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Ready to redefine what's possible in molecular diagnostics? Join a team of brilliant, passionate innovators who wake up every day determined to transform healthcare. At BillionToOne, we've built something extraordinary-a culture where transparency fuels trust, collaboration drives breakthroughs, and every voice matters in our mission to make life-changing diagnostics accessible to all. We don't just aim for incremental improvements; we strive to build products that are 10x better than anything that exists today. Our people are our greatest asset: talented scientists, engineers, sales professionals, and visionaries united by an unwavering commitment to changing the standard of care in prenatal and cancer diagnostics. This is where cutting-edge science meets human compassion-every innovation you contribute helps remove fear of unknown from some of life's most critical medical moments. If you're driven by purpose, energized by innovation, and ready to help build the future of precision medicine, this is where you belong. We are looking for a LIMS Associate to join our Automation team in support of clinical patient testing in our high-throughput CLIA lab. The LIMS Associate will be responsible for (1) Supporting smooth and continued operation of clinical workflows, (2) Troubleshooting, investigating, and performing corrective actions for non-conformance reports in a timely manner, (3) Developing tools, scripts, and apps to provide self-service options for non-standard functions to LIMS operators. This role will help to build upon the strong technology and execution found at BTO. This is considered an onsite role at our Union City lab, with flexibility to work from home or at our Menlo Park site when applicable. Responsibilities: Support operators in resolving LIMS issues to minimize sample turnaround time Investigate the root cause of uncommon issues and propose solutions Triage & escalate unresolved technical issues to appropriate team members Monitor sample queues and follow up on unresolved issues or delays Assist in testing and documenting new LIMS workflow versions Assist in performing LIMS code reviews, verifications, and validations Ensure compliance to all relevant corporate and regulatory requirements Requirements: Bachelor's degree with Biological or Computational focus (e.g. Bioinformatics) Proficient in Python 1+ Years Experience bench work experience 2+ Years Experience with developing LIMS, apps, or customer-facing tools (or 0 years with a Master's Degree) Ability to troubleshoot and diagnose advanced technical issues Experience developing scripting solutions to automation problems, especially in a fast paced/agile setting Strong attention to detail and ability to work flexibly and well under given timeframes Highly organized, strong written and verbal communication skills Creative problem-solver that finds a way to get things done Enjoy a wide variety of daily tasks in a fast-paced, time-sensitive environment Nice-To-Haves: Experience with Clarity LIMS (Especially Python API) Experience working in CLIA Lab, medical device, or pharma Experience with data analysis using Python, SQL, or Excel Familiarity with Quality Management Systems and related regulations (CFR 21 Part 11, ISO 13485, etc) Benefits And Perks: Working alongside brilliant, kind, passionate and dedicated colleagues, in an empowering environment, toward a global vision, striving for a future in which transformative molecular diagnostics can help millions of patients Open, transparent culture that includes weekly Town Hall meetings The ability to indirectly or directly change the lives of hundreds of thousands patients Multiple medical benefit options; employee premiums paid 100% of select plans, dependents covered up to 80% Extremely generous Family Bonding Leave for new parents (16 weeks, paid at 100%) Supplemental fertility benefits coverage Retirement savings program including a 4% Company match Increase paid time off with increased tenure Latest and greatest hardware (laptop, lab equipment, facilities) Free daily on-site lunches provided from top eateries A variety of perks on campus (state of the art gym, restaurant) Free on-site EV charging (compatible with all EVs, including Tesla) At BillionToOne, we are proud to offer a combination of a (1) base pay range (actual amount offered is based on experience and salary/equity options split that the candidate chooses), (2) generous equity options offering, (3) corporate bonus program, on top of (4) industry leading company benefits (free healthcare options, 401k match, very generous fully paid parental leave, etc.). For this position, we offer a total compensation package of $101,312-$136,161 per year, including a base pay range of $73,920-$105,601 per year. BillionToOne is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. For more information about how we protect your information, we encourage you to review our Privacy Policy. About BillionToOne BillionToOne is a next-generation molecular diagnostics company on a mission to make powerful, accurate diagnostic tests accessible to everyone. Our revolutionary QCT molecular counting technology enhances disease detection resolution by over a thousandfold using cell-free DNA-a breakthrough that's already transformed the lives of over half a million patients worldwide. Our Impact: We've pioneered game-changing diagnostic solutions that are redefining industry standards. Unity Complete™ stands as the only non-invasive prenatal screen capable of assessing fetal risk for both common recessive conditions and aneuploidies from a single maternal blood sample. In oncology, our Northstar liquid biopsy test uniquely combines treatment selection with real-time monitoring, giving oncologists unprecedented precision in cancer care. Our Growth: From $0 to $125 million in Annual Recurring Revenue in just four years. We've raised close to $400 million in funding, including a $130 million Series D round in June 2024, achieving a valuation of over $1 billion. This backing comes from world-class investors including Hummingbird, Adams Street Partners, Neuberger Berman, Baillie Gifford, and Premji Invest. Our Recognition: Forbes recently named us one of America's Best Startup Employers for 2025, and we were awarded Great Place to Work certification in 2024-with an incredible 100% of our people reporting they are willing to give extra to get the job done. These honors recognize not just our innovation but the exceptional culture we've cultivated-one that remains authentically collaborative and transparent even as we've scaled. Our Future: Headquartered in Menlo Park with facilities in Union City, California, we're continuing to push the boundaries of what's possible in molecular diagnostics. Recent clinical outcomes data for Unity Fetal Risk Screen and new advances in cancer diagnostics prove we're just getting started. At BillionToOne, you'll join a diverse team of passionate innovators who believe that the best science happens when brilliant minds collaborate openly, think boldly, and never lose sight of the patients whose lives depend on our work. Ready to help us change the world, one diagnosis at a time? Learn more at ********************

The Senior Manager, Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized Biologics Quality Assurance support, including oversight of upstream and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for managing clinical and commercial product quality to ensure global supply for Otsuka's patients. **** + Provides Biologics QA support for Drug Substance and Drug Product, including upstream and downstream biologics manufacturing processes, ensuring GMP compliance for cell culture, bioprocessing, purification, and formulation activities. + Responsible for the day-to-day quality oversight of assigned GMP contract manufacturers. + Responsible for the OPDC GPQ batch record review and release activities of assigned products (API, Drug Product and Final Packaged/Labeled Investigational Medicinal Product) for use in clinical studies and commercial products. + Works collaboratively with GMP Suppliers, OPDC Technical Operations, QC and Clinical Supplies Operations, and other Otsuka Companies, Affiliates and Subsidiaries as applicable in releasing R&D products for use in clinical studies and commercial supply. + Reviews/approves deviations, investigations, CAPA plans and change controls per Otsuka Policies and Procedures. Dispositions quality system records to ensure their timely initiation, execution, and closure. + Provides quality oversight for QC-related activities that support OPDC R&D products; including LIMS data, method development & validation, method transfers and testing (release, stability). + Maintains KPIs/quality metrics to monitor performance and help drive continuous improvement activities. + Negotiates quality agreements for assigned GMP Suppliers and ensures they are established per Otsuka Policies and Procedures. + Participates in audits of GMP Suppliers to ensure compliance with local and global requirements as well as applicable regulatory requirements. + Works collaboratively with local and global Otsuka departments and GMP Suppliers in support of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating Procedures, Working Practices and Job Aids. + Works collaboratively within the Global Quality and other functional areas across Otsuka Affiliates and Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces with project teams supporting research and development projects to assure that the goals set by the team as they relate to potential suppliers are consistent with global and local quality objectives and relevant governmental requirements. **Qualifications** Required + Bachelor's degree in Chemistry, Biology, Engineering or related Science. + Four years of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Products or Commercial Products. + Two to three years of quality experience in managing CMOs/CDMOs (or experience in internal/external auditing). + Proven experience with biologics GMP DS and DP manufacturing, including upstream (cell culture, bioreactors) and downstream (purification, filtration, formulation) processes.as well small molecule manufacturing. + Ability to handle interactions and resolve issues with internal customers and GMP suppliers in a tactful, professional, and effective manner. + Experience in using MS Office (Word, Excel, PowerPoint). + Experience in using TrackWise. + Excellent interpersonal and communication skills. + Technical Writing Experience: writing Investigations and performing root cause analysis. + Thorough understanding of GMP requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and 211. + Experience with Pre Approval Inspections for NDAs and BLAs. + Analytical problem solving and decision-making skills. + Ability to identify gaps/risks and propose corrective and preventative actions. + Position requires approximately 20% domestic travel; Occasional international travel may also be expected. Preferred + Experience with quality oversight of controlled substances. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $131,153.00 - Maximum $196,075.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Our Why At Dotmatics At Dotmatics, we believe science, data, and decision-making must be deeply intertwined for innovation to thrive. Our Portfolio includes Luma, LumaLab Connect, ELN Platform, Graphpad Prism, Geneious, SnapGene, Protein Metrics, OMIQ, FCS Express, LabArchives, NQuery, EasyPanel, MStar, SoftGenetics and Virscidian. We have a vision for a new Lab of the Future that will change the future of scientific research. We have created the world's most comprehensive digital science platform - best-of-breed software applications already used by more than 2 million scientists, together in a single ecosystem united by a powerful, flexible enterprise data platform. This is not flat data buried away in digital graveyards. This is dynamic, multi-dimensional decision-making. Scientific enterprises need a new level of effectiveness to achieve tomorrow's breakthroughs. Illness will not wait. The biosphere will not wait. We are tireless in our vision, because the time for innovation is now. Shaping the Future of Science At Dotmatics Our global team of more than 800 colleagues are dedicated to supporting our customers in over 180 countries. Together, with our scientific community of users, we accelerate scientific innovation in order to make the world a healthier, cleaner, and safer place to live. You'll join a collaborative, global team pushing the boundaries of scientific innovation. Your ideas and efforts will have a tangible impact, accelerating scientific progress and discovery. We offer a dynamic, remote-friendly environment that fosters high integrity and collaboration, empowering you to excel. Dotmatics is a company built by scientists, for scientists. Combined, we are now the world's largest cloud-based scientific research R&D platform. We need your help to keep growing and pioneering the future. We are Science Driven. We are Customer Centric. We are Better Together. What do we need Dotmatics is transforming how science gets done. As the world's leading scientific R&D SaaS platform, we connect data, people, and processes across the innovation lifecycle-from experiment design to manufacturing scale-up. We're seeking a Global Commercial Leader for Pharma R&D/Luma to help define and execute the go-to-market strategy for our enterprise customers. This leader will serve as the commercial bridge between science, data, and digital operations-driving adoption of the Dotmatics Luma platform across global pharma and biotech organizations. This role is ideal for a domain expert who can connect the dots between scientific workflows, enterprise SaaS capabilities, and business transformation-translating complex R&D challenges into scalable, high-impact digital solutions. As a Commercial Leader, you'll play a pivotal role in shaping how the world's largest pharma organizations realize that vision-connecting science, data, and automation through the combined power of Dotmatics and Siemens. In this role you will get to Domain Leadership & Market Strategy Define and own the commercial strategy for pharma R&D, aligned with Dotmatics' enterprise growth objectives and Siemens' digital industries vision. Shape the market narrative around data-centric science, connected labs, and AI-enabled discovery, positioning Luma and the Siemens digital thread as the backbone of enterprise innovation. Serve as the voice of the R&D customer, influencing portfolio strategy and messaging to ensure commercial and scientific relevance. Partner with