Cambrex jobs in Durham, NC

- 116 jobs

TALENT PIPELINE-Sr. Scientist I (ARD)
Cambrex 4.4
Cambrex job in Durham, NC
Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,400 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing. Your Work Matters. At Cambrex, we strive to build a culture where all colleagues have the opportunity to: engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more! Your Future Matters. Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today! Job Overview Execute analytical methods and provide general analytical support, such as release and stability testing of drug substances and drug products. Able to organize routine work independently and to evaluate, troubleshoot and interpret generated data. Demonstrated understanding of method development and qualification / validation principles. Routinely and effectively interacts with clients to discuss data and methods. Works on problems of moderate and sometimes advance scope in which analysis of situation or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Responsibilities Execute analytical methods for in-process control, release testing and stability monitoring of bulk drug substances and drug products under cGMP guidelines Independently develop and evaluate methodologies, design and implement experiments. Participates in experimental design, including development of methods and testing requirements to demonstrate method suitability. Maintains compliant records with little or no supervision Able to write technical documents with assistance Strong understanding and proficiency in use and maintenance of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks Perform assigned tasks carefully, safely and on schedule according to SOPs and supervisor instructions Sets up various instrumentation for testing according to written test methods and with little to no supervision. As needed, troubleshoots laboratory instrumentation Leads a sample project with assistance May participate in client level meetings, with approval May lead and develop other team members. May advise clients on site procedures. Responsible for ensuring compliance with cGMP and other regulatory guidelines. Analyze information for technical correctness and accuracy Compile, maintain, interpret and extrapolate data on results of analysis and communicate these results to supervisor Perform routine laboratory procedures in a timely and efficient manner Gain familiarization with analytical techniques Participate cGMP activities Provides input on SOPs and client questions Maintain laboratory equipment and supplies as directed May support peer-led laboratory investigations process with assistance Maintain a clean and safe work-space Maintain laboratory notebook and/or computer files (i. e. LIMS) according to standard, accepted practices Participate in group and project meetings as required Enter project hours promptly and update project status on appropriate tracking and/or timekeeping systems Attend seminars as required Participate in and comply with all current safety, health and environmental programs Shows initiative and interest in learning new techniques and tests Participates in technical discussions and brainstorming sessions Communicates issues or challenges to senior staff and/or management May review test data acquired by others and witness others' notebooks Assists with writing technical documentation such as OOS, atypical investigations, deviations and CAPAs Assists with writings standard operating procedures (SOPs), methods, qualification protocols and other standard documents as directed Provides input on SOPs and client questions With guidance, prepares well written and organized development reports Performs other related duties as assigned. Qualifications/Skills Working knowledge of experimental design, including chemistry supporting method development Working knowledge of analytical techniques and instrumentation such as NMR, IR, MS and HPLC. Working exposure to cross functional techniques including organic chemistry. Understands the chemical properties relating to method development, qualification /validation and troubleshooting. Able to comply to SOPs and basic regulatory compliance Working knowledge of scientific concepts, principles and procedures Actively and positively engages with team and supports process improvements Ability to read and execute compendial methodologies Strong understanding of current FDA and cGMP regulations General knowledge of chemistry and scientific calculations Hands on experience in analytical techniques such as HPLC, GC, etc Basic computer skills Ability to operate laboratory equipment and computers Ability to take direction from experienced scientists and contributes in a team environment Good problem-solving skills Good attention to details Can repeat and follow detailed scientific procedures with supervision Able to clearly present results verbally in group meetings and in written progress reports Routinely and effectively presenting findings to clients Good interpersonal skills and is willing to ask questions about procedures and concepts Aptitude and willingness to gain more skills and knowledge in support of GMP regulations Good written and verbal communication skills Familiarity with computer software such as Empower ChemDraw, Microsoft Word, PowerPoint, and Excel. Aptitude and willingness to gain more skills & knowledge. Good attention to detail and good problem-solving skills. Education, Experience & Licensing Requirements S. /B. A. Chemistry with 6+ years of experience in related industry or MS with 2+ years related experience Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. Travel: Not applicable Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required. Environment and Protective Equipment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is occasionally exposed to moving mechanical parts and vibration. The noise level in the work environment is usually very quiet. S. /B. A. Chemistry with 6+ years of experience in related industry or MS with 2+ years related experience Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. Execute analytical methods for in-process control, release testing and stability monitoring of bulk drug substances and drug products under cGMP guidelines Independently develop and evaluate methodologies, design and implement experiments. Participates in experimental design, including development of methods and testing requirements to demonstrate method suitability. Maintains compliant records with little or no supervision Able to write technical documents with assistance Strong understanding and proficiency in use and maintenance of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks Perform assigned tasks carefully, safely and on schedule according to SOPs and supervisor instructions Sets up various instrumentation for testing according to written test methods and with little to no supervision. As needed, troubleshoots laboratory instrumentation Leads a sample project with assistance May participate in client level meetings, with approval May lead and develop other team members. May advise clients on site procedures. Responsible for ensuring compliance with cGMP and other regulatory guidelines. Analyze information for technical correctness and accuracy Compile, maintain, interpret and extrapolate data on results of analysis and communicate these results to supervisor Perform routine laboratory procedures in a timely and efficient manner Gain familiarization with analytical techniques Participate cGMP activities Provides input on SOPs and client questions Maintain laboratory equipment and supplies as directed May support peer-led laboratory investigations process with assistance Maintain a clean and safe work-space Maintain laboratory notebook and/or computer files (i. e. LIMS) according to standard, accepted practices Participate in group and project meetings as required Enter project hours promptly and update project status on appropriate tracking and/or timekeeping systems Attend seminars as required Participate in and comply with all current safety, health and environmental programs Shows initiative and interest in learning new techniques and tests Participates in technical discussions and brainstorming sessions Communicates issues or challenges to senior staff and/or management May review test data acquired by others and witness others' notebooks Assists with writing technical documentation such as OOS, atypical investigations, deviations and CAPAs Assists with writings standard operating procedures (SOPs), methods, qualification protocols and other standard documents as directed Provides input on SOPs and client questions With guidance, prepares well written and organized development reports Performs other related duties as assigned.
$57k-78k yearly est. Auto-Apply 34d ago
Manager, Laboratory Operations - Biologics , Mass Spectrometry and Bioseparation
Alcami Corporation 4.1
Durham, NC job
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary The Manager, Laboratory Operations - Biologics is accountable for driving results in a fast-paced environment by providing strategic, technical, and operational leadership for the biologics department of Bioseparations & Mass Spectrometry within Laboratory Operations. This position requires a balance of scientific expertise, business acumen, and customer focus to ensure high-quality services, efficient execution, and sustained growth. The ideal candidate will be a collaborative leader with a proven track record in biologics development and testing, who thrives in a client-driven CDMO environment. On-Site Expectations 100% on-site position. 1st Shift: Monday - Friday, 8:30am - 5:30pm. Responsibilities Acts as the primary point of contact for key biologics clients, ensuring exceptional customer service and responsiveness. Oversee analytical services supporting biologics and other large molecules, including bioseparations using a variety of chromatographic and electrophoretic methodologies, characterization, release, stability testing, and other specialty studies. Extensive experience with mass spectrometry as applied to biologics, including method development, characterization, troubleshooting of instrumentation, data interpretation, and application of advanced analytical techniques to complex biologics. Translate client needs into actionable project plans while balancing scientific rigor with business requirements. Serve as subject matter expert in Biologics for internal and external stakeholders. Ensure projects are executed on time, on budget, and to the highest quality standards. Lead capacity planning, resource allocation, and prioritization of biologics projects across the analytical team. Drive operational efficiency, technical advancements, and laboratory innovation. Foster a culture of quality, compliance, scientific excellence, and continuous improvement. Drive professional development, technical training, and succession planning for staff. Attract, develop, and retain a high performing team to meet the current and evolving needs of the business through effective selection, training and development, coaching and mentoring and performance management. Promote a collaborative and innovative environment that encourages problem-solving and accountability. Ensure adherence to SOPs, training, and other regulatory requirements. Stays current on industry and regulatory laboratory trends and adapts the quality systems, practices, and procedures, as necessary. Qualifications Doctorate degree with 8+ years, or Master's degree with 10+ years, or Bachelor's degree with 12+ years of related experience in Chemistry, Biochemistry, or related field. 2+ years of previous supervisory experience. Experience in development, validation, and verification of analytical testing methods. Experience with inspections/audits by regulatory agencies and clients. Previous experience within CMO, or CDMO preferred. Previous experience in pharmaceutical GMP environment required. Knowledge, Skills, and Abilities Proven experience in CDMO/CMO environment desired. Thorough knowledge of GMP requirements and regulatory compliance. Understanding of biologics modalities (mAbs, proteins, cell & gene therapies, etc.) and analytical methodology (HPLC/UPLC, electrophoresis, mass spectrometry, AUC, UV/Vis, potency assays, etc.). Demonstrated success in building and leading teams, driving operational performance and achieving business growth. Excellent communication and interpersonal skills with ability to effectively represent the organization holistically to external clients. Demonstrated business acumen with ability to balance scientific excellence and commercial priorities. Demonstrated experience representing analytical or biologics operations during regulatory inspections. Strong organization and management skills required. Record of accomplishment in change management and proven ability to build teams. Self-motivated with high-energy and an entrepreneurial team spirit, willing to get “hands on” to build the business. Excellent written and verbal communications and presentation skills required. Strong skills with Microsoft Office (Word, Excel, and PowerPoint) required. Travel Expectations Up to 5% travel required. Physical Demands and Work Environment The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, manufacturing or clinical areas for inspections or work discussions. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc.
