Novavax Jobs

Senior QC Analyst page is loaded **Senior QC Analyst** **Senior QC Analyst** locations Germantown, MD time type Full time posted on Posted Yesterday job requisition id JR100720 If you find science, speed, and helping address serious infectious diseases exhilarating, you have come to the right place. Individually, we're skilled, driven, and confident risk-takers. Collectively we're collaborative and accomplished. We're SuperNovas! Together we use our unique experiences, cultures, and learnings to turn innovation into reality while maintaining the highest standards. We value balance, encourage growth, and recognize that you are our most important asset. Build your future with us while bringing innovative vaccines to the world. We have a place for you! Novavax, Inc (Nasdaq:NVAX) is a biotechnology committed to helping address serious infectious diseases globally through the discovery, development and delivery of innovative vaccines to patients around the world. We have more than a decade of experience contending with some of the world's most devastating diseases, and we are here to make a difference. Hard-won lessons and significant advances illustrate that our proven technology based on solid science tested by decades of research, has tremendous potential to make a substantial contribution to public health worldwide. The Quality Control Senior Analyst is responsible for day to day operations related to release and stability testing, maintaining QC cell culture lines, and writing SOPs, deviations, change controls and CAPAs as part of typical QC operations. **Responsibilities include but are not limited to**: * Performs GMP release and stability testing in Quality Control * Write technical reports and supporting documentation such as deviation, reports, testing protocols, and trend analyses * Review of laboratory notebooks, protocols and reports * Perform day to day activities for cell propagation used for QC release and stability assays. * Participate in technology transfer, method qualification and validation * Perform validations or transfers of analytical methods in accordance with applicable policies or guidelines * Participate in internal assessments and regulatory audits as required * Ensure that written records and work undertaken are performed in accordance with cGMP and company procedures * Leading the lab in 5S and routine housekeeping activities * Maintain effective communication with other relevant groups, including but not limited to Quality Assurance, Manufacturing and Analytical Development * Other duties as assigned **Minimum requirements**: * Minimum of a Bachelor's degree or equivalent in a scientific discipline * Minimum 8 years of industry experience in a cGMP laboratory, preferably related to biopharmaceutical industry operations * Hands on experience performing ELISA in a cGMP environment * Hands on experience performing SDS-PAGE in a cGMP environment * Working knowledge of Sf9 Insect Cell Culture Procedures and cell-based assays e.g. HS plaque and Rapid Titer assay * GxP (regulatory relevant skills and knowledge) GLP/GCP/GMP required * Excellent analytical skills and knowledge * Strong troubleshooting skills for equipment and software * Solid ability to work independently (minimum supervision) * Ability to lead others, as needed * Ability to effectively collaborate with others * Excellent communications skills and be conversant in computer systems * Excellent multi-tasking and organizational skills. * Excels in time management * Strong attention to detail * Job holder should be a good understanding of relevant regulatory/industry standards and requirements The annual base salary (or hourly wage) for this position falls within the range of kr33,555.00 - kr41,950.00. However, the actual base pay offered may vary based on several individualized factors, such as market location, job-related knowledge, skills, and experience. Novavax offers a base salary, annual bonus, equity grants, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.Equal Opportunity Employer/Veterans/Disabled Novavax is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals on an at-will basis, regardless of their race, color, national origin, religion, ancestry, citizenship status, military or veteran status, sex, sexual orientation, gender identity or expression, age, marital status, family responsibilities, pregnancy, disability, genetic information, protective hairstyle, or any other characteristic protected by applicable federal, state, or local law. If you find science, speed, and success exhilarating, you have come to the right place. Novavax, Inc (Nasdaq:NVAX) is a biotechnology company that creates transformational vaccines that address some of the world's most pressing infectious diseases. We have more than a decade of experience contending with some of the world's most devastating diseases, including COVID-19, seasonal influenza, RSV, Ebola, MERS, and SARS. Hard-won lessons and significant advances illustrate that our proven technology has tremendous potential to make a substantial contribution to public health worldwide. Our scientists are committed to developing vaccine candidates for some of the world's toughest viral threats by utilizing the power of our innovative recombinant nanoparticle vaccine platform. Our vaccine technology combines the power and speed of genetic engineering with the immunogenicity enhancing properties of our Matrix-M™ adjuvant to efficiently produce highly immunogenic particles targeting some of the most pressing viral infectious diseases. Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic.

We go where others won't, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life. JOB SUMMARY The Regulatory Operations Specialist will be an integral member of the Global Regulatory Operations Team, providing support with various ongoing submissions to remain in compliance with all FDA and other U.S. and international regulatory requirements and company standards. The qualified candidate will be responsible for supporting the compilation of regulatory submissions in eCTD format and providing support in the Emergent Regulatory Information Management System (RIM) under the oversight of the Senior Manager (or Manager), Regulatory Operations. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. The main duties and responsibilities include but are not limited to: * Track and compile regulatory submissions from electronic sources; assemble, and publish submission documents in accordance with established timelines, global regulations, and relevant company procedures * Review published submissions prior to filing to a Health Authority * Interact with internal regulatory staff and external vendors to facilitate on-time publishing and submission of regulatory documents * Assist in the development, implementation, and maintenance of document standards, templates, and procedures related to the formatting and publishing of electronic submissions and best practices in the Emergent RIMS. * Participate on project teams as Regulatory Operations representative * Support document migration as a part of potential company integration activities * Format MS Word documents that have been provided by Regulatory Affairs according to the Emergent Style and Formatting guide standards. * Format PDF files to ensure that they meet company-defined standards for submission, such as PDF version, bookmarks, links, OCR, etc. * Manage multiple requests, meeting all timelines, and ensuring all updates are captured The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. MINIMUM EDUCATION, EXPERIENCE, SKILLS * B.Sc. or B.A. or a college diploma program with specialized training in Regulatory Affairs * Minimum of 3+years of experience in publishing global submissions required, biological and vaccine products preferred. * Experience with DocuBridge submission publishing and Veeva document management preferred. International publishing experience preferred. * Experience in Formatting documents in Microsoft Word * Strong written and verbal communications. Strong interpersonal skills. Ability to establish sound professional relationships. * Ability to solve routine problems with minimal supervision * Ability to manage multiple submission publishing jobs effectively * Technical ability to understand data object associations and data flow. * Careful attention to detail and accuracy required. If the hiring manager expresses an interest in interviewing you for the open position, you must discuss your interest in the open position with your current manager prior to an interview being scheduled. U.S. Base Pay Ranges and Benefits Information The estimated annual base salary as a new hire for this position ranges from $101,000 to $122,300]. Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.] Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: ************************************************************* (*Eligibility for benefits is governed by the applicable plan documents and policies). If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits. ABOUT EMERGENT Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life. Our drive towards this vision informs all of our actions-whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community-we strive every day to achieve this shared goal. WE BELIEVE IN OUR VALUES * Lead with Integrity * We gain trust and confidence through ethics, quality, and compliance excellence * Stand shoulder to shoulder no matter what * We combine our best thinking and communicate openly to support each other. * Own it always * Every person at Emergent is engaged and accountable for delivering on our commitments. * Break through thinking * We take smart risks, pursue innovation and challenge ourselves to constantly improve. * Compete where it counts * We set the right goals and respect each other as we conquer them together.