Marketing and Corporate Strategy to drive thought leadership, campaign content, and executive engagement across pharma, biotech, and CRO/CDMO markets. Enterprise Solution Alignment Collaborate with Product Management, Solution Architecture, and Customer Success to build integrated enterprise value propositions across the Dotmatics portfolio (Luma, Geneious, SnapGene, Prism, Protein Metrics, Virscidian, OMIQ, and others). Translate complex scientific workflows-biology, chemistry, analytical development, and CMC-into clear commercial use cases that demonstrate measurable business outcomes. Help define and package enterprise capabilities spanning data management, analytics, and process automation into cohesive commercial offerings. Field Enablement & Go-to-Market Execution Partner with Regional Sales, Pre-Sales, and Industry teams to deliver enablement playbooks, success stories, and executive-level messaging for pharma R&D accounts. Support multi-solution selling motions, ensuring consistency across account planning, opportunity development, and joint Siemens co-sell activities. Provide domain insight to strengthen sales governance, forecast accuracy, and strategic account planning. Strategic Partnerships & Ecosystem Engagement Act as a commercial thought leader in Siemens Digital-Dotmatics joint engagements, driving collaboration across automation, AI/ML, and digital twin initiatives. Engage with strategic customers (e.g., Merck, Takeda, Pfizer, Novo Nordisk) to co-develop roadmaps and co-innovation programs built around connected data and digital lab strategies. Represent Dotmatics and Siemens at key industry events and roundtables, articulating a unified vision for the connected, intelligent lab of the future. We are looking for people who have 10+ years of experience in SaaS, life sciences software, or scientific informatics with a strong grasp of pharma R&D processes (discovery through CMC), and ideally holding a Degree in Life Sciences, Chemistry, Biology, or Engineering; MBA or advanced scientific degree preferred. The Key Skills we are looking for: Commercial strategy, domain leadership, or enterprise solution management -Proven success in the life sciences sector. Biopharma / Life Sciences Insight - Deep understanding of the data flow across R&D-from ELN/LIMS to analytics, visualization, and digital twin in the Life Sciences industry Strong storytelling and executive communication skills-able to translate technical concepts into business outcomes for senior R&D, IT, and digital transformation leaders. Technical Translation: Ability to bridge technical capability (engineering) and business value (scientific outcomes). Strategic Partnership Management: Ability to identify, build, and nurture high-value alliances that drive joint business outcomes. Ecosystem Thinking: Understands how partners, customers, and internal teams interconnect within a digital ecosystem (automation, AI/ML, digital twin). Thought Leadership: Capable of shaping industry narratives through panels, roundtables, and publications. Relationship Management: Trusted advisor to both internal and external stakeholders, able to balance interests and drive shared success. Research shows us the confidence gap and imposter syndrome can get in the way of meeting outstanding candidates, so please don't hesitate to apply - we'd love to hear from you. By submitting your application, you agree that Dotmatics may collect your personal data for recruiting, global organization planning, and related purposes. Dotmatics Privacy Notice explains what personal information we may process, where we may process your personal information, our purposes for processing your personal information, and the rights you can exercise over Dotmatics use of your personal information. Dotmatics is an equal opportunity employer. We are a welcoming place for everyone, and we do our best to make sure all people feel supported and connected at work.

Tulip, the leader in AI-native frontline operations, is helping companies around the world equip their workforce with composable, connected apps, leading to higher quality work, improved efficiency, and end-to-end traceability across operations. Tulip's cloud-native, no-code platform, powered by embedded AI, is driving the digital transformation of industrial environments through composable, human-centric solutions that go beyond disrupting the Manufacturing Execution System (MES) category. A spinoff out of MIT, Tulip is headquartered in Somerville, MA, with offices in Germany, Hungary, Singapore, and Israel. Tulip has been recognized as a World Economic Forum Global Innovator, a 2024 Deloitte Technology Fast award winner, one of Energage's Top Workplaces USA, and one of Built In Boston's “Best Places to Work” and “Best Midsize Places to Work.” About You: You are on the front lines working with large strategic customer accounts from the life sciences industry. You are equally experienced and comfortable presenting from top-level executives to front-line manufacturing operators in Life Science companies. Mapping and navigating complex relationships with multiple stakeholders each with individual interests and responsibilities will be key to your success. You successfully navigated a complex sale into companies from the life sciences space. You are used to building, managing and closing opportunities within a new pipeline and including proof of concept and expansion deals. Acronyms like ERP, MES, GxP, eBR,eDHR, LIMS and LES are part of your daily conversations. What skills do I need? 7+ years selling into Life Science accounts at top management levels; manufacturing and or lab solutions to the life sciences industry required Recent experience managing a diverse pipeline across multiple types of life sciences customers and achieving 100% plus quota Demonstrated ability to operate and move deals through complex organizations, prospect and penetrate new accounts and work with channel partners Excellent written and oral communications and presentation skills Experience in value-based selling, MEDDPICC and closing large enterprise deals Proficiency with Salesforce.com, organizing & reporting sales productivity on a consistent basis Experience with SaaS/PaaS, manufacturing software, R&D, clinical manufacturing, and/or lab software is a plus Location preference: Research Triangle Park, NC Key Responsibilities: Break into and drive large, complex deals from lead to close. Experience navigating complex company procurement processes. Drive account strategies and coordinate selling efforts with channel partners to execute a sales process and win deals. Manage multiple customer opportunities with multiple partners at once while maintaining a high level of attention to detail. Build accurate forecasting and an operational cadence with management Drive referenceable customer satisfaction in your accounts Expertly demonstrate Tulip technology to end users Have passion for technology and speak fluently about current trends related to SaaS, PaaS, IoT and cloud solutions. Develop champions, stakeholder mind-share and close at the VP/C-level. Leverage and collaborate with internal/external resources as a team player; Customer Team, Sales Engineering, Marketing, Channel Partners, Operations, Finance, etc. Key Collaborators: Sales Team and Customer Success Team Working At Tulip: We know even great candidates experience imposter syndrome. Even if you don't match every requirement, applying gives you the opportunity to be considered. We're building a strong, diverse team that values hard work, families, and personal well-being. Benefits of working with us include: Direct impact on product and culture Company equity Competitive benefits package including Health, Dental, Vision, Short-term Disability, Long-term Disability, Life Insurance, AD&D Insurance, Flexible Spending Account (FSA), Commuter Benefits, Parental Leave, and 401(K) Flexible work schedule and unlimited vacation policy Virtual company events and happy hours Fitness subsidies We are an equal opportunity employer. At Tulip, we celebrate all. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. Help us build an inclusive community that will transform frontline operations. The compensation information displayed on each job posting reflects the range for new hire pay rates for the position across all US locations. Within the range posted, actual compensation will be determined depending on multiple factors including job-related knowledge & skills, experience, business needs, geographical location, market compensation data, and internal equity. Expected compensation ranges for this role may change over time. The salary range for this position is $100,000 - $150,000 per year. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

LabAnswer is the leading and largest laboratory informatics consultancy; combining science, laboratory, regulatory and information technologies. We have the people, processes, methodologies, IP and experience to deliver comprehensive laboratory informatics solutions. LabAnswer has architected, implemented, deployed and/or supported hundreds of major scientific informatics systems across more than a thousand laboratories. LabAnswer performs significant laboratory automation work in pharmaceuticals, bio-pharmaceuticals, medical devices, forensics, and life sciences research laboratories spanning research, development and manufacturing/QC operations. The LabAnswer team has a rare combination of laboratory science, IT, business and regulatory expertise. We specialize in helping companies strategize, architect, implement and support scientific data management and laboratory automation projects. Travel Requirements: This is a remote position so the candidate can live anywhere in the USA. The position will require 11-25% travel. Job Description: The LIMS SME/Business Analyst will provide support for an enterprise StarLIMS implementation for the Food and Drug Administration (FDA) Office of Regulatory Affairs (ORA). The duties for this position is as follows: •Work with end users and management to analyze and document user needs •Participate in and facilitate meetings, •Work with the project team and FDA leadership to identify data needs for LIMS and/or ELN functionality. •Provide strategic direction to the IT, Scientific, and Management teams. •Define data migration requirements. •Create and maintain SDLC & EPLC documentation. •Contribute in all areas of system implementation including but not limited to vendor interaction, system compatibility, change control, qualification, deployment, and training •Work with project teams to ensure compliance with regulatory requirements and internal policies and processes. •Develops plans and strategies for the LIMS/ELN. •Analyzes user interfaces / functional needs and requirements. •Maintain hardware and software performance tuning, analyze workload and computer usage, maintain interfaces with outside systems, analyze downtimes, analyze proposed system modifications. •Analyzes Problem and information to be processed. •Defines the problem, and develops system requirements and program specifications from which programmers prepare detailed flow charts, programs, and tests. •Coordinates closely with programmers to ensure proper implementation of program and system specifications. Develops, in conjunction with functional users, system alternatives. •Possesses requisite knowledge and expertise in the professional community that the Government is able to qualify the individual as an expert in the field for an actual TO •Demonstrates expertise with LIMS, including integration with workflows outside of laboratories and provides expert analysis advice and recommendations Qualifications Minimum Qualifications: •LIMS and/or ELN experience, StarLIMS preferred •BS + 1 yr experience for Jr Level / BS + 5 years experience for Sr Level •Excellent verbal and written communication skills •Sr. Level - Demonstrated exp implementing enterprise data capture/management technologies •Experience implementing technology under a defined corporate and compliant methodology •Expert understanding of computer and application architecture and technology •Strong analytical and problem solving skills Desired Qualifications: •3-5 Years of consulting experience •Certified Business Analysis Professional (CBAP) certification FDA Project Information: LabAnswer is pursuing a contract with the Food and Drug Administration (FDA) Office of Regulatory Affairs (ORA) for the continued implementation, deployment, integration, training, testing and support of FDA's Laboratory Information Managements System (LIMS). We are currently working on the project as a subcontractor. The new contract is anticipated to be awarded in late July, 2016 for a period of 7 years. There are approximately 6 remote LIMS SME positions. Travel Requirements: This is a remote position so the candidate can live anywhere in the USA. The position will require 11-25% travel. Additional Information We offer comprehensive benefits to regular full-time employees including but not limited to: •Unlimited ceiling for professional growth opportunities within LabAnswer •You will also have opportunities to take advantage of training programs to advance your career; our extensive online library includes a assortment of technical and professional training tools and resources •Opportunities to work across a variety of industries (Pharmaceutical, Medical Device, Consumer Products, Energy, Environmental, Forensics, Genomics, Government etc.) •Opportunities to work across a variety of laboratory environments (analytical testing, biotech, clinical trials, forensics, medical device, pharmaceutical, public health and research hospitals) •Comprehensive health and welfare programs to fit your individual or family's needs: •Health Insurance •Dental Insurance •Vision Insurance, •401(k) Retirement Saving that includes a generous employer match •Paid Time Off (vacation, sick, holiday) •Company Paid Life Insurance •Company Paid Short and Long Term Disability Insurance •Wellness Plans and Rewards •Strong company values of team work, culture and values, personal and professional development, work-life balance, and recognition •Competitive compensation with opportunities to participate in employee bonus plan and travel bonus plan At LabAnswer we offer a very competitive compensation package based on experience and education. We are looking for exceptional people to join our team, those who are looking to join an organization for the long term. We invite you to visit ***************** to review our Employee Value Proposition and Philosophy, and welcome you to apply, or refer a candidate to apply, through our careers page for employment consideration.