$70k-107k yearly est. Auto-Apply 22d ago
Director, Information Security & End User Computing (EUC)
Alcami Corporation 4.1
Durham, NC job
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary The Director, Information Security & End User Computing (EUC) is a senior IT leader responsible for safeguarding Alcami's information assets, overseeing enterprise security programs, and managing all end-user computing services and support functions. This role leads teams across security operations, infrastructure protection, and EUC support, ensuring reliable, secure, and high-quality technology experiences for all employees. The Director is expected to coach, develop, and grow technical talent while driving operational excellence, resilience, and continuous improvement across their areas of responsibility. On-Site Expectations 100% on-site position. 1st Shift: Monday - Friday, 8:30am - 5:30pm. Responsibilities Information Security Leadership Serve as Alcami's Information Systems Security Officer (ISSO) and lead enterprise security governance, assessments, and compliance programs. Manage security risk assessments across applications, cloud environments, and infrastructure. Maintain continuous security monitoring, vulnerability management, and incident response readiness. Oversee documentation and controls aligned with NIST RMF, ISO standards, and applicable regulatory frameworks. Partner closely with the CIO, CISO (if applicable), and other business leaders to strengthen Alcami's security posture. Contribute to COOP/DR strategy and ensure security considerations are embedded across all technology operations. End User Computing (EUC) Leadership Lead the EUC function, including Service Desk, desktop support, endpoint management, mobile devices, and collaboration tools. Oversee deployment, configuration, and lifecycle management of laptops, desktops, mobile devices, peripherals, printers, and standard office applications. Ensure timely, high-quality support for all users, with strong SLAs, KPI tracking, and a culture of ownership. Manage endpoint security controls, patching, and compliance across all devices. Drive standardization of images, device configurations, and application delivery. Strengthen ITIL-aligned service processes, change management discipline, and incident/problem management routines. Oversee Microsoft 365 administration in partnership with relevant infrastructure teams. People Leadership & Operations Recruit, develop, mentor, and retain high-performing teams across Security and EUC. Establish a culture of accountability, continuous learning, partnership, and proactive communication. Build operational roadmaps, establish strategic objectives, and manage departmental performance against goals. Develop and manage annual budgets for Security and EUC. Represent IT in cross-functional meetings and partner with customers across the organization to drive value. Continuous Improvement & Technical Leadership Drive innovation, process optimization, and automation across both Security and EUC operations. Provide technical guidance for troubleshooting complex security, infrastructure, and EUC issues. Maintain strong knowledge of emerging technologies, vulnerabilities, and best practices. Support audits, client assessments, and regulatory inspections. Qualifications Bachelor's degree in a related field; equivalent experience considered. 12+ years of experience in IT, including significant experience in Information Security and EUC operations. 6+ years of leadership experience managing technical teams. CISSP or equivalent security certification preferred. Deep expertise in security architecture, risk assessment, vulnerability management, and cloud security. Experience managing enterprise EUC environments, endpoint security, and Microsoft 365. Strong communication, customer engagement, and cross-functional collaboration skills. Proven ability to build high-performing teams and drive operational excellence. The ability to obtain and maintain a U.S. government issued security clearance is required. U.S. citizenship is required, as only U.S. citizens are eligible for a security clearance. Knowledge, Skills, and Abilities Must have experience with the following: Cloud expertise, and the ability to teach Mobile experience SCADA, infrastructure protection, and/or engineering experience Must be eligible to obtain a sensitive clearance - Position of Public Trust - and may be required to obtain a higher security clearance. Ability to manage responsibility for security assessments of a variety of applications or domains, to include cloud computing, and to manage several project/initiatives of large size, complexity, and risk. Demonstrated proficiency in implementing security controls, conducting risk assessments, and documenting compliance measures based on NIST RMF and ISO standards to meet organizational and regulatory requirements. Demonstrated proficiency in successfully evaluating and supporting documentation, validation, and accreditation processes necessary to assure that new and existing information technology (IT) systems meet the organization's information assurance (IA) and security requirements. Demonstrated proficiency in ensuring appropriate treatment of risk, compliance, and assurance from internal and external perspectives. Demonstrated ability to support development of actionable security blueprints, principles, models, designs, standards, and guidelines to ensure enterprise IT architecture and support is consistent, usable, secure and adds value to the business. Experience with network and vulnerability scanning tools and technologies to interrogate systems for configuration and status. In-depth understanding of security architecture principles and best practices to design, implement, and maintain secure IT infrastructures in alignment with corporate policies and compliance standards. Experience in computer forensic techniques. Excellent technical knowledge of mainstream security technologies and understands operation of them, such as network security appliances, Intrusion Detection Policies, identity and access management (IAM) systems, anti-malware solutions, antivirus solutions, automated policy compliance tools, desktop security tools, CASB, Email Protection, DNS filtering, IPS/IDS, XDR, and Vulnerability Management. Expert knowledge of Microsoft product-based systems. Strong knowledge of Service Now administration. Strong knowledge of application deployment, OS deployment, OS patching, and inventory management. Demonstrated experience in advanced troubleshooting of computer hardware and software. Excellent communication and interpersonal skills. Strong technical skills for area managing. Strong business acumen. Strong understanding of company SOPs, and regulatory guidance documents. Strong knowledge of safety procedures and quality compliance for assigned area. Strong knowledge of cGMP requirements. Strong experience with client audits. Excellent analytical and problem-solving skill, with the ability to think strategically. Strong attention to detail as well as time and resource management. Good presentation skills. Strong personnel and professional integrity and trustworthiness with strong work ethics and the ability to work independently with some direction. Promote a safe environment for work. Comply with the general policy of the company. High level of personnel and professional integrity and trustworthiness with strong work ethics and the ability to work independently with minimal direction. Ability to develop and manage a high-performance team focused on quality, accountability, and meeting and exceeding expectations. Communicate well orally both for internal customers and team members as well as external customers. Ability to write reports and business correspondence. Ability to listen and respond well to external customers, partners, and colleagues at all levels. Highly goal and result oriented. Prioritizes tasks according to business objectives and can pursue several objectives simultaneously. Can work independently with a high degree of self-motivation. Knows how to obtain support from different collaborations. Tackles problems with enthusiasm and curiosity. Treats colleagues at all levels with respect. Very effective listening skills with the ability to hear attentively and process information correctly. Travel Expectations Up to 25% travel expected including training. Physical Demands and Work Environment The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision. While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, manufacturing or clinical areas for inspections or work discussions. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc.
