Medical Specialist I - Allergy - Portland, OR
Regeneron Pharmaceuticals job in Portland, OR
Our Medical Specialists are at the forefront of engaging Allergists and other key customers. We are seeking someone who is highly proficient in presenting clinically focused sales messaging that resonates and compels potential and existing customers. At Regeneron, we are driven by the highest degree of integrity and appreciation for always doing what is right - aligned with our core beliefs and values.
As a Medical Specialist, a typical day might include the following:
• Developing strategy and implementing tactics within key accounts in our Allergy/Immunology therapeutic areas to generate product utilization
• Establishing and fostering strong relationships with Allergy/Immunology health care professionals. This will include: physicians, advanced practitioners, nurses, office staff and other important personnel as well as key patient advocacy support groups.
• Collaborating with regional colleagues, as well as other field-based and home office teams to proactively address customer needs
• Analyzing market dynamics and trends to develop strategies which support brand and corporate objectives
• Participating in initiatives to support sales success such as industry-related congresses, local and regional meetings and medical conferences.
This role may be for you if you:
• Are confident in demonstrating strong and consistent sales performance that exceeds expectations related to goals
• Are innately guided by core values of ethics and compliance and always act in a manner consistent with those values
• Can demonstrate a competitive spirit and harness your “grit” to power your approach to sales
• Collaborate effectively with internal and external partners
• Share a passion and learning interest in science and are proactive in strengthening knowledge related to disease states, treatment options and healthcare trends
To be considered you must possess a Bachelor's degree with a Master's degree or other advanced education/certifications are preferred. We expect that a successful candidate will have specialty pharmaceutical/biopharmaceutical experience with a minimum of 5 years' pharmaceutical sales experience. Having a minimum of 2 years' selling in the Immunology market or a similar subcutaneous self-injectable biologic specialty market is preferred as is Allergy/Immunology experience. We need someone with demonstrated success and consistent sales performance in complex markets across diverse customer segments. This role requires the ability to travel and cover large geographic territories.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit ********************************************************************* For other countries' specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$141,400.00 - $184,800.00
Auto-ApplyDirector, Drug Product Quality Assurance
Hillsboro, OR job
Hillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche's commercial portfolio & pipeline products. The Quality organization at HTO comprises Quality Assurance, Quality Systems & Compliance, Quality Control, and Quality Engineering & Validation. Together, we produce millions of units of life-saving medicine every year to patients around the world.
The Opportunity:
In this exciting role, you will lead a dynamic and inclusive team responsible for ensuring Quality supply of life-saving medicines for our patients. You have the unique opportunity
to lead our Quality Assurance team and drive compliance and continuous improvement initiatives at the site and through our network. The Head of Quality Assurance is accountable for quality oversight for all cGMP operations, ensuring products meet quality standards and regulatory requirements. Quality Assurance responsibilities include ensuring procedures and specifications are followed, reviewing and approving production records, investigating deviations (non-conformances), determining the acceptability of each batch for release, and for continuously improving the quality system. This role provides Quality leadership for key initiatives to establish Hillsboro Technical Operations as a center of excellence for aseptic drug product manufacturing.
* You will provide quality oversight for all cGMP operations, ensuring products meet quality standards and regulatory requirements (including shop floor oversight, batch production record review, investigations for non-conformances, document approvals, batch release).
* You will create an environment with strong team spirit, timely and effective communication, sense of urgency and high motivation, and inspire teams to achieve short-term and long-term goals.
* You will support product launches through all stages of Regulatory relevant activities, including successfully managing inspections.
* As a member of the Quality Site Leadership Team, you will drive site strategy realization, networking activities, coordination, cross-functional planning and decision making.
* You will take proactive measures to promote a positive safety culture and ensure all applicable safety, health and environmental requirements are met in accordance with company policies and local legal requirements.
* You will embody Pharma Technical (PT) Lean principles and methodologies and promote a continuous improvement culture throughout the organization by encouraging experimentation and learning.
* You will optimize and protect our Quality operating model, and continually adapt to both current and future needs of the organization (skills, capabilities, technologies, staffing, etc.).
* You will partner with Manufacturing, Manufacturing Sciences and Technology, and Engineering Quality to create an environment conducive for efficient manufacturing execution and continuous improvement.
* You will help establish HTO as a center of excellence for Drug Product Manufacturing including all unit operations such as drug substance thawing, filtration, filling, lyophilization and crimping for vial and prefilled syringe products.
Who you are:
* You have a BS/MS degree in Science or Engineering with 15+ years of deep, relevant bio/pharmaceutical experience
* You have significant cross-functional and direct group management, ideally in manufacturing or Quality. Previous experience in Quality is preferred.
* You are an exceptional leader-able to inspire and motivate teams to make a big impact and deliver their best every day.
* You have experience in working in an FDA regulated environment in a parenteral facility, and in-depth understanding of cGMP, regulatory requirements and quality management systems.
* You are a strategic and systems thinker with a compliance focus, anticipating technology trends and driving excellence in execution.
* You have experience implementing and driving a continuous improvement culture.
* You are able to work in a dynamic and fast-paced environment while always ensuring the highest quality and safety standards.
The expected salary range for this position based on the primary location for this position of Hillsboro, OR is $142,600 - $263,000.. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. This position also qualifies for the benefits detailed at the link provided below.
Link to Benefits. Relocation benefits are provided
#gnehtoquality
Occasional international business travel may be required depending upon ongoing business activities.
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
Digital Strategy Delivery Specialist
Hillsboro, OR job
A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche.
At Roche, we thrive to deliver more benefits to our patients as part of our 10-year Pharma vision. An integral part to achieving this vision is to deliver new and innovative data analytics solutions to our scientists across Pharma Technical Operations (PT). To do so, we have formed a new organization called PT Digital and Operational Excellence (PTE) with the aspiration to digitally transform and to become a lean organization.
The Opportunity
PTE is the new organization that will catalyze the global development and execution of PT's Digital and Operational Excellence strategy to enable PT to realize our performance promises. We will build a strong cross-functional and inclusive community, put the power of data into the hands of our people, further develop the Lean and Digital skills across PT, and scale up our Digital and Advanced Analytics solutions, for the benefit of our colleagues and patients.
We aim to activate data citizenship and digital mind, revolutionize our FAIR data ecosystem and systems landscape, re-design excellent processes, and generate transformative insights. We collaborate closely with global functions to deliver impactful value to our patients.
Major Responsibilities
PTE will work in partnership across major global business functions, establishing and implementing an overall Digital / Technology strategy and driving the delivery and scale of key data & digital solutions in support of our vision.
This role is responsible for driving the digital technology strategy through the delivery of key digital initiatives and use cases. You will partner with stakeholders across IT and PT functions to plan, execute, and sustain digital solutions to achieve the PT Digital Aspirations.
* Assume product owner or digital translator role and drive the implementation of key digital use cases.
* Define and manage user requirements / backlog.
* Coordinate implementation teams consisting of data scientists, data engineers, UX/UI designers, IT specialists and/or SMEs.
* Act as a digital translator.
* Ensure and track value delivery.
* Coordinate the build-up of capabilities.
* Lead deployment of a global solution in a function or site.
* Build digital product owner and translator best practices.
* Engage with a community of product owners and digital translators to build and share best practices. Radiate those to the broader organization, e.g., by delivering trainings and coaching.
* Other duties as needed to support process improvement, portfolio management, data management, workforce strategy, product delivery, support strategy, partnership and collaboration with IT, PTx and externals.
Scope of role: projects primarily in PT Manufacturing and PT Quality
Do you bring experience as a digital product owner or digital translator and have delivered digital use cases that include advanced analytics technologies? We are seeking an individual with good knowledge of the pharma data ecosystem, informatics systems, tools, and techniques.
Who You Are
* BS/MS in Science or Engineering Field with a minimum of 5 years related experience.
* Experience in systems/data management and informatics strategy development and execution.
* Experience in leading a (matrix) team is an advantage.
* Outcome focused and proactive in identifying solutions. Customer centricity; understand the customers' business, challenges, and goals.
* Excellent people, leadership, interpersonal, analytical, and written/verbal communication skills.
* Skilled in managing cross-functional partner relationships in a complex organization.
* Ability to inspire and lead cross-functional project teams.
* Strategic and analytical thinking required.
Relocation benefits are not available for this posting.
The expected salary range for this position based on the primary location of Oceanside, CA is $102,100.00 - $189,500. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Benefits
#LI-PK1
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
Performance Excellence Delivery Lead
Hillsboro, OR job
At Roche, we are committed to delivering greater benefits to our patients. To achieve this, we are seeking a hands-on Operational Excellence expert to drive breakthrough performance improvements and build long-term capabilities. This role is about delivering step-change improvements, not just marginal gains, by embedding structured, data-driven methodologies that enhance efficiency, quality, and overall operational performance. As a member of the Performance Excellence Delivery team within our Pharmaceutical Global Operational Excellence organization, you will work with site teams, integrating traditional Lean principles with cutting-edge digital solutions to drive true transformation. Our Holistic and well-defined Breakthrough Methodology follows four key steps: Diagnose, Design, Implement, and Sustain, ensuring a structured and lasting impact.
This is a role for a true impact driver, someone who thrives in hands-on environments, collaborates closely with teams, and is passionate about accelerating performance and creating tangible, sustainable results.
