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Foundation Medicine jobs in Morrisville, NC - 31 jobs

  • Strategic Operations Lead

    Foundation Medicine 4.8company rating

    Foundation Medicine job in Morrisville, NC

    About the Job The Strategic Ops Lead is designed to complement and support the responsibilities of the Site Enablement and Product Operations team within Strategic Operations. This role offers professionals in cancer diagnostics the opportunity to contribute to strategic initiatives, operational planning, and cross-functional coordination, while gaining exposure to leadership and product development processes. Key Responsibilities * Support the Site Enablement and Product Operations Team in coordinating cross-functional activities across LabOps, Supply Chain, Client Services, and Quality. * Assist in documenting operational requirements and supporting data-driven decision-making. * Contribute to communications and stakeholder engagement across Strategic Operations and Product Development. · Participate in strategic initiatives and project planning, with a focus on scalability and patient impact. * Help track progress toward project team objectives and key results. * Coordinate the execution of E2E activities. * Attend and contribute to meetings, workshops, and collaborative sessions. * Provide insights and recommendations based on prior experience in cancer diagnostics. * Champion collaboration and operational agility across teams. * Other duties as assigned. Qualifications: Basic Qualifications: * Bachelor's degree and 2+ years of experience in the cancer diagnostics field * Strong communication and collaboration skills * Ability to manage time effectively across dual responsibilities Preferred Qualifications: * Masters degree and 1+ years of experience in the cancer diagnostics field * Experience with Next Generation Sequencing (NGS) * Experience writing technical documentation, including laboratory verification plans * Familiarity with product development and design control processes * Demonstrated ability to work in cross-functional and global teams * Agreement to maintain confidentiality regarding sensitive company, employee, and proprietary data and information * Commitment to reflect Foundation Medicine's values: Integrity, Courage, Passion The expected salary range for this position based on the primary location of Morrisville, NC is $67,300 - $84,100 per year. The salary range is commensurate with Foundation Medicine's compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits. #LI-Hybrid
    $67.3k-84.1k yearly 60d+ ago
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  • Sr. Pathologist and Associate Medical Director

    Foundation Medicine 4.8company rating

    Foundation Medicine job in Morrisville, NC

    About the Job The Sr Pathologist and Associate Medical Director is involved in all aspects of delivering Foundation Medicine's clinical laboratory testing services and serves as an internal subject matter expert, applying medical knowledge to advise decision makers in support of Foundation Medicine's mission to transform cancer care. The Sr Pathologist is responsible for review of patient samples, review of results generated from genomic profiling and other methodologies, and approval of reports. As an Associate Medical Director, the Sr Pathologist develops, reviews, and approves policies and procedures to ensure consistent, timely, and accurate clinical testing strategies; and participates in instrument, IT and test methodology selection, qualification and documentation; as well as new assay development, validation, and operationalization. The incumbent also serves as an ambassador for comprehensive genomic profiling through education and research efforts within and external to Foundation Medicine's. This is a regulated position and additional information may be available from QA on the qualifications for this role pertaining to regulatory guidelines. Key Responsibilities * For clinical and biopharma testing performed at Foundation Medicine: * Review patient specimens and accompanying documentation prior to testing in collaboration with other applicable stakeholders. * Review test results and approve reports. * As appropriate for the role, testing may include FoundationOne CDx, FoundationOne Heme, FoundationOne RNA, FoundationOne LiquidCDx, FoundationOne Tracker, and/or PD-L1 IHC assays, among others. * Function as an Associate Medical Director for the laboratory operations to ensure compliance with regulatory guidelines and promote audit readiness. * Interface directly with clients to support patient care. * Support Foundation Medicine's Commercial Team initiatives and programs through traveling to and administering programs at hospitals, cancer centers, and academic medical centers. * Participate in new assay development and validation, and optimization of existing assays. * Provide clinical expertise for strategic research initiatives to expand new testing capabilities. * Support Quality Assurance, Compliance, and Regulatory activities. * Perform research studies leading to abstracts, peer-reviewed publications, and presentations at medical/scientific meetings that highlight Foundation Medicine's assays and data. * Provide subject matter expertise on established specialty areas. * May independently manage direct reports, including Senior Pathologists, Pathologists, and Clinical Staff Pathologists in the execution of the pathology clinical services, and support their career development and growth. * Other duties as assigned. Qualifications: Basic Qualifications: * Doctor of Medicine Degree * Medical Licensure in the state of primary clinical laboratory affiliation * Formal pathology training * American Board of Pathology - Anatomic Pathology Certification * 3+ years of experience in diagnostic pathology, biomedical research, or biotechnology after completion of clinical training Preferred Qualifications: * American Board of Pathology - Clinical Pathology Certification * American Board of Pathology - Molecular Genetic Pathology Certification * Subspecialty training and/or expertise in cancer biology, genomics, or clinical trials * Strong history of achievement demonstrated by leadership activities, publications, presentations, or other activities * Collaboration skills and ability to effectively communicate with internal and external team members * Process-oriented, flexible mindset and approach to creative problem solving * Demonstrated history of cross-functional leadership and/or participation in cross-functional teams * Demonstrated ability to: * Meet deadlines * Work well under pressure while maintaining a professional demeanor * Self-organize and operate effectively without day-to-day oversight, while staying tightly connected to key leaders and teams across the collaborations * Work in a laboratory environment in the presence of chemicals and reagents * Agreement to maintain confidentiality regarding sensitive company, employee, and proprietary data and information * Commitment to reflect Foundation Medicine's values: Integrity, Courage, and Passion The expected salary range for this position based on the primary location of Morrisville, NC is $250,000 - $310,000 per year. The salary range is commensurate with Foundation Medicine's compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits. #LI-Onsite
    $250k-310k yearly 60d+ ago
  • HIV Customer Representative - Houston, TX

    Merck 4.6company rating

    Raleigh, NC job

    The HIV Customer Representative is a key member of the Customer Team and plays a critical role in supporting our Company's customer centric business model. He/she is responsible for working with the Customer Team to understand and identify customer needs, supporting pull-through activities relative to the customer strategy, keeping with our Company's values and standards as governed by our policies and ensuring that our Company is viewed as demonstrating better health outcomes to healthcare professionals and their patients. The Virology Customer Representative demonstrates professionalism and leadership by modeling the required knowledge for successful execution of all Field Sales competencies. **Territory Information:** + This position will cover the greater Houston, TX area including but not limited to Beaumont and Galveston, TX. + The ideal location to reside is within this territory or within a reasonable commuting distance to workload center. + Travel (%) varies based on candidate's location within the geography. **Primary Responsibilities:** + Communicates product information in a way that's meaningful and relevant to each individual customer; customizes discussions and client interactions based on understanding of customer's needs. + Engages in informed discussions about products with HCP customers - knowing when/how to seek and provide additional information. + Within select customer accounts, acts as primary point of contact for customer, meets with key customers/personnel to understand practice structure, business model, key influencers (IDS, ADAP, DOC, VAs, DOH)/network structure, customer needs and identifies business opportunities. + For select customer accounts/HCPs, coordinates with customer team to develop customer strategy - outlining strategy for interactions/ relationship, solutions and potential offerings for customer + Shares learnings and best-practices from one customer to help other customers meet their needs. + Demonstrates a focus on better health outcomes (considers the HCP & patient experience). + Provides input into resource allocation decisions across customers. + Identifies and selects programs/services available in the library of our "resources" to address customer needs. + Maintains current understanding of practice structure, business model, key influencers/ network structure and makes information available to relevant stakeholders. + Influences beyond their specific geography or product area. + Embraces and maximizes new technological capabilities and channels to engage customers. + Engages in all job responsibilities and activities with the highest standards of ethics and integrity, with particular emphasis on compliance with all relevant laws, policies and regulation. **Virology Specific:** The Virology Customer Representative demonstrates the ability to execute at each stage of the sales process. He/she creates a compelling and logical rationale in positioning our Company's Virology products versus the competition by focusing on appropriate patient types and use of supportive approved resources. + Demonstrates the ability to stay ahead of market trends, assesses impact of dynamics on current business state and makes proactive recommendations to meet the future needs of the business. Demonstrates innovation, resilience and is able to adapt to ambiguous/evolving business environments. + Demonstrates advanced ability to ask strategic, insightful questions to obtain information on customer healthcare needs. Uses the insights to position Virology products and collaborates with customers on focused and customized business strategy. + Demonstrates the ability to identify customer/market segments and industry conditions in local market. Special emphasis on Specialty Pharmacy to leverage business opportunities and understanding of Virology products distribution channels/challenges. + Demonstrates the ability to drive results by appropriately managing the total Virology product portfolio by prioritizing individual opportunities and plan execution through customer segmentation, targeting and business analysis. + Articulates the complexities of the HIV payer environment, recognizing the role each stakeholder plays in the ability to access our company's Virology product portfolio. + Demonstrates the ability to apply understanding of account needs and inter-dependencies in order to develop and execute account plans. Collaborates and models teamwork with extended members of the Virology Account Team (CLs, CTLs, Managed Care, Marketing) in the development of long-term account plans and customer centric solutions to improve value for both customers and patients. + Demonstrates the ability to embrace and maximize current and future technological capabilities and multi-channel opportunities to engage customers. + Demonstrates high-level collaboration skills to optimally maximize customer interactions and territory management with cross-functional Virology and non-Virology stakeholders such as Community Liaisons, IDS executives, fellow District members etc. + Demonstrates the ability to forge and manage business relationships with difficult to access customers in a "no sample" environment. + Demonstrates ability to function effectively and employ a "business owner mindset" during business cycles undergoing a high-degree of change, including flexing across customer segments, product portfolios, and working in flexible matrix configurations. + Demonstrates high-level compliance with all Company policies and procedures. **Position Qualifications:** + Bachelor's Degree with 2-6 years Sales experience **OR** a minimum of high school diploma with at least 6 years of equivalent experience which could include professional sales, experience in marketing, military or healthcare/scientific field that is not sales related (pharmaceutical, biotech, or medical devices). + Valid Driver's license. **Preferred Experience and Skills:** + Minimum of two (2) years working in one or more of the following areas: account management or sales experience working with Infectious Disease customers, with a preference for HIV product experience and/or launch experience. + Preference for specialty sales experience across multiple specialty markets with a preference for launch experience. + Experience in pharma, biotech or medical device sales. + Demonstrated experience developing and executing plans for engaging customers and meeting customer needs. + Demonstrated success in establishing, developing and maintaining relationships. + Prior experience working in a highly regulated industry or environment where compliance to laws and policies is critical. + Account experience working in complex hospital systems, teaching Institutions and community hospitals. + Demonstrated skill set to identify account inter-dependencies and build partnerships with key stakeholders/departments. + Experience with complex payer environments, recognizing the role each stakeholder plays in the ability to access the product portfolio, especially pharmacy stakeholders. + Current disease state customers acknowledge individual as a trusted and reliable representative. + Experience interacting with scientific thought leaders and developing advocates across an adoption continuum. + Demonstrated ability to develop customer relationships in a challenging-to-access or "no sampling" environment. + High level of business acumen and account management skills. + Current relationships with key opinion leaders within designated account preferred. + Leadership, planning and organization, self-motivation and initiative, ability to learn, understand and convey complex information. + Understanding of the value and importance of approaching job responsibilities with ethics and integrity and working in a highly compliant environment. **Required Skills:** Account Management, Account Management, Account Planning, Adaptability, Business Analysis, Client Communication, Customer Experience Design, Customer Experience Management, Customer Feedback Management, Customer Segmentation, Customer Strategy, Hospital Sales, Infectious Disease, Interpersonal Relationships, Lead Generation, Market Analysis, Medical Devices, Medical Virology, Pharmaceutical Sales Training, Product Information, Resource Allocation, Sales Calls, Sales Metrics, Sales Operations, Sales Pipeline Management {+ 5 more} **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $106,200.00 - $167,200.00 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 employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company 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. **Employee Status:** Regular **Relocation:** **VISA Sponsorship:** **Travel Requirements:** **Flexible Work Arrangements:** Remote **Shift:** **Valid Driving License:** **Hazardous Material(s):** **Job Posting End Date:** 01/22/2026 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R381458
    $34k-59k yearly est. 7d ago
  • Molecular Technologist I

