Krystal Biotech jobs in Pittsburgh, PA

About Krystal Bio: At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the discovery, development, manufacturing, and commercialization of genetic medicines to treat diseases with high unmet medical needs. Founded in 2016, Krystal is distinguished in three powerful ways: science and technology using our patented gene therapy platform, innovative manufacturing supported by our commercial scale facilities, and a unique commercialization model that focuses on the patient's end-to-end experience. Krystal received U.S. FDA approval for the first and only redosable gene therapy treatment, VYJUVEK, for the treatment of Dystrophic Epidermolysis Bullosa (DEB). Krystal continues to leverage our proprietary platform to rapidly advance a robust pipeline of investigational genetic medicines in respiratory, oncology, dermatology, and ophthalmology. Krystal is headquartered in Pittsburgh, PA, which is home to our two state-of-the-art CGMP manufacturing facilities with teams around the world and satellite offices in Switzerland, Germany, and Japan. We are a company built and run by people who care, are fearless in the face of a challenge, love the work they do, and practice the highest level of scientific integrity. As we grow, we are seeking team members that embody these values. Job Description Summary: Krystal Biotech, Inc. is seeking a highly motivated and experienced Quality Associate to support quality systems, GMP manufacturing processes and documentation practices at our headquarters in Pittsburgh's South Side. Primary Responsibilities: * Work with internal teams to obtain an understanding of the product and the documentation requirements. * Produce high-quality documentation that meets applicable standards and is appropriate for its intended use. * Develop expertise on FDA regulations and audit processes. * Initiate and update GMP manufacturing associated documentation, such as clearing procedures. * Provide oversight of daily QA functions which include review and approval of records generated by manufacturing and quality control documents. * Provide support for updates on standard operating procedures and associated forms. * Assist with QA efforts for site cGXP documentation related to the operation of gene therapy manufacturing. * Ensure compliance with regulatory agencies and oversee continuous improvement of company's QA and compliance functions. Requirements & Desired Competencies: * Minimum of a Bachelor's Degree (Biology or related Life Science) with 3+ years of relevant quality systems experience in the biotech or pharmaceutical industry. * Background that includes knowledge/experience in GMP, GLP, and GCP. * Experience with FDA audits is highly preferred. * Strong knowledge of GMP and ICH requirements. * Must be a self-starter and capable of working with minimal oversight. * Must be able to handle multiple roles and work in a fast paced and changing environment and know how to prioritize activities appropriately. * Excellent oral and written communication skills. Krystal Biotech, Inc. is an Equal Employment Opportunity and Affirmative Action Employers. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status. Headhunters and recruitment agencies may not submit resumes/CVs through this Web site or directly to managers. Krystal Biotech, Inc. does not accept unsolicited headhunter and agency resumes. Krystal Biotech, Inc. will not pay fees to any third-party agency or company that does not have a signed agreement with Krystal Biotech, Inc.

Territory: Norristown, PA - Psychiatry Target city for territory is Norristown, PA - will consider candidates who live within 40 miles of territory boundaries with access to a major airport. Territory boundaries include: Fountainville, Germantown, Doylestown and Pottstown, PA. SUMMARY: Are you a results-driven biopharmaceutical sales professional looking to be part of an organization that values being curious, adaptable and accountable? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth! As a Psychiatry Account Manager, you lead the promotion of our psychiatry portfolio, executing sales and marketing strategies with comprehensive clinical knowledge to drive sales performance. Our Account Managers are adept at executing against the toughest commercialization challenges in today's rapidly changing environment and must demonstrate strong capability in the following areas: ESSENTIAL FUNCTIONS: Business Planning & Account Leadership - Ability to use digital tools and apply data-based insights to create opportunities, develop strategy & tactics, allocate resources to enhance sales execution, monitor progress and adjust direction to maximize sales performance. Selling - Deliver messages in a clear and compelling way to customers, effectively probe customer needs to handle objections, and close every call with a commitment to action to drive changes in behavior. Customer Development - Build and maintain productive internal and external relationships based on customer needs and organizational goals, incorporating “total office” account management. Local Market & Therapeutic Area Expertise - Gather and validate key trends and dynamics in the market, map account linkages, and apply comprehensive therapeutic knowledge to uncover and prioritize unique opportunities. Reimbursement - Consistently demonstrate the ability to stay informed on reimbursement dynamics, anticipate and effectively address payer access issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources. Pharmaceutical Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. REQUIRED EDUCATION, EXPERIENCE AND SKILLS: Bachelor of Arts or Bachelor of Sciences degree from an accredited college or university. 2+ years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience. Must demonstrate the intellectual capacity to score highly on disease and product training exams, including being certified on product knowledge annually. Self-starter, with a strong work ethic and outstanding communication skills. Must be computer literate with proficiency in Microsoft Office software. Must live within 40 miles of territory boundaries. Driving is an essential duty of this job; must have a valid driver's license with a safe driving record that meets company requirements. Meeting and complying with reasonable industry-standard credentialing requirements of healthcare providers / customer facilities is required for continued employment with Lundbeck. PREFERRED EDUCATION, EXPERIENCE AND SKILLS: Previous experience within a specialty product sales force. Prior experience promoting and detailing products specific to CNS/neuroscience including: depression, schizophrenia and bipolar disorder. Documented successful sales performance. Ownership and accountability for the development and execution of fully integrated account plans. Strong analytical background, and experience using sales data reporting tools to identify trends. Experience in product launches. Previous experience working with alliance partners (i.e., co-promotions). Strong leadership through participation in committees, job rotations, panels and related activities. TRAVEL: Willingness/Ability to travel up to 30% - 40% domestically to (a) regularly meet/interact with customer base and internal personnel within assigned territory; and (b) typically attend 4-8 internal/external conferences and meetings spanning locations within the United States. Travel must be able to be completed in a timely manner. The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate's geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $117,000 - $137,000 and eligibility for a sales incentive target of $39,000. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, company match 401k and company car. Additional benefits information can be found on our career site. Applications accepted on an ongoing basis. Why Lundbeck Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site. Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site. Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify.