$106k-158k yearly est. Auto-Apply 10d ago
Metrologist - 2nd shift
Alcami Corporation 4.1
Morrisville, NC job
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary The Metrologist is a team player working in a fast-paced environment by performing calibration and preventive maintenance (PM) tasks of instruments including pressure, temperature, relative humidity, volumetric and mass in pharmaceutical manufacturing and laboratory environments. The ideal candidate will have a basic understanding of calibration and instrumentation and the use of computerized equipment and software to perform testing functions. On-Site Expectations 100% on-site position. 2nd Shift: Monday - Friday, 3:00pm - 11:30pm. Responsibilities Performs calibrations, PMs and repair on a variety of instrumentation with supervision. Utilizes several database systems. Maintains all logs and required documentation. Reads and follows Standard Operating Procedures (SOP's). Provide excellent customer service Disassembles and reassembles instruments and equipment, using hand tools, and inspects instruments and equipment for defects. Ensures timely completion and compliance with cGMP and all other relevant company training requirements. Other duties as assigned. Qualifications High School diploma or equivalent with 2+ years of relevant experience or an associate's degree with at least 1 year of relevant experience. Knowledge, Skills, and Abilities Basic understanding of circuits, components, equipment and instrumentation for manufacturing and laboratories. Excellent mechanical skills. Excellent verbal and written communication skills. Excellent organizational skills. Reliable, self-motivated, and a team player. Travel Expectations Up to 5% travel required. Physical Demands and Work Environment The physical demands and work environment characteristics described here are representative of those that must be met or encountered by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to walk; climb or balance and stoop, kneel, crouch, or crawl. The employee is occasionally required to sit. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds, occasionally lift and/or move up to 50 pounds and occasionally lift and/or move over 50 pounds with assistance. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. While performing the duties of this job, the employee is frequently exposed to moving mechanical parts, fumes or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; high, precarious places; risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc.
$89k-120k yearly est. Auto-Apply 3d ago
Pharmaceutical Packaging Technician I
United Therapeutics Corporation 4.8
Raleigh, NC job
California, US residents click here. The job details are as follows: Who we are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option. Who you are We are seeking a detail-oriented Pharmaceutical Packaging Technician I to join our team at the RTP facility. In this role, you will be responsible for setting up, operating, and cleaning pharmaceutical packaging equipment, including bottle lines, blister lines, cartoning lines, and manual kitting operations. Under direct supervision, you will support packaging and kitting operations, perform in-process checks, equipment adjustments, yield calculations, and batch reconciliations-ensuring strict adherence to company SOPs, MBRs, cGMPs, and safety regulations. If you have a keen eye for accuracy, a commitment to compliance, and a passion for pharmaceutical packaging, we'd love to hear from you! For this role you will need Minimum Requirements * H.S. Diploma or General Education Degree (GED) * Basic computer skills Preferred Qualifications * Associates Degree * 1+ years of hands-on experience in a pharmaceutical manufacturing, packaging or warehouse environment (will consider commensurate experience and/or combination of education and experience) * Ability to navigate sophisticated HMI control systems on automated pharmaceutical packaging equipment * Experience with GMP documentation requirements and have experience with completing batch packaging records, reading and understanding SOPs, and working with packaging machinery Job Location United Therapeutics requires this candidate to be on-site at our Durham, North Carolina location 100% of the time. At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good. Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit ****************************************************** United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
$33k-41k yearly est. Auto-Apply 11d ago
Manager, Facilities and Maintenance
Alcami Corporation 4.1
Morrisville, NC job
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary The Manager, Facilities and Maintenance is accountable for driving results in a fast-paced environment by managing and overseeing the programs and personnel related to maintenance of the facility, process equipment, critical utilities, general facility utilities. This includes routine support of day-to-day operations as well as special projects. Special projects include customer centric projects, plant shutdowns, and facility upgrades, renovations, or expansions. The Manager, Facilities and Maintenance administers these programs and projects by assisting in the development of project plans, schedules, and provides oversight of the work during execution. All activities are conducted under the regulatory agency requirements of the pharmaceutical industry and related products that are manufactured at Alcami, such as FDA, DEA, and EU as examples. On-Site Expectations 100% on-site position. 1st Shift: Monday - Friday, 8:00am - 5:00pm. Responsibilities Provides leadership and direction to the Maintenance (GMP and Facilities). Plans and manages projects including facility/utility capital projects and other capital efforts. Ensures GMP compliance (e.g. deviation initiation and review, CAPA assignments, compliance reports, change control generation and review). Provides maintenance program oversight (preventative maintenance programs, repairs, spare parts program, pest control program, etc.). Reviews and provides oversight to the facilities maintenance work order creation, which includes troubleshooting and guidance. Responsible for utilities such as but not limited to HVAC, compressed air, WFI, Clean Steam, nitrogen, chilled water, etc. Manages bi-annual shutdowns. Owns site security, including maintaining the camera and badge reader systems at the site, maintaining the key control list and working with the Global Security Manager on implementation of security programs and site security plan. Maintains and broadcasts key metrics to management. Ensures timely completion and compliance with cGMP and all other relevant company training requirements. Attracts, develops, and retains a high performing team to meet the current and evolving needs of the business through effective selection, training and development, coaching and mentoring and performance management. Directly supervises team of 5-8 direct reports. Participates in the hiring process of other employees. Makes hiring decisions of other employees. Schedules and reviews the work of other employees. Accountable for the curriculum assigned and timely completion of training of employees to meet regulatory requirements. Coaches, mentors and develops other employees. Prepares and delivers performance evaluations of other employees. Make recommendations of disciplinary actions of other employees. Other duties as assigned. Qualifications Bachelor's degree (Engineering disciplines) required. 6 plus years of regulated (FDA, DEA, NRC, DOE, etc.) applicable experience required; 8 to 10 years preferred. Minimum of 3 years supervisory experience required. Prior pharmaceutical experience required; CMO or CDMO experience preferred. Experience in aseptic operations a plus. Knowledge, Skills, and Abilities Expert knowledge of pharmaceutical facility operations and maintenance, and aseptic processing equipment. Knowledge of FDA regulated industry requirements, work order/calibration software, managing personnel, and EHS required. Excellent written and oral communication, coaching and mentoring skills required. Excellent ability to read and interpret engineering design, ability to read and understand equipment specifications and ability of track and trend data analysis required. Good negotiating skills required. Ability to manage a Maintenance team that works multiple shifts. Travel Expectations Up to 10% domestic travel. Physical Demands and Work Environment The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is required to frequently talk or hear. The employee is required some of the time to stand, walk, and sit. The employee is required to occasionally use hands to finger, handle, or feel; climb or balance; stoop, knell, crouch or crawl; reach with hands and arms; taste or smell. The employee must regularly lift and/or move up to 10 pounds, occasionally lift and/or move up to 50 pounds. There is no special vision requirement for this job. The employee may occasionally work in wet or humid conditions, near moving mechanical parts, in high precarious places, near fumes, airborne particles or toxic chemicals.
$75k-114k yearly est. Auto-Apply 60d+ ago
Intern - Human Resources - Strategy & Operations
Gilead Sciences 4.5
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 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. Intern - Human Resources Operations As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance our company's mission but will allow you to gain real world experience at one of the most innovative organizations in the world. You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following: Perform all assigned tasks accurately, efficiently and in accordance with applicable policies and procedures Work closely with members of assigned team to develop subject matter knowledge Attend company/department/team trainings and meetings as appropriate Maintain accurate and updated employee records in accordance with company policies and government regulations Provide answers to employee questions and problem-solves as needed Assist in the development and improvement of HR processes and procedures Compose competent employee communications regarding HR information and process changes Prepare HR-related reports and surveys Showcase your work with a final poster board presentation near the conclusion of your internship Required Qualifications: Must be at least 18 years old Must have a minimum GPA of 2.8 Authorized to work in the United States without Sponsorship now or in the future Must be currently enrolled as a full-time student in a Bachelor's/Masters/MBA/PhD program at an accredited US based university or college Must be a Rising Sophomore, Junior, or Senior in undergrad or a Graduate or Doctoral Student Must be enrolled full-time in the Fall Semester at an accredited university/college after the completion of the internship Must be able to complete a 10-12 consecutive week internship between May and August Must be able to relocate if necessary and work at the designated site for the duration of the internship Must show proof of full COVID-19 vaccination and first booster shot Preferred Qualifications: Undergrad or master's degree in any of the following fields: Biology, Chemical Engineering, Computer Science, Business Administration Proficiency with MS Office Suite Ability to identify issues and seek solutions Ability to work both independently and collaboratively Demonstrated commitment to inclusion and diversity in the workplace Efficient, organized, and able to handle short timelines in a fast-paced environment Demonstrated commitment to inclusion and diversity in the workplace Efficient, organized, and able to handle short timelines in a fast-paced environment Good analytical skills with attention to detail Ability to maintain high standards of confidentiality Show strong passion for building a career in Human Resources Workday or ServiceNow knowledge a plus but not required Gilead Core Values: Integrity (Doing What's Right) Inclusion (Encouraging Diversity) Teamwork (Working Together) Excellence (Being Your Best) Accountability (Taking Personal Responsibility) As an equal opportunity employer, Gilead Sciences has a strong commitment to diversity and inclusion. 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 ****************** for assistance. For more information about equal employment opportunity protections, please view the EEO is the Law poster. We are an equal opportunity employer. Apply online today at *********************** The expected hourly range for this position is $19.00 - $55.00. Gilead considers a variety of factors when determining base compensation, including education level and geographic location. These considerations mean actual compensation will vary. Benefits include paid company holidays, sick time, and housing stipends for eligible employees. 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.