    Foundation Medicine 4.8company rating

    Foundation Medicine job in Morrisville, NC

    About the Job The Molecular Technologist I performs procedures in a complex patient sample testing process with limited supervision. Most prominently, the position is responsible for solution and reagent preparation, equipment maintenance, and the handling and testing of patient specimens. The incumbent works one of three established shifts and may be assigned to work any day that the lab is operational. This is a regulated position and additional information may be available from QA on the qualifications for this role pertaining to regulatory guidelines. Regular onsite work at a designated Foundation Medicine location is an essential function of this role. Key Responsibilities * Prepare the Next Generation Sequencing (NGS) library. * Under limited supervision of senior lab personnel and in adherence to established Standard Operating Procedures (SOPs): * Extract and isolate nucleic acids. * Complete hybridization capture, and genetic sequencing methods. * Operate automated 8-span and 96-head liquid handling platforms. * Operate quantification, sizing, and NGS instruments. * Perform any other patient and client sample testing and processing steps needed. * Perform workflow that maintains quality, thoroughness, and optimum efficiency for Turn Around Time (TAT). * Utilize the Laboratory Information Management System (LIMS) to track and execute sample processing. * Document executed process steps per Good Documentation Practices (GDP). * Update and maintain records and data on test results per GDP. * Perform daily, weekly, monthly and as needed equipment maintenance checks. * Participate in additional continuous quality improvement activities. * Adhere to safety protocols, such as wearing laboratory coats and required safety gear. * Maintain organization and cleanliness in the labs. * Collaborate on SOPs revisions and drafts as needed to adjust for process improvement initiatives and regulatory changes. * Review SOPs at set intervals and sign-off to document knowledge of these procedures. * Document and assist with investigations for non-compliance events via Non-Conformance Reports (NCRs), Corrective Action/Preventative Action (CAPAs) and other reports. * Other duties as assigned. Qualifications: Basic Qualifications: * Bachelor's Degree in a chemical, physical, biological, or life science (per NYSDOH regulatory requirements) * 1+ years of molecular laboratory work experience in a CAP/CLIA regulated lab * Certifications or licensure that is required by the state or county in which the job is posted Preferred Qualifications: * Molecular Biology American Society of Clinical Pathology (MB-ASCP) Certification * Quality System Regulations (QSR) compliant laboratory experience * Familiarity of and experience working with DNA manipulation techniques, enzymatic reactions, and sequencing chemistry * Familiarity with high throughput platforms and common molecular laboratory equipment (such as pipettes, thermocyclers, and liquid handlers) * Experience with Laboratory Information Management System (LIMS) * Experience ensuring and maintaining integrity and quality of the laboratory in the areas of sample processing, equipment maintenance, and SOPs * Knowledge about laboratory safety protocols * Demonstrated ability to: * Work well under pressure while maintaining a professional demeanor both as an individual contributor and in a team * Prioritize and thoroughly follow up on assigned tasks * Handle multiple tasks at once and work in a fast-paced environment * Adapt to changing procedures, policies and work environment * Work in the presence of chemicals and reagents in a laboratory environment * Proficiency utilizing Microsoft Office Suite, most specifically Excel and Power Point * Excellent skills of written communication, oral communication, collaboration, and problem solving with other departments and colleagues * Excellent organization and attention to detail * Agreement to maintain confidentiality regarding sensitive company, employee, and proprietary data and information * Commitment to reflect Foundation Medicine's values: Integrity, Courage, and Passion The expected salary range for this position based on the primary location of Morrisville, NC is $54,800 - $68,500 per year. The salary range is commensurate with Foundation Medicine's compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits. #LI-On-Site
    $54.8k-68.5k yearly 60d+ ago
  • IHC Technologist II (Monday - Friday: 10:00am - 6:30pm)

    Foundation Medicine 4.8company rating

    Foundation Medicine job in Morrisville, NC

    About the Job The Immunohistochemistry (IHC) Technologist II performs routine Immunohistochemistry (IHC) testing on patient samples in a high complex clinical diagnostic laboratory using a variety of automated platforms for microscopic examination and analysis by a Pathologist. Key Responsibilities * Performs Automated Immunohistochemistry (IHC) using both the Dako Autostainer Link 48 and Ventana Benchmark Ultra Staining Systems. * Operates a microtome to produce slides or curls from paraffin blocks. * Monitors oven timers to unload slides, places them on flats and distributes them to the appropriate staining platform areas. * Handles, prepares, and unloads stainers; conducts dehydrating and cover-slipping of slides utilizing manual or automatic systems (Leica stainer). * Prepares bulk fluids for stainers and refills as needed, keeping track of lot numbers and associating bulks to instruments after filling them. * Performs the assigned tests or components of the test in accordance with assay run schedule, accurately, and within TAT and always in compliance with written SOPs. * Performs QC and/or verification steps for receiving and delivering specimens for IHC staining. * Finalizes test orders to deliver to requesting pathologist. * Performs QC testing on control tissues and reagents. * Performs routine H&E staining with possible other histological staining methods introduced over time. * Maintains attention to detail for quality completion of each task. * Sorts and labels samples by test requested while maintaining sample integrity. * Maintains proper sample chain of custody including proper specimen handling, labeling and preparation of batch records. * Maintains adequate stock and efficient use of supplies necessary for performing all procedures, and preparation of reagents as required. * Performs routine scanning of stained slides with the Aperio ScanScope. * Ability to utilize a laboratory information management system (LIMs, MS Office esp. Excel). * Follows written lab Standard Operating procedures for the correct handling and processing of specimens. * Assists in maintaining and troubleshooting equipment/instrumentation. * Effectively communicates deficiencies to appropriate personnel, including deficiencies related to specimens, paperwork, database information, and equipment. * Ability to investigate Root Cause Analysis (RCA), write Incident/Event Report (INC), and Non-Conformance Report (NCR) under senior Technologist guidance. * Complete projects under guidance of senior lab personnel. * Adhere to laboratory's quality control policies (GCP, CAP/CLIA, ISO) and document all quality control activities with the ability to recognize outliers and correct them. * Participate in biohazard, chemical, and general safety and other continuing education programs. * Receives and transmits telephone calls and/or emails regarding patient sample processing. * Resolve high volume email inquiry request. * Communicate effectively in a courteous, professional manner with all levels of management, co-workers, and clients to provide quality customer service. * Work effectively within a team-oriented department and company. * As needed, flexes to cover scheduling gaps and is included in the on-call rotation for additional weekend and/or holiday technical support. * Perform other duties as assigned. Qualifications: Basic Qualifications: * Bachelor's degree, particularly a Bachelor of Science degree in biological or life sciences * 2+ years of Histology/IHC work experience in a CAP/CLIA regulated laboratory * 2+ years of experience working with Dako, Leica, or Ventana platforms, or manual methods * 2+ years of microtomy experience Preferred Qualifications: * Bachelor's degree, particularly a Bachelor of Science degree in biological or life sciences * 3+ years of laboratory work experience in a CAP/CLIA regulated lab * 3+ years of experience in Histology experience * 3+ years of experience in Immunohistochemistry testing (manual and automated) * Certified Histotechnician (HT) or Histotechnologist (HTL) or Qualification in Immunohistochemistry (QIHC) by American Society for Clinical Pathology (ASCP) * Demonstrated attention to detail and strong organizational skills * Familiarity with Laboratory Information Management Systems (LIMS) * Relevant experience in a regulated laboratory environment (such as CAP/CLIA) * Demonstrated ability to: * Learn new tasks in appropriate timeframes * Prioritize and thoroughly follow up on assigned tasks * Understand and communicate scientific or technical information * Basic knowledge of laboratory safety protocols * Understanding of HIPAA and the importance of privacy of patient data * Demonstrated experience working within tight timelines for successful execution of project and program goals * Demonstrated experience handling multiple tasks at once * Ability to work independently as well as collaborate with peers in a fast-paced and cross-functional results-oriented team environment * Ability to work well under pressure while maintaining a professional demeanor * Ability to prioritize and thoroughly follow up on assigned tasks * Ability to adapt to changing procedures, policies and work environment * Ability to perform work in a lab environment in the presence of chemicals and reagents * Strong interpersonal skills that include excellent skills in written and oral communication, collaboration, and problem solving * Understanding of HIPAA and importance of privacy of patient data * Commitment to FMI values: Integrity, Courage, Passion The expected salary range for this position based on the primary location of Morris is $55,000 - $63,500 per year. The salary range is commensurate with Foundation Medicine's compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits. #LI-On-site
    $55k-63.5k yearly 2d ago
  • Sr. Oncology Sales Representative - North Orange County, CA