The Opportunity
* On-Site Performance Improvement - Partner with local teams to identify and implement measurable and sustainable operational enhancements
* Breakthrough Performance Gains - Lead structured initiatives that go beyond incremental changes, driving significant improvements in quality, efficiency, and productivity
* Sustainable Capability Building - Coach and develop teams to adopt best-in-class methodologies, embedding long-term operational excellence
* Systematic, Data-Driven Approach - Apply proven frameworks to ensure measurable, repeatable success
* Leveraging Digital for Operational Improvement - Utilize digital tools and data analytics to accelerate efficiency gains and optimize end-to-end processes
* Cross-Functional Collaboration and Change Leadership - Engage with all levels of the organization to drive alignment, secure buy-in, and foster a culture of continuous improvement
* Performance Monitoring & Long-Term Impact - Define and track key performance indicators to ensure initiatives deliver lasting business value, not just short-term fixes.
Who You Are
* Bachelor's degree and a minimum of 8 years of related/relevant experience; or an advanced degree with 6 years of equivalent work experience.
* Extensive experience in pharmaceutical manufacturing or related field, with a focus on sterile environments (Highly preferred).
* Proven expertise in Lean methodologies and leading structured performance improvement initiatives.
* Demonstrated success in delivering transformational impact (step-change improvements), not just incremental changes, in operational environments.
* Demonstrated ability to synthesize complex information and data sets, extract actionable insights, and craft compelling presentations that drive decisions.
* Experiences in top consulting firms (Highly preferred).
Locations
This is a primarily on-site role in Hillsboro.
Relocation benefits are available for this position.
The expected salary range for this position based on the primary location of Hillsboro is $120,400 and $224,700. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Benefits
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
QC Specialist
Hillsboro, OR job
** At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity, and diversity. We believe every employee makes a difference. We are passionate about transforming patients' lives. We are courageous in both decision and action; we believe that good business means a better world.
Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We're focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.
Hillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche's commercial portfolio & pipeline products. The Operations organization at HTO is divided into 2 value streams, which combine to produce millions of units of life-saving medicine every year to patients around the world.
**The Opportunity:**
In this exciting opportunity you will join a team that is expanding and transferring potency analytical methods to our Quality Control Lab. There is the potential to help establish HTO as a center of excellence for the North American network. This role will give you the ability to use your expertise and mentor/train others. In addition to performing and reviewing microbiological assays, the individual must be able to interpret environmental monitoring (EM) data, troubleshoot assay failures and equipment issues while adhering to strict guidelines on cGMP documentation. In addition the individual will support planned events/unplanned events/out-of specification investigations, EM assessments, and collaborate with external groups to identify improvement opportunities in technology and business processes.
+ Implementing, modifying, and enforcing Quality Control policies, procedures, specifications and testing methods consistent with cGMP, regulations, appropriate compendium, and Roche/Genentech standards, policies, plans, objectives and procedures.
+ Routine sampling, performing, and reviewing a variety of assays in the Quality Control organization in support of In-process, drug product, finished product, raw materials and incoming inspection, and environmental monitoring testing in a cGMP environment.
+ Interprets data, troubleshoots assay failures and equipment issues while adhering to strict guidelines on cGMP documentation.
+ Supports method validation activities, performance qualifications, method transfers, discrepancy/out-of-specification investigations and collaborates with stakeholders to identify improvement opportunities in technology and business processes.
+ Ensure maintenance and calibration of laboratory equipment and systems.
+ Support during cGMP audits and Health Authority inspections as needed, and follow up on any corrective measures is also required.
**Who You Are:**
+ Bachelor's Degree with 5-7 years experience working in a cGMP or similarly regulatedenvironment in the pharmaceutical or science industry. 3-5 years experience with a Master's Degree or 0-2 years experience with PhD/JD.
Work Environment / Physical Demands / Safety Considerations
+ Work in an office and laboratory environment● Lift up to 25 lbs may be required.● Ability to sit, stand, and move within work space for extended periods● May be required to sit at a computer terminal for extended periods.● Working location is Onsite.
The expected salary range for this position based on the primary location of Oregon is $68,300 to $126,900. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Benefits (****************************************************
Relocation benefits are provided
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants (***************************************************************************************************** .
Validation Engineer/Senior Validation Engineer, Quality Control
Hillsboro, OR job
Hillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche's commercial portfolio & pipeline products. The Operations organization at HTO is divided into three value streams, which combine to produce millions of units of life-saving medicine every year to patients around the world.
The Opportunity:
If you want to contribute to a fast paced operational team and you have an innate understanding of how equipment operates; then consider joining our Quality Control (QC) team! We are looking to add a QC Validation Engineer with computer system validation or equipment qualification experience to our Quality Control Support team. The site is investing in our ability to bring current and new analytical technologies to the QC labs quickly and efficiently in a standardized and compliant manner.
As a QC Validation Engineer/Senior Validation Engineer, you will qualify various types of equipment / software that supports routine operations and introduction of new product lines at HTO. This position plays a meaningful role in establishing the validation history and maintaining the validated state of various equipment (e.g. plate readers, chromatographic equipment, liquid handling equipment, microbial detection systems, general laboratory equipment) used to test our drug products or maintain our aseptic fill/finish manufacturing facility. This role serves as a technical authority and is encouraged to solve equipment functionality, sustain the qualified state of analytical equipment, and share their knowledge with junior associates to increase the overall technical capability of the Quality Control organization.
* You will author, review and complete equipment qualification / computer system qualification protocols and generate equipment lifecycle documents (i.e. User Requirements Specifications, Data Integrity Assessments, Test Protocols, Operational and Administration Procedures, etc.) using Roche's electronic validation system (ValGenesis)
* You will participate on analytical transfer teams with focus on equipment qualification. Facilitate / complete equipment gap assessments, contribute to comprehensive transfer plans, complete transfer activities related to equipment qualification in collaboration with QC Operations, Quality Validation and other Analytical Specialists from the donating and receiving sites.
* You will define, establish, standardize, and complete and/or improve practices for maintaining the validated state of QC equipment (analytical, microbial and bioassay) throughout its lifecycle through periodic reviews, monitoring, and re-qualification.
* You will serve as a site representative on network-wide validation teams formed to discuss emerging issues through resolution, and improve and standardize qualification of platform equipment. The information discussed at these teams are routinely submitted via a sponsor to decision making bodies within the relevant/impacted functional areas including HTO. As a representative, you will be the voice for HTO and are accountable for ensuring information / decisions are disseminated to and from these teams.
* You will participate in Quality Control investigations related to QC equipment issues and completing data driven impact assessments and actions.
* You will collaborate with key partners to identify and complete Corrective and Preventive Action actions.
* You will author, review, and/or approve various business process & compliance related documents such as, standard operating procedures, work instructions, monitoring protocols, monitoring reports, gap assessments, and risk assessments related to the supported methods.
Who you are:
* You hold a Bachelor's of Science degree with 1-3 years (Validation Engineer level) or 4-7 years (Senior Validation Engineer level) of dynamic experience in the pharmaceutical or scientific industry.
* You have significant experience working in a cGMP or similarly regulated environment
* You possess a deep understanding of equipment and/or computer system validation practices, regulations, and industry guidelines and consistently apply this understanding when performing your tasks.
* You are a strong problem-solver and have the proven ability to solve and resolve analytical instrument issues.
* You have the judgment / discretion to advance matters of significance, ensuring efficient testing operations and regulatory compliance.
* You possess outstanding social skills and strong written and verbal communication skills. You use these skills to build effective multi-functional teams and commit to timely informed decisions and completion of simple to moderate actions from others.
* You have a passion and ability for mentoring and encouraging others and are able to build/ maintain effective multi-functional teams without direct management responsibilities.
* You will be working on site in a flexible open space work environment with random visits to a QC laboratory environment that requires laboratory gowning (lab coat, goggles, gloves)
* You will work on/interact with analytical instruments and computerized systems/screens for long periods of time (6-8 hours)
* You may be required to lift up to 25lbs
* You may have to work with hazardous materials and chemicals.
The expected salary range for this position, based on the primary location of Oregon is $68,300 to $126,900 (Validation Engineer level) and $90,000 to $167,000 (Senior Validation Engineer level). Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Relocation benefits are available for this position.
Benefits
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
Medical Value and Health Information Technology (MVHIT) Manager - Health IT Liaison-West US
Portland, OR job
Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Medical Value and Health Information Technology (MVHIT) Manager - Health IT Liaison-West US
Territory is West, United States to include CA, AZ, CO, ID, NV, NM,OR, UT, WA, WY
What you will do
Let's do this. Let's change the world. In this vital role you will secure coverage for our brands and to support patient access. In a dynamic healthcare environment, the organization recognizes the increasing importance of Integrated Delivery Networks (IDN) within the U.S. Healthcare system. As a result, the team is focused on developing and executing strategies for the IDN customer segments. This new position is a unique and highly visible opportunity to help build a path forward for our organization in terms of tapping into the constantly evolving IDN segment and Implementation Science.