$19-55 hourly Auto-Apply 22d ago
PART TIME - Distribution Teammate - Equipment Operator
Owens & Minor 4.6
Raleigh, NC job
At Owens & Minor, we are a critical part of the healthcare process. As a Fortune 500 company with 350+ facilities across the US and 22,000 teammates in over 90 countries, we provide integrated technologies, products and services across the full continuum of care. Customers-and their patients-are at the heart of what we do. Our mission is to empower our customers to advance healthcare, and our success starts with our teammates. Owens & Minor teammate benefits include: + Medical, dental, and vision insurance, available on first working day + 401(k), eligibility after one year of service + Employee stock purchase plan + Tuition reimbursement **The anticipated pay range for this position is $20.00/hr** PART TIME - Distribution Teammate - Equipment Operator Performs warehouse tasks within the facility, primarily without the use of Material Handling Equipment (cherry picker, reach truck, double reach, sit down forklift, motorized pallet jack, etc.). Unloads, receives, and processes inbound shipments. Performs bin replenishment, moves product around the distribution center to ensure efficient processing, and prepares pick locations. Accurately picks, packs, sorts and loads outbound products in accordance with customer specifications. Ensures warehouse functions are completed safely, accurately, and on-time within company standards. **RESPONSIBILITIES** **Receiving** + Unloads pallets and cases from inbound trailers and/or containers manually using the pallet jack. + Accurately counts, verifies, and receives product using radio frequency (RF) equipment and/or Voice Pick Technology; documents variances. **LUM Picking** + Selects products and quantities as directed by Voice Pick Technology and/or RF scanner and places items into totes on conveyor belt. + Removes empty cartons from pick module as needed. **Sortation** + Prepares sortation area by setting up pallets and carts for product. + Moves cartons and totes from conveyor belts and/or rollers and places on pallets and/or carts according to assigned batch. **Loading** + Uses RF scanner to ensure that totes, pallets, and carts are loaded correctly onto trucks for customer delivery. + Uses pallet jack to load pallets. **General requirements for all functions** + Follows general sequencing and process procedures. + Maintains a safe and clean work environment. + Follows safety policies and procedures and corrects or communicates hazards to management. + Places incoming merchandise into inventory. + Conducts physical inventories as required. + Counts and performs basic math calculations. + Maintains productivity and quality standards. + Performs additional duties as directed. **EDUCATION & EXPERIENCE** + General knowledge of a variety of basic topics (math, reading, basic accounting, typing, etc.) + Prior experience working in a warehouse/distribution center a plus + Warehouse/Operations certification a plus **KNOWLEDGE, SKILLS, & ABILITIES** + Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagrammatic form + Ability to work in a fast-paced, team environment and meet performance standards/individual performance goals + Good attention to detail + Dependable and able to report to work as scheduled/have regular punctual attendance + Willingness to learn how to use new material handling equipment + Willingness to learn WMS Technology + Ability to adhere to all Standard Operating Procedures for safety rules and requirements received in training **ADDITIONAL REQUIREMENTS** + Must successfully pass pre-employment drug screen and background check + Ability to frequently work unscheduled overtime hours with minimal notice + Ability to work nights, weekends, and holidays as needed + For some functions, must be able to operate forklift and pick items as high as 35 feet in the air + Must be able to stand and walk on concrete warehouse floors for long periods of time + Must be able to squat and kneel often, and lift up to 50 lbs. individually or greater than 50 lbs. in a team lift + Must be able to safely use a step ladder or stool to reach area shelves + Must be able to safely wear steel-toed protective footwear in accordance with the OSHA General Industry standard + Must be able to safely use a provided box cutter + Must be able to move up and down multi-level stairways safely + Must be able to clearly communicate (speak and understand) in English in order to operate voice-pick technology If you feel this opportunity could be the next step in your career, we encourage you to apply. This position will accept applications on an ongoing basis. Owens & Minor is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, sex, sexual orientation, genetic information, religion, disability, age, status as a veteran, or any other status prohibited by applicable national, federal, state or local law. Owens & Minor (O&M) is a global healthcare company providing innovative products and solutions across the continuum of care. Our integrated technology, products, and services empower healthcare providers and manufacturers as they make a difference in the lives of patients every day. O&M is headquartered in Richmond, Virginia and is comprised of 17,000+ global teammates. We operate within distribution, production, customer service, and sales facilities located across the Asia Pacific region, Europe, Latin America and North America. We are proud to service healthcare industry customers in 90 countries where we do business today. **Life at O&M** When you become an Owens & Minor teammate, you're joining a diverse, vibrant organization with a focus on excellence and integrity. Guided by our shared values-Integrity, Development, Excellence, Accountability, Listening-O&M teammates strive to deliver superior service across the continuum of healthcare. O&M is committed to creating a growth-oriented culture that values each teammate's perspective and contributions.
$20 hourly 60d+ ago
SAP ABAP Developer
Alcami Corporation 4.1
Durham, NC job
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary The SAP ABAP Developer will be responsible for designing, developing, testing, and supporting custom solutions and enhancements across SAP environments. This role combines strong expertise in traditional ABAP development (ECC and S/4HANA) with modern, cloud-native capabilities on SAP BTP. The developer will work closely with functional consultants, business analysts, and cross-functional stakeholders to translate requirements into robust, compliant, and scalable solutions. This is a hands-on technical role with broad impact-contributing to innovation, automation, and continuous improvement in a regulated pharmaceutical manufacturing environment. On-Site Expectations 100% on-site 1st Shift: Monday - Friday, 8:30am - 5:30pm. Responsibilities ABAP Development: Design, develop, and maintain custom ABAP objects: Design, develop, and implement custom ABAP programs, enhancements, and interfaces (RICEFW: Reports, Interfaces, Conversions, Enhancements, Forms, Workflows) Classical/Interactive and ALV Reports BAPIs, BADIs, User Exits, Enhancements (Implicit/Explicit) Smart Forms, Adobe Forms, SAPscript OO ABAP (Object-Oriented ABAP) and Function Modules Develop and support interfaces using IDocs, RFCs, Web Services. Implement S/4HANA-specific features such as: Core Data Services (CDS) Views ABAP Managed Database Procedures (AMDP) OData services for SAP Fiori apps. Perform code optimization, debugging, and performance tuning. Collaborate with functional consultants to gather business requirements and translate them into technical designs. SAP BTP (Business Technology Platform) Development Design and implement cloud-based applications and extensions using SAP BTP services (e.g., SAP Extension Suite, Integration Suite). Develop Fiori applications and deploy them on BTP. Create and manage OData APIs, REST services, and event-driven integrations. Work with CAP (Cloud Application Programming) model for BTP applications. Implement security and authentication mechanisms (OAuth, SAML, XSUAA) within BTP applications. Build and maintain CI/CD pipelines and manage deployments to BTP environments. Integration & Collaboration: Integrate SAP on-premise systems (ECC/S4) with BTP using Cloud Connector or APIs. Work closely with cross-functional teams (Basis, Security, Functional, Integration) to ensure end-to-end solution integrity. Support system upgrades, patches, and migrations. Quality & Standards: Follow SAP development best practices, coding standards, and performance optimization guidelines. Document technical specifications, solution designs, and deployment procedures. Participate in peer code reviews. Author Change controls Other duties as assigned. Qualifications Bachelor's degree in Computer Science, Information Technology, Engineering, or related field (or equivalent professional experience). SAP ABAP or SAP BTP developer certification a plus. 5+ years of SAP ABAP development experience (ECC or S/4HANA). 2+ years of SAP BTP development experience, including building applications or extensions. Industry experience in pharmaceuticals, life sciences, or manufacturing. Knowledge, Skills, and Abilities Experience with at least one full SAP implementation or major upgrade. Experience with Agile/Scrum methodologies. Strong ABAP programming expertise: Reports, BAPIs, BADIs, Enhancements, Forms. Experience in modules like MM, SD, PLM, PP, PS, TM, FICO. Hands-on experience with S/4HANA ABAP: CDS Views, AMDP, OData service creation. Proficiency with SAP BTP services: Extension Suite, Integration Suite, CAP, SAPUI5/Fiori. Familiarity with SAP Cloud Connector and API Management. Knowledge of Git-based source control, CI/CD tools, and DevOps practices. Understanding of REST APIs, JSON, and modern web development concepts. Strong communication, stakeholder engagement, and project management skills. Strategic thinking and commercial acumen in supplier management. Strong analytical skills with the ability to interpret complex data and drive operational decisions. Excellent communication and organizational skills; strong attention to detail and compliance. Deep understanding of GMP/GDP, FDA, and international regulatory expectations. Strong sense of urgency and attention to detail. Extremely high standards of excellence. Ability to handle multiple and sometimes competing priorities. Travel Expectations Up to 20% travel expected excluding training which will require travel. Physical Demands and Work Environment The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision. While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, manufacturing or clinical areas for inspections or work discussions. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc.