    Merck 4.6company rating

    Raleigh, NC job

    Our Sales team support our customers by providing clinical information about products, educational information, clinical training programs and resources. We support healthcare providers and healthcare systems meet the goals of the patients in their communities. Our Company's Oncology organization is dedicated to delivering breakthrough innovations that extend and improve the lives of cancer patients worldwide. Our team of dauntless, forward-thinking individuals achieves this through an unwavering commitment to supporting accessibility to medicine, providing new therapeutic procedures, and collaborating with governments and payers to ensure that people who need medicines have access to them. At our company, our focus is on innovation and launch execution excellence; we translate breakthrough science into innovative medicines that help people with cancer across the globe. As we continue to grow and define the Oncology market of the future, we are looking for dynamic, entrepreneurial individuals who thrive in a team environment and are driven to succeed. The Oncology Sales Specialist is a key member of our customer facing organization and is responsible for partnering with customers to address identified needs, educating key stakeholders about our leading immunotherapy compound, and communicating our vision to the larger Oncology community. + This is a field-based sales position that will cover the **North Orange County, California** + The selected candidate must reside within the territory. + Overnight travel may be required about 25% of the time. + Travel (%) varies based on candidate's location within the geography. **General Responsibilities:** + Demonstrate in-depth knowledge of how to create a compelling and logical rationale for the value of products and how to contrast, compare, and position our company brand(s) versus competition using appropriate resources in informed discussions about products with HCP customers - knowing when/how to seek and provide additional information + Act as primary point of contact for customer. Meet with key customers/personnel to understand practice structure, business model, and key influencers. + Possess knowledge of cancer staging and possible treatment options and dosing schedules associated with different tumors/diseases, with comprehensive understanding of the impact of those options on the patient. Must understand impact and use of clinical trials in multiple tumor types/therapies, both in impact on promoted products and in practice behavior of the account. + Ability to analyze and identify trends in a complex buying environment. This includes the multiple channels of drug distribution, Oncology GPO's, wholesalers and specialty pharmacies. Review and evaluate patterns for products purchased and prescribed, outpatient vs in-patient infusion, as part of hospital contract, etc. + Demonstrate ability to understand complex account interdependencies in order to develop both short- and long-term account plans in conjunction with a wide array of stakeholders, proactively working with the account team and supervisor (known as the Customer Team Leader) to effectively execute the account plan. Share learnings and best-practices from one customer to help other customers meet their needs. + Influence beyond their specific geography or product area demonstrate advanced ability to ask strategic, insightful questions to obtain information on customer needs from all stakeholders in oncology accounts, using the insights to position our company Oncology brands and collaborate with customers on a customized strategy. + Collaborate and communicate effectively with extended "in-scope" customer team to ensure a consistent customer experience across our company's divisions and functional areas; ensure integration with the Key Account Manager, Nurse Educator, Field Reimbursement Associate, Medicare Account Executive, and other key stakeholders to share key customer learnings and support customer needs. **Position Qualifications** **:** **Minimum Requirements:** + Bachelor's degree with 6-8 years Sales experience OR a minimum of high school diploma with at least 10 years of equivalent experience + Equivalent experience can be: Professional sales experience, work experience in the healthcare/scientific field (including pharmaceutical, biotech, or medical devices) that is not sales related, professional marketing experience, or military experience + 2+ years of oncology field sales experience + Valid driver's license and ability to drive a motor vehicle + Travel the amount of time the role requires **Preferred Experience and Skills:** + Documented history of strong performance in a sales / marketing or oncology clinical role + Clinical oncology experience across multiple solid tumors (Women's cancer - Breast, Ovarian, and Cervical) + Candidates with 0 - 2 years of oncology field sales experience will be hired at the S2 Oncology Sales Representative level. + Candidates with 2+ years of oncology field sales experience will be hired at the S3 Oncology Sales Specialist level. oncosales **Required Skills:** Account Management, Account Management, Account Planning, Adaptability, Biodesign, Biopharmaceutical Industry, Cancer Diagnosis, Clinical Experience, Customer-Focused, Customer Handling, Customer Relationship Management (CRM), Customer Service, Healthcare Sales, Interpersonal Relationships, IS Audit, Lead Generation, Lead Generation Management, Market Analysis, Medical Devices, Oncology Nursing, Oncology Sales, Pharmaceutical Management, Pharmacology, Product Knowledge, Proven Commitment {+ 5 more} **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $156,900.00 - $247,000.00 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 employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company 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. **Employee Status:** Regular **Relocation:** No relocation **VISA Sponsorship:** No **Travel Requirements:** 25% **Flexible Work Arrangements:** Remote **Shift:** Not Indicated **Valid Driving License:** Yes **Hazardous Material(s):** N/A **Job Posting End Date:** 01/22/2026 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R381203
    $156.9k-247k yearly 7d ago
  • Manager, IT Engineering

    Gilead Sciences 4.5company rating

    Raleigh, NC job

    At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to pursuing scientific invention to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. You will be part of a team that is helping millions of people live healthier, more fulfilling lives. We are a close community where every individual matters and everyone has a chance to enhance their skills through ongoing development. Inclusion is one of our core values, which means we are creating and fostering a work environment where our differences are valued, and everyone feels respected and empowered to bring their authentic selves to work. Summary: This role sits within the global Gilead IT organization within the US Commercial Field Enablement IT team with the primary responsibility of supporting IT operations for Field Enablement applications. This role reports to the US Commercial IT Field Enablement lead. This role will support and liaise with a broad business team including Gilead Commercial Operations, Medical Affairs and Business Conduct. The role will also engage across IT teams who manage/support systems within the Capability ecosystem, i.e., integration touchpoints with tools such as Master Data Management platform and Commercial Analytics Hub as well as the broader IT team that enable the overall working experience for the business teams we support. This role would act as a liaison between CRM, Events and Account Management capability leads and the vendor MSP teams to manage and deliver on IT operations for field applications. This role would enable Next Gen CRM program by consolidating IT operations for field applications, quickly identifying and mitigating end user impacts and enabling focus on field experience with technology and IT change management. Some of the key activities that this role would lead include managing IT support operations teams, tracking and reporting on service requests and incidents, providing hands-on support and oversight for complex / priority tickets and escalations, participating in system testing and user acceptance testing, and managing deployment and hypercare. Core Tasks, Responsibilities & Scope of Authority: Utilize ServiceNow to record and track incidents, service requests including report requests Hands-on leadership and execution of IT support operations activities, working with MSP resources Engage with offshore service teams and onshore business and IT partners daily to deliver support operations Build and maintain a track of operational requests over time to advise leadership on trends with a key metric around first call resolution, warm transfers and minimizing field user time spent chasing IT support issues Support field events such as National Sales Meeting with onsite presence when necessary Proactive readiness and planning to support new product launches including onboarding field user groups Support launch of new applications such as Veeva Align, Next Gen CRM, ongoing platform and application enhancements Build and maintain relationships with individual field users and other support groups and product teams Lead IT operations for the field teams in a secure and compliant manner, adhering to appropriate SOPs and work instructions Additionally: Works closely with the respective Product Owners for Veeva / Vault CRM, Events Management, Align and other field applications to ensure end user experience for field applications remains positive Leads operational reporting services delivered within the platform / application using Salesforce / Vault platform reporting, MyInsights / X-Pages Basic Qualifications: Doctorate OR Master's and 4+ years of relevant experience OR Bachelor's and 6+ years of relevant experience OR Preferred Qualifications: Strong techno-functional knowledge of Veeva Commercial Cloud, including but not limited to Align, Veeva / Vault CRM, Veeva Events Management as well as Salesforce platform, Vault platform Strong problem-solving skills, experience in identifying and preventing issues from recurring, debugging and fixing code Ability to prioritize incidents and service requests based on priority levels and knowledge of support escalation paths High level of personal integrity consistent with Gilead's core values (Excellence, Accountability, Teamwork, Integrity and Inclusion) Service-oriented, willingness to put in the extra yards to provide an outstanding experience to end users Experience working in a multi-vendor scenario; vendor management experience is a plus Strong communication skills to engage directly with business users, IT and vendor teams Knowledge of ITIL framework and best practices Knowledge of working with ServiceNow IT service management platform The salary range for this position is: $126,565.00 - $163,790.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: ****************************************************************** * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For jobs in the United States: Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.
    $126.6k-163.8k yearly Auto-Apply 40d ago
  • Regional Medical Scientific Director (Medical Science Liaison) - GI Immunology (NC, SC, GA, & Southern VA) (Remote)