**For Current Kite Pharma Employees and Contractors:** Please log onto your Internal Career Site (****************************************************************************************************************************** to apply for this job. We're here for one reason and one reason only - to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We've made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows. **Job Description** Kite is seeking a highly motivated individual to work on innovative CAR-T cell therapy for cancer treatment. As a Senior Statistician II in the Statistical Sciences & Analytics (SS&A) group of Network Manufacturing Sciences and Technology (NMSAT), you will identify, develop and implement statistical methods to support new product introductions and GMP manufacturing for Kite's engineered autologous T cell therapy products. The Sr. Statistician will also help establish a statistics center of excellence to create statistical standards and harmonize statistical methods across Kite using industry guidance and best practices. **Key** **Responsibilities** include: - Identify, evaluate and apply appropriate statistical methods for study design and analysis of data related to process validation, tech transfers, process monitoring, investigations, analytical method performance, and product performance - Support the development of final product, in-process and raw material specifications - Consult and defend statistical approaches used in regulatory filings, response to questions, and regulatory inspections - Present analyses and proposed statistical / analytical strategies in a variety of cross-functional forums - Author internal technical reports, position papers, and contribute to content for regulatory submissions - Assist with coaching, mentoring, and training of data analysts and non-statisticians on the appropriate use of statistical methodologies and statistical software for their business processes - Contribute to department policies and procedures in support of establishing of a statistics center of excellence to harmonize and align on statistical tools and methodologies across Kite using industry guidance and best practices - Develop and promote the use of advanced statistical methods, e.g., Bayesian methods or predictive analytics, that contribute to a competitive advantage for Kite within the broader market - Affect statistical practices in the cell therapy industry through external meetings and conferences **Basic Qualifications:** - PhD 0+ years' experience OR - Master's Degree and 6+ years' experience in biotech / biopharma, high-tech industries OR - Bachelor's Degree and 8+ years' experience in biotech / biopharma, high-tech industries OR - High School Degree and 12+ years' experience in biotech / biopharma, high-tech industries **Preferred Qualifications:** - Advanced degree (MS or PhD) in applied or industrial statistics highly preferred, with proficiency in Design of Experiments, Statistical Quality Control, advanced modeling and simulation, Bayesian methods, and multivariate methods. Knowledge of Machine Learning, NLP or AI, is a plus. - 2 + years' experience in a technical role in the biotech / biopharma industry or other high-tech industry - Chemistry, Manufacturing and Controls (CMC) experience in gene or cell therapy is preferred - Proficiency in SAS, SAS Viya, JMP and R with a demonstrated experience of implementing statistical concepts into ready-to use software - Practical experience with cGMP manufacturing and regulatory regulations for CAR-T cell products or pharmaceuticals - Excellent scientific background and ability to drive data driven decision making within technical organizations and to engage, challenge and extend complex methodological topics, and interact with other statisticians on statistical-methodological issues for complex projects - Excellent communication skills to effectively communicate the findings of analyses with others in their organization; this includes both verbal and written communication, as well as the ability to present data in easy-to-understand, visual ways - Excellent interpersonal skills and the ability to interact effectively with internal and external stakeholders across different functions - Fluency in written and spoken English with excellent writing, presentation, and teaching skills - Ability to function efficiently and independently in a changing environment - Adaptable and comfortable in a collaborative and inclusive company environment - Ability to lead a cross-functional and diverse team while fostering inclusion - Creative and thoughtful problem-solving skills The salary range for this position is: $139,995.00 - $181,170.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: ****************************************************************** * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit ****************** . Sign up to follow @KitePharma on Twitter at ************************** . **For jobs in the United States:** As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' (********************************************** poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (********************************************************* YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION (*********************************************************************************************** Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. **For Current Kite Pharma Employees and Contractors:** Please log onto your Internal Career Site (****************************************************************************************************************************** to apply for this job. **Change The World With Us** Everyone at Kite is grounded by one common goal - curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work. We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don't take success for granted. While we've come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.

The Manager, Clinical Sciences, Hematology leads in the development, evaluation, planning and execution of clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program. The Senior Manager leads in a matrix environment as part of a cross-functional team and may contribute to candidate development projects through early and/or late phase development. The Manager reports to either Associate Director or Director, Clinical Sciences and collaborates closely with Medical Director (MD) to provide scientific expertise necessary to design and deliver on clinical studies and programs. **As a Manager, a typical day may include the following:** • Member of the Clinical Study Team and Global Clinical sub-team • Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings; may represent function in collaborative activities with other departments • Develops/maintains proficient understanding of therapeutic disease area(s) and drug candidate including underlying disease biology, clinical manifestations and therapeutic standard practice, compound(s) including mechanism of action and drug landscape • Applies basic scientific expertise to support initiation and execution of clinical research and development studies for early and/or late-stage assets • Assists with development of the Expanded Synopsis and may author clinically relevant sections and reviews other scientific portions of clinical trial protocols and amendments • Assists with and may authors/review documents related to trials, such as medical monitoring plans, SAPs, informed consents and clinical components of the Clinical Study Reports and may support development of regulatory documents; may perform quality review • Maintains compliance in accordance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety • Contributes to preparations for external /stakeholder meetings (IM, Governance, DMCs, Regulatory Authority). Presents data and information to external investigators (SIV) and internal collaborators **This role may be for you if:** • Possess demonstrated knowledge of the drug development process, Good Clinical Practice, study design, clinical research methodology & demonstrate solid medical writing skills • Proven ability to influence within team and may influence across functionally • Exhibit strong analytical and influencing skills; ability to communicate concise and clear messages, strong presentation skills • Independently uses professional concepts and company objectives to resolve complex issues in creative and effective ways To be considered for this position, you must have a minimum of Bachelor's Degree required; Advanced degree or equivalent education/degree in life science/healthcare preferred (PhD/MD/PharmD/MSc). We are seeking ≥ a minimum of 3 years of pharmaceutical clinical drug development experience. Other levels considered depending on experience. You have a basic knowledge of oncology or hematology therapeutic areas as well as a proven track in clinical trial process improvements. We need an individual with demonstrated leadership and accomplishment in all aspects of conducting global clinical trials and execution of clinical programs. Proficient knowledge of clinical development process, regulatory requirements and ICH/GCP guidelines. Resolves novel problems requiring creative application of advanced skill, training, and education. 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)**** $126,700.00 - $206,900.00 We want to be transparent about the data collected and how it is being used, so you can best exercise control over your personal data. For more information, please view our

* Serve as the local Regeneron medical contact for Oncology assets and pipelines. * Collaborate with internal teams (Clinical Development, Medical Affairs, Operations, Regulatory, Commercial) and external stakeholders (medical societies, key academic and medical experts). * Ensure compliance with local regulations for the release of promotional materials and publications. * Develop and execute integrated strategies for launch readiness, Market Access, and life cycle management initiatives. * Provide medical support to clinical development and research, including identifying key investigators and supporting patient recruitment efforts. * Maintain deep scientific and medical knowledge of relevant therapeutic areas and understand patient and physician interactions. * Lead and participate in medical strategy development for congresses, symposia, and advisory boards. * Deliver scientific presentations to diverse audiences and provide medical guidance to local clinical research teams. Our medical affairs physicians and scientists are experts on our medicines and form a valuable part of our global development organization including Regeneron Japan KK. We serve as an important liaison between Regeneron and the scientific and healthcare community. Medical Affairs is organized in an optimally aligned matrix structure for delivery of therapeutic and functional area expertise. As a key player in our Global Medical Affairs team, you will have the opportunity to shape the future of oncology treatments in Japan, working closely with internal and external stakeholders to drive impactful medical strategies and initiatives. **A typical day might include the following:** **This role may be for you if you...** * Thrive in a collaborative, cross-functional environment and enjoy working with diverse teams. * Have a strong background in oncology and experience in the pharmaceutical or biotech industry. * Are detail-oriented and have excellent medical communication skills. * Are proactive, resourceful, and able to manage multiple projects effectively. * Are fluent in Japanese and English and are willing to travel 10-30%. * Embody an entrepreneurial mindset and are committed to maintaining high ethical and scientific standards. **To be considered**, you are a healthcare/scientific professional with a medical degree (physician / medical doctor / MD) and at least 10 years of experience in oncology. You have significant pharmaceutical/biotech industry experience, including a predominance of time in a relevant medical role. Deep knowledge and experience in lung cancer and immuno-oncology are preferred. A strong working knowledge of Medical Affairs and Clinical Development in Japan, along with a thorough understanding of the local healthcare environment, is essential. 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. We want to be transparent about the data collected and how it is being used, so you can best exercise control over your personal data. For more information, please view our