The MVHIT will support and educate accounts using MAC-approved materials related to Electronic Health Records (EHR) supporting multiple therapeutic areas of interest to Amgen. This position will be responsible for directly managing prioritized accounts within their regional geography. They will advise the director and senior manage with the development of the strategy, messaging, tools, & resources to harness the organized potential of IDN's and/or health systems within the EHR space. Medical Value Health IT Liaison (MVHIT) will educate heath system in leveraging EHR-platforms to facilitate the evolution of care from a reactive episodic based care model. Relevant functionalities include clinical decision support consistent with evidence-based guidelines for identify (reporting tools), evaluating ( alerts, order-sets) and engaging at-risk patients (e.g., patient portals and reminders) and/or health systems within the EHR space.
This position will work closely within the Medical Value and Access team, MSLs and cross-functional partners to leverage population health strategies and value-based initiatives to support organizations whose goals are to deliver value through quality improvement, care management, and patient engagement.
This is an enterprise role working across all 4 prioritized Therapeutic Areas of Interest: Cardiology, Renal, and Metabolic (CRM), Oncology, Immunology, and Neurosciences. The main focus of this role is to educate these customers about health information technology (HIT) systems, including electronic health records (EHR), to enhance diagnosis, treatment, and patient management with tools that enable, for example, clinical workflows, patient stratification, and patient activation and outcomes at the point of care.
* Work with cross-functional medical and commercial account teams to gather EHR customer insights and assess opportunities
* Manage the customer accounts prioritization process for the MV Health IT Liaisons
* Contribute to the development of scalable, EHR-enabled tools and resources in relation to key therapeutic areas
* Deliver insights related to EHR objectives to key internal partners to help inform strategic decisions
* Deliver education on EHR reporting and clinical decision support tools to support health system initiatives
* Conduct regular meetings with customers to provide appropriate Health IT-related education
* Create and execute key account plans for how to navigate the customer landscape plus execute on key initiatives
* Effectively assist through training and communication MSLs and KAMs on MVHIT and EHR programs and resources and provide support to field staff to address questions
* Confidently engages customers in a field facing capacity using appropriate methods and MAC approved materials/messaging
* Demonstrates effective use of CRM tool to manage territory schedule and call documentation
* Support cross-functional workstreams to support business initiatives as requested for identified accounts, contributing strategic insights on care management evolution, quality and care initiatives, and HIT implementation
* Provide feedback and support on targeting strategies, Key Performance Indicators, and POAs
* 30-40% travel may be required
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The MVHIT Liaison we seek is a leader with these qualifications.
Basic Qualifications:
* Doctorate degree
OR
* Master's degree and 3 years of Medical Capabilities experience
OR
* Bachelor's degree and 5 years of Medical Capabilities experience
Preferred Qualifications:
* Experience in pharmaceutical/biotech industry or hospital system
* Understanding of or familiarity with EHR systems within IDNs
* An understanding of the impact of healthcare market and legislative tends that impact Health Systems, Pharma, Payers
* Experience in applying health information technology in in-patient and ambulatory settings
* Strong eye for business, analytical skills, and critical thinking ability
* Demonstrated customer-facing experience with a strong customer service mindset
* Good understanding of IDNs and key partners
* Hands-on experience with EHR products, such as Epic, Allscripts, eClinicalWorks, and Cerner
* Experience with EHR reporting tools
What you can expect from us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
* A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
* A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
* Stock-based long-term incentives
* Award-winning time-off plans
* Flexible work models, including remote and hybrid work arrangements, where possible
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Sponsorship
Sponsorship for this role is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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Salary Range
123,189.00 USD - 152,776.00 USD
Associate Marketing Representative - West Region
Salem, OR job
Job DescriptionDescription:
This position will provide agency education and instruction on the web-based tools of Johnson & Johnson and USLI to already appointed independent insurance agents. This person will also provide additional product information for a specific list of USLI products and develop sales strategies targeted at those products. The geographic territory will be Oregon & Washington, and this position will require extensive travel throughout this territory. The person will be responsible for conducting a minimum of 20 agency visits per week.
Job Responsibilities:
Develop list of targeted USLI products and present these products on each agency visit to promote the use of the products by the Agency on a regular basis.
Conduct Web Training to Agents & CSR for: USLI Products; Other J&J Products; Raters; JJPF; Accounting tools; and any other tools created for the agency to utilize to produce business on the web.
Help CSRs and Agents with questions regarding doing business with J&J by ensuring the right person in the office is in contact with the Agency Representative with a question.
Develop weekly Travel Plan to effectively execute 20 agency visits per week
Interact with the Territory Managers, Marketing Representatives and Production Supervisors/Managers to identify and follow up on individual sales opportunities.
Update a weekly “Dashboard Report” with pertinent sales data to track results of agency visits and various sales activities; present report at a weekly or bi-weekly meeting.
Utilize USLI sales training tools to create a friend in the agency, organize and execute effective sales calls and effectively train Agency Representatives on the Web based tools on the J&J website.
Provide feedback and ideas for the development and revisions of a Web Products Sales Sheet.
Must maintain all education requirements to perform in this position as set forth by management
Must have and maintain valid driver's license and be eligible for company auto insurance.
Education and Work Experience:
· College degree OR equivalent business experience preferred but not required
· Candidates will be expected to pursue continuing education and insurance designations/licenses as outlined in the training and development plan. This will require self-study.
· Strong communication and organizational skills, networking and relationship ability and ability to work independently in a fast-paced environment
· Remain flexible under the pressure of a heavy workload and critical deadlines
· Open to coaching and continuous improvement
Knowledge, Skills & Abilities:
General knowledge of the Property-Casualty Industry
Knowledge of J&J Property & Casualty products - ability to differentiate J&J products/services from competitors
Knowledge of USLI Property & Casualty products - ability to differentiate USLI products/services from competitors
Interest in selling products and services based on customer needs
Strong customer service skills
Ability to maintain confidentiality
Capacity to analyze information and general math skills
General knowledge of all applicable rating systems
Research skills
Attention to detail
Decision making
Coordination and organization of weekly Agency Visit Schedule and any follow-up items resulting from each agency visit
Ability to multi-task, prioritize, make quick decisions and be flexible in a fast-paced environment
Computer experience: MS Word, Excel, PowerPoint, MS Teams
Ability to be a team player and work productively with your teammates at J&J and USLI
Excellent oral and written communication skills
Exceptional interpersonal skills
Ability to clearly and effectively present (both written and verbal) to external business partners, management, and internal business partners
Exhibits a professional appearance when representing the organization during agency visits or business meetings
Strong negotiation skills
Typical Physical Demands:
· Requires the ability to sit or stand for long periods of time, occasional stooping, and reaching; May require lifting up to 25 pounds; requires normal range of vision and hearing with or without accommodations.
Requirements:
Executive Oncology Sales Specialist, CAR-T - Sacramento, CA - Johnson & Johnson Innovative Medicine
Portland, OR job
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
Pharmaceutical Sales
Job Sub Function:
Sales - Oncology/Hematology (Commission)
Job Category:
Professional
All Job Posting Locations:
Portland, Oregon, United States, Sacramento, California, United States of America
Job Description:
We are searching for the best talent for an Executive Oncology Sales Specialist to cover the territory of Sacramento, CA and all of Oregon.
About Oncology
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine
The Oncology Specialist (OS) in the CAR-T franchise is a Field Based role reporting to a District Manager. The OS has primary responsibility for developing the relationship with CARYKTI Certified Treatment Centers (CTCs) in their respective territory and serves as the CTC's primary point of contact with J&J. In this role, the OS is responsible for driving appropriate utilization of J&J's CAR-T therapy within the account and ensuring the delivery of a seamless customer experience. Additionally, the OS is responsible for calling on community practices and stakeholders in the Relapse Refractory Multiple Myeloma (RRMM) market. The OS will deliver awareness and education on the product and referral process to these appropriate community stakeholders. As the OS you will:
* Fulfill sales strategies by selling current and potential new oncology therapeutics.
* Demonstrate a working knowledge of the products' clinical efficacy, provide clinical support/information as needed, and achieve their sales quota.
* Conduct business analysis, actively prospect for new business within assigned territory, develop account strategies with District Manager to increase sales in the assigned territory (i.e., identifies key accounts, HCPs, develops specific plans for penetration).
* Develop customer specific pre- and post-call plans that include objectives, probes and supporting materials.
* Build customer dedication and identify and cultivate new relationships. Influence decision-makers by delivering a targeted sales message based on accurate clinical information, uses approved sales and marketing materials, and executes marketing strategies at the local level
* Use resources appropriately while working successfully with JNJ Innovative Medicine (JJIM) team members and counterparts to share ideas and information to enhance business results.
* Strong knowledge on assigned specialty products and their related markets in all areas relevant to internal and external customers: such as, clinical, technical and health economics.
* Develop a complete understanding of the health care delivery system within each assigned account, including the physician hierarchy, key pharmacy personnel, clinical nursing staff, etc.
* Maintain knowledge of reimbursement, short-and long-term sales potential relevant to percentage of patients treated, patient mix, Managed Care organizations and Specialty Pharmacies, and new protocols or new treatment modalities that impact business potential.
* Attend and participate in all required sales meetings; complete all required training curriculum in a timely manner; achieve training standards; and organize and complete administrative responsibilities efficiently, including healthcare compliance, expense reporting, call reporting, and other assignments.
* Drive multiple myeloma CAR-T brand choice and demand amongst institution-based oncology customers.
* Drive clinical and product education and awareness of CAR-T therapy to community-based providers.