The Opportunity: Reporting to the Senior Director of Global Forecasting & Portfolio Analytics, you will lead the BD&L forecasting and Analytics for Cardiovascular and Renal (CVR) and Transplant and Immunology (T&I) therapy areas In this role, you will drive decision-making across all BD&L due diligence efforts via commercial revenue forecasting for both pre- and full-fledged due diligence workstreams and represent Insights & Analytics (I&A) forecasting within the commercial due diligence team You will be expected to follow all CSL I&A forecasting standards, ensuring accuracy and alignment with business stakeholders You will be the primary point of contact representing I&A forecasting for maximization and special projects across the CSL portfolio This role would require strong consultancy orientation and the ability to communicate effectively and efficiently with all organizational stakeholders. As a part of the Global I&A team, you will play a pivotal role in shaping our strategic direction and optimizing our pharmaceutical portfolio. The Role: Lead end to end forecasting & analytics efforts for all business development workstreams at CSL for CVR and T&I Would include conducting high level assessments for early research stage assets as well as deep dive commercial assessments and valuations for late-stage opportunities or a mix of both Would need prior experience with conducting and validating market research and competitive landscape analysis along with thoughtful incorporation into BD&L forecasts Would need the ability to plan, execute and deliver multiple time sensitive projects with both accuracy and speed under tight timelines Leverage internal forecasting standards and triangulate inputs from R&D, Commercial Development, Market Research, Competitive Intelligence, Pricing & Access, Legal/IP to create robust and defendable forecasts/scenarios Represent Forecasting and Portfolio Analytics function within commercial due diligence team, providing critical insights and analysis to support strategic decisions. Collaborate with cross-functional teams to integrate data-driven insights into strategic planning, commercial strategies, and decision-making processes. Oversee the analysis of market trends, competitor landscapes, and emerging technologies to identify opportunities and risks for business growth. Provide leadership in the evaluation of potential partnerships, licensing agreements, and M&A opportunities by delivering data-driven insights. Stay updated on industry trends, regulatory changes, and advancements in forecasting and analytics methodologies within the biotech and pharmaceutical sectors. Support to ensure strategic fit of opportunities coherent with CSL TA strategy Drive continuous improvement in BD&L forecasting capabilities within the Forecasting COE, including identification of talent gaps and develop training programs to enhance team capabilities Qualifications: Minimum of a bachelor's degree with preferred focus in a scientific or business field (finance, analytics, economics, analytics/statistics or related). Post-graduate qualifications preferred 10+ years' experience in the pharmaceutical/biotechnology industry working across multiple therapeutic areas 6+ years of experience running/leading forecasting teams in biotech/pharma industry Hands on expertise with all forecasting techniques including time series modeling and statistical trending algorithms, patient-based/TRx modeling Experienced in multiple forecasting & BI tools including but not limited to Forecast Pro, @Risk or other monte-carlo simulation tools, Tableau, QlikSense etc. Experience with conducting detailed literature reviews for Epidemiology as well as expertise & thoughtful utilization of available datasets such as Oracle DB/Legacy Kantar, Datamonitor, Evaluate, Globaldata, IQVIA, Symphony, ADIVO, GERS, UNOS etc. Experience working with Rx, patient claims, pricing (WAC) and managed markets data sources (e.g. IQVIA, SHS, MMIT, Komodo, Clarivate, IPD Analytics) Strong interpersonal skills to quickly build rapport and credibility with organization leaders and key external stakeholders Extensive experience leading planning cycles in commercial, forecasting, or analytical roles This is a hybrid position out of our King of Prussia offices. You must be in the office 3 days a week and one of the days must include a Monday or Friday. Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what's available to you as a CSL employee. About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL. Do work that matters at CSL Behring!

Lead the Project Management Office for R&D Main Responsibilities & Accountabilities ••Leads PM office which will elevate the craft of all Project Managers in RD by steadily training the best personal practices, tools and methods to an end-to-end community of PM•Challenges the broader organization to be more project centric through outside in thinking, proposing process/culture/governance changes as part of the PPE group.•Provides direct management oversight of PMO group, China PM team (2), Submission PM (4 FTE + FSP) and dotted line reporting for Japan PM (4 FTE); through this ensures that all projects get consistent specialty support from these groups, and that their practices and resources meet the needs of the R&D portfolio.•Provides and trains R&D Project Managers in fit for purpose Tools, Templates and PM learning function that enable RD& projects to be planned in a consistent manner, that meets the needs of the organization for risk management, budget, critical path / timelines and resourcing issues. Qualifications & Experience Requirements •12+ years in R&D project Management or operations•Expert, first-hand knowledge of PM best practices, tools, templates and training groups on these•Experience working in cross-functional R&D teams•In-depth knowledge in drug research, development and manufacturing processes of pharmaceuticals•An advanced degree in Science, Master of Business Administration (MBA), PMP certification, or equivalent is a plus.•Proven ability to work effectively both independently and in a team setting, and to meet set goals by managing own timelines.•Involvement in cross-functional, multicultural and international teams preferable.•Excellent communication skills (written, verbal, presentation) in English; experience adapting messaging to suit the intended audiences•Excellent Strategic Thinking skills•Significant experience in the application and utilization of portfolio management systems and software••About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at *************************** Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL. You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement.

