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AGC Biologics jobs in Seattle, WA

- 314 jobs
  • Process Development Associate II

    AGC Biologics 3.6company rating

    AGC Biologics job in Bothell, WA

    Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients' lives by bringing new biopharmaceuticals to market. Job Summary We are looking for a Process Development Associate II to join our Analytical and Formulation Development (AFD) team. AFD develops robust analytical methods to support drug release testing, upstream and downstream development, and non-GMP studies. The team also provides molecular characterization and scientific expertise for deviation investigations. In this role, you'll focus on executing analytical methods - primarily HPLC/UHPLC and capillary electrophoresis (CE-SDS, ic IEF)-to support process development activities. You'll work closely with experienced scientists, contribute to method optimization, and help drive continuous improvement projects within the department. This position is a great fit for someone who enjoys hands-on lab work, collaborating with teammates, and learning in a supportive environment. Location: Bothell, WA Schedule: Monday through Friday, onsite Compensation Range: $66,960 - $92,070 Essential Job Duties / Responsibilities Perform analytical testing in support of process development following established protocols. Assist in the development and optimization of analytical methods. Support method transfer to Quality Control. Coordinate and perform instrument maintenance and troubleshooting. Ensure accurate and complete documentation of results. Author, review, and edit analytical protocols and reports. Contribute to laboratory operations and continuous improvement efforts. Leadership Skills Communicates clearly and effectively with colleagues and customers. Solves straightforward problems and explains logic and decisions to others. Collaborates with teammates to support project and department goals. Qualifications BS/BA degree in biochemistry, protein chemistry, or related field, plus 2+ years of experience in an analytical lab. Required: Experience in chromatography (HPLC/UHPLC), preferably across multiple modes (SEC, IEX, RP, affinity). Preferred: Experience with capillary electrophoresis (CE-SDS, ic IEF). Strong interpersonal and teamwork skills; able to thrive in a fast-paced environment. Ability to adapt quickly to changing priorities or technical challenges. Strong data management skills and attention to detail in documentation and execution. Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe. AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients' most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit *************** W ant to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook! AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.
    $67k-92.1k yearly Auto-Apply 55d ago
  • Automation Technician, Senior

    AGC Biologics 3.6company rating

    AGC Biologics job in Bothell, WA

    Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients' lives by bringing new biopharmaceuticals to market. Job Summary We are looking for a Senior Automation Technician to join our Site Automation and Engineering team. In this role, you'll help keep our advanced manufacturing operations running smoothly by supporting, maintaining, and improving building and industrial automation systems. You'll work with Building Automation Systems (BAS), Siemens Desigo, WebCTRL, and PLC-based control systems-playing a key part in ensuring reliable, compliant, and efficient operations across our cGMP manufacturing facilities. Experience with HVAC systems and utility integration (steam, compressed air, purified water, chilled water) is a strong plus. Location: Bothell, WA Schedule: Monday through Friday, 40 hours per week Compensation Range: $43.00 - $59.00 per hour Essential Job Duties / Responsibilities Support installation, startup, calibration, and maintenance of building and industrial automation systems (BAS, PLCs, SCADA, instruments, sensors, and related devices). Lead troubleshooting and corrective maintenance of Siemens Desigo, WebCTRL, and PLC-based systems; serve as the site subject-matter expert for escalations. Perform preventive maintenance and inspections to ensure compliance with cGMP, FDA, and site procedures. Coordinate and oversee external contractors/vendors performing automation or BAS work, ensuring compliance with site standards and timely execution. Support execution of Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for automation projects. Maintain accurate maintenance records, work orders, change controls, and investigations in compliance with GMP standards using CMMS tools (Maximo, BMRAM). Support regulatory audits and inspections by providing system documentation and technical details. Provide training and mentorship to end users and junior technicians on automation systems. Assist in qualification and validation activities for automation and building systems. Identify and implement continuous improvement opportunities to enhance system performance, energy efficiency, and reliability. Follow all quality, regulatory, and safety requirements (OSHA, FDA, EMEA, ANVISA, HS&E, etc.). Perform other duties as assigned to support site operations. Leadership Skills Flexible and adaptable to changing business needs and priorities. Strong attention to detail and commitment to quality. Excellent organization and time management skills. Clear communication and collaboration with cross-functional teams, contractors, and regulators. Qualifications Required: 7-10 years of hands-on experience with building automation and industrial control systems. Advanced troubleshooting skills with Siemens Desigo and/or Automated Logic WebCTRL. Strong PLC knowledge (Allen-Bradley, Siemens, or equivalent). Experience integrating BAS with HVAC equipment, utilities, and process systems. Knowledge of cGMP, FDA regulatory requirements, and validation practices. Ability to read and interpret engineering drawings, P&IDs, and electrical schematics. Experience using CMMS systems (Maximo, BMRAM, or similar). Strong written and verbal communication skills. Preferred: Associate's degree in electrical, automation, or related field (or equivalent technical training/experience). Experience with process control systems (DeltaV, SCADA, distributed I/O). Familiarity with Root Cause Analysis (RCA) and process improvement tools. HVAC controls experience strongly desired. Prior experience in a regulated life science, pharmaceutical, or biotech environment. Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe. AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients' most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit *************** W ant to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook! AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.
    $43-59 hourly Auto-Apply 60d+ ago
  • Multi-Specialty Account Manager - Spokane, WA

    Lundbeck 4.9company rating

    Spokane, WA job

    Territory: Spokane, WA - Multi-Specialty Target city for territory is Spokane - will consider candidates who live within 40 miles of territory boundaries with access to a major airport. Territory boundaries include: Sandpoint ID, Great Falls MT, Lewiston ID and Union Gap WA SUMMARY: Are you a results-driven biopharmaceutical sales professional looking to be part of an organization that values being curious, adaptable, and accountable? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth! We are seeking a dynamic and results-driven sales professional with a proven track record of success who is looking to grow with LundbeckOur ideal candidate will have the ability to be a specialty product expert with an understanding of requisite market complexities in order to be successful promoting our products to stakeholders in the primary care and neurology settings. As an Account Manager, you lead the promotion of our psychiatry portfolio, executing sales and marketing strategies with comprehensive clinical knowledge to drive sales performance. Our Account Managers are adept at executing against the toughest commercialization challenges in today's rapidly changing environment and must demonstrate strong capability in the following areas: ESSENTIAL FUNCTIONS: Business Planning & Account Leadership - Ability to use digital tools and apply data-based insights to create opportunities, develop strategy & tactics, allocate resources to enhance sales execution, monitor progress and adjust direction to maximize sales performance. Selling - Deliver messages in a clear and compelling way to customers, effectively probe customer needs to handle objections, and close every call with a commitment to action to drive changes in behavior. Customer Development - Build and maintain productive internal and external relationships based on customer needs and organizational goals, incorporating “total office” account management where applicable. Local Market & Therapeutic Area Expertise - Gather and validate key trends and dynamics in the market, map account linkages, and apply comprehensive therapeutic knowledge to uncover and prioritize unique opportunities. Reimbursement - Consistently demonstrate the ability to stay informed on reimbursement dynamics, anticipate and effectively address payer access issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources. Pharmaceutical Environment/Compliance - Apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. REQUIRED EDUCATION, EXPERIENCE and SKILLS: Bachelor of Arts or Bachelor of Sciences degree from an accredited college or university 2-5 years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience Must demonstrate the intellectual capacity to score highly on disease and product training exams, including being certified on product knowledge annually Self-starter, with a strong work ethic, tenacity, and outstanding communication skills Adaptability: Ability to embrace change and work collaboratively in a fast-paced team environment Problem-Solving: Proven analytical skills to identify solutions and overcome obstacles Data Analysis: Strong computer and technical skills used in analyzing data to develop both short- and long-term goals aligned with business objectives Must live within 40 miles of territory boundaries Driving is an essential duty of this job; must have a valid driver's license with a safe driving record that meets company requirements Meeting and complying with reasonable industry-standard credentialing requirements of healthcare providers / customer facilities is required for continued employment with Lundbeck Ability to lift, bend, push, pull and move items including, but not limited to equipment, pharmaceutical samples, and any other work-related materials up to 25 lbs. with or without reasonable accommodation PREFERRED EDUCATION, EXPERIENCE AND SKILLS: Recent documented successful experience selling to general practitioners (GPs) and primary care centers Prior experience promoting and detailing products specific to CNS/neuroscience Previous experience working with alliance partners (i.e., co-promotions) TRAVEL: Willingness/Ability to travel up to 30% - 40% domestically to (a) regularly meet/interact with customer base and internal personnel within assigned territory; and (b) typically attend 4-8 internal/external conferences and meetings spanning locations within the United States. Travel must be able to be completed in a timely manner. The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate's geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range $108,000 to $125,000 and eligibility for a sales incentive target of $39,000. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, company match 401k and company car. Additional benefits information can be found on our career site. Applications accepted on an ongoing basis. Why Lundbeck Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site. Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site. Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify.
    $108k-125k yearly 2d ago
  • Diagnostics Sales Specialist - Tacoma, WA

