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Iovance Biotherapeutics jobs in Philadelphia, PA - 36 jobs

  • Quality Assurance Document Control Specialist I [Contract to Hire]

    Iovance Biotherapeutics Inc. 4.2company rating

    Iovance Biotherapeutics Inc. job in Philadelphia, PA

    The Quality Assurance Specialist I, Document Control is located at Iovance Cell Therapy Center (iCTC) in Philadelphia, PA. This position requires full-time on-site presence. This position is responsible for supporting the Quality Document Control program at the iCTC facility and ensuring compliance to quality objectives and regulatory standards. The individual must have a strong quality mindset. Shift: Wednesday to Saturday from 9am to 8pm Essential Functions and Responsibilities * Responsible for issuance of unique identifier/lot number for identification and traceability of Patient and Non-Patient Manufacturing Lots. * Performs the issuance of Patient and Non-Patient batch records and required forms. * Generates and issues in-process labels for both Patient and Non-Patient Lots. * Supports the day-to-day need of Manufacturing, QC, and other departments at iCTC. * Must be proficient in Associate Level responsibilities to serve as a back-up, as needed. This includes logbooks and controlled copy issuance, and archival. * Independently manage, process, review, and approve the archival of documents in the Electronic Document Management System (eDMS). * Provide user assistance on eDMS * Responsible for problem solving related to job responsibilities. * Provides support for internal and regulatory audits and inspections as required. * Assists with maintaining Quality Assurance Document Control tracking tools for metric purposes. * Provides continuous feedback on improvements to Document Control processes. * Escalates issues or concerns to Area Management * Must adhere to Iovance Biotherapeutics' core values, policies, procedures, and business ethics. * Perform miscellaneous duties required to complete the responsibilities stated in this Job Description (i.e. maintaining inventory of supplies and purchasing, maintaining the work area tidy, attend meetings, etc.). * Perform other duties assigned by the area management, which may or may not be associated with projects. Travel - none required Preferred Education, Skills, and Knowledge Bachelor's degree in Life Sciences discipline is required. * Minimum of two (2) years of experience in document change management and archival or advanced degree without experience. * Minimum of two (2) years of experience in cGMP, FDA regulated industry is required. * Strong computer skills including MS Office Suite * Must possess a high level of attention to details and have a strong quality mindset. * Must be organized * Must be qualified, highly motivated, and a team player. * Ability to work effectively on multiple projects simultaneously with minimum supervision. * Strong interpersonal and communication skills The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation. Physical Demands and Activities Required * Must be able to remain in a stationary position standing or sitting for prolonged periods of time. * Able to crouch, bend, twist, reach, and perform activities with repetitive motions. * Able to stand and/or walk in a 10-hr day which may include climbing ladders or steps. * Must be able to move about inside an office and exert up to 30 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects. * Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, safety glasses, etc. * Must comply with Safety SOPs and laboratory procedures per the company policy. * Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading. * This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers. * Must be able to communicate with others to exchange information. Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines. Work Environment This job works in a professional office environment and a manufacturing lab setting. Potential exposure to latex, bleach, loud noise, lab equipment hazards, strong odors, and chemical/biochemical is possible. Requires operating standard office equipment and keyboards. #LI-onsite The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time. Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual's race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact *******************. By voluntarily providing information and clicking "Submit Application", you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.
    $42k-54k yearly est. 4d ago
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  • Quality Assurance Specialist I, Raw Material Release. Sunday to Wednesday [Contract to Hire]

    Iovance Biotherapeutics 4.2company rating

    Iovance Biotherapeutics job in Philadelphia, PA

    The Quality Assurance Specialist I, Raw Material Release role will support review of documentation and support releasing of raw materials, components and manufacturing kits. Schedule and Hours: Sunday to Wednesday from 7am-6pm. Essential Functions and Responsibilities: Ensure compliance to cGMPs and facility procedures. Interface with functional groups, such as Manufacturing, Quality Control, and Document Control, to determine events (errors, deficiencies, discrepancies, deviations and other observations) and report to management. Review of documentation associated with Raw materials, components in support of manufacturing operations Review batch records and related production documentation, ensuring resolution of all identified issues prior product disposition, as required. Review of deviations as assigned. Revision of documents as assigned. Work with internal functions to address all identified issues in a timely manner. Reports errors, deficiencies, discrepancies, and observations to management. Disposition incoming materials. Preparing supporting documentation for release of materials. Issuance of labels, as required. Support lot closure Other projects as assigned. Required Education, Skills, and Knowledge A Bachelor's Degree in Science, Engineering, or a related technical discipline with at least 2 years of experience in a regulated industry or an advanced degree without experience. Prior experience in cell and gene therapy preferred. Working knowledge of cGMP regulations. Strong administrative skills including use of Microsoft Word, Excel, and PowerPoint. Attention to detail. Knowledge of QMS systems is a plus. The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation. Physical Demands and Activities Required: Must be able to remain in a stationary position standing or sitting for prolonged periods of time. Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects. Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading. This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers. Must be able to communicate with others to exchange information. Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadline. Work Environment: This position will work in both an office and a manufacturing setting. #LI-onsite The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time. Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual's race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact *******************. By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.
    $59k-84k yearly est. Auto-Apply 4d ago
  • Inventory Control Specialist I