CSL is transforming its R&D organization to accelerate innovation and create greater impact for patients. With a streamlined, project-led structure and a focus on collaboration, we're building a future-ready team that excels in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Could you be our next Senior Director, Head of Global Case Management ? The job is in our King of Prussia, PA, Maidenhead UK or Zurich Switzerland office. This is a hybrid position and is onsite three days a week. You will be a strategic leader that ensures a lean, agile, and cost-efficient organization that delivers the highest standards of patient safety, while maintaining strict compliance with global regulations. The Head of Global Case Management will develop and implement innovative case management strategies across the Enterprise ensuring compliance with regulatory obligations and scientific excellence. The incumbent will spearhead and oversee strategic outsourcing initiatives, organizational redesign, and implement automation to enhance operational efficiency, data quality, and cost savings. Main responsibilities and accountabilities: Case Management Responsibilities: Oversee end-to-end case processing operations, ensuring high-quality, scientifically accurate, timely, and compliant case management across global PV activities. Monitor regulatory compliance within case processing workflows, ensuring alignment with local and international requirements, including data privacy and governance standards. Drive continuous improvements in case quality and efficiency through operational benchmarking and implementation of best practices. Business Transformation: Lead case processing transformation efforts through strategic outsourcing, automation, and workforce optimization to achieve operational excellence. Partner with HR to implement workforce change initiatives, including role repurposing, employee retraining, and organizational redesign. Develop and execute cost-saving strategies, transitioning PV operations from human-led to technology-driven processes Foster a culture of innovation and continuous improvement to drive long-term organizational agility and adaptability. Intake & Triage: Oversee intake and triage processes, including the adoption of automation solutions for initial case processing stages. Ensure seamless integration of new intake and triage technologies into existing workflows, improving data capture and efficiency. Establish performance metrics and monitoring systems to evaluate the effectiveness of intake and triage operations. Vendor Oversight and Management: Build and maintain strong vendor relationships to ensure high performance, quality, and compliance in outsourced PV operations. Develop and establish an innovative vendor oversight and management model to drive ICSR excellence Define and monitor key performance indicators (KPIs) and service-level agreements (SLAs) for vendor performance. Collaborate with vendors to implement quality improvement initiatives and address compliance challenges. Oversee vendor audits and risk assessments to ensure alignment with organizational and regulatory standards. Cross-Functional Collaboration: Collaborate with internal stakeholders, including quality, and clinical teams, to align the case management function with broader organizational goals. Manage and oversee budgets for Case Management, ensuring financial targets and project milestones are achieved. Communicate transformation goals and progress to senior leadership, ensuring alignment with the organization's strategic vision. Medical Evaluation: Establishment and maintenance of a high performing outsourced medical evaluation function Directing the medical evaluation strategy ensuring a consistent, scientifically robust approach embedded in CSL's signal detection framework Job Qualifications and Experience Requirements Bachelor's Degree in a relevant scientific or technical field (e.g., MS, PhD, PharmD) preferred. 15+ years in leading multi-year transformation projects, including outsourcing and organizational redesign within PV operations. Profound experience in vendor oversight and management applying innovative approaches to achieve case management excellence Demonstrated expertise in implementing PV technology solutions, such as intake automation, safety databases, signal detection, literature screening, and risk management. Extensive experience in managing global teams and partners Hands-on experience in vendor management, including negotiating contracts and building large offshore vendor models. Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what's available to you as a CSL employee. About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL. Do work that matters at CSL Behring!

The Senior Manager, Targeting will be responsible for leading the design, implementation, and ongoing management of sales force targeting and alignment processes for US sales forces. This role will ensure that customer segmentation, call planning, and territory alignments are executed with precision to optimize field effectiveness and support brand and corporate strategies. The position requires strong analytical, operational, and cross-functional collaboration skills to ensure that targeting strategies are aligned with business objectives and are executed in a compliant and efficient manner. The Senior Manager will partner closely with Sales, Marketing, and other I&A teams to provide actionable insights and operational excellence in targeting and alignment. Responsibilities: Lead the targeting and alignment strategy for three US sales forces, ensuring optimal customer coverage and resource deployment. Manage the execution of territory alignment processes, including design, updates, and communication to field leadership. Partner with brand and field leadership to translate strategy into actionable customer segmentation and call planning. Conduct geographic and customer-level analyses to identify market opportunities and optimize field force allocation. Collaborate with cross-functional partners to develop, test, and enhance targeting methodologies, tools, and business rules. Support periodic alignment refreshes and special projects (e.g., new product launches, resourcing shifts, field force expansion). Build and maintain processes to ensure accurate, timely, and transparent communication of targeting changes to the field. Develop reporting and dashboards to monitor territory performance and targeting effectiveness. Ensure compliance with corporate, legal, and regulatory requirements in all targeting and alignment processes. Qualifications: 7+ years of experience in pharmaceutical or biotech commercial operations, analytics, or sales force operations. Hands-on expertise in sales force targeting, segmentation, and territory alignment. Strong analytical and problem-solving skills with ability to manage large, complex data sets. Experience with targeting/alignment software platforms and field deployment tools preferred. Excellent communication and collaboration skills with ability to interact effectively with senior stakeholders and field leadership. Demonstrated ability to manage multiple projects and deliver results under tight timelines. Knowledge of US pharmaceutical commercial, legal, and compliance environment. Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable. Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what's available to you as a CSL employee. About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL. Do work that matters at CSL Behring!

