LabConnect

Role Description The Temp, GSPN Harmonization Specialist provides support for the Global Sample Processing Network (GSPN), Global Harmonization Program, as well as technical inquiries from various departments regarding clinical protocols, specialized testing strategies, and budgeting requirements. The role will support GSPN project initiation, network expansion, and data monitoring efforts as well as supporting data monitoring and laboratory compliance for the Global Harmonization program. Please note: this is a remote, full-time temporary role that is expected to end in September. Essential Duties and Responsibilities - Support project initiation of GSPN studies including protocol development, timeline management, review of qualification data, troubleshooting, and development of supporting documentation. - Support the identification and capability assessment of new laboratories to expand the GSPN laboratory network. - Ensure compliance of participating laboratories for the Global Harmonization program which may include data monitoring, instrument change management, troubleshooting, and documentation, as necessary. - Act as a main point of contact and liaison between LabConnect and GSPN and Global Harmonization laboratories. - Maintain documentation for participating GSPN and Global Harmonization laboratories. - Perform protocol reviews for new RFPs to identify the testing strategy for LabConnect support. - Submit requests for quotes to partner laboratories and review and advise on which quotes to include in the overall proposal to the sponsor. - Monitor KPI metrics to ensure laboratory performance standards are met in relation to GSPN and Global Harmonization. - Address technical or scientific requests from both internal and external sources, including but not limited to Project Services, Business Development, sponsors, or vendors. - Triage requests as necessary to subject matter experts within the Scientific Affairs, Technical Affairs or Vendor Management groups. - Act as technical/scientific liaison between the client and LabConnect as needed and appropriate via email, client calls and/or meetings. - Review validation plans/reports and laboratory data for accuracy and suitability. - Interact with U.S. and international laboratories and effectively communicate updates, reports, and recommendations to management teams. - Interpret data and KPI metrics and report results to management pertaining to vendor laboratory performance. - Provide technical support to troubleshoot specific issues that impact the project. - Recommend and implement new processes and procedures to standardize, simplify and enhance quality and compliance of the department’s operations. Qualifications - Bachelor's degree in Life Sciences or related field from a four-year college or university. - Two years industry-relevant project management, laboratory and/or operational experience. - Must be experienced in customer service and possess excellent interpersonal skills. - Project Management experience preferred. - Experience with PBMC isolation/DNA extraction preferred. Requirements - Ability to understand GLP documentation and records, scientific and/or operational documents such as SOPs, validation protocols and reports, transfer protocols and reports, and PBMC isolation techniques. - Data review, interpretation, and reporting. - Exceptional attention to detail. - Strong communication and organizational skills. Benefits - Financial Security (Base Pay and Future Eligibility of LabConnect's 401k Plan). - Health Benefits (Medical, Dental, and Vision) beginning on date of hire. - Career growth opportunities globally. - Friendly and collaborative environment with open lines of communication.

Role Description The (Senior) Scientific Project Manager will be responsible for providing project management oversight to a biopharmaceutical client tasked with managing and executing analytical testing, method development and/or validation of such assays as immunoassays, bioassays, pharmacokinetic and/or flow cytometry assays under Good Laboratory Practices (GLP). He/she will provide project management and technical support to teams conducting training, technical transfer, data review and trending analysis. The Sr. Project Manager must have the ability to effectively monitor the performance of CROs and service providers. The incumbent will also be responsible for operational documentation including SOPs, validation protocols and reports, transfer protocols and reports, and management reports. What will you do? - Vendor Management: - Lead the contracting with third-party lab service providers for assay development and validation. - Collaborate with business operations, procurement, and clinical teams to ensure appropriate SOWs and contracts. - Study Coordination: - Manage critical reagent supply and sample analysis. - Work closely with bioanalytical strategy leads, clinical trial teams, and