    Iovance Biotherapeutics Inc. 4.2company rating

    Iovance Biotherapeutics Inc. job in Philadelphia, PA

    The Inventory Control Specialist I is responsible for all aspects of inventory record keeping at the Iovance Cell Therapy Center (iCTC) located in Navy Yard, PA. They will keep detailed and accurate records of any changes in inventory or production and compile the consumption values into a database for trending and future analytical purposes. Eventually, modifications to ordering patterns may result from this exercise as it relates to changes in demand over time or changes in market supply availability. Essential Functions and Responsibilities: * Develop and implement procedures for balancing on hand inventory, demand and associated lead times to optimize inventory levels through various management programs such as Vendor Managed Inventory (VMI), KanBan systems, min/max leveling, off-site storage facilities, etc. * Participate in regular cycle counts and ad hoc inventory audits to ensure inventory integrity of >95% by verifying product identification, location and quantities with inventory management system * Research inventory discrepancies, reconcile within appropriate inventory management system when required and recommend preventive measures or process modifications to prevent future variances. * Ensure various storage depots located internally and externally are appropriately stocked to support business continuity, and when needed, supply additional materials to maintain established min/max levels. * Perform inventory data analysis using various models to identify opportunities, risks and trends around inventory consumption and make recommendations and/or offer tactical solutions to establish optimized safety stock levels while considering limitations associated with physical storage footprint and material expiries. * Monitor material status and effectively communicate low inventory, obsolete or expired materials to the respective Buyer/Planner and facilitate inventory meetings to review aged inventory and necessary disposition. * Engage in necessary warehouse cleaning duties including but not limited to sweeping the warehouse and bulk storage, mopping, general cleaning and dusting of warehouse walls, door panels, racks, containers, etc., and transport trash to disposal areas. * Performs other duties as assigned by leader. Required Education, Skills, and Knowledge * 5+ years warehouse experience in a high-volume cGMP production or manufacturing environment. * Working knowledge of MRP/ERP systems, APICS Certification is an asset. * Proficient in MS Word, Excel, Outlook. * Experience and/or certification in operating material handling equipment preferred (i.e. forklift). * Ability to collaborate across disciplines. * Strong interpersonal and team-building skills, effective communication (both written and verbal), proactive problem-solving and analytical skills. * Possess the ability to bridge relationships between various departments, levels of the organization, supplier and customer organizations. * Excellent organization skills and an ability to prioritize effectively to deliver results within reasonably established guidelines. * Must be comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities with a strong attention to detail. * Willingness to work flexible hours, including overtime and weekends. Preferred Education, Skills, and Knowledge * Experience with cell therapy products. The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation. Physical Demands and Activities Required: * Must be able to wear appropriate lab and clean room attire as well as all Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc. * Able to stand and/or walk 90% (and sit 10%) of the scheduled workday which may include climbing ladders or steps. * Must be able to use near vision to view samples at close range. * Able to crouch, bend, twist, reach, and perform activities with repetitive motions. * Must be able to lift and carry objects weighing 45 pounds. Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines. Work Environment: This position will work in both an office and a manufacturing setting. When in the lab, you may be exposed to various chemicals/biochemical, including latex and bleach. Additionally, there is potential for variable noise levels, equipment hazards, strong odors, and other detergents/sanitizers. #LI-onsite The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time. Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual's race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact *******************. By voluntarily providing information and clicking "Submit Application", you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.
    $41k-52k yearly est. 42d ago
  • Manager, Environment, Health & Safety