As the Senior Director of Sales Operations, Data & COE you will play a key role with responsibility for leading all aspects of sales force operations across the entirety of CSL Behring's US portfolio of products and sales teams. This role will lead efforts including sales force sizing and organizational design, sales customer targeting, incentive program strategy and deployment, sales force reporting, customer and sales force analysis and insight, recommendations for improvements in sales force effectiveness, data operations and deployment of tools in the US market (including CRM) to enhance sale force and operational productivity. The role requires synthesis of exceptional leadership, collaboration and analytical skills with the incumbent leading multiple cross functional projects and operations in parallel within the sales operations function and related sub-functions (Targeting/Alignment/Reporting, Incentive Compensation, Data Operations). Operates as a key member of the US Insights & Analytics leadership team and strategic business partner to the US sales and marketing leadership teams. Main Responsibilities and Accountabilities: Leadership: Leads the Sales Operations team across all work streams (targeting/alignment, reporting, sales incentives, sales analytics, sales data, CRM) providing priority setting, planning, and timely decision making of activities to ensure value delivery to all internal and external customers. Encourage a culture of innovation and continuous improvement. Represent Sales Operations on the Strategic Analytics & Pricing leadership team. Sales Incentives: Lead a cross functional team (including analytics, sales and marketing leadership) to develop quarterly/semesterly sales incentive compensation plans across US portfolio that promote alignment between CSL strategic objectives and field force activity. Oversee annual performance awards, program modeling, and implementation of approved sales incentive programs. Responsible for leading governance and related processes associated with sales incentive plans. Sales Force Alignment: Own sales force sizing, territory design, and alignment processes. Oversee the analytical effort for field force alignments, both major and minor. Ensure sales force deployment is consistent with company, brand and sales strategies and the CSL sales organization is deployed to optimally interact and promote CSL products to our customers. Ensure the alignments are sound pre and post implementation. Sales Force Targeting: Oversee the process and analysis to translate brand strategic and tactical intent into action-oriented plans for CSL customer interactions. Provide analytics to identify customers with greatest opportunity and promotional sensitivity and work with cross functional stakeholders to prioritize and optimize sales resource deployment against CSLs target customers. Operationalize customer targets across the sales force including executional oversite of planned activities. CRM: Own CRM operations for US sales and customer facing teams. Represents the US commercial organization needs on the global CRM (Veeva) operating committee within the global organization. Supports the ongoing development of initiatives across various functional areas including Sales, Medical and Marketing. Data Operations: Senior Director is a high-level leader responsible for overseeing a function responsible for US commercial data infrastructure, strategy, and governance to ensure data accuracy, security, and efficient use. This role involves setting a strategic vision for data platforms and ensuring data initiatives align with business goals to drive efficiency and informed decision-making through data and latest technologies. Global COE: Serve as a strategic advisor to U.S. and global commercial leadership, shaping the direction of field operations and sales excellence. Establish and lead the Global Sales Operations COE, standardizing tools, metrics, and processes across geographies. Drive alignment between regional and global stakeholders to ensure consistency in operations while enabling local customization where needed. Collaborate with the BE&Ops and IT team to identify, evaluate, and implement new technology solutions that support the CoE's objectives, drive efficiencies, and enhance data-driven decision-making. Management: Responsibility for oversight and effective management of all team members (i.e. direct reports) to include but not limited to the following Annual objective setting Mid-year and end of year review Coaching and counseling as appropriate Employee development Recruitment, selection and development of talent Managing, directing & measuring work on an ongoing basis. Provides timely constructive feedback to ensure quality of work meets or exceeds company standards Assuring work is completed in a customer focused manner Education BA or BS required in Finance, Accounting, or Business or related field required. MBA Highly Preferred Experience -12+ years professional experience, 8+ years' experience within the pharmaceutical industry. -Experience in specialty/rare disease data strongly preferred including acquisition and integration of specialty pharmacy data and use of secondary claims data (e.g. IQVIA claims data) -Experience across all areas of sales operations including sales incentive compensation design and operations, customer targeting, sales force alignment, analytics & reporting, leveraging associated information technology support systems -Advanced analytical skills in Microsoft Office (Excel/Access/PowerPoint); Experience with -BI tools such as Power BI, Tableau preferred. Veeva knowledge preferred. -8+ years of experience with CRM -Multiple years' experience leading and managing teams in an international and matrixed environment -Excellent negotiation, communication, and relationship-building abilities -Strong Change and Leadership skills Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable. Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what's available to you as a CSL employee. About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL. Do work that matters at CSL Behring!

The Head of Global Regulatory Affairs - Advertising and Promotion is responsible for leading and overseeing the regulatory strategy and compliance of promotional and non-promotional materials globally. This executive role ensures that all advertising, promotional, and external communications activities comply with applicable regulations, guidelines, and company policies. The incumbent will provide leadership across regions (e.g., U.S., EU, APAC, LATAM) and collaborate with cross-functional partners including Marketing, Legal, Medical Affairs, and Commercial to drive compliant and innovative messaging that satisfies regulatory requirements while meeting strategic corporate and business objectives. Main Responsibilities & Accountabilities •Strategic Leadership: Provide US/global oversight, leadership and direction to develop and execute US and global regulatory ad/promo strategies to support product commercialization, lifecycle management, and expansion into new markets.•Regulatory Review & Compliance: Oversee the review and approval process for promotional and non-promotional materials (e.g., websites, social media, HCP/patient brochures, press releases) for consistency with local and international regulatory requirements (e.g., FDA, EMA, PMDA).•Regulatory Authority Interaction: Serve as the primary point of contact with regulatory bodies on advertising and promotion matters, including submission of materials to FDA OPDP or APLB, responding to inquiries, and managing enforcement risk.•Cross-functional Collaboration: Partner with Legal, Compliance, Medical, and Commercial teams to ensure accurate and balanced content in alignment with product labeling and company strategy.•Policy and SOP Development: Lead the development and implementation of global policies, standard operating procedures (SOPs), and training programs for advertising and promotional review processes.•Team Leadership: Build and manage a high-performing global regulatory ad/promo team of reviewers. Provide mentorship, professional development, and performance management.•Risk Assessment: Identify and mitigate regulatory risks in promotional materials and campaigns. Provide guidance during concept development and campaign planning phases.•Innovation Enablement: Support the integration of digital and emerging media in advertising strategies while maintaining compliance. Qualifications & Experience Requirements •Advanced degree (PharmD, PhD, MD, JD, or equivalent) preferred; Bachelor's degree required.•12+ years of Regulatory Affairs experience, with at least 8+ years specifically in advertising and promotion within the pharmaceutical, biotechnology, or healthcare industry.•In-depth knowledge of global regulatory requirements and guidances (e.g., FDA OPDP, EMA, Health Canada).•Experience with regulatory submissions for promotional materials (e.g., Form 2253, 2254) and advisory comments from OPDP/APLB.•Proven leadership skills in managing teams, projects, and cross-functional collaborations.•Exceptional communication, negotiation, and decision-making skills.Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what's available to you as a CSL employee. About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL. Do work that matters at CSL Behring!