Now hiring! Technical Service Manager, Fuel Additives NA Remote (Houston, TX preferred) We are looking for a Technical Service Manager, Fuel Additives NA to join our Performance Chemicals team in Houston, TX. Come create chemistry with us! As an innovative partner, BASF's Performance Chemicals division offers chemicals for various customer industries, such as plastics, automotive, refining, lubricants, oilfield and mining. Our highly qualified and experienced team with outstanding market knowledge as well as our innovation platform and application know-how ensure our technological competence to provide excellent solutions to our customers. The Fuel & Lubricant Solutions business delivers innovative additive technologies that enhance performance, efficiency, and sustainability in global fuel and lubricant markets. In this role, you will lead technical service delivery for Fuel Additives, ensuring successful application development, field trials, product launches, and long-term customer satisfaction while providing essential technical support to commercial teams. As a Technical Service Manager, Fuel Additives NA, you create chemistry by... * Serving as the primary technical contact for customers, distributors, and internal sales teams for Fuel Additives, understanding customer needs and translating them into technical solutions and actionable plans. * Providing technical guidance on formulation strategies, compatibility, and best application practices, and supporting customers in integrating FPPs into fuels and lubricant systems. * Designing, executing, and overseeing field trials and pilot projects by defining success criteria, sampling protocols, data collection plans, and reporting; supporting product launch activities and coordinating manufacturing scale-up. * Applying Design of Experiments (DoE), statistical interpretation, and data visualization to analyze lab and field test results, identify root causes, and recommend corrective or optimization actions. * Acting as liaison among Sales, R&D, Product Management, Regulatory Affairs, Supply Chain, Manufacturing, and regional product stewards to ensure seamless commercialization and timely issue resolution. * Monitoring market trends, regulatory developments, and fuel and lubricant specifications, and translating these insights into technical guidance and product positioning for customers and commercial teams. * Developing and delivering technical training, application guides, troubleshooting playbooks, and technical collateral for sales teams, distributors, and customers; representing BASF at technical forums and exhibitions. * Maintaining accurate technical records, trial data, and customer interactions in CRM and knowledge systems; capturing lessons learned from trials and deployments; promoting best practices to reduce time to resolution; and managing technical escalations, coordinating corrective actions, and supporting customer satisfaction and retention. If you... * Hold a Bachelor's degree in Chemical Engineering, Chemistry, Petroleum Engineering, or a related technical discipline; an MS or PhD is a plus. * Bring 5+ years of experience in technical service, application development, or field support within fuels, lubricant additives, engine coolants, brake fluids, or related performance chemicals; experience supporting product launches and manufacturing scale-up is advantageous. * Have strong knowledge of fuel and lubricant chemistry, additive technologies, formulation strategies, compatibility issues, and relevant specifications (ASTM/EN); experience with engine coolants and brake fluids is a plus. * Demonstrate experience with DoE, statistical data interpretation, and experimental design, with proficiency in Excel and statistical/visualization tools. * Communicate effectively in verbal and written form, presenting technical findings clearly to commercial and technical audiences; Spanish language skills are advantageous but not required. * Manage multiple projects, field trials, and customer requests concurrently with strong organizational and time-management skills and are willing to travel frequently to customer sites, blending terminals, manufacturing locations, and industry events. * Are customer-focused, creative in problem solving, collaborative, and effective at building cross-functional relationships. * Have experience with CRM systems (Salesforce preferred), LIMS/lab data tools, and BI/reporting tools (Power BI, Tableau). Create your own chemistry with you@BASF At BASF, you will have the chance to do meaningful work towards building a more sustainable future. In addition to competitive compensation and benefits, BASF provides you with access to a wide range of elements to help you be your best. It's what we call you@BASF. We are committed to providing benefits, programs, and opportunities that support our employees' overall well-being, personal growth, and a safe, collaborative, and inclusive work environment. Just some of the many benefits we offer include: * Flexible work arrangements whenever possible * Highly competitive retirement savings plan with company match and investment options * Well-being programs that include comprehensive mental health support for you and your household family members * Family forming benefits (fertility, adoption and surrogacy reimbursement, maternity/parental leave, and more) * Back-up child and elder care with discount programs for families of all ages and stages * Mentoring and career development opportunities that allow you to share, learn, and thrive * Matching gifts program that allows you to deepen the impact of your contributions to qualified charities. * Employee crisis support for when the unexpected happens * Access to our BASF wine cellar, employee discounts, and much more! About us As one of the largest chemical companies in North America we have been finding solutions for your everyday needs and addressing the most complex economic, environmental, and sustainability challenges for more than 150 years! At BASF we empower our employees with the tools, guidance and opportunities they need to advance and succeed in work and life. Giving you the support you need to be your best and fulfill your personal ambitions is what helps us create chemistry. After all, our success is linked to yours. Whatever path you envision, BASF is a great place to build a rewarding, successful career. Belong to Something Bigger. #belongat BASF Privacy statement BASF takes security & data privacy very seriously. We will never request financial information of any kind via email, private text message or direct message on any social medial platform or job board. Furthermore, we will never send a candidate a check for equipment or request any type of payment during the job application process. If you have experienced any of the above, please contact ***************************** to report fraud. Pay transparency BASF is committed to pay transparency practices. The competitive Pay Range for this role is $159,200.00- $199,000.00. Actual pay will be determined based on education, certifications, experience, and other job-related factors permitted by law. Equal employment opportunities We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, age, citizenship, color, religion, sex, marital status, national origin, disability status, gender identity or expression, protected veteran status, or any other characteristic protected by law. Applicants must be currently authorized to work in the United States on a full-time basis.