* Have a comprehensive understanding of J&J and competitor products in our therapeutic area, and an in-depth knowledge of the complexities associated with the disease state.
* Works in close collaboration with Marketing, Medical Affairs, Market Access, Operations, Quality, and other internal stakeholders to ensure all customer needs are addressed. May work in collaboration with outside partner companies to co-promote products or services.
* Provide all insights to the cross functional team on appropriate and timely feedback from interactions with healthcare professionals (HCPs), including account business trends and potential changes in therapeutic landscape.
* Routinely meet with key clinical, financial, & operational CTC stakeholders to educate on the use of J&J's CAR-T therapy and communicate the latest approved messaging and clinical data.
* Can navigate a complex account environment and understand the needs/issues of various stakeholders at all levels within the account and triage to appropriate internal stakeholders for support.
* Provide exemplary customer service while cultivating relationships. Actively participates in grassroots advocacy / engagement activities within the territory to align with regional and national initiatives.
* Develop an understanding of the issues and opportunities unique to your assigned geography. Conduct business analysis, actively prospect for new business within assigned territory, develop account strategies with District Manager to increase sales in the assigned territory (i.e., identifies key accounts, HCPs, develops specific plans for penetration).
* Leverage intel and insights to develop and assertively implements an account business plan to meet customer needs and achieve corporate goals.
* Work cooperatively with internal team members on various cross-functional projects related to specific accounts or physicians.
* Assist in the identification and resolution of issues and opportunities and communicates proactively to marketing and sales management. Prepares territory budget plans for customer contacts, unrestricted educational grants, speaker events and other miscellaneous external expenditures.
* Represent J&J at National and/or local symposiums/conventions.
* Work hands-on with a sense of urgency, in a fast-paced entrepreneurial environment.
Required Qualifications:
* A minimum of a Bachelor's Degree
* Oncology specialty sales experience AND/OR Major Hospital Account Sales Experience
* Valid driver's license and the ability to travel as necessary, including overnights and/or weekends.
* A minimum of five (5) years of direct selling experience in pharmaceutical or biologic/biotech with documented success in delivering sales results and achieving targets OR relevant clinical experience
* Experience in hospital and large account sales, understand complex reimbursement and managed care dynamics with a documented history of successful sales performance in a competitive environment
* Strong relationship building skills and the ability to identify key decision makers
* Possess strong achievement motivation to meet and exceed goals
* Residing in the geography or be willing to relocate to it.
* Ability to effectively utilize virtual technology and a history of engaging customers in virtual face-to-face interactions
* Ability to travel up to 60%, depending on territory size, account locations, and location of residence
Preferred Qualifications
* Specialty sales experience and an understanding of the Oncology market, specifically Hematology, Cell Therapy and/or rare disease.
* Previous product launch experience in a highly competitive environment
* Multiple Myeloma experience
* Strong clinical understanding of cell therapy and ability to manage complex treatment logistics
* Experience in hospital and large account sales, handling complex reimbursement issues,
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.
At Johnson & Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time.
Here's What You Can Expect
* Application review: We'll carefully review your CV to see how your skills and experience align with the role.
* Getting to know you: If there's a good match, you'll be invited to complete a short-recorded video interview, giving you the chance to share more about yourself. If successful, a recruiter will also reach out by phone to walk you through the process and answer any questions.
* Interviews with the team: If you move forward, you'll meet with the hiring manager (and possibly others on the team) in one or two interview rounds, depending on the role.
* Staying informed: We know waiting can be hard, so our recruitment team will keep you updated and make sure you know what to expect at each step.
* Final steps: For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through these.
At the end of the process, we'll also invite you to share feedback in a short survey - your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. We're excited to learn more about you and wish you the best of luck in the process! #RPONA
Required Skills:
Preferred Skills:
Clinical Experience, Communication, Cross-Functional Collaboration, Customer Centricity, Customer Retentions, Data Savvy, Developing Partnerships, Hematology, Market Knowledge, Oncology, Performance Measurement, Pharmaceutical Industry, Pharmaceutical Sales Marketing, Problem Solving, Product Knowledge, Relationship Building, Sales, Sales Projections, Sales Trend Analysis, Strategic Sales Planning
The anticipated base pay range for this position is :
$111,000 - $178,250
Additional Description for Pay Transparency:
The Company maintains a highly competitive sales incentive compensation program. Under current guidelines, this position is eligible for participation in this program in accordance with the terms of the applicable plan. This position is eligible for a company car through the Company's FLEET program. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: - Vacation - up to 120 hours per calendar year - Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year - Holiday pay, including Floating Holidays - up to 13 days per calendar year - Work, Personal and Family Time - up to 40 hours per calendar year For additional general information on Company benefits, please go to: - ********************************************* This job posting is anticipated to close on December 11, 2025. The Company may however extend this time-period, in which case the posting will remain available on *************************** to accept additional applications.
Auto-ApplyEngineering Project Feasibility and Product Sourcing Leader
Hillsboro, OR job
** Doing now what patients need next... for a healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche.
This role is based in Pharma Technical Operations Technology (PTT), an organization that is responsible for ensuring Pharma Technical Operations (PT) stays at the forefront of technology in our current and future facilities. PTT, composed of global MSAT and Engineering, plays a key role in leading seamless industrialization and thorough technical product management through integrating SHE, proactive maintenance, facility fitness, performance optimization, and scalable manufacturing processes and technologies in support of the manufacturing network. In this role, you will have the opportunity to shape the manufacturing network that delivers life saving medicines to patients.
**The Opportunity**
The Engineering Project Feasibility and Product Sourcing Leader within the PTT Asset Health & Future Assets (AHFA) group conducts early feasibility and product sourcing assessments for Global Engineering CapEx projects. This role ensures that capital investments and investments supporting sourcing decisions align with and enable the Pharma long-range plan. A core responsibility of this role is partnering closely with Network Strategy, Global Product & Supply Chain Management, manufacturing sites, and Finance to develop robust business cases that inform PT governance decisions regarding capital investments and product sourcings.
+ Secures buy-in from stakeholders and senior leadership, drives cross-functional alignment, and resolves issues within the engineering community and broader network for Global Engineering CapEx projects
+ Builds robust scenarios that model best- and worst-case outcomes and provide flexibility for informed decision-making in a dynamic business environment
+ Develops comprehensive business cases for capital projects, maintaining fiduciary responsibility for real estate and equipment assets
+ Assesses requirements for product launches, technology transfers, and capital investments; ensures assumptions across options are agreed upon and aligned with stakeholders
+ Conducts complex early feasibility assessments across sites and functions, collaborating closely with senior leaders, subject matter experts, and site engineering teams
+ Partners with the engineering community/network to apply technology standards that enable successful project outcomes and reduce business risk
+ Transitions completed early feasibility assessments to Project Initiation teams and contributes as an expert reviewer during project reviews
**Who You Are**
+ Bachelor's degree in Engineering or related field
+ Minimum of 12 years of Pharmaceutical or Biotech experience, process engineering experience preferred
+ Minimum of 8 years of management leadership experience in a matrix organization
+ Experience in a complex global environment with CapEx project execution
+ International/global experience is strongly preferred
+ Flexibility for domestic and international travel as required
Relocation benefits are not available for this posting.
The expected salary range for this position based on the primary location of South San Francisco, California is $156,700 to $290,900. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Benefits (****************************************************
\#LI-PK1
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants (***************************************************************************************************** .
Regional Medical Scientific Director (Medical Science Liaison) - Cardiovascular & Metabolism - Il & IN (Remote)
Salem, OR job
**Regional Medical Scientific Director - Cardiovascular & Metabolism** The Cardiovascular & Metabolism Regional Medical Scientific Director (RMSD) is a credentialed (i.e., PhD, PharmD, DNP, MD) therapeutic and disease expert who engages in bidirectional exchange of scientific or medical information with Scientific Leaders (SLs). This MSL-type role provides balanced, factual, scientific information about non-product areas of interest to the Company and replies to scientific questions from SLs, including questions about Company products. The work of an RMSD is aligned to: Scientific Exchange, Research, Scientific Congress Support, and Scientific Insights.
Cardiovascular & Metabolism RMSDs liaise between the scientific community and the Company to enhance the comprehension of scientific foundations and goals for approved, in-development, and active Company-sponsored trials and/or investigator-sponsored research studies. The RMSD serves as a role model for other field medical team members in ways that include on-boarding and/or sharing of therapeutic expertise.
**Location details:** This role covers Illinois and Indiana. Candidates **must** reside within the territory with expected travel up to 50% within the territory.
**Responsibilities and Primary Activities**
**Scientific Exchange:**
+ Develops professional relationships and engages with national and regional SLs to ensure access to company-approved medical and scientific information on areas of therapeutic interest and Company products
+ Conducts peer-to-peer scientific discussions and maintains a reliable presence with those SLs to ensure they have a medical contact within the company
+ Addresses scientific questions and directs SL inquiries on issues outside of RMSD scope (e.g., grants) to appropriate company resources consistent with applicable policies
+ Maintains current knowledge and comprehension of dynamic scientific and clinical environment in the Company's Areas of Interest (AOI) for the RMSD's specific therapeutic area.