    EPM Scientific 3.9company rating

    Tacoma, WA job

    Point of Care Solutions Specialist Location: Tacoma, WA (Territory includes Tacoma, Peninsula, and northern Oregon down to Albany. Excludes Seattle) EPM Scientific is partnered with a global leader in Point of Care diagnostic technologies dedicated to delivering innovative solutions that help clinicians make faster, more informed decisions at the patient's bedside. This field-based role offers the chance to make a direct impact by supporting healthcare teams and driving adoption of advanced diagnostic tools across a dynamic territory. Responsibilities: Achieve sales targets through effective territory management and strategic account planning. Maintain existing business while closing new opportunities in hospitals and outpatient settings. Navigate complex sales environments with multiple stakeholders and decision-makers within IDNs and hospital systems. Develop and execute sales strategies, anticipate risks, and implement mitigation plans. Complete administrative tasks (training, expense reports, forecasts, CRM updates) accurately and on time. Travel up to 50% within territory; some overnight travel required. Ensure compliance with EHS policies and maintain the effectiveness of the Quality System. Qualifications: Required: Bachelor's degree in related field. 4+ years of relevant sales experience OR 0-3 years with a clinical background (BSN, MLT, CLS, RT, Cardiac Tech, etc.). Ability to travel up to 50% within territory and other U.S. business locations. Preferred: Diagnostics, point-of-care (POC), lab, or capital equipment sales experience. Proven track record as a top-performing sales professional Established relationships with IDNs and hospital systems in the territory. Proficiency in MS Office and CRM platforms (Salesforce.com preferred). **Applicants who do not meet the above requirements will not be considered for this role.
    $47k-88k yearly est. 4d ago
  • Product Manager

    Calyptus 3.3company rating

    Seattle, WA job

    Want to put your job search on autopilot? Join our platform, complete a 6-minute AI screening interview, and get auto-applied to 100s of high-paying roles. Sign up now at ********************************************** and let the opportunities come to you. ____________________________________________________________ Responsibilities The Principal Product Manager, Ecosystem will: Collaborate with ecosystem developers to identify opportunities for accelerating USDC usage and adoption, with a high level of external engagement. Translate developer and ecosystem insights into actionable product initiatives, owning the product vision and roadmap from concept to launch. Conduct onchain data analysis to uncover emerging use cases, trends, and high-potential dApps. Stay at the forefront of blockchain technologies, synthesizing advancements such as ZK proofs, intents, chain abstraction, and EIPs. Define and continuously refine the developer and end-user experience for stablecoin applications. Lead cross-functional efforts across engineering, legal, data science, marketing, and business teams to bring new products to market. Qualifications The ideal candidate will bring: 10+ years of product management experience, with a proven track record of owning strategy for complex, commercial products. 2+ years of experience building in crypto, with strong knowledge of blockchain infrastructure, smart contracts, and decentralized applications. Deep familiarity with stablecoin use cases across DeFi, wallets, bridges, and consumer crypto products. Active engagement with the crypto ecosystem, including reading EIPs, experimenting with dApps, and participating in community discussions. Strong technical fluency, ideally with a background in computer science or engineering. Strong analytical skills and comfort working with data. Demonstrated ability to influence cross-functional stakeholders and executive leaders. ____________________________________________________________ Want to put your job search on autopilot? Join our platform, complete a 6-minute AI screening interview, and get auto-applied to 100s of high-paying roles. Sign up now at ********************************************** and let the opportunities come to you.
    $107k-152k yearly est. 1d ago
  • Medical Science Liaison, Early Development/Hematology - Pacific NW

    Daiichi Sankyo 4.8company rating

    Seattle, WA job

    Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: Daiichi Sankyo, Inc. (DSI) is currently seeking a Medical Science Liaison (MSL) to join the Field Medical Affairs Team. The MSL develops ongoing professional relationships with national and regional healthcare opinion leaders and other healthcare professionals to provide medical and scientific support for Daiichi Sankyo, Inc. (DSI) initiatives in selected therapeutic areas. The MSL develops skills and competencies to educate healthcare professionals, DSI internal stakeholders (e.g., Medical, Marketing, and Sales), and decision makers in healthcare systems regarding therapeutic areas and related products developed and commercialized by DSI. This is a US Medical Affairs, Field based role. This territory currently covers the following states: AK, WA, OR, ID, MT, WY, UT, NV, Northern CA Responsibilities: Builds and maintains professional relationships with healthcare professionals (HCPs) by developing the skills and with guidance, implementing the following: Presenting disease state and Daiichi Sankyo product specific data to HCPs Responding to unsolicited requests for medical information Identifying and appropriately facilitating engagement of qualified 1) investigators and study committee members for DSI clinical research programs, 2) investigator-initiated research study proposals, 3) speakers for DSI Brand Speaker programs, 4) advisors for DSI scientific, clinical and marketing advisory boards Gathering customer insights regarding DSI and competitor products to help inform medical and commercial decision-making Enhanced professional expertise through attendance of select scientific meetings and professional conferences for the purpose of continuing education and scientific exchange with key opinion leaders Develops positive working relationships with local and regional internal stakeholders to enhance DSI HCP relationships Develops the ability to apply the appropriate methods to implement the FMA department strategy within his/her geography in alignment with Medical and Brand strategies Completes administrative duties, including monthly expense reporting and field activity reporting Represents the Medical Science Liaison function by participating in DSI meetings, functions, events Additional duties and responsibilities are based on position level/title, and may include but are not limited to: Provides innovation in enhancing and developing professional relationships with national and regional healthcare opinion leaders and HCPs to provide medical and scientific support for DSI initiatives. Ability to anticipate trends and capitalize on opportunities Lead special projects/initiatives. Assist in the development of team members Represent FMA leadership at DSI meetings, functions and events Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university): PharmD, MD, PhD, NP or PA in a health sciences-related field or an equivalent combination of education and experience preferred Experience Qualifications: MSL/Sr. MSL 1 or More Years' experience, including medical & scientific affairs, clinical practice, research, academic or US-managed markets preferred Previous experience in Oncology, clinical research and medical education preferred Principal MSL/Associate Director MSL 5 or More Years' experience including medical & scientific affairs, clinical practice, research, academic or US managed markets preferred Previous experience in Oncology, clinical research and medical education preferred Additional Qualifications: Must have a valid driver's license with a driving record that meets company requirements Ability to travel up to 60% Compensation and seniority level/title based on experience and qualifications. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: $150,800.00 - $226,200.00 Download Our Benefits Summary PDF
    $150.8k-226.2k yearly Auto-Apply 60d+ ago
  • Senior Lead Manufacturing Supervisor