The Pharmaceutical Sales Representative - Diabetes/ Endorcrinology is responsible for the achievement of commercial objectives in the assigned territory in alignment with Xeris' corporate goals. Reporting to the Regional Business Director (RBD), the PSR will participate in the development and execution of strategic and tactical territory and account level business plans in order to meet and exceed sales goals and business objectives. **Responsibilities** + Deliver on corporate objectives specific to territory. + With RBD and internal business partner input, develop, evolve, and execute territory and account level business plans. + Engage RBD with timely recommendations to eliminate or minimize barriers to progress specific to marketplace trends, business opportunities and threats, competitive information, etc. + Leverage internal expertise to maximize field impact. + Work with Regional Business Directors, Channel/Trade & Market Access Teams, and Sales Representatives to develop territory-specific strategies to ensure patient access to Xeris products. + Manage territory budget and resource allocations to maximize return on investment. + Create a face to the internal and external customer that demonstrates Xeris' commitment to bringing value and solutions to the customers and patients we serve. + Collaborate with peers, marketing, and training personnel to share information and implement territory initiatives/strategies. + Create, build, and maintain relationships and regular communications and sales efforts with physicians & other health care providers, and all others pertinent to Xeris' business. + Professionally and ethically represent Xeris to external customers (including but not limited to hospitals, IDNs, individual physicians and health care providers, and local diabetes chapters) and foster their respect by demonstrating our commitment to advancing patient care and outcomes. + Professionally and ethically represent Xeris internally and foster professionalism within, among, and beyond the region. + Take responsibility for ongoing professional development to maximize effectiveness in advancing Xeris' objectives. + Leverage internal training and development. + Refine ability to navigate complex and multi-layered accounts + Refine ability to effectively communicate and engage with customers while leveraging Xeris internal resources. **Qualifications** + Bachelor's Degree in Health Sciences, Business/Marketing, or related field. + Sales position level is determined by candidate experience and capabilities. At Xeris Pharmaceuticals, levels of consideration are based on the following: + 2+ years of experience in field commercial positions, including but not limited to: sales representative, hospital representative, sales trainer, and marketing (Sales Representative) + 5+ years of experience in bioscience commercial positions, including but not limited to: sales representative, hospital representative, sales training, marketing and regional account manager (Sr. Sales Representative) + A valid, US State-issued driver's license is required + Recent experience in bioscience and/or diabetes is highly desirable + Able to create and execute a thoughtful business plan adjusting when needed in order to meet organizational goals. + Proficient in understanding key data and metrics and utilizing this information to improve business performance. + Thrives in ambiguity and uncertainty; can adapt quickly in any situation and asks questions to increase depth of understanding. + Competencies: Self-directed, Organizational skills, Verbal and Written Communication skills, Time Management, Presentation skills, Project Management skills, Problem Solving, Negotiation skills, Influencer, Adaptability + Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Travel requirements will vary by territory but will minimally be 20% + Position requires vehicle travel, as necessary. _The level of the position will be determined based on the selected candidate's qualifications and experience._ \#LI-REMOTE _As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors._ _The anticipated base salary range for this position is $85,000 to $140,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for commission and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process._ _NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization._ **Job Locations** _US-PA_ **Title** _Territory Business Manager, Diabetes - Pittsburgh_ **ID** _2025-2155_ **Category** _Sales_ **Type** _Full-Time_

CSL is transforming its R&D organization to accelerate innovation and create greater impact for patients. With a streamlined, project-led structure and a focus on collaboration, we're building a future-ready team that excels in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Could you be our next Senior Project Manager, Portfolio Delivery? The job is in our King of Prussia, PA or Maidenhead UK office. This is a hybrid position and is onsite three days a week. You will report to the TA Portfolio Delivery Lead. You will lead the successful operational delivery of global R&D projects of strategic importance to CSL's product portfolio. The Role You will work with project leader to define strategy and operational tactics Responsible for the preparation and management of project budgets, sensitivities, resources, project timelines, project scope and all other project documentation Accountable for the accuracy and quality of reports to senior stakeholders Lead development teams through tactical execution of project plans Manage and resolve project issues and reduce risks Ensure documentation of main team information, actions, modifications to scope, resources, timelines and milestones in project management systems is current. Evaluate the project planning, scenarios and challenge assumptions to increase robustness of project plans Monitor performance vs. plan (budget and timeline) Coordinate program updates to Sr. Management Provide coaching to more junior members of the R&D Global Project Management Department Qualifications Bachelor's degree or equivalent in Science, Engineering, or a related field. Project Management Professional (PMP) certification, 7+ years' experience in the biotechnology or pharmaceutical industry 5+ years' experience as a project manager leading project teams in a matrixed, global environment, In-depth knowledge in drug research, development and manufacturing processes Demonstrated experience delivering projects to meet our goals on time, within budget and wit quality. BENEFITS Medical, Dental Vision 401K Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what's available to you as a CSL employee. About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL. Do work that matters at CSL Behring!