**Research:**
+ Upon request from Global Center for Scientific Affairs (GCSA),
+ Initiates discussions with SLs and/or potential investigators that include scientific/data exchange within our AOI to determine the alignment with our research strategies, studies concepts, scientific merit, and qualifications for a specific compound or trial
+ Enhances the comprehension of the scientific foundations and goals of investigator-sponsored research
+ Identifies barriers to patient enrollment and retention efforts to achieve study milestones
+ Upon request from Global Clinical Trial Operations (GCTO),
+ Recommends study sites and identifies potential investigators to participate in phase II-IV clinical development programs, conducts Site Initiation Visits (SIVs), and detects barriers to patient enrollment and retention efforts to achieve study milestones.
+ Protocol lead responsibilities in collaboration with GCTO
+ Addresses questions from investigators and provides information regarding participation in Company-sponsored clinical studies
**Scientific Congress Support:**
+ Engages in scientific congresses and medical meetings, facilitates scientific and data exchange for both Company and competitor data.
**Scientific Insights:**
+ Gathers feedback, data, or information during routine activities that can help the company better comprehend medical or scientific needs, priorities, or concerns of SLs and/or patients
**Inclusive Mindset and Behavior:**
+ Demonstrates eagerness to contribute to an environment of belonging, inclusion, equity, and empowerment
+ Leads by example and serves as a role model for creating, leading, and retaining a diverse and inclusive workforce
**Required Qualifications, Skills, & Experience**
**Minimum:**
+ PhD, PharmD, DNP, DO, or MD
+ Proven competence and a minimum of 3 years of relevant therapeutic area experience beyond that obtained in the terminal degree program, e.g., Atherosclerosis
+ Ability to conduct doctoral-level discussions with key external stakeholders
+ Dedication to scientific excellence with a strong focus on scientific education and dialogue
+ Excellent stakeholder management, communication, and networking skills
+ A thorough comprehension of FDA, OIG, HIPAA, and other ethical guidelines, laws, and regulations relevant to the pharmaceutical industry and its customers
+ Ability to organize, prioritize, and work effectively in a constantly changing environment
+ Strong working knowledge of Microsoft Office Suite (Word, PowerPoint, Excel, Teams, OneNote)
+ Familiarity with virtual meeting platforms
+ Desire to contribute to an environment of belonging, engagement, equity, and empowerment by:
+ Working to transform the environment, culture, and business landscape
+ Leveraging diversity and inclusion to ensure business value, per global diversity and inclusion strategy
+ Ensuring accountability to drive an inclusive culture
+ Strengthening the foundational elements of diversity
+ Consistent adherence to field and corporate policies and Value and Implementation Global Medical Scientific Affairs (GMSA) strategy, including field standard operating procedures (SOPs), Good Clinical Practice (GCP) guidelines, and administrative/operational responsibilities
**Preferred:**
+ Field-based medical experience in Cardiovascular & Metabolism
+ Research Experienced
+ Demonstrated record of scientific/medical publication
\#eligiblefor ERP
**Required Skills:**
Cardiovascular and Metabolic Disease (CVMD), Clinical Trials, External Collaboration, Medical Affairs, Metabolism, Pharmaceutical Medical Affairs, Population Health Management, Professional Networking, Scientific Communications, Stakeholder Management
**Preferred Skills:**
Current Employees apply HERE (*****************************************************
Current Contingent Workers apply HERE (*****************************************************
**US and Puerto Rico Residents Only:**
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (******************************************************************************************
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (**********************************************
**U.S. Hybrid Work Model**
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
The salary range for this role is
$187,000.00 - $294,400.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** .
You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
**San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
**Search Firm Representatives Please Read Carefully**
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
**Employee Status:**
Regular
**Relocation:**
No relocation
**VISA Sponsorship:**
No
**Travel Requirements:**
50%
**Flexible Work Arrangements:**
Remote
**Shift:**
Not Indicated
**Valid Driving License:**
Yes
**Hazardous Material(s):**
n/a
**Job Posting End Date:**
01/5/2026
***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.**
**Requisition ID:** R378388
District Sales Manager - Rocky Mountain - Tepezza (Ocular) - Rare Disease
Portland, OR job
Territory covers: Arizona, Colorado, Utah, Wyoming, Montana, Washington, Oregon & Alaska HOW MIGHT YOU DEFY IMAGINATION? If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of.
Live
What you will do
Let's do this. Let's change the world. In this vital role you will lead area geography and team of Specialty Account Managers (SAMs) to ensure market penetration.
* Leads area geography and team of Specialty Account Managers (SAMs) to ensure market penetration by analyzing and understanding market dynamics and data, setting related strategic action plans and excellence in execution in order to ensure that sales goals are achieved within the Endocrinology space.
* Provides a clear, compelling sales purpose both clinically and business wise for the team members.
* Ensures the effective and appropriate use of resources, including territory management tools/data, cross functional partners, marketing tools, etc.
* Builds business strategy and strategic impact in line with corporate and therapeutic area goals.
* Leads market development initiatives in line with corporate and therapeutic area goals.
* Manages administrative duties, ongoing learning of self and team members, operational expenses, program funding, etc.
* Ensures that team members operate within regulatory guidelines in all aspects of promotion, program implementation and product compliance.
* Ensures the team is trained and prepared to maximize business/sales potential, and that the product message is crisp, clear and consistently delivered with high impact.
* Achieves organizational sales goal volume, proper target reach / frequency objectives as well as other relevant KPIs related to excellence in execution.
* Establishes a productive work environment by creating trust and respect within the broader national Endocrinology sales team and establishes self as a business partner across the business unit.
* Must be able to work closely with and effectively collaborate across all divisions within the business unit to achieve business objectives.
* Develops an atmosphere of confidence and strength and creates opportunities to recognize and reward outstanding individual and team sales performance.
* Builds an organization reflecting a highly professional workforce in the eyes of external and internal partners.
* Addresses performance issues decisively and appropriately.
* Develops internal and external customer relationships to successfully drive Amgen's business objectives within the therapeutic area.
* Fosters informative flow of insights and delivers influential messages that gain support for initiatives.
* Develops and communicates a professional growth plan for self and team members.
* Continually educates self and team on Endocrinology market issues / trends and product knowledge as it pertains to specific business interests.
* Applies new / innovative technologies to enhance efficiency, expands knowledge base and refines skill building.
* Weekly ride-alongs with written feedback and coaching of respective team members.
* Represent the organization at local, regional and national trade shows.
* Provide input to regional and national sales meetings (content and objectives).
* Strives to maintain a safe working environment through the prevention of accidents, the preservation of equipment, and the achievement of safe working practices.
* Maintains a positive and professional demeanor toward all customers and coworkers.
* Adheres to all policies and procedures of Amgen.
* Performs other duties as assigned.
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The District Manager - Ocular we seek is a motivated professional with these qualifications.
Basic Qualifications:
Doctorate degree AND 2 years of Sales/Marketing experience
OR
Master's degree AND 6 years of Sales/Marketing experience
OR
Bachelor's degree AND 8 years of Sales/Marketing experience
And
2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.
Preferred Qualifications:
* Sales experience in biologics, infusion, and/or rare/specialty products preferred.
* Rare disease experience strongly preferred; Rare Disease launch experience preferred.
* Immunology and / or Rheumatology experience preferred.
* Buy-and-bill experience preferred.
* Experience working with institutions and integrated delivery networks preferred.
* Requires approximately 80% travel, some overnight and weekend commitments.
* Proficient in Microsoft Office.
* Professional, proactive demeanor.
* Strong interpersonal skills.
* Excellent written and verbal communication skills.
Essential Core Values and Competencies:
Growth
* Manages Ambiguity
* Strategic Mindset
* Demonstrates Self-awareness
* Cultivates Innovation
* Develops Talent
Accountability
* Drives Results
* Ensures Accountability
* Decision Quality
Transparency
* Courage
* Collaboration
* Instills Trust
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.
In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
* Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
* A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
* Stock-based long-term incentives
* Award-winning time-off plans and bi-annual company-wide shutdowns
* Flexible work models, including remote work arrangements, where possible
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
Application deadline:
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.
Salary Range
201,353.00 USD - 226,463.00 USD
Principal Automation Engineer
Hillsboro, OR job
** Genentech's Hillsboro Oregon campus-Hillsboro Innovative Therapies (HIT)-serves as a critical hub for emerging cell & gene therapy manufacturing. Housed within a modern 75-acre facility just outside Portland, HIT is at the forefront of advancing cell and gene therapy medicines through accelerated clinical and commercial manufacturing capabilities, aligning with Genentech's mission to bring transformative therapies to patients.
This role is a valuable part of our Manufacturing Sciences and Technology (MSAT) team, which is committed to achieving our mission of delivering innovative cell and gene therapies to patients. As a member of this team, you will have the opportunity to collaborate closely with key stakeholders in Process Development, Analytical Development, Manufacturing, and Quality.
**The Opportunity:**
As a **Principal Automation Engineer** , you will play a key role in developing, implementing, and optimizing automation solutions to support emerging cell and gene therapy manufacturing. You will collaborate with cross-functional teams to streamline processes, improve efficiency, and ensure alignment with regulatory and quality standards to advance our mission of delivering transformative therapies to patients. Additionally, you will:
+ Perform automation tasks for commissioning and qualification of new systems while ensuring compliance with regulatory and operational standards.
+ Collaborate with cross-functional engineering teams to enhance the performance and reliability of automation and production equipment.