    Merck 4.6company rating

    Raleigh, NC job

    Responsibilities The Regional Medical Scientific Director (RMSD) is a credentialed (i.e., PhD, PharmD, DNP, MD) therapeutic and disease expert who engages in bidirectional exchange of scientific or medical information with Scientific Leaders (SLs). This MSL-type role provides balanced, factual, scientific information about non-product areas of interest to the Company and replies to scientific questions from SLs, including questions about Company products. The work of an RMSD is aligned to: Scientific Exchange, Research, Scientific Congress Support, and Scientific Insights. RMSDs liaise between the scientific community and the Company to enhance the comprehension of scientific foundations and goals for approved, in-development, and active Company-sponsored trials and/or investigator-sponsored research studies. The RMSD serves as a role model for other field medical team members in ways that include on-boarding and/or sharing of therapeutic expertise. This position will support our Company's Gastrointestinal (GI) Immunology program Location details: This role covers North Carolina, South Carolina, Georgia, & Southern Virginia. Candidates must reside within the territory; Travel up to 50% within the territory. Responsibilities and Primary Activities Scientific Exchange Develops professional relationships and engages with national and regional SLs to ensure access to company-approved medical and scientific information on areas of therapeutic interest and Company products Conducts peer-to-peer scientific discussions and maintains a reliable presence with those SLs to ensure they have a medical contact within the company Addresses scientific questions and directs SL inquiries on issues outside of RMSD scope (e.g., grants) to appropriate company resources consistent with applicable policies Maintains current knowledge and comprehension of dynamic scientific and clinical environment in the Company's Areas of Interest (AOI) for the RMSD's specific therapeutic area. Research Upon request from Global Center for Scientific Affairs (GCSA), Initiates discussions with SLs and/or potential investigators that include scientific/data exchange within our AOI to determine the alignment with our research strategies, studies concepts, scientific merit, and qualifications for a specific compound or trial Enhances the comprehension of the scientific foundations and goals of investigator-sponsored research Identifies barriers to patient enrollment and retention efforts to achieve study milestones Upon request from Global Clinical Trial Operations (GCTO), Recommends study sites and identifies potential investigators to participate in phase II-IV clinical development programs, conducts Site Initiation Visits (SIVs), and detects barriers to patient enrollment and retention efforts to achieve study milestones. Protocol lead responsibilities in collaboration with GCTO Addresses questions from investigators and provides information regarding participation in Company-sponsored clinical studies Scientific Congress Support Engages in scientific congresses and medical meetings, facilitates scientific and data exchange for both Company and competitor data. Scientific Insights Gathers feedback, data, or information during routine activities that can help the company better comprehend medical or scientific needs, priorities, or concerns of SLs and/or patients Inclusive Mindset and Behavior Demonstrates eagerness to contribute to an environment of belonging, inclusion, and empowerment Leads by example and serves as a role model for creating, leading, and retaining an inclusive workforce Required Qualifications, Skills, & Experience Minimum PhD, PharmD, DNP, DO, or MD Proven competence and a minimum of 3 years of relevant therapeutic area experience (gastrointestinal) beyond that obtained in the terminal degree program Ability to conduct doctoral-level discussions with key external stakeholders Dedication to scientific excellence with a strong focus on scientific education and dialogue Excellent stakeholder management, communication, and networking skills A thorough comprehension of FDA, OIG, HIPAA, and other ethical guidelines, laws, and regulations relevant to the pharmaceutical industry and its customers Ability to organize, prioritize, and work effectively in a constantly changing environment Strong working knowledge of Microsoft Office Suite (Word, PowerPoint, Excel, Teams, OneNote) Familiarity with virtual meeting platforms Desire to contribute to an environment of belonging, engagement, and empowerment by: Working to transform the environment, culture, and business landscape Leveraging inclusion to ensure business value, per global inclusion strategy Ensuring accountability to drive an inclusive culture Strengthening the foundational elements Consistent adherence to field and corporate policies and Global Medical Scientific Affairs (GMSA) strategy, including field standard operating procedures (SOPs), Good Clinical Practice (GCP) guidelines, and administrative/operational responsibilities Preferred Field-based medical experience Research Experience Demonstrated record of scientific/medical publication #eligiblefor ERP Required Skills: Clinical Immunology, Clinical Research, Clinical Trials, Gastroenterology, Gastrointestinal Disease, Immunology, Medical Affairs, Medical Relations, Pharmaceutical Medical Affairs, Relationship Management, Scientific Research, Stakeholder Engagement, Stakeholder Management Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $190,800.00 - $300,300.00 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 employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ******************************************************* You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company 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. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 50% Flexible Work Arrangements: Remote Shift: Not Indicated Valid Driving License: Yes Hazardous Material(s): n/a Job Posting End Date: 03/1/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
    $89k-122k yearly est. Auto-Apply 2d ago
  • Director, Statistical Programming

    Gilead Sciences, Inc. 4.5company rating

    Raleigh, NC job

    At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world's most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. Director, Clinical Data Science - SAS Macro and Data Operations leads the end-to-end strategy, development, qualification, and lifecycle management of Statistical Programming tools, macro libraries, applications and automation solutions that accelerate clinical analysis and reporting. The role owns a multi-disciplinary team spanning statistical programming, data engineering, and platform operations, and partners closely with Biostatistics, Clinical Operations, Regulatory, and Quality to ensure compliant, efficient, and scalable delivery. Core technologies include SAS Macros, Python, Linux scripting, and modern cloud services. Key Responsibilities: Strategic Leadership & Team Management * Lead, mentor, and develop a team of SAS macro programmers, data engineers, and application developers (including Linux scripting, Python console, and web applications) to deliver high-quality statistical programming solutions for clinical trials and regulatory submissions. * Set clear goals, conduct performance assessments, and foster professional growth and continuous learning within the team. Programming Oversight & Technical Excellence * Oversee the design, development, validation, and maintenance of SAS macros, scripts, and applications supporting clinical data analysis, reporting, and regulatory deliverables (e.g., SDTM, ADaM datasets, TLFs). * Ensure programming infrastructure is robust, scalable, and compliant with regulatory standards (e.g., FDA 21 CFR Part 11, GxP), and supports reproducibility and audit readiness. * Promote automation and standardization of programming workflows to improve efficiency and consistency across studies. Project Delivery & Resource Management * Accountable for the timely and quality completion of all programming deliverables across assigned projects and studies, including resource allocation and prioritization. * Manage project timelines, budgets, and external vendor relationships as needed. Cross-Functional Collaboration * Collaborate with Biostatistics, Clinical Data Management, Regulatory Affairs, and IT to define programming requirements, align on analysis/reporting deliverables, and ensure data integrity. * Represent the statistical programming function in cross-functional meetings and strategic initiatives. Process Optimization & Innovation * Lead the development and implementation of programming standards, best practices, and innovative solutions (including cloud-based platforms, AI/ML, and automation pipelines) to enhance efficiency and quality. * Evaluate and integrate emerging technologies into statistical programming workflows. Compliance, Documentation & Quality Assurance * Ensure all programming activities adhere to SOPs, regulatory requirements, and internal quality standards; maintain audit readiness and documentation for all deliverables. * Oversee code quality, version control, and documentation governance frameworks. Stakeholder Engagement & Training * Provide technical guidance and training on advanced programming techniques, tools, and industry trends to team members and stakeholders. * Act as a key point of contact for external vendors and partners, ensuring alignment on programming standards and deliverables. Basic Qualifications PhD / PharmD and 8 years of experience OR Master's and 10 years of experience OR Bachelor's and 12 years of experience Preferred Qualifications: * Education: BS/MS/PhD in Biostatistics, Computer Science, or related field; advanced degree preferred. * Technical Skills: Expert in SAS Macros and strong proficiency in Python; working knowledge of R and Linux scripting; familiarity with AWS Cloud. * Core Competencies: Strategic thinking, cross-functional influence, compliance mindset, talent development, user-centric engineering. People Leader Accountabilities: * Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams. * Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose. * Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem. The salary range for this position is: Bay Area: $210,375.00 - $272,250.00. Raleigh: $181,730.00 - $235,180.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: ****************************************************************** * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For jobs in the United States: Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.
    $210.4k-272.3k yearly Auto-Apply 31d ago
  • Associate Director, Intelligent Solutions Engineering

    Gilead Sciences, Inc. 4.5company rating

    Raleigh, NC job

    At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. **Job Description** **Job Summary** We are seeking an Associate Director of Intelligent Solutions Engineering to lead delivery teams and initiatives building AI-powered platforms and cloud applications that streamline clinical trial processes and accelerate medicine delivery to patients. In this hands-on technical leadership role, you will oversee the architecture and development of custom products that automate workflows, enable data-driven decisions, and extract insights from diverse data sources. You'll drive technical execution by working directly with engineers, data scientists, business users, and cross-functional stakeholders to deliver robust, scalable, and maintainable solutions. This role requires balancing innovative AI technologies with real-world application requirements, ensuring our platforms are both technically sound and usable while aligned with business objectives. **Key Responsibilities** + Lead technical strategy, roadmap, and architecture for scalable, cloud-native software solutions across onshore and offshore engineering teams. + Partner with data science teams and business stakeholders to identify priorities and modernize processes. + Communicate technical vision to align and influence cross-functional teams and senior stakeholders. + Architect and implement platforms that integrate, analyze, and visualize data using serverless, modern web technologies, and full-stack AWS deployments. + Serve as technical subject matter expert for AI solutions, including Generative AI applications, context engineering, document generation, and agentic workflows. + Drive end-to-end product development from inception through production deployment and maintenance. + Establish and enforce software engineering standards, design patterns, and architectural principles. + Implement automation-first DevOps practices and champion continuous improvement initiatives. + Oversee offshore vendor partnerships to ensure quality delivery and product sustainability. + Mentor engineering teams on AI-driven software development practices and establish best practices for code quality, testing, and documentation, including training on AI tooling and implementation. + Research and apply emerging AI technologies and innovative approaches to solve complex technical challenges. **Basic Qualifications** + BA/BS with at least 10 years of relevant experience, MA/MS/MBA with at least 8+ years of relevant experience, or PhD with at least 2 years of experience. + 4+ years of cross-functional technical project management or other relevant leadership experience in a business environment, including multiple years managing project teams. + Expert-level understanding of software engineering fundamentals including data structures, algorithms, complexity analysis, and system design principles. + Proven experience leading full SDLC implementations across multiple methodologies (Agile/Scrum, waterfall, hybrid) and product development lifecycles. + Advanced Python proficiency building production REST APIs and async systems; working knowledge of modern frontend frameworks (React preferred). + DevOps proficiency with CI/CD automation (GitHub Actions, Terraform), containerization (Docker), and cloud security best practices (IAM, secrets management, network security). + Production AWS expertise: serverless architectures (Lambda, ECS), storage solutions (S3, RDS, DynamoDB), and infrastructure-as-code (Terraform). + Data integration engineering including API development, middleware solutions, event-driven architectures, and automated data synchronization pipelines. + Generative AI expertise with LLMs, prompt engineering, and frameworks (LangChain). + Proficiency with AI-powered development tools (GitHub Copilot, Cursor, Claude) for accelerated code generation and refactoring. **Preferred Qualifications** + Experience working in or alongside clinical, regulatory, or real-world evidence (RWE) functions. + Familiarity with GxP, 21 CFR Part 11, and other relevant compliance frameworks. + Experience with AI/ML applications in healthcare, including model evaluation, validation frameworks, and integration of multimodal data sources. **What You'll Gain** You'll have the opportunity to shape technical strategy at the intersection of software architecture and AI, working on transformative projects that deliver real business impact. This role offers the chance to build strong cross-functional relationships while staying at the forefront of emerging AI technologies. You'll develop your ability to bridge technical and business contexts, lead high-performing teams, and drive meaningful results through a pragmatic, value-focused approach to innovation-all while maintaining the technical depth to contribute from architecture to code. The salary range for this position is: Bay Area: $195,670.00 - $253,220.00. Raleigh: $168,980.00 - $218,680.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: ****************************************************************** * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. **For jobs in the United States:** Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' (********************************************** poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (********************************************************* YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. **For Current Gilead Employees and Contractors:** Please apply via the Internal Career Opportunities portal in Workday. Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
    $195.7k-253.2k yearly 7d ago
  • Sales Executive - Prenatal - Raleigh, NC