Our team of expert medical affairs physicians and scientists at Regeneron bridge the gap between our innovative medicines and the scientific and healthcare community. As the Director Medical Affairs Hematology, you will represent Regeneron in Medical Affairs and Clinical Development providing scientific and medical leadership for our Hematology assets. In this strategic role, you will work within a multifunctional, matrix organization, aligning with Global and US teams to ensure that medical and clinical activities in Germany are in sync with global strategies and goals. You will collaborate with internal colleagues across Medical Affairs, Clinical Sciences, Operations, and Regulatory, and provide guidance to Commercial teams. As the key medical resource for Hematology in Germany, you will be instrumental in enhancing Regeneron's presence in the field, reporting to the Senior Medical Director DACH, and leading a dedicated medical team. **A typical day might include:** * Acting as the Regeneron medical contact in the country for the Hematology program and as a key liaison for both internal and external stakeholders. * Representing Medical Affairs for Hematology at cross-functional internal meetings, working closely with the Country Medical Director and Global Medical Directors in the US. * Leading the Hematology Medical team, ensuring compliance with the Medical Affairs business plan, conducting field visits, and providing coaching and development for direct reports. * Providing medical support to clinical development and research, identifying key investigators and medical centers, and supporting operational tasks. * Maintaining deep scientific and medical knowledge of the therapeutic area and understanding patient and physician interactions. * Engaging with external communities to advance scientific and medical understanding, and representing Regeneron at professional and medical meetings. * Collaborating with the field medical team to develop and execute medical strategies for congresses, symposia, and advisory boards. * Delivering scientific presentations to diverse audiences and providing medical guidance to local clinical research teams. * Assessing medical education needs and developing educational strategies. * Providing medical input to commercialization strategies and ensuring compliance with local healthcare laws for promotional materials and publications. **This role may be for you if you:** * Thrive in fast-paced, innovative, and rapidly changing environments and remain flexible, proactive, resourceful, and efficient under pressure. * Possess an outstanding work ethic and integrity and uphold high ethical and scientific standards. * Excel in motivational, negotiation, listening, judgment, analytic, and conflict management skills and have demonstrated leadership abilities. To be considered, you hold an advanced clinical/science degree (e.g., MD, PharmD, PhD) with expertise in Hematology and relevant pharmaceutical/biotech industry experience, particularly in Medical Affairs and Clinical Development in Germany. You possess a thorough understanding of the local healthcare environment with experience and success in working in a matrix, cross-functional setting. You can identify opportunities in Hematology to optimize strategic and tactical planning. You demonstrate strong leadership and management skills, fostering inclusion, developing and coaching others, inspiring and motivating teams, and promoting collaboration with an enterprise mindset. You can cultivate and maintain relationships with key internal and external stakeholders, including key opinion leaders. You lead business and technical discussions internally and externally, explaining scientific/medical concepts to all levels. You understand and strictly adhere to the compliance culture representative of Regeneron. You are proficient in German and English and willing and able to travel 30-50% of the time. 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. We want to be transparent about the data collected and how it is being used, so you can best exercise control over your personal data. For more information, please view our

By clicking the Accept button, you agree to us doing so. ** VP, Global Strategy Marketing & Commercial Development** The Vice President, Commercial Development & Global Strategic Marketing will shape and drive Emergent's global long-range commercial strategy in support of the company's long-term growth strategy, in service of protecting, enhancing and saving lives around the world. The VP is responsible for identifying strategic opportunities and developing integrated strategies to unlock therapeutic area potential and maximizing product value, throughout each stage of development and life-cycle management. As the critical bridge between R&D and Commercial, the VP sets a clear course for value creation, empowering R&D and Commercial teams to define how best to capture these opportunities. This newly created, collaborative leadership opportunity ensures alignment of scientific and commercial goals, fueling sustained long-term growth across Emergent's diverse portfolio. **II. ESSENTIAL FUNCTIONS** Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. BRAND STRATEGY & LIFECYCLE MANAGEMENT * Develop franchise strategies for long-term market success and value creation through R&D and commercialization * Partner with R&D and Commercial to support the development of global brand strategies and plans that ensure effective positioning and differentiation in competitive markets. Oversee product lifecycle management from pipeline through commercialization, including developing long-term lifecycle management strategies and plans for pipeline and marketed products across Emergent's portfolio, inclusive of development, regulatory, commercial, market, and competitive factors and considerations * Create of global product target profiles (TPPs) and positioning frameworks that include key outcome measures and competitive attributes that resonate with physicians, patients, and other customer segments, and drive competitive advantages * As appropriate, support the commercial team with development of global pricing and market access strategies by partnering with health economics, payers, and reimbursement support/agencies to ensure optimal product uptake * Responsible for establishing Therapeutic Area/Franchise competencies that shape TA strategy and the framework to incorporate them into the enterprise. This includes hiring roles with relevant scientific and business expertise. STRATEGIC PARTNERSHIP & FINANCIAL COLLABORATION * Engage closely with Business Development to evaluate potential partnership and acquisition opportunities, providing commercial assessments, including market forecasts, key assumptions, and strategic insights that drive product valuations. * Partner with Finance to deliver critical input for valuation models, including pricing strategies, market size, revenue potential, and other key commercial drivers. * Work cross-functionally with R&D to ensure that pipeline development aligns with market needs, commercial potential, and financial expectations. * Collaborate with market and competitive insights team to evaluate the market landscape, monitor competitor activities, and conduct research and analytical efforts that inform strategic decision-making. * This individual will be responsible for identifying long-term commercial opportunities to ensure overall market success for assets within the company's portfolio, both marketed and pipeline. These opportunities include, but are not limited to, global brand planning, commercial assessments, product profile development and product positioning frameworks, pre-commercialization and, lifecycle management strategy, and geographic expansion strategies. * In addition, this individual will have responsibility for establishing Therapeutic Area/Franchise competencies that shape TA strategy and the framework to incorporate them into the enterprise. This includes hiring roles with relevant scientific and business expertise. TEAM LEADERSHIP & CROSS-FUNCTIONAL ALIGNMENT * Represent commercial interests in senior leadership discussions, influencing key strategic decisions and aligning commercial strategies with corporate objectives. * Create, write, and communicate briefings, presentations, and memos for senior management. * In partnership with Corporate Strategy and Development, support the development of strategic plans, specifically around commercial (and franchise) strategy and plans, including measuring success, identifying gaps and recommending solutions. * Work closely with Corporate Development and Corporate Strategy to provide key commercial assumptions for business development opportunities, valuations, and assessment of potential inorganic R&D/pipeline and pre-commercial assets * Support the preparation of reports and presentations to the Executive Management Team, Strategic Transactions Committee and Board of Directors. * Lead a team of biopharmaceutical professionals. * The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. **III. MINIMUM EDUCATION, EXPERIENCE, SKILLS** * Bachelor's degree in life sciences, business, marketing, or a related field is required; advanced degree (MBA, Ph.D., MD) is preferred. * 20+ years of experience in commercial development, global marketing, or strategic marketing roles within the pharmaceutical or biotechnology industry. * Global marketing expertise, with deep knowledge of global market dynamics, pricing, market access, and customer segmentation. * Proven experience in leading global strategic marketing initiatives, including brand strategy development, product positioning, and lifecycle management. * Significant experience working in collaboration with Business Development and Finance to assess commercial opportunities and BD&L opportunities and provide key inputs for valuations and financial models. * Experience in commercial excellence, including the development and implementation of best practices across commercial and marketing functions. * Demonstrated experience in leading market research and competitive intelligence initiatives, in service of driving data-driven decision-making across the organization. * Proven track record of successfully launching and commercializing products globally, with experience across both mature and emerging markets. International experience is strongly preferred * It is critical that this individual is an adaptable, flexible, and collaborative senior leader, who is exceptionally skilled at soliciting input and achieving alignment across core product development and commercialization functions (e.g., R&D, Commercial, Business Development, Manufacturing, Finance, etc.) * Experience leading and managing teams in complex, matrixed environments, with a focus on cross-functional collaboration. * Strong quantitative and qualitative analytical capabilities. * Able to lead and influence in complex and ambiguous environment that is fast changing. * Maturity and executive presence to organize, lead, and motivate ad hoc teams and navigate and develop relationships at all levels in the organization. * Strong leadership skills, with the ability to mentor, develop, and inspire high-performing teams across multiple geographies and functions. * Excellent interpersonal and communication skills, with the ability to influence in