lab service providers to finalize study documents and meet timelines. - Support the development of novel Bioanalytical processes. - Documentation and Data: - Provide input into clinical trial documents (e.g., eCRFs, ICFs, SOWs). - Drive the delivery of data transfer specifications and ensure data accuracy. - Sample Logistics: - Track and reconcile sample testing, resolving any issues that arise. - Contribute to cleaning and finalizing data. Qualifications - Bachelor’s, or Master’s level equivalent degree in Life Sciences or related field, required. - 2 - 3 years' experience in the drug development and/or clinical trial processes for Scientific Project Manager, required. - 5 - 6 years’ experience in the drug development and/or clinical trial processes for Senior Scientific Project Manager, required. - Equivalent amount of experience managing projects, including timelines, budgeting and forecasting. - Experience with method development, validation and troubleshooting. - Extensive knowledge and experience in bioanalysis within regulatory environments (GLP/ GCP) to include experience with PK/ADA and/or biomarker analysis. - Experience working in Oncology is preferred. - PMP certified and formal change management training strongly preferred. - Highly proficient in MS Office Suite, including MS Project, Word, Excel and PowerPoint, Smartsheet and SharePoint. - Strong planning, attention to detail, communication, and organizational skills. - Excellent verbal and written communication skills. Working Hours, Location, Travel - US-based, EST preferred (alignment with working hours). - Fully remote position with potential for <5% travel. Benefits - Financial Security (Base Pay, 401k Match and Possible Annual Bonus Eligibility). - Health Benefits beginning on date of hire. - PTO plan, plus 11 Paid Company Holidays, and 1 Day to Volunteer in your community. - Short and Long-Term Disability, Life Insurance, and AD&D.

Role Description The Research Administrator will be directly responsible for managing a portfolio of outsourced in Vitro and in Vivo analytical work in Discovery Research and ADME. They will also be responsible for providing operational support to a team of Scientific Project Managers and Project Coordinators overseeing biopharmaceutical client research Bioanalytical deliverables across a clinical research portfolio. Support includes: - Management and maintenance of trackers and timelines - Reviewing compound and dosing information - Facilitating communications with client points of contact - Managing and submitting documents to internal client and external vendor laboratory systems - Logistics oversight and escalation and mitigation support - Generating shipping requests - General data entry Qualifications - Bachelor’s degree and related industry relevant experience: administrative support in healthcare, pharma, or biotechnology - OR Two-year college or university program certificate with 5 years of related industry relevant experience: administrative support in healthcare, pharma, or biotechnology Requirements - Strong organizational and multi-tasking skills - Clear and professional communication - Proactive problem-solving and issue resolution - Ability to manage competing priorities under tight deadlines - Comfortable working independently in a remote environment Benefits - Financial Security (Base Pay and Future Eligibility of LabConnect's 401k Plan) - Health Benefits (Medical, Dental, and Vision) beginning on date of hire - Career growth opportunities globally - Friendly and collaborative environment with open lines of communication

Role Description The Senior Biospecimen Project Manager will be the centralized point of contact to drive biospecimen lifecycle management and resulting analytical data from clinical studies. Please note: This is a remote role is open to candidates based in the United States. Candidates located in California are eligible only if they reside outside of the San Francisco Bay Area (defined as locations more than 100 miles from the Bay Area). Responsibilities: - Drive biospecimen lifecycle management from sample receipt to analysis and final disposition - Ensure accurate specimen metadata - Communicate study specimen updates to client groups and stakeholders - Increase the efficiency of specimen management through sharing of knowledge and best practices - Provide site support and drive query resolution - Participate or lead special projects as assigned - Adhere to client policies and Standard Operating Procedures - Review clinical study protocols and service providers’ scope of work documents for sample handling and processing details - Set up and maintain a complex study sample tracker – experience in manual sample tracking for complex clinical studies - Create and manage project plans - Manage data transfer plans with analytical laboratories - Manage data received from external and internal laboratories, including data