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

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: The Oncology Clinical Educator role provides disease state, REMS, and product safety education and training to key healthcare providers within Oncology clinics, and health care providers (HCPs) in both the hospital and clinic/office setting. The individual will work within a specified region to enhance disease, REMS, and product safety knowledge, coordinate and provide staff training, and enhance proper administration. The Oncology Clinical Educator (OCE) role is a position that is field based and is comprised of nurses working under the general direction of the Regional Director of Clinical Nurse Managers. The OCE is responsible for educating HCPs/clinics with infusion and related education for prescribed DSI products. The OCE serves as the disease state and product safety expert for their assigned territories. The OCE serves as a resource to clinical leaders by identifying disease state, REMS, and product safety educational needs of staff and implements programs to fulfill knowledge gaps. This collaborative approach will serve to provide education and enhanced clinical care. The OCE is bound by the product label for all educational efforts, and in the interaction with non-commercial counterparts. Excellent organizational, creative and analytical problem solving, communication, and presentation and skills are required. This individual must be flexible and adaptable to new and constant changing situations. Responsibilities: Provides education to health care professionals about disease states and REMS and product safety information for specified DSI products in the medical community within an assigned geographical area in accordance with DSI general direction and policy, focused on the assigned targeted segments (i.e: Hematology/Oncology, Gastroenterology, Nephrology, Hospital Pharmacy, OB/GYN and Cardiology). Develops strong, long-term relationships with clinical personnel Ensures appropriate and compliant utilization of product and disease state education as it relates to DSI products. Executes disease state educational presentations and on label product safety presentations for in-office/in-hospital educational programs to customers that are guided and designed to address clinical knowledge or product gaps. Must be able to educate and use multiple approaches to explain complex and difficult material and use experiences to illustrate ideas and facilitate understanding while maintaining the ability to stimulate customer interest. Collaborates to identify and strategizes on how to best educate customers. Develops and executes geographical based strategic and tactical plans to meet targeted customer needs. Monitor, collect, and communicate to the Director, Clinical Nurse Manager on customer insights regarding their need for information regarding disease state, REMS and safety information with respect to DSI marketed products. Collaborate with managed care counterparts or MSLs to provide ongoing clinical updates that are impacted by reimbursement and/or clinical guidelines. Identifies and contributes to the development of nursing/HCP specific materials to fulfill customer needs to include, but not limited to, patient educational aids, product reference aids and slide deck content topics. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) Bachelor's Degree required Experience Qualifications 4 or more years in pharma industry preferred, ideally Hematology/Oncology or 3 or more years of healthcare related experience required Experience with infusion nursing experience preferred Ability to travel up to 90% within geography and to required meetings. Licenses and Certifications RN - Registered Nurse - State Licensure and/or Compact State Licensure The ideal candidate will be a Registered Nurse with previous relevant clinical as well as pharmaceutical industry experience calling on different levels of the health care providers (HCPs) in both the hospital and clinic/office setting required Additional Qualifications: Ability to travel up to 90% within geography and to required meetings. Must have a valid driver's license with a driving record that meets company requirements Compensation and seniority level/title based on experience and qualifications. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: $140,480.00 - $210,720.00 Download Our Benefits Summary PDF

CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. The Medical Evaluator provide clinical expertise on all aspects of individual case assessments with special emphasis on ongoing evaluation of safety information during late-stage development and post marketing. You will apply sound medical judgment for analysis and interpretation of clinical safety data. Strong product knowledge is needed for success in the role. The role ensures that the medical aspects of individual cases: Comply with legal requirements and company standards of the PV (Pharmacovigilance) tasks and responsibilities. Provide Key information to prevent harm from adverse reactions in humans arising from the use of authorized medicinal products within or outside the terms of the market authorization. The role interfaces with internal stakeholders, contributes to regulatory reports / submissions / queries **Key Responsibilities** Medical Evaluation and Quality Management: Ensures timely and quality assessment of medical report cases, and answers to queries from Health Authorities according to consistent quality standards. Regulatory Agency Requests: Responsible for timely and concise responses to Regulatory Agency requests relating to medical evaluation of cases. Inspections: Ensures regulatory agency inspection findings and internal audit findings relating to the medical assessment processes are addressed and resultant Corrective Action Plans (CAPA plans) are implemented efficiently and effectively in the function **Skills and Experience Required** 2 years pharmaceutical / CRO industry experience preferred 2 years of clinical practice experience preferred **Qualifications and Education Required** Advance Science Degree (MD - RN preferred) **Our Benefits** CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site (******************************************* to see what's available to you as a CSL employee. **About CSL Behring** CSL Behring (*********************** is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma (************************* . Our parent company, CSL (********************* , headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. **We want CSL to reflect the world around us** At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL (**************************************************** . **Do work that matters at CSL Behring!** R-263751 CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. ************************************************

Leads the execution of digital enablement initiatives across R&D by guiding agile teams, driving process transformation, and supporting change management. Acts as a key partner to R&D functions to ensure alignment of digital programs with business needs and successful adoption of digital solutions. Translate digital strategy into executable programs and initiatives across R&D functions. Lead business analysis and partner with stakeholders to identify digital needs and prioritize opportunities. Guide process design, reengineering, and change adoption for digital initiatives. Oversee agile delivery teams and ensure alignment with product owners and stakeholders. Implement change management strategies and user engagement plans to foster adoption. Monitor project impact and value realization through defined KPIs and feedback loops. Contribute to the evolution of digital operating models across the scientific organization. Bachelor's or Master's in Business, Life Sciences, or Technology-related field. 10+ years of experience in digital transformation, business analysis, or agile program delivery. Proven success leading agile teams in R&D or scientific organizations. Experience with tools such as Jira, Confluence, Miro, and Smartsheet. Strong communication and stakeholder management skills. About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at *************************** Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL. You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement.