    Iovance Biotherapeutics Inc. 4.2company rating

    Iovance Biotherapeutics Inc. job in Philadelphia, PA

    The Senior Manager, Environment, Health & Safety role is responsible for providing compliant EHS programs to all departments at the IOVA-A facility. Integrates EHS programs into daily operations to assure regulatory compliance, achieves continuous performance improvement, meeting EHS performance objectives. Partners with operations to develop objectives to achieve these goals in alignment with site business goals and values. Provides technical leadership to ensures the biological safety programs adhere to federal, state, and local EHS regulations. Manages the day-to-day requirements and activities of the EHS incident management and reporting system. Essential Functions and Responsibilities * Serves as the site subject matter expert regarding general safety, chemical hygiene, biosafety (BSL 2), and environmental management. * Implements new and improves existing EHS programs to ensure compliance with federal, state, and local environmental, safety, medical surveillance and sustainability laws, regulations, codes, rules, and consensus standards. * Provides and executes programs, policies, procedures, and trainings as the site SME for high-risk work programs including but not limited to working from heights, electrical safety, hot work, confined space entry, lockout tagout, and contractor safety. * Completes hazard assessments, coordinates IH monitoring, process hazard analysis, life safety reviews, incident investigations, environmental reports, and permit applications as needed. * Participates in and supports EHS operational and tier discussions, safety committees and teams, self-assessments, and audits. * Reviews processes, facilities, procedures, and management of change documents to assure conformance to recognized EHS regulations, standards, and guidelines. * Provides support to staff in completing injury/illness investigations, additional training, data analysis, and addresses specific concerns as they are raised. * Participates in regulatory inspections and assists in addressing noted concerns and citations. * Reviews site data for the EHS reporting system (Enablon); manages user permissions; identifies data gaps and other concerns; generates output reports and dashboards using the appropriate BI tools; tracks and communicates EHS score card metrics. * Perform miscellaneous duties as assigned. Travel * May require up to 5% domestic travel. Required Education, Skills, and Knowledge * Bachelor's degree in Occupational Safety, Industrial Hygiene, Chemical Engineering, Process Safety Management, or a related technical discipline required. * Minimum 8 years relevant EHS work experience required. * Technical working knowledge of federal, state, and local regulations as well as CDC, NIH, BMBL guidelines, and other regulations and consensus standards required. Preferred Education, Skills, and Knowledge * RBP, CBSP, CIH, and/or CSP certification preferred. * Working knowledge of six-sigma and operational excellence a plus. * Experience with GMP environments and biotechnology processes preferred. * Demonstrated ability to quickly interpret complex regulatory issues and provide recommended course of action. * Strong written and verbal communication skills with the ability to communicate clearly to all levels of the organization. * Self-motivated, flexible, creative, able to prioritize, and work in a fast-paced, dynamic environment and effectively deal with conflicting and changing priorities. * Strong working knowledge of computers and programs including Microsoft Office, SharePoint, Teams, Enablon, etc. * Excellent interpersonal, relationship management, and organizational skills. Physical Demands and Activities Required: * Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc. * Must meet requirements for and be able to wear a half-face respirator. * Able to stand and/or walk 90% (and sit 10%) of a 10-hr day which may include climbing ladders or steps. * Able to crouch, bend, twist, reach, and perform activities with repetitive motions. * Must be able to lift and carry objects weighing 45 pounds. The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation. Work Environment: * This position will work in both an office and a manufacturing lab setting. * When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach. * Able to work in cleanroom with biohazards, human blood components, and chemicals. * Potential exposure to noise and equipment hazards and strong odors. #LI-Onsite The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time. Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual's race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact *******************. By voluntarily providing information and clicking "Submit Application", you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.
    $61k-79k yearly est. 60d+ ago
  • Senior Director, Sales Commercial Learning & Development - Dermatology