$93k-123k yearly est. Auto-Apply 60d+ ago
Scientist - Matrix Biology
United Therapeutics Corporation 4.8
Raleigh, NC job
California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option. How you'll contribute We are looking for our missing puzzle piece, an extracellular matrix (ECM) enthusiast who is looking to apply that expertise to a scale with impact that could change the world? This position will advance progress towards the generation of a functional engineered lung, with a specific focus on the role of the lung scaffold during cellular repopulation, including cell-matrix interactions, matrix changes during culture, and the impact of matrix properties on cellular repopulation. Interested? We can't wait to meet you - let's chat soon! * Characterize the stability of matrix components, identify relevant degradation profiles, and mitigate degradation of key components, as appropriate * Identify potential process changes or storage conditions to mitigate stability concerns, and contribute to the evaluation and implementation of changes to process or storage conditions * Analyze recellularization outcomes to understand the role of the ECM scaffold in the biology of regeneration in engineered lung constructs * Evaluate and optimize scaffold ECM stability from decellularization through recellularization and terminal pulmonary function assessments * Determine the proper chemical conditions for ECM stability, ECM component supplementation and adsorption, and ECM-cell interactions * Analyze matrix composition, turnover, and cell-derived matrix deposition in engineered tissues, interpret these findings, and provide insightful and actionable methods to improve or stabilize the function of the engineered tissues which may include supplementation with bioactive matrix or matrix-associated molecules * Assess the mechanical function of the scaffold at the organ (pulmonary mechanics) and tissue (interstitial, alveolar, and microvascular integrity) levels and develop methods to promote the proper organization and function of the matrix molecules to achieve optimal regeneration of native organ function * Evaluate the consistency of findings between in vitro assays and large-scale recellularization studies, adjusting or developing new assays as necessary * Independently integrate analyses from experiments across multiple sub-teams to determine key factors which drive outcomes, as needed * Develop new techniques, laboratory procedures, and/or protocols to support lung scaffold recellularization and characterization efforts, as needed * Proficiently perform complex scientific tasks and independently make complex technical or scientific decisions * Proficiently analyze data, potentially utilizing sophisticated or in-depth analyses, and through such analyses, identify novel data trends * Evaluate new technologies or methods, applying scientific insights to the process. Coordinate tech transfer with academic & industrial collaborators. * Develop and implement novel, impactful, and/or complex experimental plans. Generate insightful complex hypotheses and conclusions. Apply scientific knowledge and literature evidence to experimental planning. * Prepare and present regular reports on research strategy and progress * Independently contribute to focused research areas through maintenance and continued development of knowledge using past and current scientific literature as well as collaborative thinking * Commit to supporting individual, group, and departmental goals to achieve key objectives * Appropriately document performance and methods * Help maintain smooth operations of the lab, including maintaining lab supplies, monitoring equipment and providing lab support * Perform other duties as assigned For this role you will need Minimum Requirements * Masters degree with 6+ years of related industry or academic faculty-level experience or a PhD with 2+ years of related industry or academic faculty-level experience * 5+ years of experience and comfort developing, optimizing ,and performing analytical assays, evaluating and interpreting data, and optimizing and troubleshooting analytical assays * Experience includes proficiency with at least 4 of the following analytical tools in support of research efforts: histology, immunohistochemistry, image analysis, SEM/TEM, biochemistry, ELISA, Western Blot, and/or proteomics/glycomics, mechanical testing * Experience with statistical analysis utilizing JMP, GraphPad Prism, R or other comparable program * Proficiency and experience developing, optimizing ,and performing analytical assays, evaluating and interpreting data, and optimizing and troubleshooting analytical assays * Proficient in applying Design of Experiments (DOE) principles and advanced statistical methods for experimental planning and data interpretation * Familiarity with material and device biocompatibility evaluation and associated regulatory requirements Preferred Qualifications * Doctor of Philosophy (PhD) in protein/cell biology, biomaterials, biotechnology, biomedical engineering, biomechanics, or related field * Performs and interprets results of uniaxial mechanical testing * Experience with MatLab and/or Python * Comparative Proteomic Quantitation/Comparative Analysis Program(s) * Previous regenerative medicine or tissue engineering experience involving cellular and matrix or scaffold interactions * Experience/knowledge in one or more of the following: - Mechanical characterization of biomaterials, Chemical modifications of extracellular matrix, - Immunological techniques (IHC, ELISA), - Accelerated degradation study of biomaterials, product or prototype characterization of proteins, and/or - Protein detection, western blot or ELISA especially as applied to ECM component or degradative products * Contribution to regulatory filing(s) in support of clinical candidate development Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit ****************************************************** United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
$59k-93k yearly est. Auto-Apply 28d ago
Supervisor, Bulk Manufacturing (Dry Powder Inhalation)
United Therapeutics Corporation 4.8
Raleigh, NC job
California, US residents click here. The job details are as follows: What We Do We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation. We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization. Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of "medicines for life". We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan diseases. How you'll contribute United Therapeutics supplies Dry Powder Inhalation (DPI) medicines from the RTP, NC facility. This Supervisor is responsible for overseeing the setup, operation, and cleaning of all Bulk manufacturing operations equipment, ensuring that all machines within the supervised area(s), run efficiently and meet operations targets. The Bulk Supervisor will also lead a team of technicians, assigning tasks, monitoring performance, coaching and mentoring, and ensuring the smooth flow of operations across different workstations. * Provide leadership and guidance to technicians assigned to a given operations area, including but not limited to: performing and documenting all start-up checks, in-process checks, equipment adjustments, and batch reconciliations * Effectively direct and manage direct reports to include responsibilities for training, goal setting & achievement, coaching, mentoring; provide input to performance evaluations, and support career development, retention, and recruitment process. Promote open communication, address concerns promptly, and foster a positive and collaborative work environment while ensuring an uninterrupted operations flow. * Responsible for scheduling of operations personnel based on daily deliverables and personnel constraints * Effectively communicate operations needs and/or issues with leadership * Coordinate with warehouse staff for components needed for each operation; with QA staff for batch record issuance, room clearances and batch record checks as required; with manufacturing staff to issue labels and manage additional staffing needs; with maintenance staff for equipment troubleshooting and preventative maintenance * Ensure all operations completed in full compliance with company SOPs as well as GMPs. Ensure batch documentation as well as all cleaning records and labels are complete and accurate. Participate in resolving any non-conformance events; responsible for strict adherence to all OSHA and Company Safety Policies. * Author SOPs, batch documents and investigation reports * Perform all other duties as assigned For this role you will need Minimum Requirements * H.S. Diploma or General Education Degree (GED) * 9+ years of hands-on experience in a cGMP manufacturing, packaging or warehouse environment with a H.S. Diploma/GED or * 7+ years of hands-on experience in a cGMP manufacturing, packaging or warehouse environment with an Associates Degree or * 5+ years of hands-on experience in a cGMP manufacturing, packaging or warehouse environment with a Bachelor's Degree * Must have (or be willing and able to obtain) a valid Passport * Ability to navigate sophisticated equipment control systems on semi- and fully automated pharmaceutical equipment * Familiarity with the use and operation of in-process test equipment such as scales, balances, torque tester, and count checker * Experience with GMP documentation requirements * Must possess excellent written and oral communication skills * Ability to interact with other departments effectively * Ability to review work performed by other personnel, communicate problems and deficiencies, elicit corrections, and enforce company policy and procedures as they relate to manufacturing requirements * Ability to write and contribute to the development of SOP's and standard work instructions * Ability to work either a 24/5 or 24/7 work schedule Preferred Qualifications * Associates Degree or Bachelor's Degree in a relevant field * 2+ years of experience as an Operations Supervisor or equivalent * Knowledge of complex products and processes in a drug manufacturing facility At United Therapeutics, you'll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients. Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit ****************************************************** United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
$74k-99k yearly est. Auto-Apply 3d ago
TALENT PIPELINE -Project Manager 2
Cambrex 4.4
Cambrex job in Durham, NC
Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing. Your Work Matters. At Cambrex, we strive to build a culture where all colleagues have the opportunity to: engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more! Your Future Matters. Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today! Job Overview The Project Manager 2 is responsible for providing project management support and coordination to cross-functional project teams and clients ensuring that project deliverables are accomplished as outlined in the project's development plan. In addition, this position will help coordinate project progress and completion with business operations to ensure timely and accurate revenue recognition. Routinely coaches and mentors and may lead team members based on business needs. Responsibilities Key Job Responsibilities: • Manage client(s) portfolio across Cambrex sites & cross functional teams. • Develop Full Scale Project Plans & Project Resource Requirements • Reconcile Project Level Strategy with Overall Organizational Capacity & Strategy • Effective communication of client needs and escalations. • Identify and analyze issues and mitigate risks to project deliverables. • Escalation of critical project risks to management • Meeting Scheduling & Attendance • Meeting Notes & Action Item Tracking • Track Project Task Progress and Completion dates • Financial Monitoring & Milestone Invoicing Events • Participate in resolution of business-related conflicts. • Participation in business-related decisions and actions for managed projects • Promote a safe environment for themselves and their cross-matrix team. • Supervise and plan duties with external firms (auditors, etc. ) • Comply with the general policy of the company. • Drive key initiatives around operational excellence and site improvement programs • Host onsite customer visits • Escalate client feedback. • Facilitate change(s) of scope. • Mentoring of PM staff as needed • Work closely with your direct manager and Site Leadership when making decisions for programs supported. Essential Job Requirements: • Ability to effectively present status updates and business correspondence • Ability to listen and respond well to external customers, partners and colleagues at all levels. • Provide an advanced level of customer service (Internal and External) • Ability to negotiate and manage conflict. • Able to manage client requests professionally and in a timely manner. • Complete understanding of project related finances and status for project deliverables • Intermediate experience with application of project management techniques and tools. • Prioritizes tasks according to business objectives and can pursue several objectives simultaneously. • Knows how to obtain support from different stakeholders Qualifications/Skills Required Knowledge/ Skills/Abilities Knowledge • Moderate understanding of CDMO industry, Cambrex capabilities and pharmaceutical life cycle. • Computer understanding in Microsoft 365 Office Suite (word, excel, power point, teams, etc. ) o Must Have: ability to create Gantt charts. Skills / Abilities: • Highly goal and result oriented. • Strong interpersonal skills • Strong, Effective Communication (verbal & written) • Time Management and Scheduling • Highly organized • Advanced Business Acumen • Ability to work in a fast-paced cross-functional team. • Tackles problems with enthusiasm and curiosity • Treats colleagues at all levels with respect. Education, Experience & Licensing Requirements Education & Experience • A bachelor's degree or higher, preferably in the life sciences with minimally 4+ years of related industry experience including at least 2+ years of managing projects (preferably in the capacity of a Project Manager). • Qualification in project management (PMP certification) or equivalent preferred. Travel: As needed (5 - 10%) Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision. Environment and Protective Equipment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, manufacturing or clinical areas for inspections or work discussions. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to: safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc. LIMITATIONS AND DISCLAIMER The above is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position. All job requirements are subject to possible modification to reasonably accommodate individuals with disabilities. Some requirements may exclude individuals who pose a direct threat or significant risk to the health and safety of themselves or other employees. This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position. Employees will be required to follow job-related instructions and to perform other job-related duties requested by their supervisor in compliance with Federal and State Laws. Requirements are representative of minimum levels of knowledge, skills, and/or abilities. To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently. Education & Experience • A bachelor's degree or higher, preferably in the life sciences with minimally 4+ years of related industry experience including at least 2+ years of managing projects (preferably in the capacity of a Project Manager). • Qualification in project management (PMP certification) or equivalent preferred. Key Job Responsibilities: • Manage client(s) portfolio across Cambrex sites & cross functional teams. • Develop Full Scale Project Plans & Project Resource Requirements • Reconcile Project Level Strategy with Overall Organizational Capacity & Strategy • Effective communication of client needs and escalations. • Identify and analyze issues and mitigate risks to project deliverables. • Escalation of critical project risks to management • Meeting Scheduling & Attendance • Meeting Notes & Action Item Tracking • Track Project Task Progress and Completion dates • Financial Monitoring & Milestone Invoicing Events • Participate in resolution of business-related conflicts. • Participation in business-related decisions and actions for managed projects • Promote a safe environment for themselves and their cross-matrix team. • Supervise and plan duties with external firms (auditors, etc. ) • Comply with the general policy of the company. • Drive key initiatives around operational excellence and site improvement programs • Host onsite customer visits • Escalate client feedback. • Facilitate change(s) of scope. • Mentoring of PM staff as needed • Work closely with your direct manager and Site Leadership when making decisions for programs supported. Essential Job Requirements: • Ability to effectively present status updates and business correspondence • Ability to listen and respond well to external customers, partners and colleagues at all levels. • Provide an advanced level of customer service (Internal and External) • Ability to negotiate and manage conflict. • Able to manage client requests professionally and in a timely manner. • Complete understanding of project related finances and status for project deliverables • Intermediate experience with application of project management techniques and tools. • Prioritizes tasks according to business objectives and can pursue several objectives simultaneously. • Knows how to obtain support from different stakeholders
$69k-100k yearly est. Auto-Apply 34d ago
Research Associate I - HLA/SLA
United Therapeutics 4.8
Morrisville, NC job
California, US residents click here (******************************************************************************************************************************************* . **The job details are as follows:** **Who We Are** We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. United Therapeutics (Nasdaq: **UTHR** ) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease ( **PH-ILD** ) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis ( **PF** ). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option. **Who You Are** The Research Associate I - HLA/SLA (Xeno/RMO) is responsible for assisting developing, validating, and performing immunogenetics testing to support xenotransplantation research and regulatory milestones. This role focuses on performing assays to characterize swine leukocyte antigen (SLA) and human leukocyte antigen (HLA) compatibility, optimizing crossmatch and antibody screening assays, and ensuring high-quality, reproducible data to guide clinical and preclinical decision-making. The position plays a key role in advancing translational research by collaborating with multidisciplinary teams to refine protocols, analyze results, and support regulatory submissions. + Perform routine and complex immunogenetics testing (e.g., PCR-based typing, Next-Generation Sequencing, Luminex/Intelliflex assays) on human and porcine samples + Assist in development, validation, and optimization of assays for histocompatibility testing (HLA/SLA) + Isolate, culture, and prepare PBMCs, endothelial cells, and other relevant cell populations for compatibility testing + Troubleshoot technical issues, maintain assay performance, and document deviations or corrective actions + Maintain and calibrate laboratory equipment, ensuring readiness for regulated testing and audits + Contribute to scientific manuscripts, abstracts, and conference presentations + Stay current with relevant literature, technologies, and regulatory guidelines in HLA/SLA testing and xenotransplantation research + Document all laboratory activities in compliance with GLP, CLIA, CAP, EFI, and/or FDA regulatory requirements + Assist in writing, reviewing, and updating SOPs, validation protocols, and quality records + Participate in internal audits, CAP inspections, and regulatory reviews + Assist in training junior staff and collaborators in proper laboratory techniques and assay workflows + Collaborate with clinicians and R&D scientists to design experiments and refine donor-recipient matching strategies Minimum Requirements + Bachelor's Degree in a related field + 1+ years of histocompatibility experience + Proficiency in laboratory techniques (pipetting, cell handling, molecular assays, flow cytometry) + Capacity to participate in multiple projects with competing timelines in a fast-paced research and clinical environment + Effective problem-solving skills to troubleshoot assay failures and identify root causes + Competence with electronic laboratory notebooks (ELN), LIMS systems, and basic bioinformatics workflows + Ability to work flexible hours including evenings and weekends on an ad hoc basis. Preferred Qualifications + ABHI - American Board of Histocompatibility and Immunogenetics Certified Histocompatibility Technologist (CHT) or Supervisor (CHS) + Strong understanding of immunogenetics, including HLA and SLA systems, antigen presentation, and transplant immunology + Familiarity with xenotransplantation models, including swine genetics, immunobiology, and donor-recipient matching considerations + Working knowledge of cell culture techniques, including PBMC and endothelial cell isolation and maintenance + Knowledge of crossmatch methodologies (CDC, flow cytometry) and interpretation of cytotoxicity/antibody binding data + Excellent technical documentation skills for SOP writing, assay reports, and regulatory submissions Job Location This job is an Onsite role requiring 5 days per week in the Morrisville, NC location. At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good. Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit ****************************************************** United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities. _We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success._ _We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work._
$55k-72k yearly est. 37d ago
Intern - IT - Enterprise Data & Analytics
Gilead Sciences, Inc. 4.5