We are seeking a dedicated Associate Manufacturing Process Technician to join our team. You will be responsible for performing moderately-complex to complex manufacturing processes following Standard Operating Procedures (SOPs). This role involves solution preparation, equipment cleaning, and operation preparation to ensure smooth and efficient production. Responsibilities + Perform moderately-complex to complex processes according to Standard Operating Procedures (SOPs). + Move totes and handle large-scale solution preparation and equipment cleaning. + Steam and prepare equipment for production use. + Ensure components and products are readily available for continuous operations. + Utilize human-machine interfaces (HMIs) to identify alarms and address line stoppages. + Use computer systems to support training, communication, and electronic batch record documentation. + Follow standardized operating procedures for material handling, record keeping, assembly, and packaging, adhering to Good Manufacturing Practices (GMPs). + Report any discrepancies to the Team Leader or Production Supervisor to maintain quality standards and safety. + Assist fellow staff with manufacturing processes, equipment, and general needs. Essential Skills + Biotech DS manufacturing experience, preferably in solution preparation. + Understanding of measurements, calculations, and the metric system. + Basic knowledge of Good Manufacturing Practices (GMPs). + Familiarity with Electric Batch Records, DeltaV, and LIMS. + Experience in GMP environments and manufacturing processes. + Ability to review and manage batch records. Additional Skills & Qualifications + High School Diploma or GED is required. + Prior experience in manufacturing or production is necessary. + Experience in GMP or pharmaceutical environments is preferred. + Experience with electronic batch records is a significant advantage. Work Environment Join us in our brand new, state-of-the-art facility, which is already undergoing expansion. Our environment fosters growth and innovation, providing ample opportunities for professional development. Please direct any questions or inquiries to '*****************************' Job Type & Location This is a Contract position based out of New Albany, OH. Pay and Benefits The pay range for this position is $18.00 - $19.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in New Albany,OH. Application Deadline This position is anticipated to close on Dec 18, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. The Clinical Biomarker Specimen Specialist works collaboratively with the Clinical Biomarker Operations Manager, Study Managers, and Scientific stakeholders to ensure timely and smooth collection, transfer, and testing of clinical trial specimens. This role will ensure full chain of custody is maintained through the specimen lifecycle from collection through testing and final sample disposition. This role requires clinical study, specimen management, and project management experience. As well as knowledge of GxP and vendor-sponsor best practices. Key Accountabilities: Oversight of programming activities: Clinical specimen management from collection through testing and final disposition Ensures compliance with clinical protocol and informed consent. Maintain chain of custody for specimens Organize and oversee the collection, shipping and proper storage and maintenance of clinical specimens Resolve and/or triage specimen queries from sites or vendors Ensuring proper documentation of specimen destructions are obtained and filed appropriately Collaborative relationships: Collaborate on implementation and maintenance of specimen tracking system Work collaboratively with internal key stakeholders (e.g. Project Management, Clinical Operations, Biomarker and Bioanalytical Scientific Study Leads, Data Management) to ensure proper alignment and study-level execution of specimen management Compliance with Parexel standards: Complies with required training curriculum Completes timesheets accurately as required Submits expense reports as required Updates CV as required Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements Skills: Effective project management and time management skills; able to prioritize successfully Technologically savvy; quickly picks-up on new information, standards, regulations, tools, methods or software as it relates to position and profession Detail oriented; performs quality and accurate work with minimal oversight Excellent written/verbal communication skills Can identify opportunities for efficiency improvements and simplification, recognizes appropriate. Resources for deliverables, has effective organizational skills Interpersonal skills; encourages collaboration, is a team player and is cooperative, builds constructive and effective relationships, is approachable, communicates effectively Flexible, easily adapts to change, and is energized by challenges and problem-solving Can learn new skills and knowledge, able to offer new ideas but also willing to adapt style to existing process as appropriate Other competencies include managing complexity and ambiguity, decision quality, collaborates, cultivates innovation, customer focus, nimble learning, balances stakeholders, and action oriented Proficiency in written and spoken English - required Proficiency in local languages (as applicable) Knowledge and Experience: Years of experience: 2-5 years; dependent on level of related skills and education Laboratory background and/or strong knowledge of commonly tested biomarkers in the Oncology setting, latest and advanced analytical tools and assays Proficiency with data sets and Excel, understanding of data relationships and metadata Confident in overseeing vendors and communicating with experts to drive quality deliverables Preferred: Previous biobanking, sample tracking and handling experience Previous LIMS (Laboratory Information Management System) experience Working knowledge of the clinical drug development process Working knowledge of the Food & Drug Administration (FDA) regulations, International Council for Harmonization (ICH) Good Clinical Practice (GCP) guidelines, Study Data Tabulation Model (SDTM), Clinical Data Interchange Standards Consortium (CDISC), database development and User Acceptance Testing (UAT). Oncology experience and/or working knowledge Proficiency with timeline management Education: Bachelor of Arts/Bachelor of Science in relevant field, or other relevant experience/qualification EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson's disease, and Pompe disease. AskBio's gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive array of capsids and promoters. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, Scotland, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre-clinical and clinical testing. Our vision: Pioneering science to create transformative molecular medicines. Our mission: Lead innovative science and drive clinical outcomes to transform people's lives. Our principles: Advance innovative science by pushing boundaries. Bring transformative therapeutics to patients in need. Provide an environment for employees to reach their fullest potential. Our values: Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need. Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view. Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers. Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action. Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what's right in every situation. Make clear commitments and follow through. Position Summary The Senior IT Business Analyst is considered the IT application product owner and will be responsible for the implementation and support of various enterprise applications at AskBio. Enterprise applications including Electronic Laboratory Notebook and Quality by Design applications and others as necessary. The Senior IT Business Analyst leads the implementation and adoption of new capabilities within enterprise applications, ensuring alignment with business and technical requirements. This role involves collaborating with cross-functional teams to drive strategic initiatives, manage vendor relationships, and oversee application administration. The analyst is responsible for mentoring junior team members and facilitating change management processes, ensuring that applications evolve to meet the changing needs of the organization. This position plays a critical role in enhancing operational efficiency and delivering effective technological solutions. Preferrable location for this role is RTP, NC or Philadelphia, PA and will report to the Director, IT Enterprise Applications. Job Responsibilities Act as the technical IT application owner for scientific enterprise applications such as Benchling. Lead the development and implementation of new capabilities for enterprise applications. Collaborate with functional leads to translate business and technical requirements. Work with scientists to create, mature and develop ELN standards for data capture, definitions and mapping across laboratories. Collaborate with scientists and understand their data management needs including creation of ELN templates, reports, queries, and visualizations. Manage vendor relationships and monitor application roadmaps. Oversee application administration and provide end-user support. Facilitate change management initiatives during application updates. Keep up to date with industry knowledge and bring back key information related to enterprise applications to IT and the business that can be used to enhance quality and operational efficiencies. Plans and manages vendor upgrades, including Change Control where appropriate, to maintain currency of applications. Develops procedures and maintains knowledge base information related to respective application configurations to ensure data integrity and support change management. Provide group training for employees on new applications and features Minimum Requirements Bachelor's degree in Computer Science, Information Systems, Business Administration or related field with 5+ years of related experience OR Masters degree in a related field with 3+ years' experience. Prior experience within the Biopharma sector Relevant industry experience implementing and supporting commercial off-the-shelf Laboratory applications Excellent communication and stakeholder engagement skills with proven ability to align technical capabilities with business objectives Strong analytical and problem-solving abilities Experience creating dashboards in Power BI or other BI tools using SQL Self-motivated and organized Preferred Education, Experience and Skills Benchling experience Forward-looking mindset and ability to stay current with emerging technologies Track record of successful cross-functional collaboration and leadership Understanding of laboratory instrumentation, LIMS, ELN, and related data standards and protocols Experience with regulatory compliance requirements (GxP, 21 CFR Part 11) Excellent written and verbal communication skills with the ability to work both independently and in a team-oriented setting Sound judgement and an understanding of business processes Experience working in a GxP compliant environment AskBio Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job‐related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at ************** or sending us an email at ******************. Agencies: Please do not contact any employee at AskBio about this requisition. Any resume submitted by a recruitment agency to any employee at AskBio, through any medium, will be deemed the sole property of AskBio unless the agency was engaged by AskBio Talent Acquisition team to recruit for that position. All agencies must have a prior executed service agreement with AskBio prior to any search engagement. If a candidate who was submitted outside of the AskBio agency process is hired by AskBio, no fee or payment of any kind will be paid to the agency.

At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. We are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, manufacturing, and supply chain solutions. With over 50 years of experience across industries and a vast network of over 100 sites worldwide, Jabil combines global reach with local expertise to deliver both scalable and customized solutions. Our commitment extends beyond business success as we strive to build sustainable processes that minimize environmental impact and foster vibrant and diverse communities around the globe. Job Summary: The Director of Validation will lead all validation activities across pharmaceutical and medical device manufacturing operations with a strong focus on sterile/aseptic manufacturing environments. The scope of responsibility encompasses all planning and implementation of drug and medical device overall validation activities, including validation of facilities, utilities, equipment, cleaning, computer systems and process in compliance with global regulatory requirements (FDA, EMA, ICH, etc.)aseptic fill-finish environment and ensuring the proper validation of all equipment and processes. The Validation Director will also schedule the appropriate resources for assistance with validation, to meet the established production schedule, vendor/contract activities in the cleanrooms, maintain a state of control within the cleanroom environment, and support facilities and other operations, development, and maintenance of validation program documents including SOPs, Validation Project (VPP) and Validation Master (VMP) Plans. This individual should manage tasks and responsibilities with minimal guidance and demonstrate outstanding multi-tasking, problem-solving, and communication skills in a dynamic and challenging contract manufacturing environment. The role ensures a state of control is maintained across all systems and processes, supporting product quality, patient safety, and regulatory compliance This position requires strategic leadership, cross-functional collaboration, and technical expertise to drive validation excellence across multiple production areas and projects. Duties/Responsibilities: * Lead the development, execution, and lifecycle management of validation programs (VMPs, VPPs, SOPs) for sterile and non-sterile operations. * Responsible for directing and mentoring validation staff across multiple production areas to ensure the proper and continuous function of the operations team and adherence to the established procedures and schedulesin alignment with corporate quality and operational goals. * Assess process validation capabilities within the Operations organization and propose strategies for improvements to help achieve both short-term and long-term corporate objectives. * Direct personnel to the author, complete, and review all associated validation protocols (IQ, OQ, PQs). * Write, review, and approve change control orders and CAPAs, validation deviations, investigations, Quality Management System (QMS) oversight, audit, inspection follow-up (CAPA), and support readiness activities for validation. * Collaborate with senior validation leadership, outline validation strategy for new processes/equipment, and translate those required to appropriate validation protocols and standard operating procedures. * Oversee, assign, and manage all aseptic validation activities and equipment (e.g., lyophilizers, isolators, autoclaves, filling lines), clean utilities (WFI, PW, HVAC), and critical systems.. * Accountable for maintaining the Master Validation Plan of aseptic and non-aseptic processing. * Provide strategic direction to process validation strategies, serve as the Subject Matter Expert (SME) to support inspections/audits by third parties (e.g., regulatory agencies), and the timely closure of observations/audit terms. * Interface with Regulatory agencies, as required, in conjunction with facility inspections and technical interchanges to represent the company's position concerning validation. * Mentor and develop staff regarding teamwork, validation techniques, and procedures to ensure cGMP compliance and other duties, as assigned or as business needs require. * Provide direction and serve as project and resource management for the validation teams. * Provide oversight and strategic direction for the Computer System Validation (CSV) program and supervise CSV associates. Ensure compliance with cGMP, FDA, EMA (Annex 1), and other global regulatory requirements for validation and qualification. * Collaborate with Engineering, Quality Assurance, Manufacturing, and Client to ensure validation strategies support product lifecycle and regulatory submissions. * Manage risk-based validation approaches and implement continuous improvement initiatives. * Provide strategic input on new facility and equipment design to ensure validation readiness. * Lead validation readiness for tech transfers, new product