* Lead the HIV cross-functional team- particularly with all the local commercialization team: Medical, Market access, Comm Ops, Public and Governmental affairs- providing vision, motivation, support and coaching to drive the business and achieve our commercial objectives, through articulated and aligned cross-functional plans for both current portfolio, as well as of future Launches. * Drive development and execution of commercial strategy and action plans for HIV portfolio, both in Treatment and Prevention. * Lead & ensure an innovative and effective marketing & sales team, securing and optimized organization. * Drive Operational Excellence in marketing & sales efforts and business/forecast planning * Establish effective working relationships with opinion leaders and other key stakeholders & be recognised as partner of choice in HIV care. * Partner with costumer facing functions (in *primis*, but not only, Medical Affairs) to ensure effective development and implementation of strategies & tactics, at national, regional and account level. * Partner with Government Affairs and Public Affairs to ensure a positive policy environment to curb the HIV epidemics in Italy, securing adequate funding for Gilead portfolio * Support Market Access activities to maximize current portfolio profitability, and support successful new launches * Create an environment in which every member of the team has an opportunity to be its best version, being a role model of Gilead culture, values and leadership commitments * Participate, once relevant, in HIV Global strategic teams and forums, contributing to the broader Gilead organization success * Lead the preparation, and presentation of the HIV business and Plans, at senior leaders, in a proficient English * Participate actively in the LT and contribute to setting a ONE TEAM approach, that drives a successful organization in Italy, in the short, mid and long term * Represent the Gilead leadership team, internally and externally. * MBA or Advanced science degree (MD, Pharm D, PhD, business administration) preferred * Relevant knowledge of the Italian pharmaceutical market, particularly within the Hospital & Speciality Business. and experience with the Italian reimbursement system. * Relevant pharmaceutical industry experience to include expertise in marketing & sales strategy and operations * Demonstrated track record of marketing success, as demonstrated by successful product launches and/or sustained commercial growth in established portfolios. * Previous experience in highly competitive therapeutical areas, managing complex cross- functional matrix teams can be a plus - particularly if in Virology or HIV * Field sales management or other field-based management experience essential * Demonstrated ability to conceive, develop and implement multi-dimensional marketing and business plans * Experience with pharmaceutical regulatory requirements * Demonstrated excellence in project management and effectively managing multiple projects/priorities * Track record of successful P&L management with an understanding of revenue forecasting and expense budget planning and tracking * Proven planning skills, routinely anticipates and plans for alternative/unlikely scenarios * Matured people leadership experience * Excellent interpersonal and relationship building skills, internally and externally * Extensive understanding and network of key healthcare stakeholders * Ability to lead, work in and contribute to high performance cross functional teams * Good communication and presentation skills and experience * Consistently engages and motivates others to create energy and enthusiasm and commitment to an inspiring vision * A leader and motivator that the team willingly wants to follow. * Coaches and develops direct reports and cross-functional teams to sustained growth and success. * Excellent and demonstrable command of written and spoken Italian- or to learn in up to 6 months- and English, plus proficiency at communicating verbally and in written form. * International Experience, either working in a Global or Regional role or in context of above country project teams is desirable

If you find science, speed, and helping address serious infectious diseases exhilarating, you have come to the right place. Individually, we're skilled, driven, and confident risk-takers. Collectively we're collaborative and accomplished. We're SuperNovas! Together we use our unique experiences, cultures, and learnings to turn innovation into reality while maintaining the highest standards. We value balance, encourage growth, and recognize that you are our most important asset. Build your future with us while bringing innovative vaccines to the world. We have a place for you! Novavax, Inc (Nasdaq:NVAX) is a biotechnology committed to helping address serious infectious diseases globally through the discovery, development and delivery of innovative vaccines to patients around the world. We have more than a decade of experience contending with some of the world's most devastating diseases, and we are here to make a difference. Hard-won lessons and significant advances illustrate that our proven technology based on solid science tested by decades of research, has tremendous potential to make a substantial contribution to public health worldwide. The Senior HRIS Analyst, Workday will be a key member of Novavax HRIS and Operations team, which is responsible for the design and delivery of innovative solutions using various HR Tech platforms. This group is responsible for delivering the best employee experience and enabling our HR teams to focus on the highest-value work through operational excellence, technology and analytics. This is an exciting new role in optimizing our capabilities and investment in our foundational new HCM platform and engaging our key stakeholders, inclusive of Functional Process Owners, Center of excellence, HR teams supporting the business and People Leaders. Reporting to Senior Manager HR Technology, this role will act as the Core HR SME for various areas in HCM Workday including but not limited to Core HCM, Compensation and Advanced Compensation, Reporting, Adaptive Planning, Workday Extend, Talent Management, Recruitment and Security. The successful candidate will be adept at working in a virtual environment across multiple time zones, have high level of proficiency in analytical tools and methodology and have a customer-oriented disposition. Essential Functions The Senior HRIS Analyst, Workday plays a pivotal role in HR Technology projects, including Workday product configuration, reports development, HR data integration projects and data management. This position will be a Workday subject matter expert and works closely with internal HR, IT staff, and business leaders to effectively meet the HR technology needs of the organization. Workday Analyst is expected to be able to perform under limited supervision and with independent decision-making the certain key responsibilities including, but not limited to: Will be an expert in Workday configurations and take on a functional lead role in the execution of HR technology projects and be overall responsible for the day- to-day Workday support for the global HR team, primarily in the US and Sweden. Performs HRIS core functions including implementation of new modules, security maintenance, business process configuration, data loads, user management, integrations, feature testing and upgrades including change management Will have deep knowledge, expertise, and configuration responsibilities in one or more areas and should possess strong knowledge in core HCM, Advanced Compensation, and preferably good knowledge in Absence and Recruiting. Lead and manage Bi-annual Workday release testing Responsible for creating complex reports and dashboards for HR teams and company leadership as needed Configure Advanced Compensation and Performance Management module based on business requirements. Support year-end Compensation module launches, and other HR annual cycle activities. Be the champion for Workday optimization and provide subject matter expertise on Workday best practices and partner with Process Owners to understand pain points, identify opportunities to improve processes and gain efficiencies Act as the functional lead and point of contact for US and global Payroll integrations, troubleshoot Benefits Integration feeds from Workday functional perspective as well as other Workday integration feeds in liaison with 3rd party Vendors and support groups Partner with IT teams supporting Workday Integrations. Prioritizes workday deliverables based on criticality and be able to support multiple HR teams and set expectations for all Workday deliverables. Provide training to new HR team members as needed. Follows internal IT Change Management protocols including creation of Change Requests for any system changes; and best practices for documentation and testing; follow SOX compliance guidelines and ensure highest confidentiality of employee personnel data. Understands the importance of following a system design methodology, while executing appropriate documentation for requirements and testing Assists with System audits and tenant management activities Serve as a data steward to ensure HR systems meet data integrity and architectural requirements across the enterprise Identifies and drives continuous improvement initiatives to improve the employee experience, reduce risk and costs, and improve compliance and controls Provides day-to-day support for HR systems and ensure that HR data is captured, recorded, modified and/or updated in the relevant systems and/or files. Ensure that confidential data is maintained in secure manner. Should be proficient in running various reports for audits and keeping the data clean and maintain Integrity of the data. Required Knowledge, Skills, and Abilities Experience with large scale organizational transformations and or implementations strongly preferred Experience in design, configuration, implementation of Core HR Workday HCM, Talent, Recruitment, Compensation, Advanced Compensation, Absence Experience working with Europe and having good understanding of EU country laws Excellent knowledge on Workday Security model General knowledge of Workday reporting and dash boards strongly preferred. Knowledge of Power BI or MS Access is a plus Experience with Service Now HRSD and Integration with Workday High degree of attention to detail Strong technical aptitude and knowledge of Microsoft applications including Word, PowerPoint, Access, and Microsoft Excel for analysis of data Solid oral and written communication skills with the ability to frame communications for key customer groups. Strong collaboration, negotiation and problem resolution skills. Strong analytical and decision-making skills. Education, Experience, Licenses & Certifications Education: 4-year University degree in a relevant field, or equivalent work experience Direct and demonstrated Workday experience, preferably at least 6 to 8 years including experience being part of large, complex, enterprise wide, Workday HRIS projects. Minimum 4-6 years of Global experience (specifically Europe) Minimum 2-3 Workday full life cycle Implementations Minimum 1-2 year on Service Now The annual base salary (or hourly wage) for this position falls within the range of $109,900.00 - $142,900.00. However, the actual base pay offered may vary based on several individualized factors, such as market location, job-related knowledge, skills, and experience. Novavax offers a base salary, annual bonus, equity grants, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.Equal Opportunity Employer/Veterans/Disabled Novavax is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals on an at-will basis, regardless of their race, color, national origin, religion, ancestry, citizenship status, military or veteran status, sex, sexual orientation, gender identity or expression, age, marital status, family responsibilities, pregnancy, disability, genetic information, protective hairstyle, or any other characteristic protected by applicable federal, state, or local law.