    Basic American Foods 4.5company rating

    Moses Lake, WA job

    Senior Lead Manufacturing Specialist provides advanced leadership and strategic oversight across multiple production lines or departments. This role is responsible for driving operational excellence, ensuring compliance with safety and quality standards, and mentoring frontline leaders. The Senior Lead plays a key role in aligning plant operations with business goals, leading cross-functional initiatives, and fostering a culture of continuous improvement and accountability. Essential Job Duties/Key Accountabilities Safety Leadership: Champions a proactive safety culture by leading SAFE process initiatives, coaching teams on best practices for personnel and food safety and ensuring compliance with all regulatory and internal safety standards. Operational Oversight: Oversees multiple production areas, ensuring adherence to production schedules, quality standards, and staffing plans. Coordinates with planning, maintenance, and quality teams to optimize throughput and minimize downtime. Team Development & Leadership: Provides mentorship and guidance to Lead Specialists and frontline supervisors. Owns development plans, performance reviews, and succession planning. Facilitates cross-shift communication and ensures consistent leadership presence across operations. Strategic Problem Solving: Leads root cause analysis and resolution of complex production issues. Utilizes lean tools, A3 thinking, and data-driven decision-making to drive sustainable improvements. Compliance & Quality Assurance: Ensures compliance with GMP, HACCP, and customer audit requirements. Partners with QA and sanitation teams to uphold high standards of cleanliness, documentation, and product integrity. Continuous Improvement: Drives plant-wide CI initiatives, leveraging lean manufacturing principles and the Basic Way tools. Identifies and implements value-added projects that enhance efficiency, reduce waste, and improve employee engagement. Emergency & Policy Response: Acts as the senior on-shift authority for emergency response, policy enforcement, and incident resolution. Coordinates with HR and leadership on investigations and corrective actions. Education & Experience A bachelor's degree and have 5-7 years of experience in a manufacturing environment, including at least 3 years in a leadership role. Knowledge, Skills & Abilities Advanced knowledge of manufacturing systems, lean tools, and ERP platforms (e.g., IFS, SAP). Strong leadership and coaching skills with the ability to influence at all levels. Excellent analytical, organizational, and communication skills. Deep understanding of workplace safety, GMP, and food safety regulations. Proficiency in Microsoft Office Suite, data analysis tools, and reporting systems. Work Environment & Physical Demands Manufacturing plant environment with exposure to heat, humidity, and noise. Must be able to lift/move up to 50 lbs. Ability to work rotating shifts and respond to off-hours emergencies as needed. Food and Workplace Safety Requirements Upholds all principles of the SQF Food Safety Code. Immediately reports any food safety, quality, or workplace safety concerns to management. DISCLAIMER: Incumbent may be asked to perform other duties as required. At BAF, we are an equal-opportunity employer. We value diversity and strive to create a supportive and inclusive community of individuals committed to helping each other and our company thrive. All qualified applicants will receive consideration for employment without regard to race, color, ethnicity, disability, religion, national origin, gender, gender identity, gender expression, marital status, sexual orientation, age, protected veteran status, or any other characteristic protected by law.
    $61k-74k yearly est. 60d+ ago
  • Director, Protein Therapeutics

    Vertex Pharmaceuticals, Inc. 4.6company rating

    Seattle, WA job

    Vertex is seeking an accomplished and highly skilled scientific leader to join our Protein Therapeutics team in Seattle. This role will be critical in advancing our pipeline of innovative biologics from early development to clinical readiness in a dynamic, fast-paced, and highly collaborative environment. The ideal candidate will leverage deep scientific expertise, strong leadership and mentorship skills, and strategic vision to deliver transformational protein-based therapeutics for diseases with serious unmet medical need. Key Duties & Responsibilities * Provide strategic leadership and scientific direction for a team specializing in protein engineering and production while fostering a culture of scientific rigor, professional growth, and a collaborative work environment. * Direct purification and analytical characterization of diverse biologics modalities including Fc fusions, monoclonal or bispecific antibodies, and novel protein formats. * Identify and implement emerging technologies (e.g., computational design, high-throughput screening) to accelerate development timelines. * Identify, evaluate, and manage CRO/CMOs for antibody discovery campaigns, protein engineering, and production. * Contribute to cross-functional and cross-site project teams, ensuring alignment with internal and external stakeholders to execute on research programs, deliver results, and influence decision making. Required Education Level Ph.D. in Biochemistry, Biomedical Engineering, Molecular Biology, or a related discipline with a minimum of 10 years of research experience in a biotechnology or pharmaceutical setting is required. Required Knowledge/Skills * Ability to lead a diverse team of high-performing scientists focused on protein engineering and protein purification. * Proven track record in therapeutic antibody discovery and optimization, including antibody screening, engineering, and developability assessment. * Deep expertise with diverse biophysical and bioanalytical techniques such as SPR/BLI, DLS, thermal stability, and aggregation assays. * Experience with computational protein modeling or developing AI/ML pipelines is highly desired. * Demonstrated ability to design, analyze, and interpret complex data sets with exceptional attention to detail and scientific rigor. * Experience managing antibody discovery campaigns with CROs is highly desirable. * Strong record of scientific innovation and impact, supported by patents and/or peer-reviewed publications. * Excellent communication and interpersonal skills, with the ability to clearly present experimental results and recommendations to cross-functional teams, leadership, and external collaborators. * Highly motivated, collaborative, and adaptable, with a passion for advancing breakthrough protein therapeutics in a fast-paced, multidisciplinary environment. #LI-KM4 Pay Range: $188,800 - $283,200 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: On-Site Designated Flex Eligibility Status: In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Onsite Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
    $188.8k-283.2k yearly Auto-Apply 10d ago
  • Environmental Health Specialist I - Lab