introductions, and capital projects. * Ensure robust training and development programs for validation staff. * Oversee the aseptic process simulation (APS) program to ensure compliance and readiness for regulatory inspections. * Other assigned responsibilities, as needed. Required Skills/Abilities: * Ability to read, write, and speak English fluently. * Deep understanding of aseptic processing, cleanroom classifications, and contamination control principles. * Demonstrated leadership in managing cross-functional teams and complex projects. * Proficiency in validation lifecycle documentation and electronic systems (e.g., QMS, VMS, LIMS). * Proficient in the operation of manufacturing equipment and processes; knows and complies with Safety Data Sheets and SOP requirements and trained in cGMP's. * Mechanically inclined; reads and interprets equipment and process documents; follow operating instructions; and has good computer skills. * Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality. Consistently checks all documents for errors and constantly strives for right the first-time mentality. * Observes safety and security procedures; responsible for meeting department safety objectives and developing ongoing safe operating procedures consistent with the job requirements. * Advanced understanding of applicable regulatory requirements (FDA, EMA, WHO, ICH, international regulatory). Audit experience is strongly preferred. * Advanced understanding of industry standards for commissioning and validation of facilities, utilities, and process equipment for cGMP manufacturing. * Demonstrate SME-level knowledge of process/equipment validation, computer systems, standards, and GxP regulations. Expertise in validation of sterile manufacturing equipment and processes. * Strong technical experience in the successful management of complex validation is required. * Able to effectively lead and coordinate complex requests/projects and allocate resources across multiple sites, managing local and remote-based staff. * Strong oral and written (reports) communication, organization, and leadership skills. Education and Experience: * Bachelor's degree in Science or Engineering, Master's degree preferred * Minimum 15 years of progressive leadership of operational validation experience in the Pharmaceutical or Biotechnology industry, with at least 5 years in sterile/aseptic operations. * Sound industry knowledge of pharmaceutical and medical device facilities, lyophilization technology, cleanrooms, facilities clean utilities. WFI, purified water, process gasses, HVAC, and industrial processes and utilities. * Experience in successfully managing complex technical issues using structured analysis and methodology and articulating clear and concise direction to other operations staff. * Proven track record of leading validation programs in a regulated environment. * Experience with regulatory inspections and successful remediation of validation-related findings. * Strong experience with project and people management, particularly for large validation projects or programs. * Experience in Facility, Equipment, and Utility or Cleaning validation is a must. Experience with Process Validation as a plus. The pay range for this role is $68,800 - $123,800. Job-related, non-discriminatory factors used to determine the actual offered rate include qualifications and experience, geographic location, education, external market data, and consideration of internal equity. As part of the total rewards package, Jabil offers benefits to enhance your health, wealth, and resilient self. These include medical, dental, and vision insurance plans; paid time off; paid parental leave; company-paid holidays subject to change yearly; 401(k) retirement plan; and employee stock purchase plan. BE AWARE OF FRAUD: When applying for a job at Jabil you will be contacted via correspondence through our official job portal with a jabil.com e-mail address; direct phone call from a member of the Jabil team; or direct e-mail with a jabil.com e-mail address. Jabil does not request payments for interviews or at any other point during the hiring process. Jabil will not ask for your personal identifying information such as a social security number, birth certificate, financial institution, driver's license number or passport information over the phone or via e-mail. If you believe you are a victim of identity theft, contact the Federal Bureau of Investigations internet crime hotline (************* the Federal Trade Commission identity theft hotline (********************** and/or your local police department. Any scam job listings should be reported to whatever website it was posted in. Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, age, disability, genetic information, veteran status, or any other characteristic protected by law. Accessibility Accommodation If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Jabil.com/Careers site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to Always_******************** or calling ************ with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail or phone number. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to. #whereyoubelong #AWorldofPossibilities #EarlyCareer

The Role: The Scientist will be responsible to support the protein quantification and proteomics analysis using Mass spectrometry for PK and PD studies, ensuring the timely and efficient management of critical reagents used in the development, validation, and execution of bioanalytical and molecular assays to support clinical assays at Moderna. The successful candidate will work closely with cross-functional teams for protein analysis, qualify critical reagents, as well as establish and maintain robust systems for their monitoring, tracking, and storage. This is in person laboratory based position located in Norwood, MA. Here's What You'll Do: Support LC-MS based protein quantification/proteomics assay development, validation and sample analysis under regulatory compliance. A solid background in modern analytical techniques used in the analysis of mRNA-based therapeutic products is essential. Maintain a robust system for the monitoring, tracking, and storage of critical reagents to ensure their availability and quality. Support reagent characterization to generate CoA documentation. Knowledge of peptide/proteins, aptamer-antibody based conjugation systems for DNA, RNA, and Protein/antibodies. Maintain a database of Reference standards/reagents, including their specifications, source, usage, and expiration dates. Conduct regular audits of critical reagent inventory and work with cross-functional teams to manage the procurement and disposition of the reagents. Vendor management to ensure the availability and quality of critical reagents. Develop and implement policies, procedures, and training programs to ensure compliance with regulatory requirements and industry best practices. Collaborate with cross-functional teams to develop reagent-specific risk assessments and mitigation strategies. Monitor industry trends and advancements in critical reagent management and implement the best practices to improve efficiency and effectiveness. Here's What You'll Need (Basic Qualifications) Ph.D. in a scientific field, such as chemistry, biochemistry, or biology with 3+ years of experience in Bioanalytical Sciences/regulated bioanalysis. M.S. with at least 7 years of bioanalytical experience will also be considered. Strong knowledge of critical reagents management as well as current industry best practices and regulatory requirements. Deep understanding of Proteomics/Protein mass spectrometry for PK and biomarker analysis Demonstrated ability to work collaboratively with cross-functional teams to achieve shared goals. Excellent organizational, analytical, and problem-solving skills. Proven ability to manage multiple projects simultaneously and prioritize tasks in a fast-paced environment. Here's What You'll Bring to the Table (Preferred Qualifications): Experience with the Biophysical Characterization of Biologics (LCMS, SDS-PAGE, cIEF, SPR, BLI, SEC-HPLC, SEC-MALS, UV-VIS) Experience working in a GLP environment (ELN/LIMS/automation) Experience with HRMS and software for protein analysis/characterization At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you-at work, at home, and everywhere in between. Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs A holistic approach to well-being, with access to fitness, mindfulness, and mental health support Lifestyle Spending Accounts to personalize your well-being journey Family planning and adoption benefits Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown Savings and investment opportunities Location-specific perks and extras About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Our Working Model As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal Opportunities Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accommodations We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com. Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. #LI-NB1 -

+ The ideal candidate will be a highly experienced Project Manager with a strong background in biotech or pharmaceutical manufacturing, specifically supporting new product introductions (NPI) and facility expansions. + They should have a minimum of a bachelor's degree in science, engineering, or management and at least 7 years of relevant experience (15+ years preferred). The candidate must demonstrate hands-on experience managing end-to-end project schedules, coordinating across cross-functional stakeholders including Process Development, Capital Projects, and Supply Chain. + Strong knowledge and experience with Smartsheet, NPI variations, and Change Control generation, implementation, and closeout are required. + Strong communication, organizational, and risk mitigation skills are essential. This role requires full onsite presence in New Albany, OH, with occasional extended hours during peak project phases. **Top must have skills:** + Project management + Smartsheet + NPI variations + Change control **Preferred Qualifications:** + Bachelor's degree or higher in Chemistry, Biochemistry, or a related scientific discipline. + Minimum of 4 years of relevant laboratory experience in a GMP pharmaceutical or biopharmaceutical manufacturing environment, with a strong background in analytical testing. + Proficient in analytical laboratory techniques and instrumentation + Familiarity with laboratory systems such as LIMS and LMES/CIMS. + Demonstrated understanding of industry regulations, data integrity, and compliance standards. + Strong technical writing, documentation, and communication skills. + Experience with method and equipment validation, including verification, transfer, and change control + Excellent interpersonal skills with the ability to collaborate across teams and adapt to varying communication styles.. **Responsibilities include:** + Leading the NPI's for necessary process, facility, equipment, materials, and training modifications; + Development of project execution plans; ensuring process requirements are effectively transferred into manufacturing; and coordination/execution of NPI activities, + Change control management, + Manufacturing process modifications, equipment and technology implementation (design through qualification), and supporting manufacturing readiness activities + Engage with network partners to develop process and technology strategies that achieves clinical/commercial development schedules while minimizing transfer risks. + Facilitate the development and optimization of NPI business processes + Collaborate with Combination Product Operations, Quality, and Regulatory partners to manage change control processes and respond to regulatory questions and/or audit findings within the scope of the NPI + Support generation, revision, review, execution, and approval of relevant technical documents (e.g., manufacturing procedures, protocols, training materials, design control deliverables, and specifications). + Ensure design/process transfer requirements are appropriately implemented and aligned with current manufacturing strategies + Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations. **Project management skills** + Strong organizational skills, including ability to follow assignments through to completion + Initiate and lead cross-functional teams + Collaborate and communicate with higher-level outside resources + Skill, knowledge, and experience with processes involved in manufacturing and distribution, QA, QAL, validation, and process development + Strong communication (both written and oral), facilitation, and presentation skills + Strong skill in working independently and effectively interacting with various levels + Ability to lead and influence staff outside own organization + Ability to motivate staff and manage and distribute workloads + Able to manage performance issues and conflict + Ability to provide direction and establish goals for individual staff members and work group + Ability to evaluate documentation/operations according to company and regulatory guidelines + Ability to interact with regulatory agencies + Demonstrate the company's Values/Leadership Practices **Basic Qualifications** + Doctorate degree and 3 years of experience OR + Masters degree and 5 years of experience OR + Bachelors degree and 7 years of experience OR + Associates degree and 12 years of experience OR + High school diploma / GED and 14 years of experience **About US Tech Solutions:** US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit ************************ US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Essential Job Functions: Attends work on a regular and predictable schedule in accordance with agency leave policy and performs other duties as assigned. (40%) Enters complex patient, specimen and test information into the Laboratory Information Management Systems (LIMS) computer system. Process a minimal of 210-450 submission forms daily. Enters 80 submission forms per hour. Determines if additional information is necessary to process test reports. Completes work according to established deadlines. Permits no more than eighteen documented entry errors per year. Performs all tasks according to the Standard Operating Procedural (SOP) manual. (40%) Prints patient and specimen demographics and verifies all information entered on no less than 210-450 forms per day. Edits any information that was entered incorrectly and releases that work, same day. Process submission forms for archiving. Permits no more than eighteen documented errors of miss-caught information per year. Performs all tasks according to SOP manuals. (10%) Run end of day reports, filing, enter PKU monitoring, enter Unsatisfactory specimens, enter clinical chemistry, creating boxes for filing, running newborn screen queries, pick up microbiology and newborn screen submission forms, enter rabies specimens, reading and responding to email from lab personnel in a timely manner. (5%) Other duties as assigned include but are not limited to actively participating and/or serving in a supporting role to meet the agency's obligations for disaster response and/or recovery or continuity of operations (COOP) activation. Such participation may require an alternate shift pattern assignment and/or location. (5%) Supports the creation of a laboratory-wide safety culture by serving as a liaison to the Safety Office to ensure a healthy and safe workplace. Knowledge Skills Abilities: Knowledge of modern office practices Knowledge of and ability to work with confidential medical records/files/information Knowledge of medical terminology Skill in written and verbal communication Skill to perform task with a high degree of accuracy and paying close attention to detail Skill in data entry Ability to work with confidential material Ability to communicate to the public in a diplomatic, courteous, and objective manner Ability to prioritize work, manage time effectively and meet deadlines Ability to daily make quick rational decisions; work independently in fast paced/stressful situations Ability to work well with others as a team member Ability to handle multiple tasks at a time Must be able to type 55 words per minute Registration or Licensure Requirements: N/A Initial Selection Criteria: 1 year experience in data entry in public/private sector. Experience in proofreading and/or editing, performing quality assurance checks and/or analyze documents. Preferred experience working with confidential material. Additional Information: Requisition Number 533568 MOS Code: There are no direct military occupation(s) that relate to the responsibilities, and registration or licensure requirements for this position. All active duty, reservists, guardsmen, and veterans are encouraged to apply if they meet the qualifications for this position.