    Myriad Genetics & Laboratories 4.7company rating

    Raleigh, NC job

    Myriad Genetics is seeking top-tier sales talent who are passionate about improving patients' lives through precision medicine. As a Prenatal Sales Executive, you will drive adoption of Myriad's prenatal portfolio, securing new prenatal business while supporting existing accounts in a high-impact territory. This is more than just a sales role-it's an opportunity to be at the forefront of innovation in prenatal genomics. You'll represent Myriad's industry-leading prenatal portfolio, including Prequel non-invasive genetic screen, Foresight carrier screen, and FirstGene a combined non-invasive genetic screen that assesses risk and/or presence of chromosomal issues, recessive conditions, and RhD compatibility. You will practice a consultative approach, educating healthcare providers on the clinical utility of our prenatal genomic tests, how to integrate them into patient care pathways, and leverage insights for better informed treatment decisions. At Myriad, our culture is defined by putting patients and people first-and we're looking for someone who shares that commitment. * Note: This is a field-based sales position. Candidates must reside within the territory and be able to travel locally daily to meet with healthcare providers and stakeholders. Regular in-person engagement is essential to the success of this role. Responsibilities * Sales Execution * Manage full lifecycle of the product sales process, including new business development and lead-generation via programs and other initiatives * Apply a consultative approach to identify customer needs, present solutions, and close business * Account Development * Build and maintain strong relationships with key OB/GYN, Maternal Fetal Medicine, and Fertility Medicine accounts, including community practices, academic centers, and integrated delivery networks * Identify, develop, and manage commercial relationships with key opinion leaders in women's health and prenatal health and other key healthcare professionals. * Attend local trade shows, industry conferences and networking events. * Strategic Territory Management * Develop and execute territory plans to exceed sales goals * Identify and capitalize on commercial opportunities for growth within a specific region or geography - predominately in the traditional out-patient practices, but also inclusive of institutions, local insurance payors, physician groups, long term care facilities, etc. * Clinical Education: Deliver compelling presentations on Myriad prenatal risk assessments, genomics, and precision and personalized insights to women's healthcare providers * Cross Functional Collaboration * Collaborate with the marketing team on the development and continuous improvement of sales and marketing collateral. * Partner with medical affairs, operations, payer markets, and other internal teams to support seamless product adoption and integration * Market and Competitor Intelligence * Monitor competitive activity and provide actional insights to internal stakeholders and partners to drive and improve strategy and execution * Stay current on industry and marketplace trends in the areas of personalized medicine. * Compliance: Adhere to all regulatory and company guidelines in promotional activities. Qualifications * Education: Bachelor's degree in Life Sciences, Business, or a related field preferred * Location: this is a field-based role; you must reside within the assigned territory * Experience: * 3+ years of successful sales experience or equivalent in biotech, healthcare, medical devices, pharmaceuticals, or a related healthcare sector preferred * Experience selling clinical products to Women's Health call points, including OB/GYN, Maternal Fetal Medicine, etc. * Demonstrated ability to consistently meet or exceed sales targets in highly competitive markets. * Proven experience driving adoption in complex healthcare environments preferred. * Track record of expanding business within large health systems and integrated networks preferred. * Skills: * Strong clinical/scientific/medical acumen with the ability to interpret and communicate scientific data effectively. * Exceptional communication and presentation skills to influence and engage healthcare professionals. * Expertise in managing complex accounts and navigating multi-stakeholder decision-making processes. * Excellent presentation, training, coaching, and communication skills (both written and oral). * Strong interpersonal skills: active listening, coaching, advising, problem-solving, and facilitation. * Highly organized with attention to detail and ability to manage multiple assignments in a fast-paced environment. * Comfortable engaging customers remotely and in person. * Flexible, self-motivated, and able to work independently * Systems & Software * Knowledge of Salesforce or similar CRM systems preferred. * Proficient in MS Office * Compliance & Ethics * Working knowledge and application of HIPAA laws, privacy, and ethics surrounding patient privacy and information preferred. * Demonstrates values and ethics that support Myriad's mission, goals, and professional code of conduct. * Ability to use discretion and professionalism as it relates to handling patient and physician information and documentation. * Ability to resist pressure to compromise corporate values despite pressure to make sales * Track record of demonstrated integrity, even when inconvenient * Ability to handle sensitive and confidential information professionally. * Ability to model and live corporate values and professional ethics * Additional Requirements: * Willingness to travel extensively within the assigned territory (50-75%). * Highly self-motivated, strategic thinker with outstanding organizational and time-management skills. * Valid driver's license and driving record that meets Myriad's policy standards. Compensation & Benefits Estimated OTE Range: $180,000 - $205,000 annually (base salary + at target variable incentive). Benefits Highlights The Myriad benefits team continuously analyzes market trends to offer best-in-class comprehensive and competitive benefits designed for flexibility and value. We are proud to offer many Employer-Paid benefits and unique offerings to support you and your family including, but not limited to the following: * Health and Wellness support includes multiple medical plan options with preventive care covered at 100%, HSA and FSA Accounts with Myriad annual contributions up to $1,000, Employer Paid Parental Leave (12-weeks), and employer-paid disability plans. * Myriad's flexible discretionary time off (DTO) policy offers full-time exempt employees unlimited time for family, vacations, or personal appointments through manager-approved DTO. * Financial and Career Growth benefits include 401(k) partially funded by a 50% employer match up to 8%, employee discounted stock program, student debt repayment, and milestone bonus awards. * Additional support for families and wellness include fertility, family-care or childcare, mental health, and weight management programs. Physical Requirements Lifting Requirements - sedentary to light work or exerting 10 to 20 pounds of force frequently. Physical Requirements - stationary positioning, moving, operating, ascending/descending, communicating, and observing. Use of equipment and tools necessary to perform essential job functions. OSHA category III - normal routine involves no exposure to blood, body fluid, or tissue and as part of the employment, will not be called upon to perform or assist in emergency care or first aid. EEO We recognize that our people are our strength and the diverse talents they bring to our global workforce are directly linked to our success. We are an equal opportunity employer and place a high value on diversity and inclusion at our company. In hiring and all other employment decisions, we prohibit discrimination and harassment on the basis of any protected characteristic, including race, religion, color, national origin, gender, sexual orientation, gender identity, gender expression, age, marital or veteran status, pregnancy or disability, or any other basis protected under applicable law. In accordance with applicable law, we make reasonable accommodations for applicants' and employees' religious practices and beliefs, as well as any mental health or physical disability needs #LI-JB2
    $48k-67k yearly est. Auto-Apply 7d ago
  • Histotechnologist I (Tuesday - Saturday: 8:30am - 5:00pm)

    Foundation Medicine 4.8company rating

    Foundation Medicine job in Morrisville, NC

    About the Job The Histotechnologist I performs routine testing in FMI's high complexity clinical diagnostic laboratory and is responsible for receipt of patient samples as well as the preparation of samples for microscopic examination and analysis by Pathology. This role focuses on cutting, mounting, staining, and batching slides. This position has similar duties to the Histotechnician, but can operate more independently and work on more complex samples given prior experience in the function. This is a regulated position and additional information may be available from FMI Quality Assurance regarding regulatory guidelines. Key Responsibilities * Operate a microtome to produce slides or curls from paraffin blocks. * Automated H&E Staining and Manual Kwik-Diff Staining. * Prepare samples for nucleic acid extraction. * Manage sample movement through lab facilities. * Maintains laboratory equipment and performs all routine maintenance. * Ensure and maintain molecular safe integrity and quality of the specimens. * Provide inputs for updates to relevant Standard Operating Procedures (SOPs) and documentation to ensure regulatory compliance and reflect process improvements. * Assist in attributing and debulking clinical and research study patient samples. * Maintain adequate stock and efficient use of supplies necessary for performing all procedures and preparation of reagents as required. * Maintain Good Documentation Practice (GDP) including proper specimen handling, labeling, and quality control measures. * Participate in biohazard, chemical, and general safety and other continuing education programs. * Work in a lab environment using chemicals and regents. * Perform tasks for projects under guidance of senior lab employees. * Other duties as assigned. Qualifications: Basic Qualifications: * High school diploma or equivalent (General Education Degree) and 3 years of experience in logistics, science, technology or another regulated field * OR Associates Degree in biological, life, or laboratory sciences and 2 years of experience in logistics, science, technology or another regulated field * OR Bachelor's degree in biological or life sciences and 1 year of experience in logistics, science, technology or another regulated field * Familiarity with Laboratory Information Management System (LIMS) Preferred Qualifications: * Bachelor of Science degree in a biological or life science * Certified as a Histotechnician (HT) or a Histotechnologist (HTL) by the American Society for Clinical Pathology (ASCP) * Strong interpersonal skills that include excellent skills in written and oral communication, collaboration, and problem solving * Excellent computer/data entry skills * Demonstrated attention to detail and strong organizational skills * Demonstrated experience handling multiple tasks at once * Ability to work independently as well as collaborate with peers in a fast-paced and cross-functional results-oriented team environment * Demonstrated experience working within tight timelines for successful execution of project and program goals * Ability to work well under pressure while maintaining a professional demeanor * Ability to prioritize and thoroughly follow up on assigned tasks * Ability to adapt to changing procedures, policies and work environment * Ability to perform work in a lab environment in the presence of chemicals and reagents * Understanding of HIPAA and importance of privacy of patient data * Commitment to Foundation Medicine's values: Integrity, Courage, Passion The expected salary range for this position based on the primary location of Morrisville, NC is $45,000 - $53,000 per year. The salary range is commensurate with Foundation Medicine's compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits. #LI-On-site
    $45k-53k yearly 7d ago
  • Technician Maintenance (SkillBridge)