About Krystal Bio: At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the discovery, development, manufacturing, and commercialization of genetic medicines to treat diseases with high unmet medical needs. Founded in 2016, Krystal is distinguished in three powerful ways: science and technology using our patented gene therapy platform, innovative manufacturing supported by our commercial scale facilities, and a unique commercialization model that focuses on the patient's end-to-end experience. Krystal received U.S. FDA approval for the first and only redosable gene therapy treatment, VYJUVEK, for the treatment of Dystrophic Epidermolysis Bullosa (DEB). Krystal continues to leverage our proprietary platform to rapidly advance a robust pipeline of investigational genetic medicines in respiratory, oncology, dermatology, and ophthalmology. Krystal is headquartered in Pittsburgh, PA, which is home to our two state-of-the-art CGMP manufacturing facilities with teams around the world and satellite offices in Switzerland, Germany, and Japan. We are a company built and run by people who care, are fearless in the face of a challenge, love the work they do, and practice the highest level of scientific integrity. As we grow, we are seeking team members that embody these values. Job Description Summary: Krystal Biotech, Inc is seeking a highly motivated Maintenance Technician to join the team at our state-of-the-art manufacturing facility in Moon Township. The Technician will be responsible for performing preventive maintenance, troubleshooting, and repairs on a wide range of electrical and mechanical equipment used in our manufacturing operations. This role requires a strong attention to detail and a commitment to ensuring the facility operates at peak efficiency. Primary Responsibilities: * Conduct routine inspections and preventive maintenance activities on electrical and mechanical equipment, including but not limited to motors, generators, pumps, HVAC systems, control panels, and lighting systems. * Diagnose and troubleshoot equipment malfunctions, electrical failures, and system issues to identify root causes and implement appropriate corrective actions. * Perform repairs and replacements of faulty electrical components, wiring, circuits, and other related systems to ensure safe and efficient operations. * Collaborate with cross-functional teams to prioritize and address maintenance needs that impact manufacturing operations. * Maintain accurate records of maintenance activities, including equipment maintenance schedules, repairs performed, and parts used, utilizing computerized maintenance management systems (CMMS) or other designated tools. * Ensure compliance with applicable safety regulations, electrical codes, and industry standards while working on systems and equipment. * Assist in the planning and execution of equipment installations, upgrades, and modifications, including electrical wiring, power distribution, and control system integration. * Adhere to company policies, standard operating procedures (SOPs), and Good Manufacturing Practices (GMP) guidelines to maintain a high level of quality and compliance. Requirements and Desired Qualifications: * High school diploma or equivalent; technical certification or associate degree in electrical technology or related field is preferred. * 1+ years of professional maintenance experience in a manufacturing environment, preferably within a regulated setting. * Computer savvy and demonstrated ability to adopt new programs/systems quickly. * Proficiency in using tools, equipment, and testing devices commonly used in electrical maintenance and repair work. * Ability to read and interpret technical manuals, electrical schematics, and engineering drawings. * Strong understanding of electrical codes, safety practices, and industry standards (e.g., NEC, NFPA) applicable to biopharmaceutical manufacturing facilities. * HVAC experience is a plus. * Must be hands-on and a self-starter. * Effective communication skills, both verbal and written, with the ability to interact with individuals at various organizational levels. * Strong attention to detail, organizational skills, and the ability to prioritize tasks in a dynamic manufacturing environment. Krystal Biotech, Inc. is an Equal Employment Opportunity and Affirmative Action Employers. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status. Headhunters and recruitment agencies may not submit resumes/CVs through this Web site or directly to managers. Krystal Biotech, Inc. does not accept unsolicited headhunter and agency resumes. Krystal Biotech, Inc. will not pay fees to any third-party agency or company that does not have a signed agreement with Krystal Biotech, Inc.

The Future Talent Program features internships that last up to 12 weeks and will include one or more projects. These opportunities in our Research and Development Division can provide you with great development and a chance to see if we are the right company for your long-term goals. Our Company Research Lab's Quantitative Pharmacology & Pharmacometrics (QP2) group within the Translational Medicine department is seeking summer intern students for 2026. Quantitative Pharmacology & Pharmacometrics provides mathematical modeling, simulation, and pharmacokinetic / pharmacodynamic (PK/PD) analysis to enable drug development decisions across the pipeline - starting at discovery / preclinical investigation, through early-stage clinical trials, to late-stage clinical trials and drug registration. The intern will work closely with a Quantitative Pharmacology & Pharmacometrics scientist(s) mentor to build and apply novel mathematical, physiological, pharmacologic, or statistical models to support drug development and create new quantitative capabilities and approaches. Interns have an opportunity to collaborate with scientists in Quantitative Pharmacology & Pharmacometrics and other groups within our company, to develop external presentations / publications and to learn about drug development more broadly. A wide variety of scientific projects will be available to interns, on topics such as (but not limited to): Pharmacometrics Physiologically based Pharmacokinetics (PBPK) Translational modeling Semi-mechanistic modeling Interactive visualizations for modeling & simulation Automation and scaling of modeling analyses for rapid decision-making We are seeking intern candidates with strong academic performance, communication skills, teamwork, and the ability to work in a multi-disciplinary environment. Education: Candidates must be currently enrolled in a PhD or MS degree program in Pharmacometrics, Clinical Pharmacology, Clinical PK/PD, Mathematics / Applied Mathematics, Pharmaceutical Sciences, Statistics, Bioengineering, Chemical Engineering, Computer Science, or related areas. Required Experience and Skills: Candidates must be available to work full-time for 9 to 12 consecutive weeks beginning in May or June of 2026. Preferred Experience and Skills: Strong computational skills Experience with programming languages such as R, NONMEM, MATLAB, Monolix, SAS, Phoenix NLME, Python Experience with data visualization Familiarity with population modeling principles, differential equations, machine learning, and/or Bayesian statistics Excellent communication skills Please note that this position may be closed before the posted end date or may remain open longer, at the discretion of the company. Under New York City, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. The salary range for this role is $39,600.00-$105,500.00 USD FTP2026 RL2026 Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Intern/Co-op (Fixed Term) Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Required Skills: Clinical Research, Cloud Data Catalog, Data Analysis, Database Management, Data Science, Data Security, Data Visualization, Data Wrangling, Detail-Oriented, Event Planning, Key Performance Indicators (KPI), Project Management, Python (Programming Language), Software Proficiency, Vendor Relationship Management Preferred Skills: Job Posting End Date: 11/3/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