Established in 1991, Collabera has been a leader in IT staffing for over 22 years and is one of the largest diversity IT staffing firms in the industry. As a half a billion dollar IT company, with more than 9,000 professionals across 30+ offices, Collabera offers comprehensive, cost-effective IT staffing & IT Services. We provide services to Fortune 500 and mid-size companies to meet their talent needs with high quality IT resources through Staff Augmentation, Global Talent Management, Value Added Services through CLASS (Competency Leveraged Advanced Staffing & Solutions) Permanent Placement Services and Vendor Management Programs. Collabera recognizes true potential of human capital and provides people the right opportunities for growth and professional excellence. Job Description Role & Responsibilities • Remote configuration of TIRKS database (Layer 1 physical connection/design work) using TIRKS front end to design/provision/create end-customer fiber-based data circuits to ASR9Ks • Position will also be trained in a database that has been recently installed into the customer. This data base will be the front end to the TIRKS database and some other customer specific SQL based databases. • Work can be done remotely after training, part of a larger TIRKS design team with 15+ people • Initial travel to Denver Colorado, for orientation, project overview, and initial training apart from that its an remote work. Qualifications Minimum Qualifications • LIMS and TIRKS SME for provisioning/designing fiber based data circuits (Layer 2 and Layer 3 configuration) • (Telecordia database for managing network data circuits - 10G, 1G, 100G, OC12/OC48/DS3/T1 etc.) Additional Information To schedule your interview or for more details , Please send your resume to **************************** contact : Ankur Doshi 973 - 852 -1394

Advanced Drainage Systems is a leading manufacturer of stormwater and onsite septic wastewater solutions, committed to sustainability and innovation. With a vast manufacturing and distribution network, we deliver high-quality products across multiple industries while recycling over half a billion pounds of plastic annually. At ADS, we foster a culture where diverse perspectives drive better ideas, ensuring every employee feels valued, heard, and empowered to make an impact. Responsibilities Advanced Drainage Systems Inc. is the leading manufacturer of high-performance thermoplastic corrugated pipe providing a comprehensive suite of water management products and drainage solutions. The Material Science Lab Technician is part of a team responsible for all aspects of materials technology development including recycle material utilization and the design and formulation of low cost/higher performance material solutions. In this role the candidate will work closely with a team of technicians and engineers to process and test new resins, additive technologies, and formulations. This position has a dual focus including both processing of materials and performance testing. The candidate will be responsible for operating/maintaining process and test, documenting and analyzing results, and maintaining an organized and safe laboratory environment. Primary Responsibilities: Operate laboratory process equipment such as extruders, injection molder, and lamination press. Perform routine and non-routine material testing using a wide variety of laboratory test instruments involving chemical, mechanical, microstructural, and environmental equipment. Record all data and results into a lab management system (LIMS). Resolve problems by examining and evaluating data and identifying corrective actions. Assist in developing and writing standard operating procedures. Responsible for maintenance and calibration of assigned equipment. Ensure all safety guidelines are always followed and maintain a clean and orderly work environment. Update job knowledge by participating in educational opportunities and researching areas of business interest. Job Skills: Ability to prioritize and manage time effectively. Basic understanding of thermoplastic polymers and recycled materials. Hands-on experience running laboratory and pilot scale extrusion equipment. Technical curiosity & enthusiastic approach to solving technical challenges. Able to perform basic mathematical calculations (i.e., unit conversions). Effective communication skills - verbal and written. Proficient in MS Office software (Excel, Word, etc.) Willing to travel as required. Education Requirements: High school diploma or general education (GED), associate or bachelor's degree in a scientific field preferred. Minimum Preferred Experience: 5-8 years lab experience with H.S. Diploma 3-5 years lab experience with associates degree Experience running lab process equipment (i.e., extruder, lamination press, extruder, injection molder, etc.) Experience working with lab test equipment (i.e., chemical, physical, microstructural, environmental, etc). Physical Requirements: Able to perform physically demanding work such as moving and lifting equipment, standing for long period of time, etc. #LI-CH1 #LI-Onsite Company Benefits: Health & Welfare Benefits: Medical and prescription drug plans, telemedicine (with medical plan), dental and vision plans, virtual physical therapy*, an employee assistance program (EAP)*, and voluntary accident, critical illness, and hospital indemnification programs. Financial Benefits: Retirement 401k program with company match, an employee stock purchase plan (voluntary), financial wellness planning*, paid parental leave*, flexible spending accounts (FSA) for child care and health care, short-term and long-term disability*, basic life insurance, accidental death and dismemberment (AD&D)*, adoption financial reimbursement*, tuition reimbursement*, voluntary life insurance (for employees, spouses, and children), and voluntary identity theft and fraud protection. *100% paid by ADS. Why Join ADS? Growth Opportunities & Global Presence: With a global network of approximately 70 manufacturing plants and 40 distribution centers, ADS offers extensive opportunities for career growth and development in various locations around the world. Inclusive and Creative Work Culture: ADS fosters a culture of passion, innovation, and continuous improvement, empowering employees to shape industry-leading solutions. We value diverse perspectives, recognizing that they drive better ideas, processes, and performance. Our workplace is built on respect, inclusivity, and shared responsibility, ensuring every team member feels valued and contributes to our collective success. Innovative & Sustainability Focused: Advanced Drainage Systems is one of the largest plastic recyclers in North America, ensuring over half a billion pounds of plastic is kept out of landfills every year. Learn More: ******************************** EEO Statement ADS supports an inclusive workplace that values diversity of thought, experience, and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. ADS is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

Job Description 100% remote. Our direct client has an opening for a Java Developer 11628-1 is up to 12 months, with the option of extension, in Columbia, SC Please send rates and a resume. W2 only, no Subs allowed. Mon -Fri 8am-5pm. Must be able to work EST standard hours. Could be occasional after-hours/weekend support. Will be coordinated as-needed. This is EST Hours - please ensure candidates submitted understand and can work this time zone. We do not require the candidate(s) to reside in the Eastern Time Zone, but they will be required to work in the EST. We prefer people to start between 7 & 9 AM (finishing between 4 & 6 PM). DAILY DUTIES / RESPONSIBILITIES: The candidate will work closely with other members of the Systems Integration (SI) team, the vendor Conduent, and various programs within the Public Health agency. They will coordinate with the SI Section Manager and Team on daily assignments / tasks. The candidate should be self-motivated, team-oriented, work under limited supervision, and respond to priority tasks. The candidate must be able to independently research and design processes, create specifications, develop, lead testing, perform code reviews, actively engage with the team and stakeholders, attend meetings, provide leadership and guidance, and respond promptly. Team / Project Lead experience is preferred. Emphasis for the programmer candidate will be on the Electronic Disease Surveillance System, currently the Conduent Maven “SCION” system. This will include related upgrades and enhancements, creation and modification of system integrations, and implementation support including configuration, testing, troubleshooting, and documentation. They will independently troubleshoot complex system issues, review logs and remediate errors. The candidate will lead technical and program area staff providing guidance on configuration, data modeling, workflows, data denormalization and reporting. The programmer will perform advanced SQL queries and data optimization, back-end integration (i.e. HL7 v2.x / FHIR, XML, ELRs, CDAs / eICRs into Maven), and implement process and performance improvements. The position will plan and provide testing and validation support and guidance. They will document functional requirements, technical processes, and workflows as needed. Work will use agency frameworks following agency, industry, and security guidelines and best practices. The candidate will provide Tier 2 support for existing lab testing, lab information systems, disease surveillance systems and integrations including but not limited to OpenELIS, PHINMS, Rhapsody, REDCap, Power BI, and other in-house systems. Specific Programmer duties and responsibilities will include but are not limited to the following: • Rapidly learn and become an expert in the state's Electronic Disease Surveillance System (EDSS), currently the Java-based Conduent Maven product, and associated business processes • Master technical and business concepts in multiple disciplines / processes • Work with the EDSS vendor and IT teams to compile and deploy new releases • Lead and environment upgrades including Conduent Maven (Tomcat, Java), Rhapsody, PHINMS, etc. • Ensure maximum system uptime for critical components to ensure business continuity • Perform proactive application log reviews and automate process notifications (errors, exceptions, failures, etc.) • Independently diagnose, isolate and debug problems and perform problem resolution • Report and track bugs using JIRA for vendor assessment and remediation • Lead the implementation of data denormalization and warehousing processes • Optimize SQL and expression-based workflows, data denormalization, and SQL persistence through Hibernate (ORM) • Back-end processing of HL7 (v2.x / FHIR), XML, ELRs, CDAs (eICR), etc. into Conduent Maven • Guide developers and customers in business and data modeling using complex logic and industry best practices • Work with team members and customers to ensure all code is versioned through appropriate code repositories (SVN, Git) • Perform and participate in code reviews for authored, team written, and vendor suggested changes. Implement reviewed changes into Production. • Assist with data migrations and database migration related code changes, testing, and validation • Work collaboratively to conceptualize total systems and/or product solutions currently in place • Prepare and maintain system documentation, project documentation and architecture diagrams for applications assigned • Ability to plan, organize, review and implement associated project milestones to completion. Ability to delegate, track and evaluate tasks as needed. • Provide updates to the Project Team, Management and / or Stakeholders • Guide and advise the team on best practice and techniques. Mentor the technical team and junior developers on advanced topics. • Perform complex programming functions, assistance, and technical advice including design architecture, configuration, implementation, testing, and documentation of agency computer systems as assigned. • Ensure adherence to agency Information Technology application development standards and security requirements. Modify existing computer systems to be compliant. • Assist with the development of policies and procedures to conform and comply with agency standard cyber