generated in exploratory studies - Manage specimen metadata discrepancies and ensure resolution - Submit specimens for analytical assays per study timelines - Review status of specimens collected and completeness of data - Contribute to meeting database locks by ensuring all specimens have a final result and data transfer is complete; create reports for data management as needed - Provide guidance to others and act as technical resource within the department - Lead projections for annual and long-term planning to clinical team - Provide oversight and management to junior personnel Qualifications - Understanding of transaction-based inventory and data management systems as well as clinical trial processes - Understanding of ICH, GCP, GLP, and local regulations - LabMatrix experience preferred - Strong excel experience required, extensive macro and template building knowledge desired - Strong computer literacy, including Word, SharePoint, Smartsheet and PowerPoint - Advanced planning, organizational, time management skills Requirements - B.A./B.S. in life sciences, medical technology, or related field and 5-7 years of directly related experience - Experience in life sciences or medically related fields, including clinical development, biospecimen lifecycle management, or clinical laboratory analysis - Project Management experience is also preferred - Very high attention to detail and excellent multi-tasking skills is required for success in this position

Role Description The Bioanalytical Program Lead, supporting an Integrated Bioanalysis (IBA) Global Team, will lead the design and implementation of robust bioanalytical strategies. This role will ensure lab-based activities are aligned with context of use, working closely with other scientific and technical lab staff in a matrix environment to manage aspects such as experimental design and tech transfer in regulated bioanalysis supporting therapeutic modalities across a range of therapeutic areas. Please note: this is a remote role best suited for candidates within proximity to Gothenberg. Essential Duties and Responsibilities - Responsible for interacting closely with scientists who are primarily lab-based, aiding in experimental design where required. - Serve as the bioanalytical lead on the client’s projects, using strategic thinking, scientific knowledge and expertise while working with a range of collaborators and cross-functional groups. - Act as a Subject Matter Expert in regulated bioanalysis across a range of modalities. - Contribute to and author regulatory documents to support submissions across a range of countries and geographies. - Work with regulatory agencies and Health Authorities across a range of countries and geographies to mitigate risk, submit regulatory documents, and respond to Health Authority questions. Qualifications - Bachelor of Science in relevant subject required. - At least 10 years of experience in Bioanalysis required (large and small molecule). - Proven experience required as a Subject Matter Expert in regulated bioanalysis across a range of modalities PK/CK, PD and immunogenicity assessments (cellular and humoral). - Required experience as a bioanalytical lead across diverse project teams - defining, leading and executing on bioanalytical strategy to advance a portfolio that may include Biomarker and Target Engagement strategy for dose decision endpoints. Skills and Ability - Required scientific ability to assess and discern the advantages and pitfalls of a range of analytical techniques which may include molecular assays (ddPCR, 1PCR, RT-qPCR), flow cytometry, ELISpot, viral assays, cytokine assays, ligand binding assays and Mass Spectrometry. - Requires deep understanding of small and large molecule Bioanalysis. - Requires proven publication and presentation record. - Requires exceptional written and verbal communication skills. - Requires proficiency in speaking and writing in the English language. - Preferred knowledge of immunology and/or metabolic diseases. - Preferred experience working in a matrix environment. Physical Demands - Prolonged periods of sitting at a desk and working on a computer. - Prolonged use of computer and headphones for conference calls. - Communicate effectively via phone, video, and email. - Use hands and fingers to operate a computer and other office equipment. Benefits - We truly live our values: People First, Quality Focused, Customer Centered, Technology Driven and Accountability Always. - The opportunity to make a meaningful impact on a passionate and growing team. - Strong communication and collaboration within a smaller sized team. - Access to tools and resources that empower you to excel in your role. - In addition to great perks and challenging work assignments, we invest in our people with enriching career growth opportunities, globally. - We believe in a friendly and collaborative environment with open lines of communication.