    Benton Franklin Health District 3.9company rating

    Kennewick, WA job

    The Environmental Health Laboratory Specialist performs a variety of chemical and biological analyses on environmental samples to support public health and environmental protection programs. Working primarily in the Water Laboratory, this position is responsible for preparing, analyzing, and reporting results for drinking water and environmental samples in accordance with state and federal certification requirements. The specialist operates, maintains, and troubleshoots analytical instruments and ensures the generation of high-quality, defensible data through strict adherence to quality assurance and quality control procedures. Additional duties may include laboratory maintenance, sterilization of equipment, data entry, delivering education to clients, and a range of activities in the environmental health field as required and related to the classification of an Environmental Health Specialist. Essential Job Functions: Performs a variety of biological and chemical analyses on environmental samples to support certification testing including sample preparation, sample processing, data entry, data analysis, data peer review, and data reporting. This position focuses on setting up methodology and performing routing water tests to support certification testing using instruments and analytical techniques such as, but not limited to, LC MS/MS, IC, and ELISA. Operate, perform troubleshooting, and maintenance of analytical instruments and methods in the water testing area. Ensure instruments operate within specifications and maintain accurate maintenance and calibration records. Provide a high level of data quality by keeping traceability records for client samples and requests, equipment maintenance, method modification, standard deviations, and all data analysis. Generates and sends out reports, maintains files on all clients serviced by the laboratory. Maintain traceability records for samples, instrument maintenance, and method performance. Participate in the training, improvement of the existing methods, development and validation of new methods for expanding the test capability to support health district's service expansion. Assist and participate in training other Environmental Health Laboratory Specialists. Comply with safety protocols, chemical hygiene, and waste disposal regulations. Washes and sterilizes laboratory glassware, containers, pipettes and other laboratory equipment. Participate in routine cleaning and lab maintenance. Explain laboratory findings in understandable terms, offer guidance on corrective actions when water quality standards are not met, and share educational resources to promote safe water use and well maintenance. Collaborate with environmental health staff to support outreach and community education efforts related to drinking water safety and public health protection. Assist in maintaining the laboratory and drinking water program's webpage and social media content to ensure timely, accurate, and engaging communication with the public. Respond to public health emergency drills/exercises or actual events as required. Performs other duties as assigned. Knowledge, Skills, and Abilities: Knowledge of laboratory principles, practices, and techniques involving environmental laboratory tests; Knowledge of laboratory equipment, supplies and reagents; Ability to understand, develop, and follow approved standard analytical methodologies; Skills to understand and follow complex written and oral directions, formulas and charts; Strong data management skills and experience with laboratory information management systems (LIMS); Ability to interpret regulations and state environmental rules, explain the testing methods used, prepare clear and concise reports; Ability to work effectively with minimal supervision after initial training; Ability to troubleshoot and interpret experimental results and effectively present conclusions; Ability to communicate and work effectively with other lab staff; Ability to respond flexibly to multitasking schedules; Excellent customer service skills and ability to interact with the public and clients on a professional level; Ability to distinguish colors; Ability to distinguish odors; Ability to lift 50 pounds on an occasional basis. Minimum Qualifications: Bachelor's Degree involving a major study in chemistry, biology, microbiology, bacteriology and public health, or environmental health. Successful applicants should be eligible for registration with the Washington State Board of Registered Sanitarians. Preferred Qualifications: Analytical lab experience with preferred minimum 3 years of hand-on experience in operating and maintenance of instruments such as LC MS/MS, ICP MS system. Experience in method development or validation. Additional Requirements: Job duties may occasionally require work on weekends, evenings, and holidays to ensure laboratory operations are maintained. A valid driver's license is required only if driving or vehicle operation is an essential part of the position. When a District fleet vehicle is unavailable, employees may use their personal motor vehicle, provided they have appropriate auto insurance. Selection Process: The most qualified applicants, based in part upon evaluation of the completed application and related information will be invited for an interview. Benton-Franklin Health District Vision: BFHD is a proactive leader uniting knowledgeable staff and proven practice with strong partners and informed residents to form a resilient, healthy community where all of us can learn, work, play, and thrive to our greatest potential. Benton-Franklin Health District Mission: BFHD provides all people in our community the opportunity to live full productive lives by promoting health lifestyles, preventing disease and injury, advancing equity and protecting our environment. Criminal Background Check required upon candidate selection.
    $59k-80k yearly est. 36d ago
  • Principal Regulatory Affairs Specialist

    Philips 4.7company rating

    Bothell, WA job

    As a critical member of the Philips Ultrasound- Regulatory Affairs Organization, the Principal Regulatory Affairs Specialist will lead and provide regulatory oversight for critical new product development projects, ensuring our state-of-the-art Ultrasound Products meet FDA, and other governmental agency/notified body Regulatory Compliance standards/requirements. Your Role: * Leads business critical new product development projects and provide regulatory oversight to maintain lifecycle ensuring that requirements are maintained. Identify risks within regulatory strategies, project plan, and outline proposal for balancing the project risks to projects teams and RA management. Mentor and coach Philips Ultrasound regulatory professionals in their development. * Will negotiate directly with regulatory enforcement entities (e.g. governmental agencies, notified bodies, etc.) on regulatory filings at the reviewer level. All significant issues will be reviewed with the RA management. * Driving improvement in regulatory aspects of the Quality Management System and in developing processes and documenting procedures to ensure an effective Quality System is maintained. Providing regulatory support for (pre-) clinical studies, including recommending strategies to optimize clinical study approvals and review of clinical study protocols. * Providing guidance on current, new and updated Regulatory compliance procedures globally, such as CE Marking and product registrations, clinical evaluations in accordance with MDD Annex X, ISO 13485 and ISO 14155, China NMPA, Canadian CMDCAS, Japan JPAL, compliance with FDA's guidance documents, and including requirements that are relevant to the overall Philips Ultrasound priorities globally. * As needed, you will represent Philips Ultrasound Regulatory Organization in both internal audits and external audits by various key market regulatory agencies, including inspections and surveillance visits by Notified Body. May represent Philips in an international committee chartered to develop an applicable standard. You're the right fit if: * You have a minimum of 8+ years' Regulatory Affairs experience within FDA regulated Medical Device/HealthTech product environments. Experience with Software as Medical Device (SaMD) and Ultrasound Imaging Devices highly desired. * You have strong knowledge of US FDA, China NMPA, CE Marking, EU MDD/MDR, JPAL, Canadian CMDCAS etc. with proven/successful preparation and submission of Technical Documentation, 510(k), De Novo, PMA, and registrations of medical devices globally. * You're able to work in a large, matrixed organization and collaborate with globally dispersed partners/team members. * You have a minimum of a Bachelor's Degree in Regulatory Affairs, Engineering, Life Sciences or comparable disciplines (Required). Master's degree, RAC Certification desired. * You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position. How we work together: We believe that we are better together than a part. For our Office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations. This is an Office role. About Philips: We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality. healthcare that we all deserve. Do the work of your life to help improve the lives of others. * Learn more about our business. * Discover our rich and exciting history. * Learn more about our purpose. * Learn more about our culture. Philips Transparency Details: * The pay range for this position in Bothell, WA is $128,520 to $205,632. The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here. Additional Information * Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Bothell, WA. This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.
    $67k-91k yearly est. Auto-Apply 7d ago
  • Inventory Specialist

    Knipper 4.5company rating

    Vancouver, WA job

    THIS IS A PART-TIME/CASUAL OPPORTUNITY. THE NUMBER OF HOURS PER WEEK WILL VARY. This position is responsible for performing audits of client inventories, storage site inspections and inventory closeouts. J. Knipper and Company and KnippeRx are Equal Opportunity Employers Responsibilities KEY RESPONSIBILITIES: Conduct audits of client inventories at client specified storage site. Follow client business rules, finalize necessary reconciliation(s), and complete required documentation. Complete all assignments in a professional and timely manner in accordance with Company and Client business rules. Submit all assignment status changes using the on-line Audit Inventory Management System (AIMS). Review all instructions and forms required to complete assignments prior to audit to ensure quality service levels. Ensure that assignments are scheduled in accordance within Client expectations and timelines Communicate with client representatives and AIMS management team via email, US mail, and/or phone. *The above duties are meant to be representative of the position and not all-inclusive. Other Responsibilities: Ability to utilize smartphone to update AIMS and complete assignments. Follow all department and company policies and procedures. Strive to exceed client needs. Communicate clearly and professionally in email and phone calls. Qualifications MINIMUM JOB REQUIREMENTS: Education/Training: High School Diploma or GED Required College Degree Preferred Must have mobile electronic device. Must have transportation to audit sites. If driving a motor vehicle, must have valid driver's license with records that satisfy Company standards as well as current motor vehicle insurance. Related Experience: Pharmaceutical industry and/ or Pharmaceutical Sales experience preferred. Knowledge, Skills, and Abilities: Strong communication skills, intermediate math skills, attention to detail, and computer skills Physical Requirements: May be required to bend, squat, kneel, or stand for long periods. May be required to lift up to 25 lbs. periodically Reasonable accommodations may be made to enable individuals with disabilities to perform the essential responsibilities of this job.
    $32k-42k yearly est. Auto-Apply 60d+ ago
  • Facilities Technician III