    Incyte 4.8company rating

    Chadds Ford, PA job

    Overview Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value. The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules. Job Summary (Primary Function) The Senior Director, Sales Commercial Learning & Development (CL&D) - Dermatology will report to the Vice President of Sales and serve as the strategic leader responsible for building the capabilities and supporting the development of the Dermatology sales commercial team, while fostering a learning culture within the organization. This role will architect and execute a comprehensive, future-focused learning strategy that elevates field effectiveness, strengthens leadership capability, and ensures commercial readiness across the evolving dermatology landscape. The Senior Director will focus on five strategic learning pillars - Coaching & Selling Skills Effectiveness, Access & Fulfillment, Leadership Development, Key Account Management (KAM), and Business Planning & AI Innovation - ensuring the field force and leadership teams are fully equipped to deliver exceptional patient and customer impact. Essential Functions of the Job (Key Responsibilities) Strategic Learning Leadership • Develop and implement a comprehensive commercial learning roadmap that enhances selling excellence, market & patient access acumen, and leadership effectiveness across the Dermatology franchise. • Serve as the strategic learning advisor to Sales, Marketing, and Access leadership, aligning learning objectives with business imperatives and product lifecycle goals. • Champion a continuous learning culture grounded in science, empathy, and innovation-advancing both field and leadership capabilities in support of long-term franchise growth. Coaching & Selling Skills Effectiveness • Lead the evolution of the dermatology sales model to a consultative, solution-oriented, and access-aware approach, focused on improving patient outcomes and practice engagement. • Build advanced coaching frameworks that enable first- and second-line leaders to develop their teams through insight-driven, metrics-based coaching. • Drive training initiatives that strengthen disease state fluency, clinical dialogue, and access navigation, ensuring seamless and compliant customer engagement. Access & Fulfillment Excellence • Partner with Market Access, Reimbursement, and Patient Support teams to embed deep understanding of Access & Fulfillment dynamics within all sales and leadership training curricula. • Develop learning experiences that improve field fluency in payer, HUB, and specialty pharmacy pathways, empowering representatives to navigate fulfillment barriers and support appropriate patient access. • Ensure cross-functional training alignment between Sales, Access, and Patient Services for "One Dermatology Team" execution. Leadership Development • Design and deliver a tiered leadership curriculum for field and HQ leaders that builds commercial acumen, agility, coaching, and enterprise leadership capability. • Create a leadership pipeline and succession strategy for Dermatology Sales and Training, preparing future leaders through structured learning, mentoring, and stretch development opportunities. • Partner with HR and Commercial Strategy to align leadership capability frameworks with company values, culture, and business priorities. Key Account Management (KAM) • Lead the build-out of advanced Key Account Management and business planning capabilities, ensuring alignment to the evolving dermatology marketplace. • Implement training that sharpens strategic account planning, data-driven territory management, and cross-functional collaboration with marketing, medical, and access partners. • Equip field leaders and account managers to deliver value beyond the product-through insights, partnerships, and ecosystem navigation. Business Planning & Continuous Learning Leveraging AI Innovation to Impact Performance • Introduce AI-enabled learning platforms and analytics to personalize learning journeys, predict skill gaps, and continuously improve performance outcomes. • Partner with Sales Operations and Analytics to connect learning data to sales performance, creating a closed-loop model that guides business planning and resource allocation. • Foster innovation in learning through emerging technologies-including adaptive learning, micro-learning, and experiential simulations-to accelerate readiness and impact Operational Excellence & Governance • Manage learning vendors and agencies to drive innovation, efficiency, and return on investment. • Oversee the CL&D budget, forecasting, and performance reporting, ensuring resources are optimized for maximum strategic value. Qualifications (Experience, Education, and Competencies) • Bachelor's degree or equivalent experience; Master's or MBA preferred. • 10-15 years of progressive experience in pharmaceutical or biotech commercial leadership, learning & development, or sales force excellence • Deep understanding of specialty dermatology markets, biologic therapies, and the access/fulfillment ecosystem. • Proven success designing and leading sales capability and leadership development programs in high-growth or launch environments. • Experience implementing AI-enabled, data-driven, or omnichannel learning systems preferred. • Strong cross-functional collaboration skills and executive presence, with the ability to influence across Sales, Access, Medical, Marketing, and HR. • Demonstrated track record of building high-performing, patient-focused commercial teams. • Excellent communication, facilitation, and presentation skills at all levels of the organization. • Willingness to travel 25-35% nationally for leadership summits, field engagements, and major learning initiatives. Key Success Measures • Enhanced sales force effectiveness and measurable improvements in coaching consistency. • Increased field fluency in Access & Fulfillment, driving improved patient access and provider satisfaction. • Accelerated leadership readiness and talent pipeline depth within Dermatology Sales. • Adoption of AI-enabled learning insights that link training performance to commercial outcomes. • Strong stakeholder engagement and cross-functional alignment on learning priorities. Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer. We Respect Your Privacy Learn more at: *********** incyte. com/privacy-policy The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate. During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here. You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work. You can learn more about Incyte's data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable). Please contact privacy@incyte. com if you have any questions or concerns or would like to exercise your rights.
    $110k-148k yearly est. 32d ago
  • Senior Lab and Endpoint Support Analyst