We are recruiting for a Manager, Analytics Solutions within the Johnson & Johnson Innovative Medicine R&D Data Science organization. The primary location for this position is flexible - either Spring House, PA or Titusville, NJ. Remote work will be considered. Johnson & Johnson Innovative Medicine develops treatments that improve the health and lifestyles of people worldwide. Research and Development areas encompass Oncology, Immunology, Neuroscience, Cardiopulmonary and Specialty Ophthalmology. Our ultimate goal is to help people live longer, healthier lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market - from patients to practitioners and from clinics to hospitals. To learn more about Johnson & Johnson Innovative Medicine, one of the Pharmaceutical Companies of Johnson & Johnson, visit ******************************** In this role, you will: Partner closely with members of the Johnson & Johnson Innovative Medicine R&D data science organization and other business leaders to understand the organization's needs for data collection, analysis, reporting, and applications. You will be responsible for the delivery of engaging and innovative data products, such as dashboards, web applications and other solutions to support our clinical trials. You will partner with teams across R&D such as Data Science, Biomarker & Dx Development, Clinical Operations to deliver innovative solutions for study teams' most impactful questions. 1. Lead the development of interactive visualizations as well as the data engineering for analysis ready data sets which non-technical users in the Johnson & Johnson Innovative Medicine R&D organization will use as a single source of truth to provide data insights into business and trial performance. 2. Help shape and implement the vision of the analytics team figuring out best solution for the business need and continuously look for new ways to meet unmet needs, evaluating new technologies and helping the team grow. 3. Develop relationships and connect with the teams we support in order to understand their needs and set appropriate expectations on the status of their projects. 4. Manage project intake. Prioritize projects within the team ensuring a good balance of tasks so that high quality work is delivered timely. 5. Support the growth of team members. Lead all aspects of analytics development team. Supervise the products built by other team members, including technical/code reviews. **Qualifications** + A minimum of a Bachelor's degree is required, preferably with a major in BI/ IT/CS. + 5 years of experience in analytics, programming and/or data visualization space. + Proven ability in designing and maintaining Tableau, RShiny, or a similar technology dashboards (visualization portfolio preferred). + Experience cleaning and clinical trial data, statistical analysis, creating reports, dashboards and analytics for scientific audience + Experience using SQL/R/Python to work with large data sets and build analysis ready datasets for downstream products and to conduct analysis. + Knowledge of working with sample and biomarker data and integrating these data with clinical data. + Strong leadership, communication, and interpersonal skills with desire to learn. + Comfortable working in a fast-paced role and interacting with many analytics consumers. + Able to run multiple workstreams and handle changing priorities. Experience using Agile (Scrum or Kanban methodologies). + Previous experience leading an analytics / development team of 2+ direct reports. Preferred: + Understanding of UX and UI design is a plus. + Experience with Javascript and Python programming languages is a plus. + Experience in web design languages (HTML, CSS, etc.) is a plus. The anticipated base pay range for this position is $115,000 to $197,800. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. + 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)). + This position is eligible to participate in the Company's long-term incentive program. + 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 of Work, Personal and Family Time - up to 40 hours per calendar year + Additional information can be found through the link below. ********************************************* The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market." Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability. \#LI-GR1 \#JRDDS \#JNJDataScience \#innovativemedicine \#LI-Hybrid

Johnson & Johnson Innovative Medicine is recruiting for multiple Clinical Pharmacology and Pharmacometrics summer interns in 2025 at its US (Spring House PA, Raritan NJ, Titusville NJ, and La Jolla CA) and EU (Beerse, Belgium) sites. Clinical Pharmacology and Pharmacometrics (CPP) is an integrated part of the Global Development organization within Johnson & Johnson Innovative Medicine. Members of CPP work in cross-disciplinary compound development teams and apply Clinical Pharmacology principles and pharmacometrics methodologies across the R&D portfolio to enable optimal decision-making in drug development. CPP summer internships are available for PhD and PharmD students in science related programs such as Pharmacology, Pharmacometrics, Pharmaceutical Sciences, Molecular or Computational biology, Biostatistics, Mathematics, Engineering, or a related discipline. Students will have the opportunity to work with clinical pharmacologists and pharmacometricians and learn about CPP, including principles of pharmacokinetics or pharmacodynamics (PK/PD), translational modeling and principles of model-based drug development (MIDD) in a pharmaceutical R&D setting. Our teams learn from the student's academic training and in turn contribute to the further professional development of the intern, providing exposure to drug development and a first-hand opportunity to evaluate the student's potential for future employment. + CPP summer interns will be involved in various activities to support Research and Development in areas ranging from preclinical to early/late-stage clinical development, including: + Clinical Pharmacology and Medical literature review + Data analysis of PK, biomarker, preclinical and/or clinical data, trial design, etc. + PK and PD model-building and analyses + Development of computer programs or state-of-the-art quantitative methodologies (e.g., population PK/PD, quantitative systems pharmacology [QSP]) + Model based meta-analysis (MBMA), advanced data visualization (e.g., RShiny), and machine learning applications integrating publicly available and in-house data + Diseases areas of immunology, oncology, neuroscience, infectious diseases & vaccines, pulmonary hypertension, or cardiovascular and metabolic diseases. + Therapeutic areas of immunology, oncology, neuroscience, pulmonary hypertension, or cardiovascular and metabolic diseases **Qualifications** Qualifications: + Candidates must be enrolled in an accredited college/university pursuing (not necessarily taking classes) and pursuing a degree in a life-sciences related discipline such as Pharmacology, Pharmacometrics, Pharmaceutical Sciences, Molecular or Computational biology, Biophysics, Biostatistics, Mathematics, Engineering, or Medicine. + Candidates must be available to work full-time for at least 10-12 weeks from May - August 2025 + Candidates must be detail-oriented, highly organized and able to manage multiple tasks. + Candidates must have the ability to work individually (independently) as well as on a team. + Candidate must be eligible to work in the US (or EU as applicable) at the time of, and for the duration of their employment and will be required to furnish evidence of work authorization. Others: + Remote work flexibility is available. Reimbursement for travel relocation (housing stipend) will be available. Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit ********************