    AGC Biologics 3.6company rating

    AGC Biologics job in Bothell, WA

    Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients' lives by bringing new biopharmaceuticals to market. Job Summary Join our team in Bothell, WA as a Facilities Maintenance Technician III and be a vital part of ensuring smooth operation of our sites. You will maintain and improve preventative maintenance programs for buildings, equipment, utilities, and systems critical to our manufacturing success. This hands-on role supports clinical and commercial manufacturing with a focus on safety, reliability, and regulatory compliance. Location: Bothell, WA Schedule: Sunday through Thursday, 7:00 am - 4:00 pm, day shift Compensation: $28.70 - $39.50 per hour Essential Job Duties / Responsibilities Perform preventative maintenance on equipment such as steam boilers, HVAC systems, pumps, pneumatic valves, fire sprinkler systems, compressed air/vacuum systems, and other facility utilities supporting manufacturing. Troubleshoot, install, and repair complex instrumentation on laboratory and facility systems in line with manufacturer specifications and AGC Biologics SOPs. Maintain a safe work environment by following safety SOPs and wearing required personal protective equipment. Support facility fit and finish on campus to maintain inspection readiness and general upkeep. Complete maintenance work orders and preventive maintenance tasks within scheduled timeframes. Maintain maintenance records, work orders, and training documentation accurately using the CMMS and Document Management Systems. Assist during regulatory and internal audits/inspections, adhering to good documentation practices. Coordinate with vendors and contractors to obtain maintenance quotes and ensure work complies with AGC policies and facility standards. Help review and develop Maintenance Department procedures. Assist with investigations and documentation for quality events related to the facility. Provide training, coaching, and technical direction to junior maintenance technicians. Ensure compliance with all applicable regulations including FDA, OSHA, and CFR. Perform other duties as assigned. Skills Intermediate to advanced knowledge of maintenance for utility systems including emergency generators, fire systems, boilers, vacuum pumps, incubators, analytical and lab equipment, process tanks, and facility construction. Strong written, verbal, and interpersonal communication skills. Solid analytical and problem-solving skills applied to technical maintenance challenges. Proficiency with MS Office tools (Word, Excel, Outlook, PowerPoint). Experience with CMMS software such as Blue Mountain or similar is desirable. Ability to independently manage moderately complex assignments with sound judgment. Knowledge of electrical, mechanical, building automation controls, PLCs, root cause analysis, biotechnology, pharmaceutical utilities, and facility repairs preferred. Familiarity with cGMP documentation requirements is a plus. Ability to read and interpret engineering drawings, P&IDs, and electrical schematics with support as needed. Comfortable working efficiently in a fast-paced environment with limited supervision. Demonstrated professionalism, customer service orientation, and teamwork. Qualifications High school diploma required; Associate's degree or vocational training in mechanical or electrical disciplines preferred. 7 to 10 years of maintenance experience, ideally in cGMP, FDA-regulated, or biotech manufacturing environments. Experience with startup and commissioning of cGMP facilities preferred. Equivalent education and experience may substitute for stated requirements. Physical Requirements Ability to sit, stand, walk, bend, stoop, and stretch for extended periods. Comfortable climbing ladders and stairs of various heights. Ability to work in wet, humid, noisy, and outdoor environments as needed. Ability to regularly lift and move up to 45 pounds and occasionally up to 70 pounds. Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe. AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients' most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit *************** W ant to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook! AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.
    $28.7-39.5 hourly Auto-Apply 60d+ ago
  • Field Specialist-Salem, OR. & Chehalis, WA.

    DSM 4.3company rating

    Chehalis, WA job

    Field Specialist Salem, OR & Chehalis, WA, US "Essex Laboratories, a Company of the dsm-firmenich group" Join Essex Labs as a Field Specialist and play a pivotal role in managing and optimizing the production of proprietary and conventional mint varieties. You'll build strong grower relationships, drive innovation in field management, and help shape the future of our breeding program. Be part of a team dedicated to growth, opportunity, and agricultural excellence. Your key responsibilities * Oversee field production operations with contracted growers, from planting to harvest and distillation. * Develop and maintain strong relationships with growers, field agents, and suppliers. * Manage root-expansion processes and relationships with root producers. * Support procurement and advise on contracting strategies and yield targets. * Set up and manage field data systems, ensuring accurate recordkeeping and yield projections. * Lead field research, technology adoption, and IP protection initiatives. * This role will require 50% of your time in the field. We offer * A culture that prioritizes safety and well-being, both physically and mentally; * The opportunity to work for a company where sustainability is much more than a claim and is core to our strategy and purpose; * Barrier-free communities within our organization where every employee is equally valued and respected - regardless of their background, beliefs, or identity; * A firm belief that working together with our customers is the key to achieving great things; * An eagerness to be one team and learn from each other to bring progress to life and create a better future. * We offer competitive pay, career growth opportunities, and outstanding benefit programs. You bring * Experience in agricultural field management, ideally with mint or specialty crops. * Strong data management and recordkeeping skills. * Excellent communication and relationship-building abilities. * Knowledge of regional agricultural practices and competitive crop landscapes. * Ability to travel regionally and work independently. * Commitment to innovation, quality, and IP protection. The salary or hourly wage scale provided reflects the pay range Essex Laboratroies expects to pay the successful candidate for the position. Individual pay offered will be based on the applicant's job-related skills, experience, relevant education, or training, and primary work location. Salary $62,000-$70,000. In addition to base salary, we also offer a comprehensive total rewards package, inclusive of annual incentive pay, a retirement savings plan, health care coverage, paid time off, recognition programs and a broad range of other benefits. All benefits and incentives are subject to eligibility requirements. About Essex Laboratories, LLC "Essex" is an acronym derived from Essential Oils and Extracts, which describes the focus of Essex Laboratories, LLC., as a peppermint and spearmint essential oil and flavor house. Founded in 1992, we continue to broaden our horizons through innovation and healthy relationships. As a supplier of strategic peppermint-based ingredients, we are sensitive to the importance of our customers' standards and market reliance. Known for our dedication to sustainability and our holistic approach to mint supply, Essex is the preferred source for mint for some of the world's leading fragrance, food, and packaged goods marketers. Our multidisciplinary team includes chemists, biologists, geneticists, agronomists, logistics, and production specialists. We believe that diversity is our greatest strength and welcome the opportunity to bring in new talent to contribute to our continued growth and success. Additionally, we have a JV association with Firmenich, the world's largest privately held Fragrance and Flavor company, (which has now merged with DSM and doing business as dsm-firmenich). DEI and equal opportunity statement We believe being a force for good starts with the way we treat each other. When people feel supported, included, and free to be themselves, they do their best work - and that's exactly the kind of culture we're building. A place where opportunity is truly equal, authenticity is celebrated, and everyone has the chance to grow, contribute, and feel they belong. We're proud to be an equal opportunity employer, and we're serious about making our hiring process as fair and inclusive as possible. From inclusive language and diverse interview panels to thoughtful sourcing, we're committed to reflecting the world we serve. We welcome candidates from all backgrounds - no matter your gender, ethnicity, sexual orientation, or anything else that makes you, you. And if you have a disability or need any support through the application process, we're here to help- just let us know what you need, and we'll do everything we can to make it work. Agency statement Of We're managing this search directly at dsm-firmenich. If you're applying as an individual, we'd love to hear from you. We're not accepting agency submissions or proposals involving fees or commissions for this role.
    $62k-70k yearly 5d ago
  • Intern Clinical Supervisor - Renton, WA

