contributing to service projects to foster cross-functional alignment, accelerate customer issue resolution, enhance long-term product performance in the field and respond to strategic priorities while addressing regional market dynamics. Working in close cross functional collaboration with R&D, Marketing, Manufacturing/Supply Chain/QA, vigilance and regional (local) teams, this role ensures service strategy definition for the Franchise, operational execution, technical proactivity, and continuous improvement across the product lifecycle to optimize field support and operational excellence, and therefore reach business growth expectations and enhance customer experience. Applies practical knowledge of job area typically obtained through advanced education and work experience. Responsibilities typically include Works independently with general supervision. Problems faced are difficult but typically not complex. May influence others within the job area through explanation of facts, policies and practices. Individual contributor, no direct responsibility for leading others. Facilitate consensus with external parties to bio Merieux through adaptable approaches that rely on explanation and occasionally on persuasion, while encouraging flexibility and compromise where there is a common interest to find solutions. Make minor changes in existing processes and occasionally identify problems and adapt or modify working methods in own role to increase efficiency in day-to-day activities. Problems and issues may be only vaguely defined and require understanding and consideration of other disciplines and job areas. Possesses a broad understanding of service operations, with growing expertise in coordination and efficiency Primary Duties Investigation & Technical support ownership Manage technical support requests and customer complaints from subsidiaries and Distributors: Provide leadership in delivering effective technical support to subsidiaries and distributors Promote proactive troubleshooting and technical coaching to local ional support teams Share best practices and contribute to project transformation and continuous improvement initiatives based on trend analyses Manage and coordinate end-to-end technical investigations with Manufacturing, R&D, and Quality Contribute to the Field Action process: contribute in audit preparation - Participate to audit. Follow CAPA activity relative to technical complaints. Participate to FA boards Establish and maintain ERP certification: Meet quality plan standards and all departmental KPIs, including those with impact on CHP and service Service Project Execution & Strategy Contribute to services launches & support Coordinate peers for service deliverables (documentation, validation, CSNs, etc.) and service project activities during product development and launch (PDP/G2M/GOM processes), working in alignment with Marketing, Training, and Global Deploy service strategies in alignment with Marketing, Training, and Global Operations Contribute in Go-To-Market strategy and support transition to obsolescence phases Represent the technical voice of the field to influence upstream and downstream decisions / Go out of market Contribute to other Franchise projects and initiatives as needed Hypercare & Lifescience Management Contribute to hypercare efforts to secure products launches, stabilize product performance, strengthen GO live of our solutions ensuring rapid resolution Contribute to phase out (obsolescence) with associated KPI Experience Bachelor's degree in a biological science, engineering, or other related field. In lieu of Bachelor's degree, 4+ years of relevant laboratory, engineering, and/or industry experience. 4+ years of relevant laboratory, engineering, and/or industry experience Clinical laboratory experience in Microbiology, Molecular Biology and/or Immunoassays experience preferred. 3+ years of customer service experience. Knowledge, Skills & Abilities Knowledge of bio Merieux products and Salesforce is a plus. Excellent written and oral communication skills. English speaking Proficiency in a variety of computer programs including Microsoft Office Suite. Attention to detail, great organizational skills, and ability to multitask in a fast-paced environment. Promotes teamwork and cooperation, previous project management experience a plus. Proven ability to coordinate critical technical investigations and field escalation actions. Experience in cross-functional project coordination (R&D, SC, QA, MFG, Marketing, etc.) and working with global, subsidiaries, distributors. Knowledge with PDP process, G2M, GOM, CHP, Field deployment and post launch service stabilization The estimated salary range for this role is between $75,000 - $105,000. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bio Merieux's bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate's experience and will be presented in writing at the time of the offer.In addition, bio Merieux offers a competitive Total Rewards package that may include: A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options Company-Provided Life and Accidental Death Insurance Short and Long-Term Disability Insurance Retirement Plan including a generous non-discretionary employer contribution and employer match. Adoption Assistance Wellness Programs Employee Assistance Program Commuter Benefits Various voluntary benefit offerings Discount programs Parental leaves #LI-US#biojobs Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bio Merieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bio Merieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site or contact us at [emailprotected]. BioMerieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant's identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMerieux's or its affiliates' application process by contacting us via telephone at , by email at [emailprotected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