Role Description The Senior Scientific Project Manager – Molecular will be responsible for providing project management oversight to a biopharmaceutical client tasked with managing and executing analytical testing, method development and/or validation of such assays as immunoassays, bioassays, pharmacokinetic and/or flow cytometry assays under Good Laboratory Practices (GLP). He/she will provide project management and technical support to teams conducting training, technical transfer, data review and trending analysis. The Senior Scientific Project Manager – Molecular must have the ability to effectively monitor the performance of CROs and service providers. The incumbent will also be responsible for operational documentation including SOPs, validation protocols and reports, transfer protocols and reports, and management reports. Essential Duties and Responsibilities - Lead the design and optimization of bioanalytical assays, addressing critical challenges in tissue handling/processing, sensitivity and specificity, and multiplex assessment of multiple endpoints in a single sample. - Spearhead the strategic planning and execution of ex vivo bioanalytical projects, including the selection of appropriate CROs and assay platforms with attention toward opportunities to cut costs, alleviate risks and drive continuous improvement. - In collaboration with CROs, develop and optimize mRNA, protein, and oligo exposure assays specifically for tissues treated ex vivo with oligonucleotides or gene therapies, with emphasis on nervous system-related tissues. - Coordinate with internal stakeholders including chemistry, biology, and ADME teams. - Develop and validate Protein Biomarker assays for DRG, nerve, and skin tissues. - Leverage expertise in platforms with high levels of sensitivity, including single cell and spatial RNAscope endpoints, to provide a deep, nuanced understanding of RNAi delivery. - Retrospectively evaluate and compare datasets across past experiments to generate understanding of assays performance. - Work with large data sets, using database and/or coding approaches, to organize, interpret, and share results. - Move oligonucleotide projects from preclinical to first-in-human studies, leveraging experience in the use of rodent NHP intrathecal models to rapidly actively advance projects into the clinic. - Interact with U.S. and international CROs and effectively communicate updates, reports and recommendations to management teams. - Provide analytical project oversight by performing data review and trending analysis, evaluate assay quality, monitor performance and manage timelines. - Recommend and implement new processes and procedures to standardize, simplify and enhance quality and compliance of the department’s operations. - Participate in the management and control of GLP documentation and records, and contribute to and (co)author scientific and/or operational documents such as SOPs, validation protocols and reports, transfer protocols and reports, posters, journal publications and other technical reports. Qualifications - PhD in Molecular Biology, Biochemistry, Genetics, or a related field is required, and a focus on RNA biology, RNA therapeutics, and ex vivo tissue analysis is strongly preferred. - Minimum of 5 years of experience in bioanalytical assay development for RNA based therapeutics in a pharmaceutical or biotechnology setting. - Alternatively, MS or BS/BA in indicated fields with a minimum of 10 years of experience will be considered. - Proven experience in overseeing collaborations with external Contract Research Organizations (CROs) and internal ADME teams. - Deep experience in bioanalysis of tissues from rodent and NHP models. Skills and Ability - A thorough understanding of bioanalytical methods with a focus on designing, optimizing, validating, and overseeing molecular, biochemical, or cell-based assays to advance research and drug discovery. - Hands-on expertise in nucleic acid quantification methods including LC-MS, RT-qPCR, SL-qPCR, RNAseq, DNA, and ELISA. - Demonstrated skill in selection, development, and troubleshooting of molecular assays such as ELISA, capillary electrophoresis, bead-based multiplex platforms (e.g. Luminex), Simoa, and MSD. - Proficiency in data handling, analysis, and presentation for large in vivo datasets, using database and/or coding tools (e.g. Spotfire, python). - Entrepreneurial mindset, eager to quickly and efficiently develop and apply endpoints within fast-moving projects. - Adept at adapting strategies based on evolving data, technologies, and portfolio requirements. - Exceptional communication skills, both written and verbal, with the ability to articulate complex scientific concepts to a variety of audiences and demonstrate proficiency in scientific documentation and reporting. - Working knowledge of Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and/or Clinical Laboratory Improvement Amendments (CLIA). - Strategic project oversight in regulated scientific environments. - Strong cross-functional leadership and stakeholder coordination. - Advanced problem-solving and analytical thinking. - Ability to manage vendor relationships and performance. - Adaptability in fast-paced, remote work settings. Benefits - Financial Security (Base Pay, 401k Match and Possible Annual Bonus Eligibility). - Health Benefits beginning on date of hire. - PTO plan, plus 11 Paid Company Holidays, and 1 Day to Volunteer in your community. - Short and Long-Term Disability, Life Insurance, and AD&D.