    Consejo Counseling and Referral Service 3.9company rating

    Renton, WA job

    Intern Clinical Supervisor- Renton, WA Consejo Counseling and Referral Service is seeking to hire a full-time Intern Clinical Supervisor. We offer Relocation Cost Assistance, a sign-on bonus, and exceptional benefits, including medical, dental, vision, a 401(k) plan, vacation time, sick leave, paid holidays, personal days, life insurance, accidental death and dismemberment (AD&D) coverage, training funds, and a paid birthday off. Summary of Job Description: Since its inception, CONSEJO has been dedicated to providing mentorship, resources, and opportunities that support student-interns in their journey toward clinical and professional development. As such, we offer a well-established internship program, maintain affiliations with over 40 academic institutions in allied behavioral health professions (e.g., social work and mental health counseling), and train more than 20 student-interns annually. Additionally, we provide guidance to staff with associate licenses, helping them meet the requirements for full licensure. This position is responsible for providing clinical supervision to both student-interns and associate licensees across multiple CONSEJO locations, ensuring they meet their personal aspirations as well as their academic and licensure requirements. ESSENTIAL DUTIES AND RESPONSIBILITIES: Supervision Provide individual supervision to student-interns and associate licensees, ensuring compliance with Washington Administrative Code (WAC), federal Medicaid regulations, managed care regulations, ethical guidelines, and best practices. Provide case consultation. Offer guidance, support, and feedback to help supervisees increase their knowledge base, build clinical skills, develop professionalism, gain confidence in their competence, ensure ethical practices, and meet academic and licensure requirements. Foster a supportive and educational environment that encourages growth, reflection, and skill-building. Develop and maintain clear, reasonable guidelines to direct student-interns' tasks and support their development. Ensure supervisees deliver culturally competent and client-centered care. Educate student-interns on proper documentation practices (e.g., treatment notes, confidentiality, mandated reporting, etc.). Review and approve client treatment plans, progress notes, and other documentation to ensure adherence to agency policies, ethical standards, legal guidelines, and best practices. Review and address suspected abuse or neglect reports, ensuring actions align with legal and ethical standards. Monitor adherence to safety, privacy, and confidentiality standards in client interactions and clinical tasks. Review incident reports related to student-interns' cases, assess necessary actions, and implement changes to prevent future incidents. Monitor student-interns' compliance with Relias Online Training. Document and track supervision for each supervisee, including modality (i.e., individual vs. group), date, duration, and competencies discussed. These agency-owned records serve to demonstrate the type of supervision provided and received. Complete formal evaluations of student-interns, assessing the achievement of learning objectives and competencies, including clinical skills, professionalism, communication, work performance, attendance, and punctuality. Address any areas of concern promptly and develop action plans to help student-interns improve. Network, Collaboration, and Learning Opportunities Attend internship fairs and recruitment events, as delegated by the manager, to promote the agency's internship program, network, and connect with potential student-interns. Serve as a liaison between the agency and academic institutions, ensuring clear communication about student-intern expectations, progress, and performance. Participate in internal and external meetings, committees, and management team discussions as needed. Develop and deliver training sessions, didactics, and seminars to educate student-interns on agency policies and procedures, ethical practices, documentation requirements, and behavioral health treatment modalities. Collaborate with clinical staff to provide student-interns with opportunities to observe and engage in diverse treatment modalities and interventions. Maintain current knowledge of Consejo's internal programs and community resources to assist interns with client referrals and service coordination. Support of Administrative Functions Assist with interviewing prospective student-interns, including reviewing qualifications to assess suitability for the program. Assist in coordinating student-intern schedules and hours to ensure compliance with academic and agency requirements. Assign caseloads to student-interns and monitor workload, adjusting as necessary for a balanced and effective internship experience. Provide back-up clinical care when assigned student-interns are unavailable, and offer coverage for other student-intern supervisors as needed. Participate in quality improvement program, ensuring supervisees follow quality improvement standards. Assist the manager with relevant tasks on an as-needed basis. Assist with agency clinical needs on an as-needed basis. QUALIFICATIONS: A license without restrictions in Social Work, Mental Health Counseling, Marriage and Family Therapy, or related field that has been in good standing for at least 2 years. A License Independent Clinical Social Worker is preferred. A completed state-approved clinical supervisor training certificate, which includes a minimum of fifteen clock hours of training in clinical supervision. Twenty-five hours of experience in supervision of clinical practice. At least 5 years of professional experience treating adults and/or children with mental health conditions. Experience working in a Community Mental Health Center, managing and providing care to Medicaid, non-Medicaid, and Apple Health clients. Experience working with Latinx, BIPOC, and low-income communities. A valid driver's license, an acceptable driving record, reliable transportation, and car insurance. Spanish proficiency is preferred. WORK SCHEDULE This full-time position works from Monday to Friday. SALARY $85,000 - $95,000 annual salary. Pay will depend on experience, qualifications, and credentials. READY TO JOIN OUR TEAM? We understand that your time is valuable, so we have designed a quick and easy application process. If you are a good fit for this position, we encourage you to complete our mobile-friendly application. We are excited to meet you and discuss how you can contribute to our team! Job Posted by ApplicantPro
    $31k-41k yearly est. 6d ago
  • Senior Specialist, Product Data Management

    Bristol Myers Squibb 4.6company rating

    Bothell, WA job

    Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. As part of BMS global supply chain management, the Cell Therapy Product Data Management (CT PDM) team works to establish and manage those processes and procedures which identify, integrate, and align key product data across all cell therapy sites and systems in support of commercial and clinical GNSP operations. The Senior Specialist, Supply Chain Product Data Management will identify data owners and engage, define, coordinate, and document key data management processes, along with respective roles and responsibilities, for the coordination of data entry, reporting, and exception handling in IBP planning systems and the ERP landscape. This position will implement data governance standards and principles working across data stewards in acquisition, alignment, sequencing, and timely entry of key data elements to harmonize data management activities in a multi-system, multi-site, cross-functional, collaborative environment. To accomplish this, the position will: * Define basic work flows for proper alignment and sequenced entry of master data as needed. * Develop and refine global PDM processes leveraging available tools and system functionality. * Ensure overall data accuracy, input, and readiness in a timely manner. * Engage and maintain cross functional support of the process to ensure data integrity and alignment. * Responsibilities will include, but are not limited to, the following: * Direct support of the product data configuration process which ensures accurate translations of demand to cell therapy supply. * Ensures quality of master data in ERP and Planning systems. * Develop and document processes with other functional data owners to support ongoing maintenance and data integrity. * Provide end user training for Supply Chain Planning System users as needed. * Partner with BPM and IT for enhanced solutions, functionality, and data management capabilities in response to business and program requirements. * Define and implement service level agreements and performance targets concept for key applications and services. * Coordinate cross-site integration of master data inputs, procedures, and governance polices in boundary systems. * Provide visibility on delivered service levels to all key stakeholders. * Ensure compliance to internal and external requirements, regulations, local and global procedures. * Onboard, train, mentor new staff and help develop Product Data Management group. * Skills/Knowledge Preferred: * Minimum bachelor's degree with a background in Supply Chain Management, Business, or Engineering. * 2 to 4 years prior experience in master data management role interacting with materials management, manufacturing operations, demand planning, supply planning, quality, supplier QA, finance, and regulatory organizations. * Strong process development background and data savvy. * Strong interpersonal and outstanding communication skills. * Strong attention to detail. * Hands-on team leader and team player willing to work in an environment where individual initiative, accountability, and professional maturity are required. * Strong project management experience. * Advanced time management and organization skills with ability to reprioritize with business needs. * Strong PC experience, Microsoft Office Suite experience required including; Excel; Outlook; PowerPoint. * Oracle EBS / Advance Supply Chain Planning or IBP/SAP experience preferred. If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: Bothell - WA - US: $80,410 - $97,438 Devens - MA - US: $78,220 - $94,781 Madison - Giralda - NJ - US: $73,100 - $88,580 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit ************************************* Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. Supporting People with Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to **************************. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: ********************************************* Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at ***************************************** Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
    $80.4k-97.4k yearly Auto-Apply 4d ago
  • Scientist, Predictive Biology and AI