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** As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance our company's mission but will allow you to gain real world experience at one of the most innovative organizations in the world. You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. **Key Responsibilities will include, but are not limited to the following:** + Learning Objectives: US Commercial Data, AWS and Databricks data pipelines, Gilead culture + Data & Analytics DevOps: Assist the team in adhoc DevOps manager tasks + GenAI: Lead Innovation POCs with GenAI-first approach to improve team operations and end-user experience + Strategy & Roadmap: Influence cross-functional partners like the Platform team to streamline team's technical Roadmap intake and monitor its execution + Team support: Assist the team in broader communication activities like newsletters, QBRs and team events organization + Showcase your work with a final presentation (PPT) near the conclusion of your internship **Required Qualifications:** + Must be at least 18 years old + Must have a minimum GPA of 2.8 + Authorized to work in the United States without Sponsorship now or in the future or CPT/OPT through your University. + Must be currently enrolled as a full-time student in a Bachelor's/Masters/MBA/PhD program at an accredited US based university or college + Must be a Rising Sophomore, Junior, or Senior in undergrad or a Graduate or Doctoral Student + Must be enrolled full-time in the Fall Semester at an accredited university/college after the completion of the internship + Must be able to complete a 10-12 consecutive week internship between May and August + Must be able to relocate if necessary and work at the designated site for the duration of the internship **Preferred Qualifications** **:** + Preferred Degree qualification: BA/BS + Proficiency with MS Office Suite + Ability to identify issues and seek solutions + Ability to work both independently and collaboratively + Demonstrated commitment to inclusion and diversity in the workplace + Efficient, organized, and able to handle short timelines in a fast-paced environment **Gilead Core Values:** + Integrity (Doing What's Right) + Inclusion (Encouraging Diversity) + Teamwork (Working Together) + Excellence (Being Your Best) + Accountability (Taking Personal Responsibility) The expected hourly range for this position is $19.00 - $55.00. Gilead considers a variety of factors when determining base compensation, including education level and geographic location. These considerations mean actual compensation will vary. Benefits include paid company holidays, sick time, and housing stipends for eligible employees. **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.
$36k-46k yearly est. 31d ago
Controls Engineer II, Operational Technology
United Therapeutics Corporation 4.8
Raleigh, NC job
California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option. Who You Are You're looking to grow your career in automation and excited about supporting multiple cutting edge projects as we expand our manufacturing and packaging operations. You want to be part of a top-notch Operational Technology team where you'll have the opportunity to develop amongst some of the very best in the industry. The Controls Engineer II, Operational Technology will provide key technical and automation support for complex distributed control systems and manufacturing automation systems, including Schneider EcoStruxure, AVEVA Archestra, and JCI Metasys in a regulated, validated environment. * Provide key support of distributed control systems and manufacturing automation systems - Perform system and equipment troubleshooting; - Troubleshoot and maintain PLCs, VFDs, HMIs and field devices under strict change control; - Perform preventative maintenance procedures on system and/or equipment as required; - Perform network troubleshooting, database troubleshooting and repair programming; - Ensure PLC specifications, designs, programming standards and implementation and verify those standards are being met; - Ensure GAMP/cGxP procedures and testing implementation are followed * Provide system support for Operational Technology systems to include Enterprise Quality Management System (TrackWise), Enterprise Resource Planning (ERP) Systems (SAP), and Electronic Document Management Systems (EDMS) (Adept and MasterControl) * Perform other duties as assigned For this role you will need Minimum Requirements * Associate Degree in information technology or engineering or Bachelor's Degree in information technology or engineering * 4+ years of automation experience with an Associate Degree or 2+ years of automation experience with a Bachelor's Degree * Prior experience working in an FDA regulated pharmaceutical manufacturing environment * Organizational skills including, but not limited to, the ability to handle multiple demands and assignments, the ability to prioritize tasks effectively and efficiently, and the ability to effectively manage resource procurement and utilization * Superior database maintenance / development experience * Computer hardware / software validation and change control experience * PLC programming and connectivity experience * Industrial networking experience * Experience with Schneider EcoStruxure, AVEVA Archestra, and JCI Metasys * Experience working in small, fast paced project teams. Ability to work under pressure and adhere to deadlines Preferred Qualifications * Certified Automation Professional-ISA * Prior experience working on constructions projects Job Location This role is required to be 100% onsite located in either our Durham, NC OR Silver Spring, MD location and requires up to 10% travel. The salary range for this position is $84,000 - $115,000/yr and reflects our good-faith estimate of the compensation for this role at the time of posting. An employee's position within the salary range will be based on factors such as education, qualifications, experience, skills, geographic location, and business needs, as well as other factors permitted by law at the time of posting. This range may be modified in the future based on company and market factors. At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good. Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit ****************************************************** United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
$84k-115k yearly Auto-Apply 8d ago
Operations Supervisor
Owens & Minor 4.6
Raleigh, NC job
At Owens & Minor, we are a critical part of the healthcare process. As a Fortune 500 company with 350+ facilities across the US and 22,000 teammates in over 90 countries, we provide integrated technologies, products and services across the full continuum of care. Customers-and their patients-are at the heart of what we do. Our mission is to empower our customers to advance healthcare, and our success starts with our teammates. Owens & Minor teammate benefits include: + Medical, dental, and vision insurance, available on first working day + 401(k), eligibility after one year of service + Employee stock purchase plan + Tuition reimbursement **The anticipated pay range for this role is as follows: $67k/yr-$70k/yr** **Schedule: Monday-Friday 8am-4:30pm + overtime (weekends as needed)** We are **hiring immediately** for an **Operations Supervisor** on our **First** **shift** . This role is the life support that keeps regional hospitals stocked. Whether you're packing PPE products or surgical equipment- the items that are in your hands end up in the hands of doctors & nurses to help advance today's healthcare. We know that you make a difference, so we strive to make a difference in your life as well with the competitive pay and benefits you'd expect from an industry leader, plus: + **Medical, Dental, and Vision Benefits on Day 1 of employment** + **Career growth opportunities** + **Tuition reimbursement** + **401K matching** + **Employee Stock Program** **Job Summary** : Responsible for coordinating and managing multiple warehouse functions including receiving, warehousing, and shipping. This position has overall warehouse operations responsibility during the absence of the Warehouse Manager and have the ability to supervise Distribution Supervisors. **Core Responsibilities:** + Analyzes and resolves work problems, or assists teammates in solving work problems. + Works with teammates to review bills of lading of incoming merchandise and customer orders to plan work activities. + Works with Warehouse Manager and Lead Driver to prepare truck driver's delivery schedule. + Assigns teammates to specific duties, such as verifying amounts of and storing incoming merchandise and/or assembling customer orders for delivery. + Establishes work schedules and ensures that the schedules are correctly implemented and that jobs are assigned effectively and completed properly. + Responsible for supervising Leads, warehouse teammates and other supervisors as appropriate to ensure all warehouse functions are completed in a timely and accurate manner. + Screens and hires warehouse teammates; ensures teammates receive the appropriate training for their job function including the efficient and safe operation of all material handling equipment and warehouse machinery. + Interprets company policies to teammates and enforces safety regulations; Initiates or suggests plans to motivate workers to achieve work goals. + Conducts performance reviews and recommends or initiates personnel actions, such as promotions, transfers, discharges, and disciplinary actions. + Recommends measures to improve quality and suggests changes in working conditions and use of equipment to increase efficiency. + Ensures total adherence to all Federal statues regarding warehouse operations including DEA and OSHA regulations. + Works with non-warehouse departments such as Account Receivable, Purchasing, Sales, and Customer Service to ensure coordination of warehouse activities. + Must possess the general ability to use Windows based programs and the routine ability to retrieve and utilize available reports related to essential job activities **Qualifying Experience:** + General knowledge of a variety of basic topics, such as math, reading, basic accounting, typing, etc. Equal to a high school diploma. + Successful completion of all company warehouse training modules resulting in certification. Certified on all warehouse machinery + At least three years of O&M experience required; for external hires at least one year supervisory experience required and at least two years warehouse experience preferred. \#LI-ML1 If you feel this opportunity could be the next step in your career, we encourage you to apply. Owens & Minor is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, sex, sexual orientation, genetic information, religion, disability, age, status as a veteran, or any other status prohibited by applicable national, federal, state or local law. Owens & Minor (O&M) is a global healthcare company providing innovative products and solutions across the continuum of care. Our integrated technology, products, and services empower healthcare providers and manufacturers as they make a difference in the lives of patients every day. O&M is headquartered in Richmond, Virginia and is comprised of 17,000+ global teammates. We operate within distribution, production, customer service, and sales facilities located across the Asia Pacific region, Europe, Latin America and North America. We are proud to service healthcare industry customers in 90 countries where we do business today. **Life at O&M** When you become an Owens & Minor teammate, you're joining a diverse, vibrant organization with a focus on excellence and integrity. Guided by our shared values-Integrity, Development, Excellence, Accountability, Listening-O&M teammates strive to deliver superior service across the continuum of healthcare. O&M is committed to creating a growth-oriented culture that values each teammate's perspective and contributions.