Role Description LabConnect has an immediate opening within FSP Solutions for a Scientific Project Coordinator. This person will be responsible for providing operational oversight and support for outsourced analytical testing in ADA and PK bioanalysis. Support will include: - Monitoring timelines - Managing documentation and contracts - Maintaining tracking logs - Working with external vendor partners - Facilitating communications - Participating in all aspects of a study life cycle from initiation to closure Responsibilities - Manage analytical method support documentation including dosing documents, reagent qualifications, reagent expiry extensions, and bioanalytical reports. - Manage study timelines and monitor scheduling and conduct of bioanalytical testing to ensure alignment with data transfer deliverable requirements. - Assist with monitoring outsourced bioanalytical method performance and identifying analytical trends. - Communicate project updates and issues to cross functional teams including scientific project managers, internal scientists, CRO staff and operational teams. - Manage and lead recurring cross-functional meeting series. - Assist in facilitating contracts with external suppliers. - Support shipping and reagent requests. - Maintain trackers related to issues and program-specific information. - Support sample disposition requests. - Contribute to the maintenance of external collaboration sites. - Manage logistics for new clinical study initiation. - Participate in and/or lead operational process improvements. Qualifications - B.S., Life Sciences or related field. Master's Degree and/or 2 year degrees may be considered with different levels of work experience. - 4 years of industry-relevant project and/or laboratory management experience, required. - 1 - 3 years of Large Molecule PK/ADA/NAb Bioanalytical bench experience preferred (validation experience in the laboratory is a plus). - Demonstrated project and timeline management skills. - Proactive mindset/self-starter. - Solid organizational skills with attention to detail and ability to develop and follow process. - Strong oral and written communication skills with experience in both strong team collaboration and technical writing. - Experience working with vendors/service providers. - Understanding of clinical trial processes. - Working knowledge of Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and/or Clinical Laboratory Improvement Amendments (CLIA). - Strong computer literacy, including word processing, SharePoint, presentation, and spreadsheet applications. - Ability to work effectively in a cross-functional team matrix environment. Work Hours/Travel - 100% remote with the ability to travel to the client site up to approximately 1 - 2 times per year, on the west coast. - Occasional meetings later in the day may be necessary to accommodate west coast hours. Benefits - Financial Security (Base Pay, 401k Match and Possible Annual Bonus Eligibility). - Health Benefits beginning on date of hire. - PTO plan, plus 11 Paid Company Holidays, and 1 Day to Volunteer in your community. - Short and Long-Term Disability, Life Insurance, and AD&D.

Role Description The Quality Specialist, Sr. is responsible for assisting Quality Leadership with ensuring compliance, optimizing quality processes, and implementing strategic enhancements of the Quality Management System (QMS) in support of clinical trial operational activities. The Quality Specialist, Sr. will serve as administrator for the quality management software (QMS) and is responsible for development, configuration, and management of the QMS. Please note: this is a fully remote role, with candidates required to be based on the east coast. Responsibilities - Supervise and assist in management of QMS Quality Event reporting and related investigation, root cause analysis, proposed corrective and/or preventive measures, and timely closure. - Leads and project manages QMS activities, ensuring robust implementation and continuous improvement of document control, change control, non-conformance reporting, and supplier qualification/requalification processes within the QMS framework. - Communicates with internal team and clients on quality related matters. - Serves as team lead on QMS-related systems, ensuring compliance with regulatory standards. - Responsible for QMS metrics and reporting to leaders across the company. - Trains QMS users on workflow and associated tasks for modules within the QMS. - Leads configuration, optimization, and continuous improvement initiatives for electronic QMS (eQMS), ensuring alignment with organizational quality objectives and regulatory requirements. - Identifies and drives QMS-centric Lean and process efficiency initiatives, leveraging data analytics and stakeholder input to enhance system performance and user experience. - Assists management in assuring organizational readiness for regulatory inspections by scheduling, coordinating, conducting and documenting QMS module gap analyses. - Provide expert-level QMS compliance guidance and strategic quality assurance consultation to internal teams and external partners, ensuring adherence to industry best practices and regulatory expectations. - Schedules and conducts monthly quality review meetings as required. - Prepare training materials and conduct training for QMS topics. - Collaborates with Human Resources regarding training program requirements affected by the QMS. - Serves as Quality subject matter expert for configurable systems validation projects. - Conducts research and compiles reports. - Performs other tasks as defined by the Quality Assurance Leadership. Qualifications - 4-year degree preferred with 5-7 years of Quality Assurance Experience; or a 2-year degree with 8-10 years related experience and/or training; or equivalent combination of education and experience. - Must possess strong organizational and interpersonal skills. - Experience with QMS platforms such as Veeva is highly preferred. - Proven track record of leading QMS implementations or enhancements is a strong asset. Requirements - Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. - Ability to write reports, business correspondence, and procedure manuals. - Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the public. - Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. - Ability to apply concepts of basic algebra, statistics, and geometry. - Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. - Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. - To perform this job successfully, an individual must have working knowledge of Microsoft Office applications, including word processing software, spreadsheet software, MS PowerPoint, and MS Project. - Advanced proficiency in QMS platforms (e.g., Veeva), including configuration, reporting, and user training and experience with eLMS also preferred. Benefits - Financial Security (Base Pay, 401k Match and Possible Annual Bonus Eligibility). - Health Benefits beginning on date of hire. - PTO plan, plus 11 Paid Company Holidays, and 1 Day to Volunteer in your community. - Short and Long-Term Disability, Life Insurance, and AD&D.