    Iovance Biotherapeutics Inc. 4.2company rating

    Iovance Biotherapeutics Inc. job in Philadelphia, PA

    Iovance Biotherapeutics is seeking Senior Lab and Endpoint Support Analyst to help ensure seamless, compliant device management and operational support for our lab infrastructure. This role is vital to both maintaining GxP compliance and enabling efficient endpoint/device operations. The successful candidate will bridge desktop and lab operations under the guidance of our endpoint engineer and collaborate with cross‑functional teams. This individual will also serve as the on-site owner of lab device asset management for lab manufacturing. Essential Functions and Responsibilities * Provide hands‑on support for lab devices, instrumentation, and endpoint systems, ensuring operational readiness and compliance with GxP regulations. * Serve as on‑site presence for lab shifts: support troubleshooting, incident triage, preventive maintenance, and quick resolution of lab device issues. * Create and upkeep of SOPs, documentation, SOP adherence, and maintenance of device validation records for audit readiness. * Serve as the on-site SME of lab device asset management and all asset management on the lab manufacturing side, ensuring accurate tracking, lifecycle management, and audit readiness. * Be the escalation point for the Operational issue in the Lab and be able to come in work as need be to support the shift duties if needed * SME for Lab support team in configuration, deployment, patching, imaging, and lifecycle management of devices (laptops, desktops, lab PCs, specialized lab instruments). * Manage device integrations: collaborate with engineers to roll out validated device builds, ensure correct configurations, security settings, and endpoint compliance. * Collaborate with the desk side team to ensure that all devices and systems are up to date with the latest security patches, software updates, firmware, and best practices. * Partner with Endpoint Engineering and/or Automation teams to identify process improvements and help automate manual desktop/lab support tasks. * Own and manage Lab Print Services by overseeing configuration, operation, and support of Lab and manufacturing printing systems used across Iovance labs, ensuring accuracy, compliance and minimal downtime. * Train and mentor junior level support staff on lab device protocols and endpoint management best practices. * Must adhere to Iovance Biotherapeutics' core values, policies, procedures, and business ethics * Perform miscellaneous IT duties as assigned. General Responsibilities: * Develop and maintain technical documentation, including knowledge base articles and SOPs * Collaborate cross-functionality with IT, Security, Infrastructure and Application teams on IT projects * Evaluate and recommend emerging technologies to improve end user experience * Share and help to implement continuous improvement ideas Required Education, Skills, and Knowledge * 8+ years of hands‑on IT support experience, especially with device endpoints (imaging, patching, builds) and lab device/instrument support. * Strong understanding of device management tools (MDM, Intune, SCCM, etc.) and experience ensuring endpoint security and configuration compliance. * Experience working in GxP / GMP / lab environments, understanding of regulatory requirements and validation documentation. * Knowledge of instrument connectivity, USB drivers, vendor software, lab network security. * Solid troubleshooting skills-hardware, software, networking-as applied to both typical desktops and specialized lab systems. * MS365 admin understanding and have a good understanding of Network concepts * Excellent communication skills, both written and verbal; ability to document configurations, incidents, and standard operating procedures. * Ability to work across shifts / flexible schedule to provide lab coverage. Preferred Education, Skills, and Knowledge * ITIL foundations * Demonstrated knowledge in both wired and wireless network technologies * Demonstrating excellent written, verbal and phone communications skills * Advanced troubleshooting and issue resolution skills. * Excellent communication, customer service, and interpersonal skills. * Ability to work independently and manage multiple priorities in a fast-paced environment. * Willing to work overtime and weekends when needed * Ability to make independent judgment calls to resolve urgent and critical matters * Can-do attitude, defaulting to "yes, we will figure out a way" * Automation or scripting experience (PowerShell, Bash, or similar) for device deployment or maintenance tasks. * Previous experience in biotech / manufacturing / lab operations. The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodation may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request accommodation. Physical Demands and Activities Required * Must be able to pass gowning requirements and be prepared to support in the cleanroom, gown required areas * Must be able to remain in a stationary position standing or sitting for prolonged periods of time. * Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly lift, carry, push, pull, or otherwise move objects. * Must have visual acuity to perform activities such as preparing and analyzing data and figures, viewing a computer screen, and extensive reading. * This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers. * Must be able to communicate with others to exchange information. Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines Work Environment This job works in a professional office environment and a manufacturing lab setting. Potential exposure to latex, bleach, loud noise, lab equipment hazards, strong odors, and chemical/biochemical is possible. Requires operating standard office equipment and keyboards. #LI-onsite The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time. Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual's race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact *******************. By voluntarily providing information and clicking "Submit Application", you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.
    $56k-72k yearly est. 60d+ ago
  • Shipping Logistics Specialist I