$67k-70k yearly 30d ago
Scientist, Formulations
Alcami Corporation 4.1
Morrisville, NC job
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary The Scientist - Formulations is accountable for driving results in a fast-paced environment and leading formulation development studies for the design and identification of safe, stable, robust and manufactural pharmaceutical dosage forms. The Scientist - Formulations independently designs, plans, performs, interprets and reports results of scientific experiments for the preparation and timely delivery of drug products (DP), processes and procedures needed for technology transfer and manufacture of the product. The position requires superior leadership behaviors as well as expertise in functional competencies including scientific principles, laboratory practices, cGMPs and regulatory requirements for pharmaceuticals and biologicals. On-Site Expectations 100% on-site position. 1st Shift: Monday - Friday, 8:30am - 5:30pm. Responsibilities For Liquid and Sterile Formulation: Creates formulation development plans and executes well-designed experiments to define the qualitative and quantitative formulation composition. Conducts design of experiments (DoE) studies to identify and investigate key and critical quality attributes to confirm formulation robustness as per ICH Q8. Writes and executes protocols to prepare formulations for testing and characterization, methods development and technology transfer. Records and reports study results in compliance with good scientific policy and procedures. Evaluates new scientific technologies/equipment to enhance capability, capacity, and efficiency. Reports and presents scientific/technical results internally and to external clients. Utilizes complex tools/equipment, lab automation tools, and specialized facilities. Maintains and operates equipment according to safety standards and operating procedures. Reviews own work and conduct peer review. Participates in scientific conferences and contributes to scientific journals. Provides coaching and mentoring to junior colleagues and newcomers. Ensures timely completion and compliance with SOPs and all other relevant company training requirements. Other duties as assigned. Qualifications Bachelor's degree in Pharmaceutical Sciences, Chemistry, or equivalent with 6-8 years of experience or Master's degree with 2+ years of experience. Strong customer service focus and excellent customer contact skills. Knowledge, Skills, and Abilities Thorough fundamental knowledge and understanding of solubility and stability theory and practice. A solid understanding of drug solubilization and stabilization techniques in liquid dosage forms. Hands on expertise in aseptic techniques for liquid formulation, compounding, and manufacturing. Experience in aseptic filtration, terminal sterilization and lyophilization process techniques. Knowledge of raw material selection strategy and criteria for parenteral and liquid dosage forms. Basic understanding of physical characterization tools such as DSC, particle size and different viscometers. Hands-on experience in analytical techniques such as UV-Vis and HPLC. Basic understanding of quality attributes and regulatory requirements for parenteral and liquid dosage forms. Basic understanding of quality attributes for biologics formulations. Knowledge of methods for characterization and testing of liquid and parenteral dosage forms. Ability to plan and manage multiple tasks for timely achievement of results. Ability to efficiently organize work with little or no supervision. Travel Expectations Up to 5% travel required. Physical Demands and Work Environment The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts and vibration. The noise level in the work environment is usually very quiet. While performing the duties of this job, the employee is frequently exposed to moving mechanical parts, fumes or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; high, precarious places; risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc. Other tasks involving elevated work may require the use of a body harness and lanyard. Additionally, the employee may be required to operate an industrial vehicle.
$64k-91k yearly est. Auto-Apply 10d ago
Manager, IT Engineering
Gilead Sciences 4.5
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 1d ago
Associate Director, Clinical Data Science Compliance Oversight
Gilead Sciences, Inc. 4.5
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 Responsibilities:** + Lead in the development and implementation of quality strategy and associated capabilities to support the CDS objectives + Manage quality review of clinical trial documents, workflows, and outputs within the CDS organization to ensure clinical trials are conducted in compliance with Gilead procedures, GCP and applicable global regulations + Analyze trends to identify process gaps, improvement opportunities and areas requiring corrective/preventive actions + Lead new quality focused initiatives focused on new learnings, findings, and observations to continuously improve CDS quality practices and methods + Work closely with Gilead CDS study team to provide expert advice on compliance issues and risk mitigation actions + Collaborate with the audit, inspection and CAPA management team within Gilead R&D Quality on internal audits, regulatory agency inspections, risk assessment, deviations and CAPA activities + Liaison and coordinate with business experts and stakeholders to support resolution of audit outcomes which require further action or response. Partner closely with business units to lead, track and manage corrective actions or risk mitigation activities + Serve as a Change Champion for Gilead QMS-related communications to the CDS organization consolidating and channeling just-in-time information and resources to prepare the organization for change + Analyze new regulations and polices with emphasis Good Clinical Practices (GCP) and partner with business experts and stakeholders to update internal documentation and practices accordingly based on areas of impact + Foster a commitment to quality in individuals and a culture of quality across the CDS organization and with CDS related service providers **Basic Qualifications:** **Bachelor's Degree and Ten Years' Experience** **OR** **Masters' Degree and Eight Years' Experience** **OR** **PhD and Two Years' Experience** **Preferred Qualifications:** + 10 years of relevant experience with a BS degree in life sciences or related field with significant experience advising business functions in the biopharma industry on quality and compliance requirements, evolving regulations, risk minimization and mitigation, and vendor management + 8 years of relevant experience with a Master's degree in life sciences or related field with significant experience advising business functions in the biopharma industry on quality and compliance requirements, evolving regulations, risk minimization and mitigation, and vendor management + Experience working across a broad spectrum of quality and compliance activities, including authoring and reviewing SOPs, facilitating internal audits, supporting regulatory inspections, developing and managing CAPAs and deviations, and training others on quality and compliance requirements + Significant experience participating in cross-functional projects and teams with responsibilities related to clinical trials or other drug development activities + Familiar with the practice of recording and monitoring quality observations through a Quality Management System (QMS) **Knowledge & Other Requirements:** + In-depth knowledge of regulatory requirements applicable to the conduct of clinical trials and guidelines (e.g., FDA, EMA, ICH) and related industry standards and trends + Through knowledge of the drug development process, including all key functions involved in the various stages of drug development from early research through post-marketing + Strong analytical skills to assess quality issues and lead the resolution in a collaborative manner across functions + Significant experience advising business function and senior leadership team on quality & compliance requirements, evolving regulation, risk mitigation, and continuous improvement + Strong track record of cultivating and maintaining strategic relationships and collaboration both internally and externally **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: $182,070.00 - $235,620.00. Raleigh: - . 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.
$182.1k-235.6k yearly 45d ago
Cloud Platform Engineering Architect (AWS)
Gilead Sciences 4.5
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.
$195.7k-253.2k yearly Auto-Apply 18d ago

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