Role Description The QC Specialist is responsible for the review of low complexity study setup and study setup amendment documents to ensure accuracy and completeness of information. They will review Operational Specification Documents (OSD) and any ancillary study documents and liaise with other departments as needed to ensure that the study is set up correctly. This is a remote role. Essential Duties and Responsibilities - QC of laboratory specification documents for accuracy of data or information presented including Operational Specification Document (OSD), Testing Schedules, Blood Volume Charts, Exclusion/Alerts/Blinding programming, Kit components (kit builds, requisitions and labels), and Laboratory Manuals. - Verify documents completeness and consistency within a document and between related documents, including but not limited to study protocols, budgets, kit components, requisitions, and labels, and internal scope of work documents. - Verify documents are completed on most recent template versions. - Cross departmental collaboration to ensure QC reviews are consistent with current process and quality standards. - Work closely with Project Initiation, LIS, DM, BDD, Contracts, Project Amendment and PRM teams to resolve problems or quality findings identified during QC review. - Oversee and facilitate QC timelines with PRI, Project Amendment and PRM to ensure milestones are met. - Capture detailed documentation of noted QC findings for each document reviewed. - Capture, maintain, and analyze findings for trend analysis, metrics, and opportunities for enhanced training and process improvements. - Work performed must be in accordance with ICH Guidelines for Good Clinical Practice. - Assure that all QC findings and deviations are shared clearly and in a timely manner with the applicable study manager or team to be corrected or addressed in a manner consistent with good practices and company SOPs. - Organize, maintain, and archive electronic and hard-copy quality records in accordance with document control and record retention requirements; ensure accurate filing, traceability, and accessibility of controlled documents. - Support the electronic Quality Management System (eQMS) by assisting with the creation, review, issuance, revision, and change control of quality documents. - Utilize eQMS to log, monitor, trend, and report quality-related actions, Quality Events, client complaints, audit findings, and CAPAs to ensure timely closure and visibility. - Maintain quality logs, metrics, and dashboards to support management review, audits, and continuous improvement initiatives, ensuring compliance with internal procedures and regulatory expectations. - Work as a liaison between support groups as applicable. - As needed, interface with laboratory(ies), BD, Operations, and Data Management to communicate study needs or for problem solving. - Effectively and respectfully communicate with Project Managers to resolve any discrepancies or address any open questions or concerns. - Provide back-up assistance for other departmental functions, when needed. - Train incoming employees in all departmental processes. - Perform other related duties and tasks as necessary or as assigned. Qualifications - Required - Associate’s degree (A.A.A., A.S, A.A.S), or 4 years’ customer clinical research industry experience, 4 years set-up-related experience and/or Clinical Trials Materials or clinical specimen collection kit build experience. - Experience in contract research and/or research setting preferred. Skills and Ability - Excellent attention to detail, strong planning, and problem-solving skills. - Excellent organizational and time management skills. - Excellent listening and verbal comprehension skills. - Must be able to multitask throughout the workday, driving completion of work towards deadlines. - Ability to make well-thought-out decisions and adapt to changing environments and requirements. - Self-motivation and ability to work well independently as well as using a collaborative team approach. - Ability to adhere to established timelines, processes, and procedures. - Proficient in Microsoft Word, Excel, and database software. Physical Demands - Prolonged periods of sitting at a desk and working on a computer. - Prolonged use of computer and headphones for conference calls. - Communicate effectively via phone, video, and email. - Specific vision abilities required by this job include close vision, color vision, depth perception, and ability to adjust focus. - Use hands and fingers to operate a computer and other office equipment. - Walk and/or reach with hands and arms. - Read text of various sizes. - Lift, pull and/or push up to 25 pounds. Travel Requirements - Minimal Benefits - Financial Security (Base Pay, 401k Match and Possible Annual Bonus Eligibility) - Health Benefits beginning on date of hire - PTO plan, plus 11 Paid Company Holidays, and 1 Day to Volunteer in your community - Short and Long-Term Disability, Life Insurance, and AD&D