+ Monitor, troubleshoot, and maintain running automation systems to ensure uninterrupted plant operations and resolve system issues.
+ Develop solutions for recurring issues, create necessary change records, and provide proactive strategies for process and system improvement.
+ Conduct investigations into cross-site issues with potential enterprise-level impact, implementing effective resolutions.
+ Support the development of user requirements, design reviews, and planning for new equipment integrations.
+ Mentor and support junior Automation Engineers while providing guidance on troubleshooting, technical best practices, and continuous improvement opportunities.
**Who You Are:**
+ You possess a Bachelor's degree in engineering, computer science, or related field, with 5 or more years of experience in automation engineering within the pharmaceutical or biotechnology manufacturing industry.
+ You possess extensive hands-on experience with automation platforms and systems such as SCADA, DCS, PLCs, Human Machine Interfaces (HMIs), and thin clients to support complex manufacturing processes.
+ You possess advanced expertise in troubleshooting and resolving complex automation issues, performing root cause analysis, and implementing robust technical solutions.
+ You have proven experience integrating automation controls with factory manufacturing processes, including the successful integration of electrical and mechanical systems.
+ You have a demonstrated ability to manage and influence diverse stakeholders while building effective partnerships across Process Development, Analytical Development, Manufacturing, and Quality functions.
+ You possess significant experience navigating matrixed environments, managing multiple cross-functional projects, and balancing competing priorities in a fast-paced setting.
+ You possess in-depth knowledge of FDA regulations, cGMP standards, and compliance requirements specific to pharmaceutical and biotechnology production.
+ You are able to serve as a member of the 24/7 Rotational On Call Support Team.
**Preferred:**
+ Cell/gene therapy industry experience.
+ Experience working in an environment utilizing change control and good documentation practices.
+ Experience with Rockwell and Emerson Automation technologies.
+ Experience developing automation solutions.
+ Experience interpreting electrical schematics and P&ID drawings.
The expected salary range for this position based on the primary location of Oregon is $95,200 - $176,800. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed in this **link (***************************************************** **.**
**Relocation benefits are approved for this posting.**
**This is an on-site position; no remote options are offered at this time.**
\#LI-CA1
\#ptcareers
\#cellandgenetherapycareers#
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants (***************************************************************************************************** .
Process Engineer/Senior Process Engineer
Hillsboro, OR job
** Genentech's Hillsboro Oregon campus-Hillsboro Innovative Therapies (HIT)-serves as a critical hub for emerging cell & gene therapy manufacturing. Housed within a modern 75-acre facility just outside Portland, HIT is at the forefront of advancing cell and gene therapy medicines through accelerated clinical and commercial manufacturing capabilities, aligning with Genentech's mission to bring transformative therapies to patients.
This role is a key part of our innovative Manufacturing Sciences and Technology (MSAT) team, dedicated to advancing transformative therapies for patients. The MSAT team drives the development, optimization, and validation of cutting-edge manufacturing processes, working at the intersection of science and engineering. As part of this collaborative and dynamic group, you will partner with experts across Engineering, Process Development, Manufacturing, and Quality to support technology transfer, process optimization, and pioneering solutions in medicine production.
**The Opportunity:**
As a **Process/Senior Process Engineer** , you will play a pivotal role in designing, optimizing, and validating novel manufacturing processes for transformative therapies. You will be responsible for leading process design initiatives, supporting technology transfers, and providing hands-on experimental and technical support to manufacturing operations. Additionally, you will:
+ Design, development, and implement innovative processes to support the manufacturing of transformative therapies.
+ Drive process validation activities, ensuring robust and scalable manufacturing workflows.
+ Collaborate with cross-functional teams to coordinate seamless technology transfer to manufacturing operations.
+ Conduct hands-on experimentation in the MSAT process optimization laboratory to refine and optimize processes.
+ Support daily manufacturing operations through process monitoring, troubleshooting, deviation investigations, and optimization initiatives.
+ Author comprehensive technical assessments and validation documentation.
+ Work closely with stakeholders in Engineering, Process Development, Manufacturing, and Quality to align strategies and deliverables.
**Who You Are:**
+ You possess a Bachelor's or advanced degree in a relevant scientific or engineering discipline with relevant industry experience in manufacturing sciences, biotechnology, or pharmaceutical development.
+ You possess at least 2 - 5 years of relevant technical background in process design, validation, and manufacturing workflows, particularly within biopharmaceutical operations.
+ You have the demonstrated ability to analyze complex processes, troubleshoot issues, and implement efficient optimization strategies.
+ You have proven experience working in cross-functional teams and supporting stakeholders in a matrixed environment.
+ You possess excellent communication and collaboration skills to engage with diverse teams and ensure alignment on project goals.
The expected salary range for this position based on the primary location of Oregon is $80,500 - $149,500. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at this **link (***************************************************** **.**
**Relocation is approved for this position.**
**This is an on-site position; no remote options are offered at this time.**
\#LI-CA1
\#ptcareers
\#cellandgenetherapycareers#
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants (***************************************************************************************************** .
Project Director - Capital Projects
Hillsboro, OR job
** A healthier future. That's what drives us. Always innovating, we bring together dedicated people and diverse perspectives from across our global network, empowering each other to keep breaking new ground. That's what makes us who we are. That's what makes us Roche.
This role is based in Pharma Technical Operations Technology (PTT), an organization that is responsible for ensuring Pharma Technical Operations (PT) stays at the forefront of technology in our current and future facilities. PTT, composed of global MSAT and Engineering, realizes new assets for the PT manufacturing network of drug substance, drug product, and device industrialization facilities. You will have the opportunity to build manufacturing facilities that deliver life saving medicines to patients.
**The Opportunity**
As a Capital Project Director, within the capital delivery group, you will be responsible for leading large and/or complex facility/equipment improvement projects within our US manufacturing network as well as potentially at our international sites.
+ Build and lead the project team, motivating them through your strong communication and leadership skills with clear decision-making to maintain project flow.
+ Model collaboration through strong partnership with User Team Lead and other key customers and stakeholders
+ Champion both design and construction safety as a key priority, engaging the Safety, Health, and Environment team throughout the project lifecycle.
+ Accountable for fiscal control of the project by
+ Developing funding strategy in alignment with execution strategy,
+ managing scope and schedule of the capital project within the agreed business case, and
+ keeping team focused on execution plan
+ Engage with senior executive sponsors, site leadership and other key leaders on development of business case, execution & funding strategy and resolution of any impediments that arise
+ From early concept, through design, construction and commissioning and qualification,, deliver the project not relenting until the project's business intent is actually met.
**Who you are:**
+ B.S. in engineering, architecture or construction with a minimum of 10 - 15 years successfully managing projects in the biotech/pharmaceutical industry, with at least 5 - 10 years managing large, complex projects, some preferably in an international environment.
+ Known for your exceptional interpersonal and leadership skills in capital project delivery.
+ Proven expertise in effectively applying and/or developing advanced project management tools and methodologies.
+ Broad understanding of the principles of various engineering disciplines, in-depth understanding of one engineering discipline directly related to Roche core business of manufacturing.
Preferred:
+ MS in Engineering and/or an MBA and/or a PE/equivalent
+ Special knowledge requirements include biopharmaceutical and pharmaceutical processes and facility design approaches, plus solid understanding of Pharmaceutical cGMP requirements.
+ Understanding of risk based qualification
+ Lean Construction knowledge and practitioner
Relocation benefits are not available for this posting.
The expected salary range for this position based on the primary location of California is $136,200 to $253,000 annually. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
**Benefits (******************************************************
\#LI-PK1
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants (***************************************************************************************************** .
Head of Quality Systems Validation (Director/Senior Director)
Hillsboro, OR job
Genentech's Hillsboro Oregon campus-Hillsboro Innovative Therapies (HIT)-serves as a critical hub for emerging cell & gene therapy manufacturing. Housed within a modern 75-acre facility just outside Portland, HIT is at the forefront of advancing cell and gene therapy medicines through accelerated clinical and commercial manufacturing capabilities, aligning with Genentech's mission to bring transformative therapies to patients.
This role is a part of our Quality Systems and Validation (QSV) team, which is dedicated to supporting the design, startup, and operation of a cutting-edge GMP facility. As a member of this team, you will collaborate closely with stakeholders across Clinical Facilities, Technical Development, and Global Quality to define and implement robust Quality Systems, Validation strategies, and automated QC methods that ensure compliance with cGMP regulations and enable instantaneous product disposition. You will play a pivotal role in driving innovation, fostering a continuous improvement mindset, and shaping processes for next-generation production in a dynamic and engaging environment.
The Opportunity:
As the Head of QSV, you will serve as a pivotal strategic architect, designing and orchestrating a world-class QSV framework for a cutting-edge, high-throughput GMP manufacturing facility. This is not merely a compliance role; it is a leadership mandate to bridge the gap between innovative engineering and regulatory excellence. You will act as a primary influencer across the global network, harmonizing complex stakeholder interests to enable rapid product disposition and next-generation production goals. Key strategic responsibilities include:
* Architecting and leading a scalable Quality Systems and Validation roadmap and strategy aligned with cGMP regulations and project milestones.
* Championing quality as an enabler mindset by building a high-performance team of subject matter experts who serve as strategic consultants to the business, rather than just compliance enforcers.