security policy design related to information risk management, designation of data as to criticality, confidentiality, and protection. (NIST 800-53, FISMA, SC InfoSec Requirements **************************************************************************** etc.) The position will be utilized for 40 hours per week for the duration of this project. The selected candidate may be able to work flexible hours during the week to provide coverage on weekends. Total week hours (to include the weekend) should not exceed 40 unless approved in advance (i.e., hours worked on Saturday and/or Sunday would be deducted from hours worked Mon-Fri). This position would need to be available to support critical systems during business hours, on off-hours, and weekends. The candidates will work closely with the Systems Integration Section Manager to identify, prioritize, schedule, and delegate workload and implementation to IT standards and procedures. The candidate will work closely with customers and subject matter experts for system design and testing. This will also include compliance with DPH security policy/procedures as well as integrating systems, when possible, to streamline staff workflows, user security, and data correction. Module support of the project. • DPH will require that selected personnel sign the DPH confidentiality agreement and/or Business Associate (BA) agreement if applicable. • DPH will not accept any offers including an “up-lift” charge. The rate paid per consultant must not exceed the maximum rate established for this position described in the State contract terms. • Follow agency IT Standards, policies, and procedures to include documentation. • All source code (compiled and un-compiled) will become the sole property of the South Carolina Department of Public Health. Any source code, data, product, or functionality resulting from this SOW or previously owned/developed by DPH will remain the sole property of DPH and is not to be incorporated into the core product of any vendor's application. Any modifications and interfaces developed under said contract will not be used by the contractor for any independent project of the contractor or published or publicized by the contractor without written permission of DPH. • DPH has the final say on all programming choices. Payment Schedule: All timesheets shall be entered and approved in a timely manner per State contract terms. The State will not pay any extra costs (i.e. Travel, employee benefits, insurance, room and board, etc.) for temporary employees under this contract. DPH Support: DPH will provide: • All required information including formulas, data, and mechanisms to check output. • Staff to assist with any application or data questions. • Conference rooms and scheduling for any application demos. • A local workstation and required . REQUIRED SKILLS (RANK IN ORDER OF IMPORTANCE): 1. Java Experience 2. Tomcat / Apache 3. MS T-SQL (STORED PROCEDURES, ADVANCED QUERIES, OPTIMIZATION) 4. XML / XSD / XSLT 5. Hibernate (Java) 6. Configuration Management 7. Release Management 8. Source Code Management (SVN, Git) 9. Azure DevOps / JIRA / Remedy 10. HL7 (V 2.3.1 - 2.5.1) PREFERRED SKILLS (RANK IN ORDER OF IMPORTANCE): 1. Team / Project Management 2. Conduent Maven 3. PUBLIC HEALTH / DISEASE SURVEILLANCE SYSTEMS / LIMS EXPERIENCE 4. LOINC / SNOMED 5. Ant 6. Performance Testing 7. WEB SERVICES (REST, SOAP, WSDL) 8. LYNIATE RHAPSODY (V 6+) 9. Excellent written, oral, and interpersonal communication skills 10. CRITICAL THINKING SKILLS AND PROBLEM RESOLUTION REQUIRED EDUCATION: Bachelor's or Master's Degree in a relevant field of work or SQL Server tools: Profiler Yes 3 Advanced SQL Tuning Yes 3 Intermediate Apache Yes 2 Lead Source Code Management Yes 8 SubVersion (Source Control) Yes 8 T/SQL Queries Yes 3 Advanced Configuration management Yes 6 Ability to deal effectively with the needs of technical peers, technical and user management, users, vendors, and staff members, and to communicate clearly and effectively in spoken and written form No 9 Maven No 2 Performance testing No 6 Time Management No 1 Remedy Yes 9 Tomcat Yes 2 Lead Release Management Yes 7 Management No 1 Project planning experience, including effort estimation on technical tasks and resource allocation No 1 Supervisory Leadership Experience No 1 Java Yes 1 Lead SVN Yes 8 TRANSACT-SQL Yes 3 Advanced TSQL stored procedure Yes 3 Advanced XML (XSLT, XPath, XQuery etc.) Yes 4 RHAPSODY RHAPSODY No 8 Hibernate Yes 5 JIRA framework Yes 9 Knowledgeable in various Data Integration technologies No 8 ANT No 5 WEB SERVICES (REST, SOAP, WSDL) No 7 Additional Skills: REQUIRED SKILLS (RANK IN ORDER OF IMPORTANCE): 1. Java Experience 2. Tomcat / Apache 3. MS T-SQL (STORED PROCEDURES, ADVANCED QUERIES, OPTIMIZATION) 4. XML / XSD / XSLT 5. Hibernate (Java) 6. Configuration Management 7. Release Management 8. Source Code Management (SVN, Git) 9. Azure DevOps / JIRA / Remedy 10. HL7 (V 2.3.1 - 2.5.1) PREFERRED SKILLS (RANK IN ORDER OF IMPORTANCE): 1. Team / Project Management 2. Conduent Maven 3. PUBLIC HEALTH / DISEASE SURVEILLANCE SYSTEMS / LIMS EXPERIENCE 4. LOINC / SNOMED 5. Ant 6. Performance Testing 7. WEB SERVICES (REST, SOAP, WSDL) 8. LYNIATE RHAPSODY (V 6+) 9. Excellent written, oral, and interpersonal communication skills 10. CRITICAL THINKING SKILLS AND PROBLEM RESOLUTION REQUIRED EDUCATION: Bachelor's or Master's Degree in a relevant field of work or equivalent work experience REQUIRED CERTIFICATIONS: NONE By replying to this job advertisement, I agree I want to receive additional job advertisements from FHR, including email, phone and mail to the contact information I am submitting. I consent to Focused HR Solutions, its affiliates, third parties and partners processing my personal data for these purposes and as described in the Privacy Policy. I understand that I can withdraw my consent at anytime. --

Ready to redefine what's possible in molecular diagnostics? Join a team of brilliant, passionate innovators who wake up every day determined to transform healthcare. At BillionToOne, we've built something extraordinary-a culture where transparency fuels trust, collaboration drives breakthroughs, and every voice matters in our mission to make life-changing diagnostics accessible to all. We don't just aim for incremental improvements; we strive to build products that are 10x better than anything that exists today. Our people are our greatest asset: talented scientists, engineers, sales professionals, and visionaries united by an unwavering commitment to changing the standard of care in prenatal and cancer diagnostics. This is where cutting-edge science meets human compassion-every innovation you contribute helps remove fear of unknown from some of life's most critical medical moments. If you're driven by purpose, energized by innovation, and ready to help build the future of precision medicine, this is where you belong. We are looking for a Senior LIMS Associate to join our Automation team in support of clinical patient testing in our high-throughput CLIA lab. The Senior LIMS Associate will be responsible for (1) Supporting smooth and continued operation of clinical workflows, (2) Troubleshooting, investigating, and performing corrective actions for non-conformance reports in a timely manner, (3) Developing tools, scripts, and apps to provide self-service options for non-standard functions to LIMS operators. This role will help to build upon the strong technology and execution found at BTO. This is considered an onsite role at our Union City lab, with flexibility to work from home or at our Menlo Park site when applicable. Responsibilities: Support operators in resolving LIMS issues to minimize sample turnaround time Investigate the root cause of uncommon issues and propose solutions Triage & escalate unresolved technical issues to appropriate team members Monitor sample queues and follow up on unresolved issues or delays Assist in testing and documenting new LIMS workflow versions Assist in performing LIMS code reviews, verifications, and validations Ensure compliance to all relevant corporate and regulatory requirements Requirements: Bachelor's degree with Biological or Computational focus (e.g. Bioinformatics) Proficient in Python 1+ Years Experience bench work experience 2+ Years Experience with developing LIMS, apps, or customer-facing tools (or 0 years with a Master's Degree) Ability to troubleshoot and diagnose advanced technical issues Experience developing scripting solutions to automation problems, especially in a fast paced/agile setting Strong attention to detail and ability to work flexibly and well under given timeframes Highly organized, strong written and verbal communication skills Creative problem-solver that finds a way to get things done Enjoy a wide variety of daily tasks in a fast-paced, time-sensitive environment Nice-To-Haves: Experience with Clarity LIMS (Especially Python API) Experience working in CLIA Lab, medical device, or pharma Experience with data analysis using Python, SQL, or Excel Familiarity with Quality Management Systems and related regulations (CFR 21 Part 11, ISO 13485, etc) Benefits And Perks: Working alongside brilliant, kind, passionate and dedicated colleagues, in an empowering environment, toward a global vision, striving for a future in which transformative molecular diagnostics can help millions of patients Open, transparent culture that includes weekly Town Hall meetings The ability to indirectly or directly change the lives of hundreds of thousands patients Multiple medical benefit options; employee premiums paid 100% of select plans, dependents covered up to 80% Extremely generous Family Bonding Leave for new parents (16 weeks, paid at 100%) Supplemental fertility benefits coverage Retirement savings program including a 4% Company match Increase paid time off with increased tenure Latest and greatest hardware (laptop, lab equipment, facilities) Free daily on-site lunches provided from top eateries A variety of perks on campus (state of the art gym, restaurant) Free on-site EV charging (compatible with all EVs, including Tesla) At BillionToOne, we are proud to offer a combination of a (1) base pay range (actual amount offered is based on experience and salary/equity options split that the candidate chooses), (2) generous equity options offering, (3) corporate bonus program, on top of (4) industry leading company benefits (free healthcare options, 401k match, very generous fully paid parental leave, etc.). For this position, we offer a total compensation package of $101,312-$136,161 per year, including a base pay range of $73,920-$105,601 per year. BillionToOne is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. For more information about how we protect your information, we encourage you to review our . About BillionToOne BillionToOne is a next-generation molecular diagnostics company on a mission to make powerful, accurate diagnostic tests accessible to everyone. Our revolutionary QCT molecular counting technology enhances disease detection resolution by over a thousandfold using cell-free DNA-a breakthrough that's already transformed the lives of over half a million patients worldwide. Our Impact: We've pioneered game-changing diagnostic solutions that are redefining industry standards. Unity Complete™ stands as the only non-invasive prenatal screen capable of assessing fetal risk for both common recessive conditions and aneuploidies from a single maternal blood sample. In oncology, our Northstar liquid biopsy test uniquely combines treatment selection with real-time monitoring, giving oncologists unprecedented precision in cancer care. Our Growth: From $0 to $125 million in Annual Recurring Revenue in just four years. We've raised close to $400 million in funding, including a $130 million Series D round in June 2024, achieving a valuation of over $1 billion. This backing comes from world-class investors including Hummingbird, Adams Street Partners, Neuberger Berman, Baillie Gifford, and Premji Invest. Our Recognition: Forbes recently named us one of America's Best Startup Employers for 2025, and we were awarded Great Place to Work certification in 2024-with an incredible 100% of our people reporting they are willing to give extra to get the job done. These honors recognize not just our innovation but the exceptional culture we've cultivated-one that remains authentically collaborative and transparent even as we've scaled. Our Future: Headquartered in Menlo Park with facilities in Union City, California, we're continuing to push the boundaries of what's possible in molecular diagnostics. Recent clinical outcomes data for Unity Fetal Risk Screen and new advances in cancer diagnostics prove we're just getting started. At BillionToOne, you'll join a diverse team of passionate innovators who believe that the best science happens when brilliant minds collaborate openly, think boldly, and never lose sight of the patients whose lives depend on our work. Ready to help us change the world, one diagnosis at a time? Learn more at ********************