Overview LabConnect improves lives by partnering with pharmaceutical and biotech companies, and clinical research organizations (CROs) to accelerate the development of new medicines around the world. We are an independent, global, one-stop-shop focused on delivering Central Laboratory Services that are tailor-made, timely and flexible to meet the evolving study demands of traditional to increasingly complex trials. Additionally, we provide Functional Service Provider (FSP) Solutions, supporting our clients with scientific and technical expertise, acting as an extension of their team, coordinating all laboratory related needs, advising on strategies for lab data collection and providing end-to-end analytical and logistical solutions. The Scientific Project Manager supports the implementation and communication outsourcing processes and practices. Responsible for providing project management and subject matter expertise oversight of outsourced analytical testing, method development and validation of assays in the areas of flow cytometry, genomics/genetics and/or immunogenicity. Please note: this is a fully remote role, best suited for candidates located in the Pacific Time Zone or able to work Pacific Time hours, and will require travel at least twice per year to the client site, as well as occasional travel to vendor laboratories as needed. Essential Duties and Responsibilities Study Monitoring - Coordinate outsourcing activities with analytical method performance oversight and timeline management of clinical studies involving large molecule bioanalytical assays in one or more of the following areas: flow cytometry, genomics/genetics and/or immunogenicity. - The initial point of contact between external vendors and internal stakeholders for outsourcing issue resolution, vendor capacity & capability management. - Provide technical support to troubleshoot specific issues that impact the project. - Ensure contracted studies are conducted in compliance with the respective protocol and applicable guidelines & regulations Tech Transfer - Implements transfer strategy and coordinates between the product team and technical experts. - Responsible for establishing production phase monitoring requirements (PT and trending) - Technical monitoring of assay performance and evaluation of transfer pass/fail criteria. - Strong technical understanding in one or more of the following areas: flow cytometry, genomics/genetics and immunogenicity - Ensures vendor adherence to project plan. Supplier Management - Lead operational point of contact between vendor and client - Manage supplier performance and relationships with attention toward opportunities to cut costs, alleviate risks and drive continuous improvement. Department Support - Assist with writing SOPs for new laboratories - Assist with developing and implementing training documents and plans. - Assist with process improvement initiatives Education and Experience - B.S. in Life Sciences or related field. - Minimum of 5 years of industry-relevant project, laboratory, and management experience. Join our team and discover how your work can impact patients' lives around the world! Some of the Perks our LabConnectors Love: - Financial Security (Base Pay, 401k Match and Possible Annual Bonus Eligibility) - Health Benefits beginning on date of hire - PTO plan, plus 11 Paid Company Holidays, and 1 Day to Volunteer in your community - Short and Long-Term Disability, Life Insurance, and AD&D - We celebrate our differences, which enriches our culture! In addition to great perks and challenging work assignments, we invest in our people with career growth opportunities, globally. We believe in a friendly and collaborative environment with open lines of communication. While living out our values of People First, Quality Focused, Customer Centered, Technology Driven, and Accountability Always. We are proud to be an Equal Employment Opportunity Employer and value the diversity of our workforce. We do not discriminate on the basis of race, gender, age, disability, religion, sexual orientation, or any other protected characteristic. To learn more about equal employment opportunity, please view the posters here: https://www.dol.gov/agencies/whd/posters LabConnect also prioritizes the privacy and security of your personal data. All candidate information is handled in accordance with General Data Protection Regulation (GDPR). To learn more, please review our Privacy Notice on our website, by navigating to https://www.labconnect.com/ If you need assistance to complete your job application, search for a job opening, or submit an online application at LabConnect, please email talent@labconnect.com or call +1 (423) 722-3155.