About Krystal Bio: At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the discovery, development, manufacturing, and commercialization of genetic medicines to treat diseases with high unmet medical needs. Founded in 2016, Krystal is distinguished in three powerful ways: science and technology using our patented gene therapy platform, innovative manufacturing supported by our commercial scale facilities, and a unique commercialization model that focuses on the patient's end-to-end experience. Krystal received U.S. FDA approval for the first and only redosable gene therapy treatment, VYJUVEK, for the treatment of Dystrophic Epidermolysis Bullosa (DEB). Krystal continues to leverage our proprietary platform to rapidly advance a robust pipeline of investigational genetic medicines in respiratory, oncology, dermatology, and ophthalmology. Krystal is headquartered in Pittsburgh, PA, which is home to our two state-of-the-art CGMP manufacturing facilities with teams around the world and satellite offices in Switzerland, Germany, and Japan. We are a company built and run by people who care, are fearless in the face of a challenge, love the work they do, and practice the highest level of scientific integrity. As we grow, we are seeking team members that embody these values. Job Description Summary: Krystal Biotech is seeking a highly motivated Process Validation Associate (1+ years' experience) or Engineer (3+ years' experience) to support process validation planning, design, and execution. This person will be responsible for risk assessments, process improvements, investigations, and other projects. They will also play a pivotal role in technology transfer and ensuring processes transition properly from site to site. Primary Responsibilities: * Partner with Process Development and Manufacturing to ensure upstream and downstream processes are well controlled. * Apply QbD and traditional process validation principles to existing and new gene therapy products. * Perform and document risk assessments to capture existing process knowledge and to identify gaps. * Perform experiments (bench scale and manufacturing scale) to close gaps in process understanding and to support process development. * Troubleshoot process and equipment issues to help ensure efficiencies in processes. * Help implement a continuous improvement mindset to processes and departments. * Produce high-quality documentation that meets applicable standards and is appropriate for its intended use. * Work on development of new manufacturing facility to ensure proper transfer of technology and processes. * Work with CMC counterparts to draft materials intended for the agency review. Minimum Qualifications & Desired Competencies: * Bachelors' Degree in Chemical Engineering, Biomedical Engineering, or related * Relevant validation and/or engineering experience in the Biotech or Pharmaceutical industry (1+ yr for Associate, 3+ yr for Engineer level) * Background that includes knowledge/experience in GMP, GLP, and statistics * Strong knowledge of GMP and ICH requirements and QbD * Prior experience in the gene therapy field is desired * Must be a self-starter and capable of working with minimal oversight * Must be able to handle multiple roles and work in a fast paced and changing environment and know how to prioritize activities appropriately * Excellent oral and written communication skills Krystal Biotech, Inc. is an Equal Employment Opportunity and Affirmative Action Employers. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status. Headhunters and recruitment agencies may not submit resumes/CVs through this Web site or directly to managers. Krystal Biotech, Inc. does not accept unsolicited headhunter and agency resumes. Krystal Biotech, Inc. will not pay fees to any third-party agency or company that does not have a signed agreement with Krystal Biotech, Inc.

The R&D Digital Enablement Lead ensures that the people, processes, and systems across R&D are fully prepared to adopt and benefit from digital transformation. This role drives agile delivery, change management, and process design to accelerate adoption and value realization of digital solutions within the scientific organization. Main Responsibilities & Accountabilities •Lead business analysis and discovery to align TES digital projects with R&D priorities.•Drive process design, reengineering, and operating model evolution for digital programs.•Oversee agile delivery frameworks and support scrum teams as needed.•Lead change management and communication strategies for adoption.•Monitor value realization and build metrics frameworks to assess progress.•Collaborate with R&D stakeholders to continuously improve digital workflows. Qualifications & Experience Requirements •Bachelor's or Master's in Business, Life Sciences, or Technology-related field.•12+ years of experience in digital transformation, business analysis, or change management.•Proven success delivering agile initiatives in a global scientific or R&D setting.•Experience with tools such as Jira, Smartsheet, Miro, or similar.•Strong understanding of stakeholder engagement and adoption strategies.About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at *************************** Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL. You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement.

About Krystal Bio: At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the discovery, development, manufacturing, and commercialization of genetic medicines to treat diseases with high unmet medical needs. Founded in 2016, Krystal is distinguished in three powerful ways: science and technology using our patented gene therapy platform, innovative manufacturing supported by our commercial scale facilities, and a unique commercialization model that focuses on the patient's end-to-end experience. Krystal received U.S. FDA approval for the first and only redosable gene therapy treatment, VYJUVEK , for the treatment of Dystrophic Epidermolysis Bullosa (DEB). Krystal continues to leverage our proprietary platform to rapidly advance a robust pipeline of investigational genetic medicines in respiratory, oncology, dermatology, and ophthalmology. Krystal is headquartered in Pittsburgh, PA, which is home to our two state-of-the-art CGMP manufacturing facilities with teams around the world and satellite offices in Switzerland, Germany, and Japan. We are a company built and run by people who care, are fearless in the face of a challenge, love the work they do, and practice the highest level of scientific integrity. As we grow, we are seeking team members that embody these values. Job Description Summary: Krystal Biotech, Inc is seeking a highly motivated and dynamic Bioprocess Engineer to support our product manufacturing at our Pittsburgh GMP facility. This role is critical to our make a meaningful difference in the lives of underserved patient populations having rare diseases. Quality, safety and on-time delivery is a must to be successful in this role! The ideal candidate will have foundational experience in upstream and/or downstream biologics or gene therapy manufacturing. Primary Responsibilities: Perform/support/monitor the process steps/activities - buffer preparation, upstream, downstream, Aseptic Fill Document/record data following standard operating procedures or GMP documents for process steps and/or equipment activities Maintain equipment and operate - facilitate/perform qualifications, cleaning, logbooks Clean, maintain, and monitor the GMP facility Collaborate with Quality assurance, Quality control, Facilities, Materials and others Participate in learning and training to be competent in above functions Other duties as assigned Requirements and Preferred Qualifications: Bachelor's degree, preferably in life sciences Expertise working in a clean room facility, 1+ years of professional experience demonstrating proper cleanroom behavior/technique Cell culturing / Aseptic technique Familiarity with large scale bioreactors highly preferred Downstream processing experience Filtration/Purification Highly organized and detail oriented, while also demonstrating the ability to synthesize information and demonstrate strategic thinking Highly self-motivated, flexible, proactive, able to follow through in an ambiguous, fast-changing environment, and proven ability to meet deadlines under pressure A demonstrated understanding of the drug development process, biopharmaceutical industry and/or related life sciences industry Demonstrated ability to prioritize and manage multiple projects simultaneously Demonstrated ability to work effectively with many different types of personalities at all levels of the organization Excellent interpersonal, collaboration and stakeholder management skills Excellent communication skills (written/verbal) Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status. Headhunters and recruitment agencies may not submit resumes/CVs through this Web site or directly to managers. Krystal Biotech, Inc. does not accept unsolicited headhunter and agency resumes. Krystal Biotech, Inc. will not pay fees to any third-party agency or company that does not have a signed agreement with Krystal Biotech, Inc. Powered by JazzHR fUkTRwFDa4