* Cultivating high-trust relationships with global regulatory stakeholders to influence emerging standards and ensure the facility remains at the forefront of "Quality by Design" principles and acting as a key liaison between R&D, Clinical, and Commercial operations to harmonize quality standards across the product lifecycle, effectively navigating competing priorities.
* Leading complex, multi-functional task forces to resolve systemic quality challenges, utilizing data-driven storytelling to influence stakeholders toward sustainable, long-term corrective actions (CAPA) that enhance operational throughput.
* Proactively identify and resolve systemic quality challenges using data-driven storytelling and expert negotiation to align stakeholders on corrective actions that maintain both project timelines and the highest safety standards.
* Drive the standardization of validation excellence across the enterprise, influencing cross-site communities of practice to ensure that local innovations are scaled into global best practices.
Who You Are:
Note that this position can be hired as either a Director or Senior Director depending on candidate qualifications.
Director Requirements:
* You possess a Bachelor's degree or higher in Chemistry, Biochemistry, or a relevant scientific discipline along with 12 or more years of progressive leadership experience in Quality Systems and Validation within the pharmaceutical or biopharmaceutical industry; cell therapy industry experience is preferred.
* You have extensive knowledge and practical experience in developing and implementing Validation and Qualification policies, procedures, and testing methods in compliance with cGMP regulations and industry standards.
* You have demonstrated experience with writing, reviewing, and approving complex technical documentation such as equipment qualification protocols, validation reports, life cycle documents, and Quality System policies.
* You have a successful track record of leading cross-functional teams and managing stakeholders in a highly matrixed, dynamic environment to meet project goals.
* You possess a deep understanding of cGMP regulations, quality systems, and validation principles with a track record of successful regulatory inspections and submissions.
* You are a strong communicator with exceptional interpersonal skills to foster effective collaboration across internal and external partners.
* You are skilled with prioritizing competing demands, allocating resources efficiently, and delivering results in a fast-paced start-up setting.
Senior Director Requirements:
* You possess a Bachelor's degree or higher in Chemistry, Biochemistry, or a relevant scientific discipline along with 15 or more years of progressive leadership experience in Quality Systems and Validation within the pharmaceutical or biopharmaceutical industry; cell therapy industry experience is preferred.
* You have a proven history of navigating the complexities of large-scale, high-throughput biopharmaceutical manufacturing environments.
* Beyond practical experience, you are an SME in architecting and scaling Validation and Qualification policies from the ground up. You have a sophisticated understanding of how to translate global cGMP regulations and ICH guidelines into lean, agile operational workflows.
* You have a distinguished track record of serving as the final technical authority for complex documentation, including Master Validation Plans (MVPs), lifecycle strategies, and site-wide Quality policies. You are adept at defending technical rationales to internal executive committees and external regulatory bodies.
* You possess a significant track record of influence within highly matrixed, global organizations. You have successfully led multi-disciplinary teams through complex transitions, demonstrating the ability to align disparate departmental goals (R&D, Ops, IT, Legal) under a unified quality vision.
* You are a veteran of the "front room," with a proven track record of leading successful interactions with the FDA, EMA, and other global health authorities. You don't just pass inspections; you build the organizational "inspection readiness" muscle that minimizes business risk.
* You are an exceptional communicator with the executive presence required to brief C-suite leadership and the interpersonal nuance to build high-trust partnerships with external vendors and industry consortiums.
* You are a specialist in strategic resource modeling, capable of prioritizing high-stakes deliverables in a volatile, fast-paced "start-up" or "scale-up" setting. You possess the emotional intelligence and decisiveness to lead through ambiguity and rapid organizational change.
* You have significant experience overseeing the validation of next-generation technologies, including automated high-throughput systems, MES, and AI-driven data integrity platforms, ensuring that "Quality 4.0" is integrated into the site DNA.
Physical Requirements:
* Work in office and laboratory environment
* Lift up to 25 lbs may be required
* Ability to sit, stand and move within work space for extended periods
* May be required to sit at a computer terminal for extended periods
* Ability to travel up to 30% to other sites as required
The expected salary range for this position based on the primary location of Oregon is $142,000 - $263,600 for the Director and $170,660 - $316,940 for the Senior Director. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed in this link.
Relocation benefits are approved for this posting.
This is an on-site position; no remote options are offered at this time.
#LI-CA1
#ptcareers
#cellandgenetherapycareers#
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
Environmental/Sterility Quality Assurance (EQA) Specialist
Hillsboro, OR job
** Genentech's Hillsboro Oregon campus-Hillsboro Innovative Therapies (HIT)-serves as a critical hub for emerging cell & gene therapy manufacturing. Housed within a modern 75-acre facility just outside Portland, HIT is at the forefront of advancing cell and gene therapy medicines through accelerated clinical and commercial manufacturing capabilities, aligning with Genentech's mission to bring transformative therapies to patients.
This role is a vital part of our Environmental/Sterility Quality Assurance team, dedicated to ensuring the highest standards of contamination control, sterility assurance, and regulatory compliance for advanced therapeutic medicinal products. As a member of this team, you will collaborate closely with cross-functional groups, including Manufacturing, Quality Control, Facilities, and Regulatory, to uphold patient safety and product quality. Joining this team means contributing to innovative manufacturing processes, enhancing sterility programs, and shaping a culture of continuous improvement and excellence.
**The Opportunity**
As an Environmental/Sterility Quality Assurance (EQA) Specialist, you will play a pivotal role in shaping and driving the contamination control strategy, sterility assurance programs, and ensuring regulatory compliance for the HIT facility. Your contributions will safeguard product quality and patient safety while fostering collaboration across a highly matrixed environment.
+ Support the implementation and execution of site-level Contamination Control Strategy (CCS) programs, such as environmental monitoring, aseptic processes, utility systems, and HVAC qualifications.
+ Provide technical assessment, oversight, and approval of CCS and sterility assurance-related systems, ensuring alignment with cGMP, ATMP GMPs, USP, EP, and JP standards.
+ Collaborate with manufacturing, quality, and facility teams to develop unified strategies for contamination control and sterility assurance while ensuring compliance with regulatory requirements.
+ Offer Quality oversight for routine environmental monitoring and aseptic process simulations, ensuring programs meet regulatory and operational standards.
+ Act as a key resource for regulatory submissions and facilitate interactions with regulatory agencies by advancing site sterility assurance programs.
+ Drive continuous improvement initiatives by recommending enhancements to contamination controls, personnel training, and operational processes.
+ Serve as a subject matter expert (SME) in sterility assurance principles and practices, providing guidance to cross-functional teams and training them as needed.
**Who You Are**
+ You possess a Bachelor's degree in life sciences or related scientific discipline
+ You possess 5 or more years of experience in a regulated industry (e.g., pharma/biopharmaceutical or medical device) along with at least 4 years in Quality, Compliance, Regulatory, and/or Validation.
+ You have a strong understanding of quality assurance concepts, including cGMP, ATMPs, contamination control principles, sterility assurance programs, and ATMP-specific standards.
+ You have large molecule and/or ATMP drug product manufacturing and expertise in risk-based approaches to compliance and sterility assurance processes.
+ You have a proven ability to collaborate effectively in a matrixed environment and manage stakeholders across diverse teams.
+ You are a skilled communicator with the ability to influence, coach, and partner with multidisciplinary stakeholders to achieve organizational goals.
**Preferred Experience**
+ You possess experience with investigational medicinal products, product development, phase-appropriate approaches, and multiple manufacturing technologies and product lifecycles.
The expected salary range for this position based on the primary location of Oregon is $94,000 - $174,600. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed in this link (*************************************************** **.**
**Relocation benefits are not approved for this posting.**
**This is an on-site position; no remote options are offered at this time.**
\#LI-CA1
\#ptcareers
\#cellandgenetherapycareers#
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants (***************************************************************************************************** .
DeltaV System Owner
Hillsboro, OR job
We Make Medicines!
Behind every product sold by Roche is Pharma Global Technical Operations (PT). Starting with Phase I of the development process and continuing through to product maturity, PT makes lifesaving medicines at 11 locations, with the support of partners from around the world. Information (IT) and Automation Technology (OT) teams are key in producing and delivering medicine to patients. The organization is currently undergoing a transformation towards digitalization, advancing fundamental elements to meet future needs, such as using new technologies.
The Opportunity
This position, based in Genentech's Hillsboro, Oregon facility, provides the opportunity to have a key role in a highly automated pharmaceutical drug substance facility. The site employs highly integrated computer control systems to manage plant operations and manufacturing data.
The IT OT Team in Hillsboro is supporting Hillsboro Technical Operations (HTO) which is the commercial Make Assess and Release (MAR) and launch site for North America, and Hillsboro Innovative Therapies (HIT) which is transitioning into a multi-product facility for development, clinical and commercial supply capabilities for individualized and cell therapies.
As a key member of the Hillsboro IT OT team, you will take on the System Ownership and local Product Ownership accountabilities for the Distributed Control System (DCS), specifically Emerson DeltaV, to ensure seamless support for Product Transfers and Make/Assess/Release activities in a 24x7 Goods Manufacturing Practice (GMP) environment. You will be the site's primary technical and compliance expert for the DeltaV platform, contributing to global IT OT optimization and standardization efforts.