    Iovance Biotherapeutics 4.2company rating

    Iovance Biotherapeutics job in Philadelphia, PA

    The Shipping Logistics Specialist is responsible for the preparation, routing, and management of internal shipments derived from the Iovance Cell Therapy Center (iCTC) located in Navy Yard, PA and from Research and Product Development entities within the business unit as well as external shipments originating through affiliates associated with Iovance Biotherapeutics, Inc. The Shipping Logistics Specialist duties include reviewing shipment materials before distribution, collaborating with transportation systems to ensure prompt and accurate shipment pick-ups and deliveries, and monitoring shipment costs and productivity processes. Tuesday to Saturday - 8 hour day shift Essential Functions and Responsibilities: Assist with the planning and scheduling of shipments including documentation, physical preparation of packaging, pick-up and delivery arrangements, routing information, shipping instructions, and customs clearance procedures (if applicable) to ensure deliveries arrive on time and to their correct location, using a variety of transportation methods such as trucking companies, railroads, airlines, and/or shipping lines. Track goods in real time while enroute to their destination ensuring any problems that arise are resolved immediately to avoid potential delays; communicate issues to management that may hinder on time deliveries. Serve as primary point of contact for external Supply Chain Logistics team when handling inbound and outbound patient samples, tumors, and final product out of iCTC; ensure documentation, pick-up and delivery arrangements are scheduled and communicated to appropriate personnel involved in the shipment. Participate in the selection of best suited products or materials to estimate quantities or weight of shipments and type of container required for compliant storage and transport. Liaise with Finance for the preparation of invoices ensuring shipping costs are calculated accurately and passed onto respective departmental cost center. Negotiate rates with carriers and insurance agencies, and prepare tariffs for oversea shipments, ensuring approved budget targets are achieved as directed by the company. Interact with insurance companies to settle claims for damaged or lost items. Maintain a shipment database such as goods shipped, addresses, contact information, courier used, transportation method, shipment results, etc. that supports optimization efforts on future shipments. Create reports for senior management on various shipping metrics such as tracking shipments and costs, compile statistics about shipping volume and rates, monitor courier performance, and participate in continuous improvement opportunities with recommendations to enhance shipping efficacy and accuracy, while lowering costs. Performs other duties as assigned by leader. Required Education, Skills, and Knowledge 5+ years warehouse experience in a high-volume cGMP production or manufacturing environment. Working knowledge of MRP/ERP systems, APICS Certification is an asset. Proficient in MS Word, Excel, Outlook. Experience and/or certification in operating material handling equipment preferred (i.e. forklift). Ability to collaborate across disciplines. Strong interpersonal and team-building skills, effective communication (both written and verbal), proactive problem-solving and analytical skills. Possess the ability to bridge relationships between various departments, levels of the organization, supplier and customer organizations. Excellent organization skills and an ability to prioritize effectively to deliver results within reasonably established guidelines. Must be comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities with a strong attention to detail. Willingness to work flexible hours, including overtime and weekends. Preferred Education, Skills, and Knowledge Experience with cell therapy products. The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation. Physical Demands and Activities Required: Must be able to wear appropriate lab and clean room attire as well as all Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc. Able to stand and/or walk 90% (and sit 10%) of the scheduled workday which may include climbing ladders or steps. Must be able to use near vision to view samples at close range. Able to crouch, bend, twist, reach, and perform activities with repetitive motions. Must be able to lift and carry objects weighing 45 pounds. Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines. Work Environment: This position will work in both an office and a manufacturing setting. When in the lab, you may be exposed to various chemicals/biochemical, including latex and bleach. Additionally, there is potential for variable noise levels, equipment hazards, strong odors, and other detergents/sanitizers. #LI-onsite The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time. Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual's race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact *******************. By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.
    $42k-52k yearly est. Auto-Apply 25d ago
  • Maintenance Technician II-3rd Shift