Johnson & Johnson is recruiting for a Capital Sales Consultant, Sports for DePuy Synthes located in the West US. Geography will include Northern/Central CA, NV, UT, OR, WA, ID, Southwestern WY. 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 ********************* The Capital Sales Consultant, Sports will support selling and achieving objectives for the PureVue Visualization System, VAPR Radiofrequency System, and FMS Fluid Management System in the assigned territory. The Capital Sales Consultant, Sports is responsible for collaboration with local Sports sales teams to achieve their objectives. The Capital Sales Consultant, Sports will report directly to the Regional Sales Manager, Sports Capital. Key Responsibilities: * Must be able to learn/know sports procedures in the arthroscopic space enabling the successful application and sale of the entire DePuy Synthes Sports Capital Product Portfolio (PUREVUE, VAPR, FMS). Apply knowledge of sales process, product portfolio and customer knowledge to improve sales outcomes. * Secondarily, must be knowledgeable on use of PUREVUE in specialties outside of orthopedics: (ENT, general surgery, etc.) * Develop and execute quarterly business plans for targeted accounts for the assigned portfolio of capital equipment in partnership with local Sports field sales organization and Account Management. * Develop relationships with both clinical and economic champions at new and existing accounts to best understand customer needs, capital buying cycle, preferred mode of new technology acquisition. Identify and convert capital sales and program opportunities in the assigned territory. * Work with the Offer Development, Finance, Account Management, and field sales organization to develop appropriate capital offering (Rental, Lease, Share Shifts) and drive implant sales growth. * Present and negotiate capital pricing and program performance terms with the customer in collaboration with Account Management leaders and the field sales organization * Work with the customer to ensure customer can achieve their clinical and economic goals with the new technology and overall customer satisfaction driving higher customer retention rate. * Must develop and maintain expert level knowledge on all assigned capital equipment products and demonstrate a firm grasp of industry trends, understands market conditions, and develop strategies to stay ahead of the competition. Complete all assigned training in timely manner. * Collaborate with cross-functional teams and critical business partners to develop and execute customer/product specific sales strategies and tactics. * Ensure timely, accurate reporting of any complaints or technical issues, following documented procedures. * Open to travel to meet and support customers with any technical product and or service related issue on short notice. * Complies with and maintains an active and ongoing commitment to compliance with all company policies and applicable federal, state and local laws, including but not limited to HIPPA, Sunshine Act and the other guidelines on interaction with US Healthcare Professionals. * Responsible for the execution of business plan to meet/exceed all capital sales goals in alignment with direction from the Regional Sales Manager, Sports Capital. * Work collaboratively with adjacent business partners, & company support personnel to carry out the achievement of overall business unit goals. * Encourages soft tissue sales consultant trainings and hosts physician familiarization sessions (dinner programs, case observations, online training). * Work with the marketing, professional education, and commercial education teams to participate in training events, trade shows, customer visits. * Aligns with Regional Sales Manager, Sports Capital to work with internal business partners (HCC, Legal, Deal Desk, DLL, ASC team etc.) to ensure compliance with J&J capital sales process requirements for deal proposals. * Assist and inform Capital Equipment Specialist, Field Service Enablement team and Sports Consultant team with customer related activities and equipment logistical needs. * Analyze product performance and gain insights around engagements in customer facilities focused on optimizing the performance of products (both capital and consumables products), as well as optimize environments in which our products are used. * Input all opportunities into Lighthouse CRM and actively manage with updates; inform Regional Sales Manager, Sports Capital * Focus on customer satisfaction and retention through OR presence and validation of equipment usage after install. Identify areas of improvement to improve satisfaction and retention. Collaborate with CES and Sports SC to provide actions. * Maintenance, tracking and effective deployment of equipment, and assets throughout assigned area ensuring product availability. Ensure all promotional materials are maintained in a presentable manner. Leadership: * Ability to manage change through CREDO leadership behaviors * Ability to lead external engagements, build credibility, and gain influence with surgeons and administrative customers alike. * Ability to successfully work within a matrix organizational environment and demonstrate an enterprise mindset to influence/deliver results without direct authority. * Must adhere to the highest standards of professionalism, ethics and compliance, and actively support our compliance program-related initiatives, programs, trainings, and activities. * Must comply with all applicable laws and regulations relating to DePuy Synthes' business activities and Policies and Procedures of the Health Care Compliance Program and Johnson and Johnson Business Code of Conduct. The anticipated base pay range for this position is $94,000 to $151,800. 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)). * This position is eligible to participate in the Company's long-term incentive program. * 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 October 30th, 2024. The Company may however extend this time-period, in which case the posting will remain available on *************************** to accept additional applications.

By clicking the Accept button, you agree to us doing so. **Clinical, Medical & Regulatory Affairs** **Clinical, Medical & Regulatory Affairs** **Clinical/Medical Affairs:** Our Clinical & Medical Affairs team of highly trained and skilled clinical and medical affairs specialists supports key work across our business functions. We hire experienced professionals to support Safety & Pharmacovigilance, Clinical Affairs, and Clinical Development & Research. Our Clinical & Medical Affairs team is responsible for oversight and development of clinical development programs, as well as ensuring the safety of patients using our products. **Regulatory Affairs:** Our regulatory teams provide leadership and regulatory oversight to our key business units: Devices, Vaccines, Therapeutics, and Contract Development and Manufacturing. As our portfolio has grown significantly over the past five years, so has our team of capable professionals in the regulatory space. We count on our experienced regulatory leaders to ensure development and execution of global regulatory strategies and submission plans while ensuring compliance with regulatory requirements for both our licensed products and products in development. **CLINICAL & MEDICAL / REGULATORY AFFAIRS** **Clinical/Medical Affairs:** Our Clinical & Medical Affairs team of highly trained and skilled clinical and medical affairs specialists supports key work across our business functions. We hire experienced professionals to support Safety & Pharmacovigilance, Clinical Affairs, and Clinical Development & Research. Our Clinical & Medical Affairs team is responsible for oversight and development of clinical development programs, as well as ensuring the safety of the patients using our products. **Regulatory Affairs:** Our regulatory teams provide leadership and regulatory oversight to our key business units: Devices, Vaccines, Therapeutics, and Contract Development and Manufacturing. As our portfolio has grown significantly over the past five years so has our team of capable professionals in the regulatory space. We count on our experienced regulatory leaders to ensure development and execution of global regulatory strategies and submission plans while ensuring compliance with regulatory requirements for both our licensed products and products in development. **CLINICAL & MEDICAL / REGULATORY AFFAIRS** **Clinical/Medical Affairs:** Our Clinical & Medical Affairs team of highly trained and skilled clinical and medical affairs specialists supports key work across our business functions. We hire experienced professionals to support Safety & Pharmacovigilance, Clinical Affairs, and Clinical Development & Research. Our Clinical & Medical Affairs team is responsible for oversight and development of clinical development programs, as well as ensuring the safety of the patients using our products. **Regulatory Affairs:** Our regulatory teams provide leadership and regulatory oversight to our key business units: Devices, Vaccines, Therapeutics, and Contract Development and Manufacturing. As our portfolio has grown significantly over the past five years so has our team of capable professionals in the regulatory space. We count on our experienced regulatory leaders to ensure development and execution of global regulatory strategies and submission plans while ensuring compliance with regulatory requirements for both our licensed products and products in development. Results **1 - 7** of **7** Page 1 of 1 Search results for "". Page 1 of 1, Results 1 to 7 Gaithersburg, MD, US, 20879 Clinical & medical/ regulatory affairs Gaithersburg, MD, US, 20879 Clinical & medical/ regulatory affairs Gaithersburg, MD, US, 20879 Clinical & medical/ regulatory affairs Gaithersburg, MD, US, 20879 Clinical & medical/ regulatory affairs Redwood City, CA, US, 94065 Clinical & medical/ regulatory affairs Redwood City, CA, US, 94065 Clinical & medical/ regulatory affairs Gaithersburg, MD, US, 20879 Clinical & medical/ regulatory affairs Gaithersburg, MD, US, 20879 Clinical & medical/ regulatory affairs Winnipeg, MB, CA, R3T 5Y3 Clinical & medical/ regulatory affairs Winnipeg, MB, CA, R3T 5Y3 Clinical & medical/ regulatory affairs Gaithersburg, MD, US, 20879 Clinical & medical/ regulatory affairs Gaithersburg, MD, US, 20879 Clinical & medical/ regulatory affairs Winnipeg, MB, CA, R3T 5Y3 Clinical & medical/ regulatory affairs Winnipeg, MB, CA, R3T 5Y3 Clinical & medical/ regulatory affairs

By clicking the Accept button, you agree to us doing so. **Research & Development** **Research & Development** Emergent's approach is to achieve balance in the products that we develop through a pipeline comprising innovative vaccines and therapeutics that target diseases worldwide. We embrace the mindset that we are never done, never satisfied, never standing still. Innovation is the call to go higher, faster and farther in our mission to protect and enhance life. As we work on developing and supporting the plan to manufacture new products we look towards our talented team in Research & Development to lead the way. Results **1 - 2** of **2** Page 1 of 1 Search results for "". Page 1 of 1, Results 1 to 2 of 2 Gaithersburg, MD, US, 20879 Research & development Gaithersburg, MD, US, 20879 Research & development Gaithersburg, MD, US, 20879 Research & development Gaithersburg, MD, US, 20879 Research & development