    Merck 4.6company rating

    Durham, NC job

    **Job Requirements** Technician is a skilled technician with a moderate level of industry experience, responsible for performing routine operational and maintenance activities within an assigned suite or area. This role requires proficiency in mechanical and technical tasks, adherence to current Good Manufacturing Practices (cGMP), and a commitment to environmental, health, and safety (EH&S) standards. The Technician O2 works with moderate supervision, demonstrates mechanical aptitude, and actively contributes to team performance and process improvements. **Key Responsibilities** + **Operational Proficiency:** + Fully qualified to independently operate within the assigned suite or area + Performs all routine operational activities and preventative maintenance tasks independently. + Demonstrates mechanical aptitude and executes basic repairs for assigned equipment; + **Compliance and Documentation:** + Takes ownership of cGMP compliance, ensuring adherence to Standard Operating Procedures (SOPs), maintenance task lists, and proper documentation. + Proactively identifies and resolves compliance issues in the assigned suite, escalating to higher levels when necessary. + Maintains 100% training status without requiring coach input. + **Business Systems Proficiency:** + Proficient in business systems such as SAP, SAP Mobile, DeltaV, and other relevant platforms, performing tasks and transactions independently with minimal assistance. + **Problem Solving and Process Improvement:** + Recognizes operational and technical problems, using established procedures to assess and implement solutions. + Performs routine troubleshooting for assigned equipment or systems, escalating complex issues to higher-level technicians (O3/O4) as needed. + **EH&S and Team Accountability:** + Contributes to maintaining positive EH&S performance in the assigned area, actively identifying and resolving potentially unsafe conditions. + Demonstrates inclusion principles, collaborates with team members, and actively participates in team meetings, including Tier discussions. + Complies with safety and environmental regulations and guidelines. + **Work Management and Prioritization:** + Works independently to meet timeframes set by others, demonstrating reliability and follow-through on commitments. + Acts with urgency for emerging issues as directed by leadership. + **Leadership and Communication:** + Provides and receives timely, constructive one-on-one feedback to improve performance. + Listens, collaborates, and supports team decisions to meet collective goals. + **Additional Duties:** + Communicate with other departments, contractors, or disciplines + Assists with automation, validation, and additional testing as required. + Contributes to Continuous Improvement of existing processes + Complies with safety and environmental regulations and guidelines. + Other tasks that may be assigned by leadership **Work Experience** + **Minimum 3 years of plant maintenance or technical experience.** + Proficiency in **one** of the technical craft skills, including instrumentation, electrical, plumbing, or advanced mechanical systems. + Familiarity with regulatory requirements in accordance with cGMP manufacturing operations or other regulated industry. + Effective communication skills, both written and oral. + Ability to work with moderate supervision in non-routine situations. + This is a Skillbridge opportunity; candidates must be active duty military and eligible for Skillbridge opportunities. **Requisition ID:** P-100948
    $48k-63k yearly est. 45d ago
  • Executive Director, Engineering

    Merck 4.6company rating

    Durham, NC job

    The Executive Director, Maintenance and Engineering leads the HPV, VMF, Flash and Teknika Production Areas Maintenance, Clean Utilities, Site-wide Utilities, Site Services, and Site Engineering functions for the Durham site. As a member of the Durham Site Leadership Team, this role provides strategic and tactical direction to ensure asset reliability, cGMP/EHS compliance, effective shutdown and project execution, and efficient operations within budget. The leader drives continuous improvement, fosters an inclusive and positive culture, and partners with Operations/IPTs, GES, COEs, Automation, Reliability, Quality, EHS, and Finance to achieve safety, quality, service, and cost objectives. Key Responsibilities: Strategy and Leadership: Set the vision and multi‑year strategy for maintenance, utilities, and engineering aligned to business goals, capacity needs, and compliance requirements. Serve on the Durham Site Leadership Team; influence site priorities and resource allocation. Build and develop a high-performing organization (~200 employees) including associate directors, managers, engineers, technicians, and coordinators; coach/mentor leaders and ICs. Promote an inclusive, positive culture emphasizing safety, quality, continuous improvement, and accountability. Compliance, Quality, and EHS: Ensure all Maintenance, Utilities, Site Services, and Engineering processes comply with cGMP; Safety; Environmental; Industrial Hygiene; ANSI and Labor regulations. Own audit readiness and respond to/resolve compliance gaps from audits and deviations; lead or support investigations and corrective/preventive actions (CAPA). Establish and enforce procedures for lockout/tagout, machine guarding, risk assessments, Electrical Safety, Hot Work, Line Breaking, Confined Space, Elevated Work, PSM elements as applicable, and contractor management. Maintenance and Calibration Operations: Direct preventive, predictive, and corrective maintenance programs HPV, Flash, VMF and Teknika production equipment, clean utilities, facilities, and site services. Ensure equipment calibration programs are GMP-compliant; maintain integrity of equipment identification and specifications within the computerized maintenance/calibration management system. Manage shop floor support to meet safety, compliance, production, and financial goals; reduce reactive work by analyzing completed work orders and driving reliability actions. Oversee spare parts strategy including risk-based assessments, obsolescence replacement, storeroom controls, and SAP plant maintenance/spare parts procurement processes. Utilities and Site Services: Lead operation and maintenance of all plant utilities and distribution networks: boilers, refrigeration, HVAC, electrical substations, compressed air, potable/distilled water, dust collection, wastewater, storm water, and related systems. Coordinate site services (building, building services, grounds, waste, and facility support) to ensure reliable, compliant operation. Drive sustainability initiatives, ensuring regulatory compliance and implementing strategies for continuous improvement. Reliability and Continuous Improvement: Partner with reliability engineers to conduct RBAM, RCM/FMEA, root cause analysis, and implement area-specific reliability actions to improve uptime, MTBF/MTTR, and OEE. Collaborate with Automation for troubleshooting and maintenance of automated equipment; engage vendors and OEMs to resolve complex issues and improve performance. Monitor performance of maintenance, calibration, equipment, and utilities operations; identify improvement opportunities and drive continuous improvement initiatives. Shutdown and Turnaround Management: Own master shutdown schedules and execution across maintenance, calibration, capital project work, and GMP cleaning; chair/attend daily shutdown meetings to track completion. Background in reliability engineering, RBAM/RCM/FMEA, and root cause analysis. Experience with shutdown/turnaround management and multi-site coordination. Familiarity with automation/controls and vendor/OEM management. Certifications: PMP, CMRP/CRE, Six Sigma/Lean, PE or equivalent. Key Performance Indicators (KPIs): Asset availability/OEE; equipment reliability (MTBF/MTTR) Planned vs. reactive work ratio; maintenance backlog Calibration compliance and audit outcomes Utilities uptime and energy efficiency Safety performance (RIR, near-miss closure, LOTO compliance) Budget adherence (OPEX/CAPEX), spare parts inventory accuracy/turns Capital project delivery (scope, schedule, cost, qualification/closeout) Education: Bachelor's degree in Engineering, Science, or a closely related technical field (Mechanical, Electrical, Chemical, Industrial, or similar) Advanced degree (MS/MBA) or Professional Engineer (PE) preferred Required Experience and Skills: 15+ years total in industrial plant engineering, maintenance, and/or utilities management within GMP or highly regulated manufacturing environments, covering production equipment, clean utilities, building services, and facilities/utilities project engineering. 5+ years leading people, including through managers and individual contributors, in multi-disciplinary maintenance/engineering organizations. Technical Skills: Track record owning maintenance and calibration programs, reliability improvement initiatives, and capital project delivery (scope, cost, schedule, quality, qualification/validation). Proficiency with CMMS/EAM and GMP-compliant calibration systems; experience analyzing maintenance data to reduce reactive work and increase reliability. Working knowledge of SAP (Plant Maintenance and spare parts procurement) or equivalent ERP. Strong understanding of utilities operations (boilers, refrigeration, HVAC, electrical distribution, compressed air, water systems, wastewater/storm water) and associated regulatory requirements. Familiarity with automation/controls environments and collaboration with OEMs/vendors. Compliance and Safety: Demonstrated knowledge of cGMP, EHS, and relevant Safety, Environmental, Industrial Hygiene, and Labor regulations. Experience leading audits/inspections, deviations, investigations, and CAPA. Leadership and Business: Strong planning, scheduling, budgeting, and financial acumen for OPEX/CAPEX management. Excellent analytical, decision-making, and problem-solving skills; effective written and oral communication. Proven ability to drive continuous improvement and foster an inclusive, positive team culture. Preferred Experience and Skills: Certifications: PMP, CMRP/CRE, Six Sigma/Lean. Experience with shutdown/turnaround management and multi-site/COE collaboration. Direct experience in pharmaceutical or biopharmaceutical manufacturing, including equipment qualification/validation and change control. Competencies: Strategic thinking and execution Technical depth in maintenance, utilities, and engineering Financial acumen and cost control Compliance and risk management Continuous improvement and problem solving Coaching, talent development, and inclusive leadership Stakeholder influence and cross-functional collaboration Required Skills: Accountability, Contractor Oversight, Cross-Cultural Awareness, Customer-Focused, Customer Service Leadership, Engineering Design, Ethical Compliance, Facility Management, Innovation, Leadership, Management Process, Operations Management, People Leadership, Professional Engineering, Risk Management, Team Leadership, Utilities Management, Visionary Thinking Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $231,900.00 - $365,000.00 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 employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ******************************************************* You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company 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. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 01/24/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
    $231.9k-365k yearly Auto-Apply 10d ago
  • Cloud Platform Engineering Architect (AWS)