    Iovance Biotherapeutics 4.2company rating

    Iovance Biotherapeutics job in Philadelphia, PA

    The Maintenance Technician II is responsible for the maintenance and repair of equipment, utilities and systems supporting cGMP Manufacturing, Laboratories, Warehouse and commercial office space. Perform planned and corrective maintenance according to written instructions, diagnose issues in the field in real-time, propose corrective solutions, and complete and review related Facilities GMP documents. Ensure the safety and compliance of all applicable systems. Shift: 3rd Shift Schedule: Wednesday to Saturday from 10pm to 9am. Essential Functions and Responsibilities Demonstrate a strong understanding of HVAC, mechanical, electrical and process utilities systems, and be able to troubleshoot and repair. Perform repairs/installations/upgrades to building components, including plumbing, electrical, HVAC, carpentry, painting, furniture, flooring and any other general repairs as necessary. Ability to read and interpret engineering and architectural drawings, including floor plans, reflected ceiling plans, power plans, panel schedules, mechanical/plumbing piping diagrams, Piping & Instrumentation Diagrams (P&IDs) Responsible for installing/reconfiguring furniture, chairs and associated equipment, and coordinate/assist with personnel moves within the facility. Accountable for the safety of all personnel and equipment within the facility. Monitor and respond to alarms generated from the BMS/QEMS, including on-call. Work with management to develop spare parts plans and ensure adequate inventory is maintained and tracked to support the maintenance and operation of the facility and equipment. Receive, filter and execute work order requests as necessary. Ensure that any equipment repairs or maintenance activities are compliant with any applicable building codes. Maintains records on equipment manufacturers' technical notices, upgrades and safety issues. Establishes programs and solutions for increasing up-time and for equipment problems that affect the manufacturing process. Work with external vendors for the service and/or repair of equipment. Conduct routine inspections of premises and equipment. Investigating problems and diagnosing and repairing faults. Must adhere to Iovance Biotherapeutics' core values, policies, procedures, and business ethics. Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations. Comply with cGMP procedures and policies. Perform miscellaneous/ other duties as assigned. Required Education, Skills, and Knowledge Associates Degree / Trade School / Technical Certification (HVAC/R, Electrical, Plumbing) or equivalent experience is required. Requires a minimum of 4 - 6 years of related experience. A Philadelphia Engineer Grade A License is required or ability to obtain within 6 months to 1 year. A strong background in operations and maintenance of chiller/boiler plants, pumps and AHU's is required. A strong background in operations and maintenance of electrical systems, including Emergency Generators, ATS's and Switchgear is required. Experience using Computerized Maintenance Management Software (Blue Mountain) is required. Experience using Building Management Systems and Environmental Monitoring Systems (Siemens Desigo or Insight) is required. Excellent oral and written communication skills required. Must have valid driver's license Preferred Education, Skills, and Knowledge 4-6 years of related Facilities and Maintenance experience preferred. Prior experience in cell therapy manufacturing or BioPharma/Life Sciences is highly desirable. Boiler license and/ or knowledge of boiler operations. The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation. Physical Demands and Activities Required: Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc. Must meet requirements for and be able to wear a half-face respirator. Able to stand and/or walk 90% (and sit 10%) of a 8-hr day which may include climbing ladders or steps. Able to crouch, bend, twist, reach, and perform activities with repetitive motions. Must be able to lift and carry objects weighing 50 pounds. Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadline. Work Environment: This position will work in office, manufacturing, and lab settings. When in the lab/ manufacturing space, must be able to work in settings with various chemical/biochemical exposures, including latex and bleach. Able to work in cleanroom with biohazards, human blood components, and chemicals. Potential exposure to noise and equipment hazards and strong odors. #LI-onsite The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time. Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual's race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact *******************. By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.
    $48k-59k yearly est. Auto-Apply 6d ago
  • Dermatology Therapeutic Specialist, PHILADELPHIA, PA

    Incyte 4.8company rating

    Philadelphia, PA job

    Overview Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value. The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules. Job Summary (Primary function) The Dermatology Therapeutic Specialist will focus on consistently achieving or exceeding revenue targets for the U. S. Incyte Dermatology business unit. The Dermatology Therapeutic Specialist will be the primary customer contact and will play a critical role in driving demand and successfully launching future medications within the dermatology specialty and other key segments. Keys to success will be scientific or biologic product experience, strong sales background, relationships and knowledge of the different segments within the dermatology specialty, and the ability to execute national level strategies around the new launch platforms to maximize business opportunities. Essential Functions of the Job (Key responsibilities) Represent in a professional, compliant, and ethical manner. Provide feedback on marketing tools, tactics and effectiveness of sales activities. Provide exceptional customer service through total account management, including product access, reimbursement and on-label medical questions. Execute on national level strategies, deliver branded and disease state sales messages, and planned promotional programs. Demonstrate and communicate in-depth knowledge of the clinical data for Incyte's products to external stakeholders. Develop and maintain strong disease state knowledge and exemplary selling skills. Create, develop and execute a strategic business plan that coordinates efforts with regional counterparts that reflects in-depth local market and account specific knowledge. Collaborate and coordinate with other field-based stakeholders in the territory and region to proactively address customer needs, identify market dynamics, and develop strategies to ensure optimal success. Consistently engage customers through in-person interactions or virtual meetings, as requested or required by a customer, within assigned geography, delivering scientific and clinically targeted messages to launch and grow current and future brands. Consistently achieve or exceed revenue targets. Qualifications (Minimal acceptable level of education, work experience, and competency) Discover - Develop - Deliver - Collaborate Demonstrated ability to gain consistent access and develop strong professional relationships with providers. Documented history of successful product launches in a highly competitive market. A drive to achieve and operate with a high degree of integrity within compliance guidelines. Results oriented with a history of successful sales performance, as demonstrated through various metrics and feedback. Extensive experience in biotech/pharmaceutical sales, with a focus on immunology or dermatology, is preferred. Candidates with diverse backgrounds and varying levels of experience are encouraged to apply. A bachelor's degree or equivalent experience is preferred. The ability to travel is required using various modes of transportation (car, air, train, etc. ). The level and frequency of travel, including overnights, will depend on the specific territory and/or business purpose or need. We encourage applications from individuals with diverse abilities and will provide necessary accommodations for travel. Possession of a valid driver's license and a satisfactory driving record, with accommodations available for individuals with disabilities who may require them. Effective communication skills. Strong business planning acumen, highly organized with strong account management skills. Strong knowledge of dermatology patient access programs, market access, specialty pharmacies and prior authorization pull-through initiatives. Work effectively in collaboration with cross-functional teams. The ability to work effectively in collaboration with team members in order to achieve a common goal. Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer. We Respect Your Privacy Learn more at: *********** incyte. com/privacy-policy The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate. During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here. You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work. You can learn more about Incyte's data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable). Please contact privacy@incyte. com if you have any questions or concerns or would like to exercise your rights.
    $25k-36k yearly est. 3d ago
  • Senior Director, Human Resources