The Director, Clinical Trial Management is responsible for the planning, oversight, and execution of study and program-level deliverables across a range of study phases within one or more therapeutic areas to ensure corporate goals are met. This role often has responsibility for complex therapeutic areas with multiple compounds under simultaneous clinical development. This role will also manage a high performing global team of Clinical Trial Managers in the fast-paced and expanding Global Clinical Operations (GCO) organization, and may also manage individuals at the Associate Director level who also have program-level responsibilities. This position has a strong affiliation with the GCO Leadership Team and other senior stakeholders within Global Medicines and Development Affairs (GMDA). Key Duties and Responsibilities: * Represents GCO as a key Program Team member, responsible for the development and execution of clinical development plans in conjunction with the Program Teams. * Manages Clinical Trial Managers with responsibility for recruitment, resourcing, training, performance management, employee goal setting and career development. May also manage contract staff. * Develops operational strategy (study scenario planning, operational decision points and risks, initial study timeline, study financials) for assigned program(s). * Accountable for operational delivery of all clinical trials within program lifecycle, overseeing cross-functional alignment, budget, and timeline from protocol generation through completion of the clinical study report, ensuring quality and a focus on inspection readiness throughout. * Proactively identifies study and program risks and implements contingency plans, providing regular updates on study status to GCO Leadership Team and senior stakeholders in GMDA. * Participates in vendor identification and oversees Clinical Trial Managers in vendor set up and oversight. * Active involvement in investigator identification and selection, including the expansion to new geographies. * Provides oversight on the development of study documentation, including clinical trial protocols, study plans and clinical study reports. * Participates in cross functional study data review where appropriate. * Develops departmental goals and objectives for Clinical Trial Management. * Tracks key performance indicators and departmental metrics for Clinical Trial Management and identifies opportunities to optimize processes and procedures (SOPs, Work Instructions). * Leads cross-functional initiatives * Serves as representative for Clinical Trial Management on vendor-related Joint Operating Committees. Knowledge and Skills: * Demonstration of advanced project/program management skills including timeline and budget management, risk assessment and contingency planning. * Proven track record of successfully overseeing staff to execute and deliver clinical trials on time and on budget, ensuring inspection readiness throughout. * Excellent understanding of GCP, CFR and ICH Guidelines. * Effective team leadership in cross-functional study and program teams, with demonstrated strength in team building. * Significant experience with direct line management of employees. * Excellent verbal and written communication skills, organizational skills, problem solving and conflict resolution skills. * Strong interpersonal skills and demonstrated ability to effectively interface successfully with external parties, including key medical personnel at investigational sites, Key Opinion Leaders, vendors and Patient Advocacy groups. * Excellent presentation skills with ability to adapt communication and content appropriately based on the intended audience. * Self-motivated and proactive with ability to work independently in highly time sensitive environment. * Proficiency in Microsoft Office applications including Microsoft Project, Outlook, Excel, Word and PowerPoint. Education and Experience: * Bachelor's degree in life sciences discipline or related discipline * Typically requires 12 years of experience executing clinical trials globally across all phases of development and 3 years of supervisory/management experience, or the equivalent combination of education and experience. #LI-AR1 #LI-Remote Pay Range: $186,320 - $279,480 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Remote-Eligible Flex Eligibility Status: In this Remote-Eligible role, you can choose to be designated as: 1. Remote: work remotely five days per week and come into the office on occasion - you're always welcome on-site; or select 2. Hybrid: work remotely up to two days per week; or select 3. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

Johnson & Johnson is recruiting for a Strategic Account Director to join our MONARCH business. This is a field based role with the flexibility for candidates located anywhere in the United States. At Johnson & Johnson Med Tech, we're changing the trajectory of health for humanity, using robotics to enhance healthcare providers' abilities and improve patients' diagnoses, treatments, and recovery times. Johnson & Johnson Robotics was established in 2020 with the integration of Auris Health, Verb Surgical, C-SATS, and Ethicon. It comprises three key med-tech platforms: Flexible Robotics (MONARCH ), Surgical Robotics (OTTAVA), and Digital Solutions. Our ambition is to be in every OR, enhancing the work of surgeons, nurses, and everyone involved in a patient's surgical journey. To do this, we're building a connected ecosystem that aims to make surgery smarter, reduce variation in surgical outcomes, and improve patient results. Auris Health, a Johnson & Johnson company, is a technology company defining the future of medical intervention. By combining advancements in medical robotics, instrumentation, navigation, and data science, Auris Health is building a platform technology capable of expanding the applicability of robotics to a spectrum of medical procedures. Overview: The Strategic Account Director for Monarch will lead a team of managers responsible for our most critical strategic and academic accounts. This individual will be instrumental in strengthening our relationships with these key customers, creating opportunities to expand Monarch's footprint and become deeply embedded within pulmonology fellowship and residency programs. The ultimate goal is to position Monarch as the preferred solution for robotic bronchoscopy while fostering long-term partnerships that drive program growth and clinical adoption. Core Job Responsibilities: + Lead the development and communication of the Monarch sales strategy to increase revenue and market share in a defined territory of key accounts. + Manage strategic accounts team inclusive of Academic Health, IDN,s and Technical Sales Team + Lead the sales strategy in collaboration with the Business Unit Leader, National Sales Directors, field sales team, and the internal Monarch teams to drive the Monarch portfolio of products and solutions at select key accounts by aligning to the accounts areas of strategic interest and priority. + Achieve quarterly and fiscal year revenue targets. + Move strategic customers from current state to a trusted key partnership; formalize partnership through an agreement that is recognized across Monarch and the account. + Build a strong Monarch brand and relationship at the Service Line Administrator and C-Suite level within the flagship hospital and health system. + Facilitate key sales activities with the Monarch sales team to leverage individual physician relationships in Key Accounts. + Identify key customer needs and partner with the Monarch Sales Team and the Monarch Internal corporate teams to acquire and coordinate appropriate resources to deliver and implement programs that drive unique value. + Collaborate with the Business Unit Leader and Sales Directors to coach the local sales teams on key account management and solution-based selling that deliver economic value to our customers. + Implement a thorough account planning process to align local sales team on specific account level strategies, objectives, and timelines. + Co-develop a strategic business plan that identifies relevant customer needs, prioritizes initiatives and company investments, and establishes a clear action plan for success. + Perform quarterly business reviews in collaboration with the Monarch Sales management team in the Key Accounts; include broad range of non-supply chain leadership at each business review. Support quarterly business review efforts with the Sales Directors and local sales teams. **Qualifications** Required Knowledge/Skills, Education, And Experience: + Bachelor's Degree and minimum 10 years relevant healthcare experience required + A minimum of 3 years of key account leadership required + A minimum of 3 years of cross-functional experience (marketing, commercial operations, sales training, prof ed) strongly preferred. + Demonstrated ability to learn and communicate technical product as well as clinical knowledge of disease states to physicians and economic buyers is a must. + The ability to travel extensively up to 75%, including overnight travel within the assigned territory is a must for the role. + Required to work in a hospital, ASC setting, attending live patient cases as when required as part of the job and wear necessary protective gear (i.e. lead aprons, masks, etc.). + Self-starter who performs well with autonomy and problem solver who can think critically in high pressure environments. + Works well with the team and frequently shares sales strategies key learning with sales management and with peers. + Receptive to constructive feedback and collaborates and works well within a matrix team environment. + Proven ability to articulate customer needs and feedback to the entire organization as needed. + Must be highly organized with the ability to manage multiple projects/tasks simultaneously and effectively prioritize projects and tasks. + Ability to communicate at a high level and high frequency level daily with sales management and the broader organization. + Ability to work in a regulated environment in compliance to ISO 13485 and 21 CFR 820. The anticipated base pay range for this position is $146,000 - $251,850 + 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. 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 ********************* Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability. Johnson & Johnson values diversity and inclusion. We are committed to building diverse teams that reflect both the patients and the partners we support. We strive to create an inclusive work environment where our people feel at home and are given the space to realize their full potential. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit ******************** For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges. We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential. At Johnson & Johnson, we all belong! This job posting is anticipated to close on [1/10/2025]. The Company may however extend this time-period, in which case the posting will remain available on *************************** to accept additional applications.