This include activities like:
Serve as the dedicated System Owner / Local Product Owner for the Emerson DeltaV Distributed Control System (DCS) and other designated Manufacturing IT Applications in a 24x7 Good Manufacturing Practice (GMP) environment.
Oversee the procurement, advanced development, integration, modification, operation, maintenance, validation, and decommissioning of the DeltaV DCS platform. Lead Computer System Validation (CSV) efforts, including validation planning, protocol authoring, and test execution associated with owned systems.
Create, update, and maintain system lifecycle documents and procedures using document management systems (Veeva, Condor, eVal Roche), including System Descriptions, Design Specifications, and Disaster Recovery plans.
Responsibility for the Periodic System Audit Trail Review. Support regulatory audits focusing on Process Control, Automation, and Data Integrity.
Represent and mitigate application dependencies as related global systems evolve their business processes and technologies (e.g., managing the interface points between DeltaV, MES, and IMS (AVEVA PI historian)).
Lead and coordinate negotiations with vendors on DeltaV-related activities, including licensing agreements, advanced support contracts, and lifecycle management. Serve as the technical liaison for on-site vendor activities, overseeing installation, maintenance, and other services performed on administered systems.
Ensure reliable data integrity and connectivity between DeltaV and the PI Historian for long-term data retention and analysis.
Oversee the implementation and maintenance of user access controls, security patches, and network segmentation specific to the DeltaV ProfessionalPLUS and control network.
Oversee system backups, disaster recovery preparedness, and cybersecurity protocols in compliance with the ISA/IEC 62443 cybersecurity standards.
Through Agile delivery model, provide leadership, specialized DeltaV technical expertise, and local implementation experience as a member of Build and Run Squads. Work to identify opportunities to optimize control strategies and improve business processes.
Review and triage ServiceNow tickets. Provide expert-level troubleshooting and resolution for complex (DCS) system issues and technical inquiries as they arise during normal business hours, ensuring minimal disruption to operations and maintaining the integrity of critical automation systems.
Participate in an after hours on-call support rotation.
Who You Are
Bachelor's degree in Computer Engineering, Automation Engineering or Equivalent experience.
Minimum 5+ years of hands-on experience implementing, configuring, and managing the Emerson DeltaV system in a GMP environment.
Minimum 3-6 years of experience in system and/or network administration.
Must have experience in the life sciences Manufacturing domain.
Prior experience in working closely with IT OT providers/vendors.
Strong attention to details and good problem-solving skills, with a demonstrated ability to think and solve problems at a system-level.
Expert-level knowledge of Emerson DeltaV DCS with a strong emphasis on application administration and engineering, including expertise in patching, upgrades, audit support, performance tuning, system and database log review and maintenance, specifically within manufacturing control systems.
System design and administration experience supporting multiple platforms and applications in cGMP-regulated environments, ensuring compliance and high system reliability.
Experienced with troubleshooting OT systems hardware. Knowledge of Pepperl and Fuchs Thin clients and DeltaV-supported infrastructure is a plus.
Proficiency in Windows Server and Network Administration with specialization on DeltaV (DCS) proprietary communication protocols.
Specialized experience with industrial data exchange frameworks, including proficiency in classic OPC and OPC-UA protocols. Knowledge of MQTT is a plus.
SQL Database Server proficiency. Knowledge with SQL Database Cluster (Always ON), is a plus
In-depth knowledge of Good Manufacturing Practices (GMP) including familiarity with Health Authority regulations such as 21 CFR Part 11, EU Annex 11 and Global Data Integrity principles.
The expected salary range for this position based on the primary location of Oregon is $95,200.00 - $176,800. Annual Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Benefits
Relocation benefits are not available for this job posting.
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
Auto-ApplyQuality Control Analyst - Potency Assays
Hillsboro, OR job
** This position is part of a consolidated Analytical Development and Quality Control (ADQC) team within Genentech's cutting edge Pharma Technical Cell and Gene Therapy (PTC) organization. PTC is dedicated to advancing cell and gene therapies aimed at treating or curing various diseases. In this position, you'll conduct quality control (QC) activities to support the clinical progress of cell and gene therapies.
As a member of Genentech's Hillsboro Innovative Therapies (HIT) QC team, you will perform analyses of cellular attributes and secreted molecules from in-process samples and finished products, including cell-based functional, biochemical and chemical tests. You will gather data for test procedure documentation, calibrate and maintain laboratory equipment, and contribute to drafting procedures, summaries, reports and investigations. Additionally, you will support activities for method improvements and method lifecycle.
**The Opportunity:**
As a **Potency Quality Control Analyst** , your main function will be to ensure data integrity and compliance with established guidelines through various analytical tasks. Additionally, you will:
+ Conduct analytical testing, qualify and validate methods, and implement new potency assessment procedures to support GMP production
+ Draft and review documentation for equipment qualification, method implementation, and procedures
+ Collaborate with Genentech's Technical Development Teams (TDTs), PTC functions, Pharma Technical Development (PTD), and global teams to achieve clinical proof of concept and prepare for commercial production
+ Calibrate and maintain laboratory and analytical equipment to ensure accurate and consistent results
+ Support the development of new potency testing or analysis methods and protocols for routine and non-routine analyses
+ Technically review data, checking against defined acceptance criteria, and identify technical issues, deviations, and discrepancies
+ Support internal and external audits and regulatory inspections, maintaining compliance and quality standards
**Who You Are:**
+ You possess a Bachelor's degree and at least 2 years of relevant laboratory experience in Chemistry, Biochemistry, Molecular Biology or a relevant scientific discipline; Master's degree is plus
+ You are proficient in running and validating cell-based and biochemical methods, including cell viability, cell killing, barrier function and immunoassays (ELISA)
+ You possess demonstrated skills in applying scientific theories and techniques to analytical or biological testing
+ You have a strong aptitude for interpreting and implementing Quality standards
+ You are an energetic and driven self-starter, a team player with excellent verbal and written communication skills, able to effectively absorb and present information
+ You possess strong problem-solving capabilities
**Preferred Experience:**
+ You possess experience working in the pharmaceutical or biopharmaceutical industry, specifically in the contexts of QC Cell therapy
+ You have a solid understanding of cGMPs or similar regulations (strongly preferred)
**Physical Requirements:**
+ You are able to work in both office and laboratory settings, with extended periods working at benches and frequent lifting (up to 25 lbs), bending, reaching, and twisting
+ Use of stepladders and pushcarts
+ Must pass visual screening
**Relocation benefits are approved for this posting.**
**This is an on-site position. Remote and hybrid options are not available.**
The expected salary range for this position based on the primary location of Oregon is $68,300 (min) - $97,600 (mid) - $126,900 (max). Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed in this **link (*************************************************** .**
\#LI-CA1
\#ptcareers
\#cellandgenetherapycareers#
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants (***************************************************************************************************** .
Medical Specialist I-Allergy/ENT-Seattle, WA
Regeneron Pharmaceuticals job in Vancouver, WA
Our Medical Specialists are at the forefront of engaging Allergists, Immunologists and Otolaryngologists as well as other key customers. We need someone who is highly proficient in presenting clinically focused sales messaging that resonates and compels potential and existing customers to take action. Our ideal candidate must be driven by the highest degree of integrity and appreciation for always doing what is right - aligned with our core beliefs and values. We see this as an outstanding opportunity to join a fast-paced, result-oriented, customer-focused team if you are up for the challenge.
As a Medical Specialist, a typical day might include the following:
Developing strategy and executing tactics within key accounts in our Allergy/Immunology and ENT therapeutic areas to generate product utilization
Establishing and fostering strong working relationships with Allergy/Immunology/Otolaryngology health care professionals including physicians, advanced practitioners, nurses, office staff and other important personnel as well as key patient advocacy support groups as directed
Collaborating with regional colleagues, as well as other field-based and home office personnel teams to proactively address customer needs
Analyzing market dynamics and trends to develop strategies which support brand and corporate objectives
Participating in initiatives to support sales success such as industry-related congresses, local and regional meetings, and medical conferences.
This role may be for you if:
You are confident in demonstrating strong and consistent sales performance that exceeds expectations related to product goals
You are innately guided by core values of ethics and compliance and always act in a manner consistent with those values
You have a competitive spirit and harness your “grit” to power your approach to sales
You collaborate effectively with internal and external partners
You share a passion and learning aptitude for science and are proactive in strengthening knowledge related to disease states, treatment options and healthcare trends
You can effectively connect your work to the overarching brand strategy and shift focus dynamically as needed
Geography: Seattle, Washington Allergy/ENT territory
Key Markets include Seattle, Everett, Redmond, Bellevue, Bellingham, Renton
To be considered you must possess a minimum of a bachelor's degree. A master's degree or other advanced education/certifications are a plus. We expect that a successful candidate will have specialty pharmaceutical/biopharmaceutical experience with a minimum of 5 years' pharmaceutical sales experience. Having a minimum of 2 years' sales in the Immunology and/or ENT market or a similar subcutaneous self-injectable biologic specialty market is also a requirement for this role. Allergy/Immunology/Otolaryngology experience preferred. We need someone with demonstrated success and consistent sales performance in complex markets across diverse customer segments. This role requires the ability to travel and cover large geographic territories.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit ********************************************************************* For other countries' specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$143,500.00 - $187,500.00
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