    Bristol-Myers Squibb 4.6company rating

    Washington job

    Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Scientist, Predictive Biology and AI LOCATION Seattle, Brisbane CA, San Diego CA, Cambridge MA, Princeton NJ Overview The Predictive Biology and AI (PBAI) team within BMS Research develops and applies cutting-edge methods to address patient needs and answer fundamental questions in Oncology, Neuroscience, and other application areas. We work closely with our wetlab partners to both test and deliver our predictions into the pipeline as well as integrate the data they generate into our models. We seek a collaborative AI expert possessing skills spanning machine learning and statistics as well as a passion for addressing unmet patient needs. The successful candidate will thoughtfully evaluate and adapt state-of-the-art AI models and techniques to challenges in cell engineering and target discovery. The role offers the opportunity to impact directly the delivery of truly transformational and life-changing therapies in key diseases of unmet medical need. Responsibilities Apply, adapt, and in some cases create multi-modal foundation models such as large language models (LLMs), diffusion models, and encoder architectures to answer biological domain-specific questions Address real-world biological modeling challenges such as data sparsity, class imbalance, noise, experimental bias, and heterogeneity of effects Thoughtful model evaluation that incorporates appropriate benchmarks, statistical tests, and problem understanding to support technical and business decisions Work in close collaboration with partners across the organization including wet-lab scientists, Research IT, and other computational scientists to broaden the impact of AI developments Maintain and share up-to-date knowledge of modern advances in the field, including presenting work at public conferences Basic Qualifications Bachelor's Degree 5+ years of academic / industry experience Or Master's Degree 3+ years of academic / industry experience Or PhD No experience required Preferred Qualifications A Ph.D. with 0+ years industry research experience or an M.S. with 3+ years industry research experience in computer science, statistics, computational biology, or another quantitative field Expert-level understanding of and experience using deep learning tools and approaches (transformer-based encoders/decoders, LLMs, reinforcement learning, etc.) as demonstrated through publications or projects Hands-on experience leading the building and scaling of deep learning training pipelines on multi-GPU computational infrastructure using PyTorch, Huggingface, and/or other tools Knowledge of or the ability to learn biological concepts and data types, including the ability to work and communicate effectively with biologists Excellent verbal and written communication skills. Fluent verbal and written English language skills prerequisite Experience building agentic workflows is a plus Prior experience in pharmaceutical application areas is a plus If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: Brisbane - CA - US: $141,150 - $171,042 Cambridge Crossing: $141,150 - $171,042 Princeton - NJ - US: $122,740 - $148,732 San Diego - CA - US: $135,010 - $163,605 Seattle - WA: $135,010 - $163,605 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit ************************************* Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients' lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. Supporting People with Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to **************************. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: ********************************************* Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at ***************************************** Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
    $141.2k-171k yearly Auto-Apply 3d ago
  • Associate Specialist Production Planning

    Bristol-Myers Squibb 4.6company rating

    Bothell, WA job

    Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Position Summary Plans and schedules production related activities at the cell therapy manufacturing facility. Provides manufacturing operations with a plan that maximizes efficiency, resources, and capacity. Achieves on time delivery within budget. Work on projects/matters of moderate complexity. Evaluates and develops scheduling tools and provides technical expertise Duties/Responsibilities Plans and schedules production schedules to meet product demand at the site. Plan and schedule all associated production and support activities including intermediates, product shipment, facility and equipment maintenance. Work with Document Control to ensure all documents (i.e. batch records and packaging records) are ready for Manufacturing. Build strong relationships and communication with all functions. Provide exceptional customer service. Knowledge of forecasting, capacity planning, and production planning. Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy (or related) manufacturing. Ability to work independently on projects or problems of moderate scope to meet objectives. Troubleshoots and identifies causes and suggests solutions. Attention to detail and ability to perform with a high degree of accuracy. Source of imaginative, thorough, and innovative solutions to a wide range of difficult problems. Experience in lean, operational excellence, six sigma, or continuous improvement, and process mapping preferred. Supports an environment that encourages continuous improvement, best practices and appropriate risk taking. Ability to influence key stakeholders of internal and external teams. Excellent communication and presentation skills as well as the ability to effectively communicate across all levels of the company. Strong analytical and problem-solving abilities. Expert in Microsoft Office programs. Schedule: Wed - Sun 8am-5pm, Training scheduled Mon-Fri first 60 days Reporting Relationship This position reports to the Associate Director of Production Planning Qualifications Education/Experience: 0-3 years preferred; 1+ years of scheduling experience in cGMP manufacturing environment desired. HS Diploma. Experience in scheduling cell therapy manufacturing preferred. Experience in material planning and/or finite scheduling in a medium to high volume environment, knowledge of scheduling platforms preferred. If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: Bothell - WA - US: $30.94 - $37.49per hour The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit ************************************* Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients' lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. Supporting People with Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to **************************. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: ********************************************* Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at ***************************************** Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
    $30.9-37.5 hourly Auto-Apply 11d ago
  • Advisor -Regulatory Compliance and Post Market

    Eli Lilly and Company 4.6company rating

    Washington job

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Brand Description: This position is responsible for providing GMP/GxP support across the different regulatory reporting and inspection support that is provided by the RCPMR (Regulatory Compliance and Post Market Reporting) team. This includes but is not limited to; all facets of inspections (PAI/PLI/Surveillance/Post-approval/for-cause) for all global Health Authorities. Support HA reporting (FAR, BPDR, OUS requirements). Provide support for global recall and US recall activities, monitoring and reporting of US product shortages, coordinate product shortage notification for OUS countries, update drug and device establishment registrations for changes as the need arises including completion of annual changes. Key Objectives/Deliverables: In this role the individual provides support that they provide to the different programs are as shown below. Primary focus is compliance support; other duties will depend on business needs. Compliance Support * Lead inspection readiness activities * Serve as a global compliance CGMP expert providing feedback in preparation for corporate audits, agency inspections, global standard revisions, and changes in local business or manufacturing processes. * Proficient in application and use of Machine Learning and analytical tools to being continuously in a state of inspection ready. US (Field Alert Report-FAR, Biological Product Deviation Report-BPDR, EUA reporting, Illegitimate Product Report - Form 3911 per DSCSA) and Global regulatory reporting of Quality/safety/compliance issues * Works with numerous stakeholders to ensure HA reporting as required to meet all Global regulations/requirements Global and US Recall / Market Withdrawal * Supports the coordination of the execution activities related to US product recall and withdrawals. * Participate in periodic product withdrawal/recall simulations. * Consult and train local recall coordinators to assure understanding of process for product removal. * Monitors recall activities of partner organizations globally. * Provide information for use in various periodic reviews or metrics. Global and US Product Shortage * Coordinate and execute product shortage reporting for US and OUS: Includes networking with Supply chain, Global Quality Leaders, Senior Management, Legal, Regulatory, Global Patient Safety, Qualified Persons at Affiliates and others as appropriate to determine the need and document the decision for FDA reporting or for notification to OUS regulatory agencies Generate, submit and maintain product shortage documentation following local procedure. * Provide information for use in various periodic reviews or metrics. Drug and Device Establishment Registration * Determine information required for drug and device establishment registration for all manufacturers of US marketed product, such as importers, agent, and function. * Update drug and device establishment registrations for changes as required including completion of annual registrations. US Volume Reporting * Coordinate and execute annual volume reporting for US * Provide information for use in various periodic reviews or metrics. Personal Development and Shared Learning * Be continually aware of current industry trends and regulatory agency interpretation of GMP and other relevant requirements * Continue to gain knowledge vital to provide a greater understanding of GxP requirements * Participate in applicable external industry groups and forums Minimum Requirements: * Bachelor's degree - Preferred degree in a scientific field such as Pharmacy, Chemistry, Engineering or other biological sciences. * Minimum of 5 years relevant Industry or Health Authority experience in areas which may include: technical services, manufacturing operations, quality assurance, quality control or regulatory affairs Additional Preferences: * Broad knowledge of GMPs and quality systems for pharmaceutical manufacturing and marketing * Expertise in data driven approaches to assess site compliance * Experience in Quality Assurance or GxP function * Strong compliance knowledge * Excellent communication and presentation skills: ability to deliver constructive feedback * Skilled in interpreting and applying standards to diverse situations with strong problem-solving ability * Ability to work independently and collaboratively with minimal supervision * Significant experience supporting global inspections and compliance programs Other Information: * Maintain awareness of regulatory and industry tends; ensure corporate standards remain current. * Flexibility to effectively prioritize work activities to meet regulated timelines. * Ability to influence and negotiate with peers, immediate supervision, site supervision and executive management. * Must be available to travel (domestic and international) when required (estimated at 25%, might increase based on business needs). * Role can be remote or based at any Lilly site/affiliate, corporate headquarters. Preference is at a Lilly site/affiliate or headquarters. This is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements may change over time and may include additional responsibilities not specifically described in the job description. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $126,000 - $204,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $126k-204.6k yearly Auto-Apply 4d ago
  • Senior Database Solution Development & Data Management Engineer (Healthcare Industry)