    Gilead Sciences 4.5company rating

    Raleigh, NC job

    At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description The Gilead Cloud Platform Engineering (CPE) Architect role will provide architectural leadership to the CPE DevOps Team on both delivery and support. Description of Responsibilities Gilead Cloud core platform services and automation development (design, development and delivery of technical code) for the AWS Control Tower Landing Zone Terraform development impacting AWS account baselines, CI/CD integration with the platform, DMZ networking, and SCP management Core platform and automation security hardening Maintenance and support of core platform automation, guardrails and Security Control Policies (SCPs). Platform development, coding, automation, role-based access control, authentication, Cyber Security hardening and cloud support Continuous Integration/Continuous Delivery (CI/CD): Design, build, and maintain CI/CD DevSecOps pipelines to automate the building, testing, and deployment of applications. This includes Integration of CI/CD pipelines via automation with other services including security scanning, artifact repositories, ITSM, etc. Infrastructure as Code (IaC): Manage and provision cloud infrastructure using tools such as Terraform to ensure consistent and repeatable deployments. Cloud infrastructure management: Deploy, manage, and optimize cloud-based resources on platforms like AWS and Microsoft Azure. Containerization and orchestration: Work with container technologies like Docker and orchestration systems like Kubernetes to manage and scale applications. Monitoring and logging: Implement monitoring, logging, and alerting solutions to track application performance, system health, and security issues. Security and compliance: Ensure that cloud environments and deployment practices adhere to security best practices and compliance standards. Collaboration: Work closely with application teams, security, and quality assurance to troubleshoot issues and streamline processes. Automation: Identify and automate manual and repetitive processes to increase efficiency and reduce human error. Leverage AI tools for improved automation and scale. Troubleshooting: Perform root cause analysis and provide technical support to resolve issues in development, testing, and production environments. Provide daily technical leadership and guidance to the Cloud Platform Engineering Core and CI/CD Engineering Scrum Team Education and Experience Required: Minimum Required Education and Years of Experience: High School Degree and Fourteen Year's Experience OR Associates Degree and Twelve Years Experience OR Bachelor's Degree and Ten Years' Experience OR Masters' Degree and Eight Years' Experience Public Cloud Services knowledge of AWS, MS Azure (a plus) Development (coding) skills required, Terraform and GitHub expertise required CI/CD DevSecOps opinioned pipelines subject matter expertise Professional certifications a plus (Public Cloud, Architecture, Program Management etc.) Agile/Scrum knowledge and leadership skills Knowledge and Skills Required: Subject matter expert on AWS, MS Azure Public Cloud services Deep knowledge in Public Cloud Infrastructure and Application Architectures Knowledgeable in all facets of compute, network and storage as it relates to Public Cloud Application Architecture Subject matter expert in AWS Cloud Control Tower Landing Zone (CTLZ) architecture Advanced knowledge of CI/CD DevSecOps opinioned pipelines and GitHub self-hosted runner architecture Advanced code writing in multiple languages to design and deliver Gilead Cloud CI/CD pipeline services (primarily AWS, Azure a plus) Code development in multiple languages preferred, expert skills in Terraform and GitHub required Understanding and capability to Lead an Agile Scrum Team Strong root cause analysis skills to troubleshoot and resolve support escalations for Gilead Cloud core services Develop and publish infrastructure and Application architecture designs ITSM subject matter expertise to assist with implementation, integration, governance and improvement Reporting and Analytics tools and development Program Management skills - set up meetings, facilitate, assign actions, track/ follow up and report out Proficient with Atlassian (Confluence and Jira), MS DevOps, MS Office, especially Outlook, Excel and PowerPoint. Use of large/complex Excel files will be required. GitHub expertise a must. Advanced written and verbal communication skills Specific job duties may vary and will flex to align with business requirements. The salary range for this position is: Raleigh: $168,980.00 - $218,680.00. Bay Area: $195,670.00 - $253,220.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: ****************************************************************** * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For jobs in the United States: Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.
    $80k-103k yearly est. Auto-Apply 60d ago
  • Strategic Operations Lead

    Foundation Medicine 4.8company rating

    Foundation Medicine job in Morrisville, NC

    About the Job The Strategic Ops Lead is designed to complement and support the responsibilities of the Site Enablement and Product Operations team within Strategic Operations. This role offers professionals in cancer diagnostics the opportunity to contribute to strategic initiatives, operational planning, and cross-functional coordination, while gaining exposure to leadership and product development processes. Key Responsibilities Support the Site Enablement and Product Operations Team in coordinating cross-functional activities across LabOps, Supply Chain, Client Services, and Quality. Assist in documenting operational requirements and supporting data-driven decision-making. Contribute to communications and stakeholder engagement across Strategic Operations and Product Development. · Participate in strategic initiatives and project planning, with a focus on scalability and patient impact. Help track progress toward project team objectives and key results. Coordinate the execution of E2E activities. Attend and contribute to meetings, workshops, and collaborative sessions. Provide insights and recommendations based on prior experience in cancer diagnostics. Champion collaboration and operational agility across teams. Other duties as assigned. Qualifications: Basic Qualifications: Bachelor's degree and 2+ years of experience in the cancer diagnostics field Strong communication and collaboration skills Ability to manage time effectively across dual responsibilities Preferred Qualifications: Masters degree and 1+ years of experience in the cancer diagnostics field Experience with Next Generation Sequencing (NGS) Experience writing technical documentation, including laboratory verification plans Familiarity with product development and design control processes Demonstrated ability to work in cross-functional and global teams Agreement to maintain confidentiality regarding sensitive company, employee, and proprietary data and information Commitment to reflect Foundation Medicine's values: Integrity, Courage, Passion The expected salary range for this position based on the primary location of Morrisville, NC is $67,300 - $84,100 per year. The salary range is commensurate with Foundation Medicine's compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits. #LI-Hybrid
    $67.3k-84.1k yearly Auto-Apply 32d ago
  • Sr. Pathologist and Associate Medical Director

    Foundation Medicine 4.8company rating

    Foundation Medicine job in Morrisville, NC

    About the Job The Sr Pathologist and Associate Medical Director is involved in all aspects of delivering Foundation Medicine's clinical laboratory testing services and serves as an internal subject matter expert, applying medical knowledge to advise decision makers in support of Foundation Medicine's mission to transform cancer care. The Sr Pathologist is responsible for review of patient samples, review of results generated from genomic profiling and other methodologies, and approval of reports. As an Associate Medical Director, the Sr Pathologist develops, reviews, and approves policies and procedures to ensure consistent, timely, and accurate clinical testing strategies; and participates in instrument, IT and test methodology selection, qualification and documentation; as well as new assay development, validation, and operationalization. The incumbent also serves as an ambassador for comprehensive genomic profiling through education and research efforts within and external to Foundation Medicine's. This is a regulated position and additional information may be available from QA on the qualifications for this role pertaining to regulatory guidelines. Key Responsibilities For clinical and biopharma testing performed at Foundation Medicine: Review patient specimens and accompanying documentation prior to testing in collaboration with other applicable stakeholders. Review test results and approve reports. As appropriate for the role, testing may include FoundationOne CDx, FoundationOne Heme, FoundationOne RNA, FoundationOne LiquidCDx, FoundationOne Tracker, and/or PD-L1 IHC assays, among others. Function as an Associate Medical Director for the laboratory operations to ensure compliance with regulatory guidelines and promote audit readiness. Interface directly with clients to support patient care. Support Foundation Medicine's Commercial Team initiatives and programs through traveling to and administering programs at hospitals, cancer centers, and academic medical centers. Participate in new assay development and validation, and optimization of existing assays. Provide clinical expertise for strategic research initiatives to expand new testing capabilities. Support Quality Assurance, Compliance, and Regulatory activities. Perform research studies leading to abstracts, peer-reviewed publications, and presentations at medical/scientific meetings that highlight Foundation Medicine's assays and data. Provide subject matter expertise on established specialty areas. May independently manage direct reports, including Senior Pathologists, Pathologists, and Clinical Staff Pathologists in the execution of the pathology clinical services, and support their career development and growth. Other duties as assigned. Qualifications: Basic Qualifications: Doctor of Medicine Degree Medical Licensure in the state of primary clinical laboratory affiliation Formal pathology training American Board of Pathology - Anatomic Pathology Certification 3+ years of experience in diagnostic pathology, biomedical research, or biotechnology after completion of clinical training Preferred Qualifications: American Board of Pathology - Clinical Pathology Certification American Board of Pathology - Molecular Genetic Pathology Certification Subspecialty training and/or expertise in cancer biology, genomics, or clinical trials Strong history of achievement demonstrated by leadership activities, publications, presentations, or other activities Collaboration skills and ability to effectively communicate with internal and external team members Process-oriented, flexible mindset and approach to creative problem solving Demonstrated history of cross-functional leadership and/or participation in cross-functional teams Demonstrated ability to: Meet deadlines Work well under pressure while maintaining a professional demeanor Self-organize and operate effectively without day-to-day oversight, while staying tightly connected to key leaders and teams across the collaborations Work in a laboratory environment in the presence of chemicals and reagents Agreement to maintain confidentiality regarding sensitive company, employee, and proprietary data and information Commitment to reflect Foundation Medicine's values: Integrity, Courage, and Passion The expected salary range for this position based on the primary location of Morrisville, NC is $250,000 - $310,000 per year. The salary range is commensurate with Foundation Medicine's compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits. #LI-Onsite
    $250k-310k yearly Auto-Apply 33d ago
  • IHC Technologist I (Tuesday - Saturday: 10:00am - 6:30pm)