Job Description DEPARTMENT: Site Operations COMPANY: Humacyte Inc (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte's initial opportunity, a portfolio of Acellular Tissue Engineered Vessel (ATEVs), is currently approved for use in vascular trauma repair and is in late-stage clinical trials targeting multiple other applications including AV access for hemodialysis and peripheral arterial disease. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte's 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte's 6mm ATEV for urgent arterial repair following extremity vascular trauma also received the RMAT designation. For more information, visit ***************** ________________________________________________________________________________________________________________ JOB SUMMARY: The Instrumentation and Metrology Specialist III will provide metrology, instrumentation and controls knowledge and expertise for manufacturing, utility and laboratory equipment throughout the Humacyte site. Though the primary duties of this position will center on instrument calibration and equipment controls support, the position may be required to collaborate and/or assist with the general equipment and facilities maintenance group. The ideal candidate will display an advanced knowledge of GMP equipment instrumentation and controls, willingness and expertise to assist with general maintenance, and the ability to collaborate with other departments as needed. ESSENTIAL FUNCTIONS: Partner with Quality, Engineering and Operations groups to ensure strict compliance with GMP / GLP guidelines at all times, specifically to ensure that the equipment is maintained in GMP / GLP requirements. Leads, maintains, and performs basic and advance corrective, preventative maintenance calibration on GMP and non-GMP equipment and instruments. Drafts all calibration procedures needed and assists in the drafting of work instructions for all process and utility equipment. Research and provides informed recommendations for instrumentation/metrology spare parts and PM job plans. Assists in routing all required documentation for the submittal of spare parts and PM WOS. Site Subject Matter Expert to troubleshoot, test, repair and optimize instruments, equipment and control systems. Provides I&C expertise and guidance in the Capital design, appropriation, and installation processes. Collaborate with all departments in the continuous improvement efforts within the site maintenance program. Oversees and assists in the maintenance and review of calibration standards and vendor calibration documentation. Works with contract service providers and support contractor executing calibration, controls and metrology activities. Other duties as assigned. EXPERIENCE & QUALIFICATIONS: Degree in Engineering, Life Sciences or other related technical field, or equivalent military training preferred. 7 years of applicable Metrology, Instrumentation or Calibration experience required. 7 years of Quality System / Pharmaceutical experience is preferred. Instrumentation Technical Training Certificate (ISA-CCST) or equivalent preferred. Trained in electrical safety NFPA-70E (144 hours of formal instruction on electrical safety, electrical systems, electronics) preferred. Will spend time in a clean room environment for manufacturing operations and will be required to meet applicable gowning and personal protective equipment guidelines. Will be required to regularly to sit; stand for prolonged periods of time. Also, may occasionally be required to pull, lift and/or move up to 20 pounds. Position may require working holidays, weekends and overtime. SPECIFIC SKILLS: Advance understanding and application of instrument, equipment, and loop calibrations of various parameters in manufacturing, utilities and laboratory environments. Proven knowledge and understanding of electrical panels and electrical safety procedures. Advance understanding of Traceability, Substitution of Standards, and Test Accuracy and Uncertainty Ratios. Skilled with pneumatic, mechanical and electrical instrumentation; as well as manual and computer-based process control loops and systems; understands and applies basic concepts of calibration and requirements including accuracy testing. Advance understanding and application of instrument, equipment, and loop calibrations of various parameters in manufacturing, utilities, and laboratory environments. General electrical panel knowledge and electrical safety procedures. Able to make independent decisions within defined scope of work, seeks clarification and directions when needed. Must be self-driven and demonstrate ability to work with little direction. COMPENSATION & BENEFITS HIGHLIGHTS: Stock Options 401k Plan with 4% Match and no Vesting Schedule Medical, Vision and Dental Plans Company Paid Long Term/Short Term Disability Company Paid Life Insurance 23 Days Paid Time Off (PTO) 10 Company Designated Holidays + 2 Floating Holidays Paid Parental Leave Policies ** Please note, Humacyte does not provide U.S. employment sponsorship and does not accept unsolicited resumes from 3rd party firms and/or agency recruiters. ** The statements in this position profile are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time. Humacyte is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, Humacyte is committed to achieving its business objectives in compliance with all federal, state and local law.