    Fujifilm Diosynth Biotechnologies 4.0company rating

    Bothell, WA job

    The Sr. Database Solution Development & Data Management Engineer role is to develop and support the embedded applications for Fujifilm Sonosite Flagship products. The position will implement complex data management strategies for medical devices and policies to ensure data accuracy, integrity, and security. She/he creates and maintains the system's database schema, data dictionaries, data models for efficient data storage and retrieval, and finally collaborates with all her/his peers to ensure that the data access and duplication rules are followed.The engineer participates as a high-level technical expert in planning, designing, developing, coding, and debugging new software or enhancements to existing software. The engineer collaborates closely with other members of the Software team as well as with other functional teams and with project managers to execute projects on schedule. Company Overview At FUJIFILM Sonosite, we reinvent how healthcare is delivered with point-of-care ultrasound technology. As the leader in bedside ultrasound systems, our innovations save lives-from premature babies in NICUs to trauma patients in emergency rooms. We're looking for purpose-driven team members ready to build technology that impacts real-world scenarios, including natural disasters and even war zones. By joining FUJIFILM Sonosite, you'll be part of a team that thrives on collaboration, out-of-the-box thinking, and a passion for life-saving innovations. Let's make a difference together. Our headquarters in Bothell, Washington, blends riverside charm with urban amenities, quality schools, and an ever-evolving downtown-all part of the vibrant Seattle metro area. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: *************************************************** Job Description Essential Job Functions: * Analyze/harmonize disparate data sets into canonical models for analysis and operations * Plan, design, and execute the process of moving data between device and client systems for the Data migration design * Develop code and data pipelines to ingest relational databases, file shares, web services, and real-time streams * Develop code to harmonize disparate data sets into canonical models for analysis and operations * Participate in all aspects of the software life cycle using Agile development methodologies * Participate in requirements definition, system architecture design, and data architecture design * Proposes and analyzes system and software requirements relevant to data handling * Assesses technical risks/ Estimates development timeframe.Designs and implements software to offer a framework to peers to access and handle data * Communicates and documents designs and implementation * Performs software unit, integration, and system testing * Mentors peers on data handling best practices * Conduct reviews of specifications and designs * Propose design changes to improve code maintenance and robustness * Design and develop advanced data models and structure * Implement robust data security measures to protect sensitive information, including access controls, encryption, and data masking * Develop and implement data quality standards and processes to maintain data accuracy, consistency, and reliability Knowledge and Experience: * Excellent communication ability (written and verbal) * Bachelor of Science in Computer Engineering or related degree (master's degree preferred) from an ABET accredited institution. * 7+ years' combined experience in SW development * 5+ years programming experience with C++, C# experience is preferred * Experience with XML or JSON data modeling * Experience with managing database scripts in Git/Git Flow/Bitbucket and modern source code management methodology * Knowledge of database architecture and performance implications * Familiarity with embedded databases such as SQLite, SQL Express, Mongodb * Demonstrated experience in development/maintenance of robust yet efficient data access layer to fully support application CRUD * Demonstrated expertise with object-oriented design and data driven design principles * Strong knowledge of data management principles, methodologies, and best practices * Familiarity with data modeling and metadata management concepts * Expertise in ETL (Extraction-Translation-Loading) solutions for upload / download / translation of native data into a variety of transfer formats is preferred * Experience with embedded operating systems including Windows embedded and Microsoft software development tools (Visual Studio) is desired * Experience with ISO, FDA, or other regulated product development environments strongly desired Skills and Abilities: * Excellent analytical and problem-solving skills with a keen attention to detail * Must be able to multi-task effectively. * Must be able to follow corporate and regulatory standards. * Must have excellent oral and written communication skills. Salary and Benefits: * $145,000.00 - $170,000.00/year + variable bonus opportunity (Compensation will vary based on skills, experience and location; it is not typical to be hired at or above the top of the salary range). * Insurance: * Medical, Dental & Vision * Life & Company paid Disability * Retirement Plan (401k): * 4% automatic Company contribution * Fujifilm matches 50 cents for every dollar you contribute, up to 6% of your salary * Paid Time Off: * You can accrue up to three (3) weeks of PTO in your first year of employment * PTO increases based on years of service * Employee Choice Holidays: * Four (4) additional paid days off, based on date of hire in the calendar year * Paid Holidays: * Eight (8) paid holidays per year FUJIFILM Sonosite offers a fantastic compensation package, including benefits, and a 401k program. Visit us today to learn more about our exciting technologies and how you can make a difference. To apply and obtain further details regarding key responsibilities and experience requirements, check out our careers page at ******************************* To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid. #CB #LI-MW EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (******************** or ***************.
    $145k-170k yearly Auto-Apply 60d+ ago
  • Pharmaceutical Sales Representative, Endocrinology (Rare Disease) - Seattle

    Xeris Pharmaceuticals 4.2company rating

    Washington job

    Achieve territory sales goals by promoting products and services to physicians and other medical personnel within assigned geography. Educate customers on the appropriate use, characteristics, and approved indications of products. Professionally represent the company and ensure high levels of visibility and customer service in territory. Maintain effective communication and relationships with key external and internal customers. Responsibilities Effectively promote and educate specialty physicians on the appropriate use of rare disease products through one-on-one meetings and group presentations, company-approved promotional speaker programs and other company-approved means. Responsible for achieving both territory product sales goals and territory sales activity goals through company defined metrics. Ensure high performance levels of call and field productivity. Meet territory product sales goals while adhering to all defined ethical sales practices, compliance guidelines and required promotional regulations Execute company-approved Product Marketing plans and territory/regional business plan activities Support targeted customers and accounts using company-approved resources, sales materials and promotional activities/programs/initiatives as identified by Sales Leadership Appropriately managing/maintaining all company equipment and company-approved promotional materials (e.g., sales materials, company literature, product samples, etc.) according to defined company compliance guidelines Ensure optimum territory sales strategy execution using territory business plans, regional business plans and all appropriate sales reports Communicate cross-functionally to gather knowledge of best practices from peers within the organization. Attend all company-sponsored sales and medical related meetings as directed by company management. Actively pursue continuous learning and professional sales development on effective sales/communication techniques and product/therapeutic area knowledge. Qualifications BA/BS required 5-7+ years of successful pharmaceutical sales experience required. Previous experience in competitive markets preferred Proven record of sustained high sales performance and achievement (Top 10%, National Awards) 2+ years of experience promoting rare competitive disease products strongly preferred A valid, US State-issued driver's license is required Launch experience or start-up experience is a plus Experience working with Endocrinologists preferred Deep understanding of all stakeholders in an office and ability to support them in getting a patient started on therapy within guardrails established by the company Demonstrated ability to both build relationships within existing accounts as well as proactively find new accounts Previous experience working with specialty pharmacies and internal patient support roles preferred Experience navigating managed care and rare disease products preferred At Xeris, performance consists of both results and behaviors. Behavioral competencies include: Leadership skills, Teamwork & Collaboration, Attention to Detail, Self-Starter, Problem Solving, Organizational skills, Adaptability, Professionalism, Written and Verbal Communications, Adherence to compliance policies and processes, Analytical skills, Multi-Tasking skills, Decision-making skills, Accountability, Inquisitive Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel. Position requires vehicle travel, as necessary. Travel approximately 70%. The level of the position will be determined based on the selected candidate's qualifications and experience. #LI-REMOTE As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. The anticipated base salary range for this position is $110,000 to $190,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for commission and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process. NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
    $48k-69k yearly est. Auto-Apply 60d+ ago

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