    Foundation Medicine 4.8company rating

    Foundation Medicine job in Morrisville, NC

    About the Job The Technologist, Immunohistochemistry (IHC) on the Lab Operations team focused on elements of our Immunohistochemistry and Histology testing processes. The incumbent works on the bench performing immunohistochemistry assays using a variety of automated platforms. This is a regulated position and additional information may be available from FMI Quality Assurance regarding regulatory guidelines. Regular onsite work at a designated FMI location is an essential function of this role. Key Responsibilities: * Perform Automated Immunohistochemistry (IHC) using both the Dako Autostainer Link 48 and Ventana Benchmark Ultra Staining Systems. * Perform assigned tests or components of the test in accordance with assay run schedule accurately within turn-around-time and always in compliance with written standard operating procedures. * Maintain proper sample chain of custody including proper specimen handling, labeling, and preparation of batch records. * Maintain adequate stock and efficient use of supplies necessary for performing all procedures, and preparation of reagents as required. * Develop, evaluate, implement, and perform new methodology and antibody staining techniques. * Perform quality control testing on control tissues and reagents. * Complete projects under guidance of senior lab personnel. * Participate in biohazard, chemical, and general safety and other education programs. * Work in a lab environment using chemicals and regents. * Collaborate with other departments and colleagues to problem solve. * Other duties as assigned. Qualifications: Basic Qualifications: * Bachelor's of Science degree in a biological or life science * 2+ years of experience in a Clinical Laboratory Improvement Amendments (CLIA) / College of American Pathologists (CAP)-certified laboratory Preferred Qualifications: * 3+ years of automated Immunohistochemistry experience * 3+ years of experience in IHC validation and optimization * Certified Histotechnician (HT) or Histotechnologist (HTL) OR Qualification in Immunohistochemistry (QIHC) by the American Society for Clinical Pathology * Experience working with Automated Immunohistochemistry (IHC) to include both the Dako Autostainer Link 48 by Agilent Technologies and the Ventana Benchmark Ultra Staining System by Roche * Demonstrated experience working within tight timelines for successful execution of project and program goals * Demonstrated experience handling multiple tasks at once * Ability to work independently as well as collaborate with peers in a fast-paced and cross-functional results-oriented team environment * Ability to work well under pressure while maintaining a professional demeanor * Ability to prioritize and thoroughly follow up on assigned tasks * Ability to adapt to changing procedures, policies and work environment * Ability to perform work in a lab environment in the presence of chemicals and reagents * Strong interpersonal skills that include excellent skills in written and oral communication, collaboration, and problem solving * Demonstrated attention to detail and strong organizational skills * Understanding of HIPAA and importance of privacy of patient data * Commitment to FMI values: Integrity, Courage, and Passion The expected salary range for this position based on the primary location of Morrisville, NC is $43,500-$51,000 per year. The salary range is commensurate with Foundation Medicine's compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits. #LI-Onsite
    $43.5k-51k yearly 2d ago
  • Director, Statistical Programming

    Gilead Sciences, Inc. 4.5company rating

    Raleigh, NC job

    At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. **** Job Description At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world's most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. Director, Clinical Data Science - SAS Macro and Data Operations leads the end-to-end strategy, development, qualification, and lifecycle management of Statistical Programming tools, macro libraries, applications and automation solutions that accelerate clinical analysis and reporting. The role owns a multi-disciplinary team spanning statistical programming, data engineering, and platform operations, and partners closely with Biostatistics, Clinical Operations, Regulatory, and Quality to ensure compliant, efficient, and scalable delivery. Core technologies include SAS Macros, Python, Linux scripting, and modern cloud services. **Key Responsibilities:** **Strategic Leadership & Team Management** + Lead, mentor, and develop a team of SAS macro programmers, data engineers, and application developers (including Linux scripting, Python console, and web applications) to deliver high-quality statistical programming solutions for clinical trials and regulatory submissions. + Set clear goals, conduct performance assessments, and foster professional growth and continuous learning within the team. **Programming Oversight & Technical Excellence** + Oversee the design, development, validation, and maintenance of SAS macros, scripts, and applications supporting clinical data analysis, reporting, and regulatory deliverables (e.g., SDTM, ADaM datasets, TLFs). + Ensure programming infrastructure is robust, scalable, and compliant with regulatory standards (e.g., FDA 21 CFR Part 11, GxP), and supports reproducibility and audit readiness. + Promote automation and standardization of programming workflows to improve efficiency and consistency across studies. **Project Delivery & Resource Management** + Accountable for the timely and quality completion of all programming deliverables across assigned projects and studies, including resource allocation and prioritization. + Manage project timelines, budgets, and external vendor relationships as needed. **Cross-Functional Collaboration** + Collaborate with Biostatistics, Clinical Data Management, Regulatory Affairs, and IT to define programming requirements, align on analysis/reporting deliverables, and ensure data integrity. + Represent the statistical programming function in cross-functional meetings and strategic initiatives. **Process Optimization & Innovation** + Lead the development and implementation of programming standards, best practices, and innovative solutions (including cloud-based platforms, AI/ML, and automation pipelines) to enhance efficiency and quality. + Evaluate and integrate emerging technologies into statistical programming workflows. **Compliance, Documentation & Quality Assurance** + Ensure all programming activities adhere to SOPs, regulatory requirements, and internal quality standards; maintain audit readiness and documentation for all deliverables. + Oversee code quality, version control, and documentation governance frameworks. **Stakeholder Engagement & Training** + Provide technical guidance and training on advanced programming techniques, tools, and industry trends to team members and stakeholders. + Act as a key point of contact for external vendors and partners, ensuring alignment on programming standards and deliverables. **Basic Qualifications** PhD / PharmD and 8 years of experience OR Master's and 10 years of experience OR Bachelor's and 12 years of experience **Preferred Qualifications:** + Education: BS/MS/PhD in Biostatistics, Computer Science, or related field; advanced degree preferred. + Technical Skills: Expert in SAS Macros and strong proficiency in Python; working knowledge of R and Linux scripting; familiarity with AWS Cloud. + Core Competencies: Strategic thinking, cross-functional influence, compliance mindset, talent development, user-centric engineering. **People Leader Accountabilities:** + Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams. + Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose. + Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem. The salary range for this position is: Bay Area: $210,375.00 - $272,250.00. Raleigh: $181,730.00 - $235,180.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: ****************************************************************** * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. **For jobs in the United States:** Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' (********************************************** poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (********************************************************* YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. **For Current Gilead Employees and Contractors:** Please apply via the Internal Career Opportunities portal in Workday. Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
    $210.4k-272.3k yearly 33d ago
  • Molecular Technologist I

    Foundation Medicine 4.8company rating

    Foundation Medicine job in Morrisville, NC

    About the Job The Molecular Technologist I performs procedures in a complex patient sample testing process with limited supervision. Most prominently, the position is responsible for solution and reagent preparation, equipment maintenance, and the handling and testing of patient specimens. The incumbent works one of three established shifts and may be assigned to work any day that the lab is operational. This is a regulated position and additional information may be available from QA on the qualifications for this role pertaining to regulatory guidelines. Regular onsite work at a designated Foundation Medicine location is an essential function of this role. Key Responsibilities Prepare the Next Generation Sequencing (NGS) library. Under limited supervision of senior lab personnel and in adherence to established Standard Operating Procedures (SOPs): Extract and isolate nucleic acids. Complete hybridization capture, and genetic sequencing methods. Operate automated 8-span and 96-head liquid handling platforms. Operate quantification, sizing, and NGS instruments. Perform any other patient and client sample testing and processing steps needed. Perform workflow that maintains quality, thoroughness, and optimum efficiency for Turn Around Time (TAT). Utilize the Laboratory Information Management System (LIMS) to track and execute sample processing. Document executed process steps per Good Documentation Practices (GDP). Update and maintain records and data on test results per GDP. Perform daily, weekly, monthly and as needed equipment maintenance checks. Participate in additional continuous quality improvement activities. Adhere to safety protocols, such as wearing laboratory coats and required safety gear. Maintain organization and cleanliness in the labs. Collaborate on SOPs revisions and drafts as needed to adjust for process improvement initiatives and regulatory changes. Review SOPs at set intervals and sign-off to document knowledge of these procedures. Document and assist with investigations for non-compliance events via Non-Conformance Reports (NCRs), Corrective Action/Preventative Action (CAPAs) and other reports. Other duties as assigned. Qualifications: Basic Qualifications: Bachelor‘s Degree in a chemical, physical, biological, or life science (per NYSDOH regulatory requirements) 1+ years of molecular laboratory work experience in a CAP/CLIA regulated lab Certifications or licensure that is required by the state or county in which the job is posted Preferred Qualifications: Molecular Biology American Society of Clinical Pathology (MB-ASCP) Certification Quality System Regulations (QSR) compliant laboratory experience Familiarity of and experience working with DNA manipulation techniques, enzymatic reactions, and sequencing chemistry Familiarity with high throughput platforms and common molecular laboratory equipment (such as pipettes, thermocyclers, and liquid handlers) Experience with Laboratory Information Management System (LIMS) Experience ensuring and maintaining integrity and quality of the laboratory in the areas of sample processing, equipment maintenance, and SOPs Knowledge about laboratory safety protocols Demonstrated ability to: Work well under pressure while maintaining a professional demeanor both as an individual contributor and in a team Prioritize and thoroughly follow up on assigned tasks Handle multiple tasks at once and work in a fast-paced environment Adapt to changing procedures, policies and work environment Work in the presence of chemicals and reagents in a laboratory environment Proficiency utilizing Microsoft Office Suite, most specifically Excel and Power Point Excellent skills of written communication, oral communication, collaboration, and problem solving with other departments and colleagues Excellent organization and attention to detail Agreement to maintain confidentiality regarding sensitive company, employee, and proprietary data and information Commitment to reflect Foundation Medicine's values: Integrity, Courage, and Passion The expected salary range for this position based on the primary location of Morrisville, NC is $54,800 - $68,500 per year. The salary range is commensurate with Foundation Medicine's compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits. #LI-On-Site
    $54.8k-68.5k yearly Auto-Apply 33d ago

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