Before we opened Strive Pharmacy we were unsatisfied with the current state of the pharmaceutical industry. Most of the current pharmaceuticals only offer a one size fits all approach and often come with unwanted and potentially dangerous side effects. We found that through compounding we can offer a much more personalized solution to medicine. Through this we have been able to help patients get the results they are seeking for their personal needs. After years of working for corporate chains we took the risk and opened Strive Pharmacy. We are dedicated to providing a better experience for each customer and clinic that we work with. Come see the Strive difference. Our Mission We're flipping the script with personal medicine. We strive to interrupt an industry that has been closed to personalized care, accessibility, and nuance for too long. We strive to shift a reactive view of self-care and ignite a proactive baseline-shifting approach to health for all. ‘The human element' is our crux and catalyst, driving all that we do, whether we're interacting with patients, providers, or practices. We're here to partner with those ready for a change. More than a compounding pharmacy, we're on a mission to positively disrupt healthcare as we know it. Strive is about more than medicine. Strive is about striving for the personal side of healthcare. Position Overview: The Product Director for Pharmaceutical Products is responsible for defining, building, and scaling a best-in-class portfolio of pharmaceutical solutions that drive patient outcomes, provider loyalty, and organizational growth. This role owns end to end product strategy including market research, clinical and regulatory alignment, pricing strategy, product lifecycle management, commercialization, and cross functional execution. The Product Director will partner with key stakeholders across Strive to align all organizations within are driving to a common mission. Salary Range: $160,000 - $170,000 Location: Remote + 25% travel Key Responsibilities: Product Strategy & Vision Facilitate the development of multi-year product strategies and roadmaps across sterile and non-sterile compounding, specialty pharmaceuticals, and emerging therapies. Use their experience from previous markets to help translate and relay to the product owner market trends. Assist in evaluating new product opportunities based on market size, regulatory implications, financial ROI, and alignment to company mission. Execution & Delivery Mentor Product Owners in the end to end lifecycle from concept through launch to maturity and retirement. Establish and maintain a clear, prioritized backlog and ensure alignment with engineering, data, and operations. Develop launch plans including business case, pricing, go-to-market strategy, and lifecycle forecasting. Commercial & Market Partnership Collaborate with Sales and Marketing to position products effectively, enabling revenue growth and competitive market entry. Engage directly with healthcare providers, pharmacists, and payors to gather customer insights and build meaningful relationships. Stakeholder Management Act as the primary liaison between the Product, Engineering, and Operations teams ensuring seamless communication and alignment. Translate complex business needs into scalable solutions. Present roadmap updates and performance metrics to executive leadership. Data & Continuous Improvement Partner with Data Analytics for insights to measure success, improve efficiency, and drive feature adoption. Monitor key product performance indicators (time savings, user satisfaction, automation ROI, etc.). Lead retrospective sessions to identify process improvements and accelerate delivery. Qualifications: Bachelor's degree in Business, Product Management, or related field. 8+ years of experience in product management or product operations (healthcare or technology preferred).. Strong technical acumen, able to collaborate with developers and data teams. Exceptional communication and organizational skills. Proven track record of leading and developing high performance teams High bias for action, ownership, and continuous learning. Bonus Qualifications: Background in pharmacy systems, healthcare SaaS, or regulated industries. Experience with Agile methodologies and tools (Jira, Asana, etc.). Knowledge of integrations between clinical systems (e.g., EMR, LIMS, or pharmacy workflow automation). Annual Salary$160,000-$170,000 USDBenefits/ Perks Strive Pharmacy provides a comprehensive benefits package that encompasses various perks such as employer paid healthcare coverage available after 30 days of employment, the choice of an FSA/HSA, a voucher for new hire scrubs (if applicable), parental leave, a 401(k) plan with matching contributions, and the benefit of weekends and holidays off. FREE COMPOUNDED MEDS to employees and immediate family members. Culture At Strive, culture plays a fundamental role in shaping our workplace atmosphere. Beyond our exceptional benefits package, we foster a sense of community. Throughout the year, we arrange various holiday potlucks and festive celebrations. Strive is committed to promoting both personal and professional development, striving for our employees to excel and grow in every aspect of their lives, both within and outside of the workplace. EEO Strive Pharmacy is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristics as outlined by federal, state or local laws. Disclaimer*** Please do not call the pharmacy location with questions about your application or interview. A talent acquisition partner will reach out to you.

The Role We are seeking a methodical, detail-oriented Associate GxP IT Engineer to provide hands-on technical support for endpoints, laboratory instruments, and connected devices operating in Moderna's regulated (GxP) environments. This role is critical to maintaining the reliability, compliance, and cybersecurity of IT systems that support our manufacturing and laboratory operations. You will be part of the global GxP IT Support team, delivering consistent, high-quality service through disciplined execution of established processes, rigorous documentation, and adherence to security and compliance standards. You will ensure that workstations, analytical instruments, printers, and related systems remain compliant, connected, and protected against cybersecurity threats. The ideal candidate is organized, pragmatic, and process-driven-someone who values precision, documentation, and security as essential to operational excellence. This position offers an opportunity to contribute directly to Moderna's mission by strengthening the reliability and compliance of digital systems supporting product development and manufacturing worldwide. Here's What You'll Do * Provide hands-on technical support for endpoints, laboratory instruments, and connected devices in GxP-regulated manufacturing and lab environments. * Perform configuration, maintenance, and lifecycle management of GxP endpoints and instrument-connected PCs in accordance with approved SOPs and IT processes. * Troubleshoot and resolve issues involving systems such as MES (Syncade), DeltaV, OSI PI, BMS, ThinManager, and Zebra label printers, escalating complex problems as needed. * Partner with automation, lab, and manufacturing teams to ensure systems and instruments are properly installed, qualified, and supported through their lifecycle-from deployment to decommissioning. * Collaborate with Digital Core, Cybersecurity, and Quality teams to maintain compliance with Moderna's IT and regulatory standards, including patching, vulnerability remediation, access control, and endpoint protection. * Participate in incident, problem, and service request management, maintaining complete and audit-ready documentation of activities and outcomes. * Execute all work under defined change control and validation procedures, ensuring systems remain compliant and secure. * Contribute to developing and maintaining standard operating procedures, work instructions, and technical documentation to ensure consistent and compliant operations across global sites. * Identify and recommend improvements that strengthen system reliability, cybersecurity posture, and service efficiency. Here's What You'll Need (Basic Qualifications) * Bachelor's degree in Computer Science, Information Technology, Engineering, or a related field-or equivalent relevant experience. * 3 or more years of hands-on experience supporting GxP IT systems, laboratory instruments, or manufacturing technology in a pharmaceutical, biotech, or similarly regulated environment. * Solid understanding of GxP principles, computerized system validation (IQ/OQ/PQ), and regulated documentation practices. * Proven ability to follow and maintain standard operating procedures, work instructions, and controlled documentation. * Experience supporting or integrating systems such as MES (Syncade), DeltaV, OSI PI, BMS, LIMS, and ThinManager. * Strong technical skills supporting and securing Windows endpoints and instrument-connected PCs. * Familiarity with cybersecurity controls, endpoint protection platforms, access management, and vulnerability remediation. * Working knowledge of IT Service Management (ITSM) processes (incident, change, and problem management) and experience working in audit-ready environments. * Excellent communication, documentation, and organizational skills, with a focus on consistency, accountability, and security-conscious execution. * At Moderna, we are focused on delivering on our mission by enabling talent to thrive. For this role, we are currently unable to offer immigration sponsorship. Candidates must already hold work authorization in US and be able to maintain that status without the need for future sponsorship. Here's What You'll Bring to the Table (Preferred Qualifications) * Process-oriented and methodical approach with strong analytical and troubleshooting skills. * Demonstrated ability to maintain precision and discipline under pressure while supporting critical operations. * Commitment to following validated procedures, maintaining secure configurations, and documenting activities thoroughly. * Ability to collaborate effectively with IT, Automation, Manufacturing, Quality, and Cybersecurity teams. * Strong sense of ownership, accountability, and dedication to maintaining a secure and compliant digital environment. * Adaptable, organized, and consistent in managing multiple priorities while upholding high standards of security and compliance. * Collaborative mindset with a focus on partnership, transparency, and continuous improvement within a global, cross-functional team. Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you-at work, at home, and everywhere in between. * Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs * A holistic approach to well-being, with access to fitness, mindfulness, and mental health support * Family planning benefits, including fertility, adoption, and surrogacy support * Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown * Savings and investment opportunities to help you plan for the future * Location-specific perks and extras The salary range for this role is $89,900.00 - $143,800.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual's position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance. About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Our Working Model As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal Opportunities Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accommodations We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com. Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. #LI-CK1 *