Johnson & Johnson is currently seeking a Principal Business Intelligence Consultant to join our MedTech Heart Recovery Commercial Operations Team located the US or Germany. This is a remote position. 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 ********************* Responsibilities include: * Develop and implement BI strategies that align with stakeholders' business and commercial operations goals. * Collaborate with stakeholders to understand their business needs, identify BI and forecasting opportunities, and translate them into actionable insights. * Advise on industry best practices, emerging BI trends, and tool selection to ensure stakeholders remain competitive. * Lead BI projects end-to-end, including requirement gathering, data modeling, ETL, forecasting, and visualization. * Define project scopes, timelines, and deliverables, ensuring high-quality and timely completion. * Mentor and guide BI consultants, fostering knowledge-sharing and professional growth. * Provide insights that support key commercial operations functions, including sales, marketing, product management, and financial performance. * Work with stakeholders to develop metrics and KPIs that align with operational goals, optimizing data solutions for commercial success. * Design and implement forecasting models that support strategic decision-making for stakeholders. * Utilize historical data and advanced analytics to predict future trends and key performance metrics. * Communicate forecasting outcomes and recommendations to stakeholders, explaining model assumptions and limitations. * Design and build Tableau dashboards, reports, and visualizations that enable stakeholders to make informed business decisions. * Use advanced analytics techniques to derive insights and recommend actions based on data. * Ensure data integrity and accuracy by establishing and maintaining data quality standards. * Act as a primary point of contact for stakeholders, managing relationships, setting expectations, and providing regular project updates. * Present findings, insights, and forecasts to non-technical stakeholders, effectively communicating complex information in an understandable way. * Proactively identify areas where BI, forecasting, and commercial ops solutions can add value to stakeholders' operations and make recommendations. * Stay current with BI tools (e.g., Power BI, Tableau, Looker) and data platforms (e.g., SQL, Snowflake, Google BigQuery). * Experiment with emerging technologies and methodologies to continuously improve our BI service offerings, including advanced forecasting techniques. * Troubleshoot and resolve technical challenges, applying best practices in BI design, implementation, and maintenance

Quality Control Analyst page is loaded **Quality Control Analyst** **Quality Control Analyst** locations Germantown, MD time type Full time posted on Posted 18 Days Ago job requisition id JR100727 If you find science, speed, and helping address serious infectious diseases exhilarating, you have come to the right place. Individually, we're skilled, driven, and confident risk-takers. Collectively we're collaborative and accomplished. We're SuperNovas! Together we use our unique experiences, cultures, and learnings to turn innovation into reality while maintaining the highest standards. We value balance, encourage growth, and recognize that you are our most important asset. Build your future with us while bringing innovative vaccines to the world. We have a place for you! Novavax, Inc (Nasdaq:NVAX) is a biotechnology committed to helping address serious infectious diseases globally through the discovery, development and delivery of innovative vaccines to patients around the world. We have more than a decade of experience contending with some of the world's most devastating diseases, and we are here to make a difference. Hard-won lessons and significant advances illustrate that our proven technology based on solid science tested by decades of research, has tremendous potential to make a substantial contribution to public health worldwide. We are seeking a Quality Control Analyst to join our Quality Control team in Germantown, MD. Qualified individuals will be responsible for providing testing and technical support for Novavax's clinical development product pipeline, regulatory findings, and operations related to the Quality Control Microbiology Testing group. **Responsibilities include but are not limited to:** * Support the overall scientific and technical efforts of the Quality Group as it pertains to Microbiology and Raw Material Testing. * Provide oversight for Microbiology/Raw Material testing associated with OTLs and CMOs. * Troubleshoot and investigate trends in Microbiology/Raw Material method performance associated with OTLs and CMOs. * Write, review, and edit SOPs and reports. * Support the activities of the Microbiology Laboratory including sampling and testing, analysis, and determining if the results meet acceptance criteria. * Support the activities of the Raw Material Laboratory, including receiving and sampling of raw material test samples and retains and determining if results meet acceptance criteria * Support Microbiology and Raw Material outsourcing of test samples including submission and shipping to outside testing labs (OTL's), reviewing OTL results, and completing testing documentation. * Support equipment cleaning and general laboratory maintenance for the Microbiology and Raw Material Laboratories * Maintain inventory for consumables used in the QC Microbiology and Raw Material Laboratories * Support quality-related events such as deviations, CAPA, OOS investigations, and change controls * Review of data generated from Microbiology and Raw Material Testing. * Support trending of EM and utility data * Work cross- functionally with various internally (E.g.: Manufacturing, Quality Control, Quality Assurance and Validation) and externally (E.g.: CMOs, OTLs, etc.) * Maintain accurate written records compliant with current GMP, GLP, and GDP requirements and company procedures. * Attend general and/or cross-functional meetings as required. **Minimum Requirements:** * Bachelor's degree in biological science. QC Microbiology experience required. * 2+ years of years' experience in a cGMP laboratory, preferably related to pharmaceutical/biotech operations industry * Experience in working with GMP documentation including SOPs, deviations and assay protocols. * Preferable strong technical background in general QC Micro and/or Raw Material Testing. * Proficient in Windows based software including Excel and Word. * Experience in sample and data tracking software such as quick base. * Good communication (oral, written, presentation) and organizational skills. * Ability to multi-task and work independently. * Experience with LabVantage or other LIMS platforms a plus but not required. The annual base salary (or hourly wage) for this position falls within the range of $66,100.00 - $82,600.00. However, the actual base pay offered may vary based on several individualized factors, such as market location, job-related knowledge, skills, and experience. Novavax offers a base salary, annual bonus, equity grants, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.Equal Opportunity Employer/Veterans/Disabled Novavax is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals on an at-will basis, regardless of their race, color, national origin, religion, ancestry, citizenship status, military or veteran status, sex, sexual orientation, gender identity or expression, age, marital status, family responsibilities, pregnancy, disability, genetic information, protective hairstyle, or any other characteristic protected by applicable federal, state, or local law. If you find science, speed, and success exhilarating, you have come to the right place. Novavax, Inc (Nasdaq:NVAX) is a biotechnology company that creates transformational vaccines that address some of the world's most pressing infectious diseases. We have more than a decade of experience contending with some of the world's most devastating diseases, including COVID-19, seasonal influenza, RSV, Ebola, MERS, and SARS. Hard-won lessons and significant advances illustrate that our proven technology has tremendous potential to make a substantial contribution to public health worldwide. Our scientists are committed to developing vaccine candidates for some of the world's toughest viral threats by utilizing the power of our innovative recombinant nanoparticle vaccine platform. Our vaccine technology combines the power and speed of genetic engineering with the immunogenicity enhancing properties of our Matrix-M™ adjuvant to efficiently produce highly immunogenic particles targeting some of the most pressing viral infectious diseases. Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic.

Job Title: Postdoctoral Researcher - AI in Digital Health Location: The position can be based in Belgium, Netherlands, France, Germany, Spain, UK, Switzerland, Italy and Boston, USA. Remote work options may be considered on a case-by-case basis and if approved by the company. Description The Data Science Analytics & Insights team is actively searching for a highly motivated and visionary postdoctoral researcher, with a primary research focus on innovative Artificial Intelligence/Machine Learning (AI/ML) algorithms to extract valuable insights from structured and unstructured multimodal data sources. We are particularly interested in candidates with expertise in natural language processing (NLP) and a deep passion for making a meaningful impact through their work. Your contributions will involve developing and validating AI/ML solutions to solve complex problems across various therapeutic areas within the organization. Key Responsibilities: * Conceive, develop, and validate AI/ML solutions for high-priority scientific research projects. * Analyse and interpret multimodal data - including speech, text, and actigraphy data - from various sources. * Participate in cross-functional collaborations with internal stakeholders and external partners. * Clearly communicate the state-of-the-art methods and results to diverse audiences and partners to support decision-making. * Publish findings in top-tier journals and conferences.