    Incyte 4.8company rating

    Chadds Ford, PA job

    Overview Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value. The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules. Job Summary (Primary function) Incyte is seeking a strategic and collaborative Senior Director, HR Partner to support our US Dermatology Commercial organization. This role will serve as a trusted advisor to business leaders, aligning people strategies with commercial objectives while fostering a high-performance, compliant, and inclusive culture. Key Responsibilities Strategic Business Partnership Serve as a strategic HR partner to Commercial and Field leadership within the US Dermatology organization. Translate business objectives into integrated people strategies that support growth, capability building, and organizational effectiveness. Provide data-driven insights and recommendations on workforce planning, organizational design, and talent needs. Talent Management & Development Partner with leaders on talent assessment, succession planning, and leadership development initiatives. Support performance management processes, including goal setting, coaching, and development planning. Identify and address capability gaps through targeted development solutions. Employee Relations & Engagement Act as a first point of contact for employee relations matters, ensuring fair, consistent, and timely resolution in compliance with company policies and employment laws. Coach managers on effective people management, engagement, and change leadership. Support employee engagement initiatives that reinforce Incyte's values and culture. Change Management & Organizational Effectiveness Lead and support change management efforts related to commercial transformations, new product launches, and evolving operating models. Partner with HR Centers of Excellence (COEs) to deliver scalable solutions in areas such as compensation, benefits, learning, and DE&I. Support field-based and home-office teams, ensuring alignment and consistency across a geographically dispersed workforce. Compliance & Governance Ensure adherence to all employment laws, regulatory requirements, and internal policies, particularly in a highly regulated pharmaceutical environment. Partner with Legal and Compliance as needed to mitigate risk and support sound people decisions. Qualifications Required Bachelor's degree in Human Resources, Business Administration, or a related field. 7+ years of progressive HR experience, with demonstrated success as an HR Business Partner or HR Partner. Experience supporting Commercial organizations, preferably in the pharmaceutical, biotech, or life sciences industry. Strong knowledge of US employment law and HR best practices. Proven ability to influence and partner effectively with senior leaders. Excellent communication, coaching, and problem-solving skills. Preferred Master's degree or HR certification (e. g. , SHRM-CP/-SCP, PHR/SPHR). Experience supporting field-based sales organizations. Familiarity with dermatology, specialty, or rare disease commercial models. Experience working in a matrixed, fast-paced environment. Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer. We Respect Your Privacy Learn more at: *********** incyte. com/privacy-policy The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate. During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here. You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work. You can learn more about Incyte's data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable). Please contact privacy@incyte. com if you have any questions or concerns or would like to exercise your rights.
    $166k-223k yearly est. 28d ago
  • Exec. Dir., Oncology Training & Development

    Incyte 4.8company rating

    Chadds Ford, PA job

    Overview Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value. The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules. Job Summary: The Exec. Director, Oncology Training & Development is responsible for establishing and executing the strategic vision for all Sales, Marketing, and Market Access training initiatives within the Oncology business unit. This leader will design, deliver, and manage comprehensive training programs to ensure the commercial organization is equipped with the knowledge, skills, and resources necessary to excel in a dynamic oncology market. The role oversees the development and implementation of training curricula for new product launches, ongoing product education, and leadership development, ensuring alignment with organizational goals and compliance standards. Responsibilities: · Develop and implement the overall training strategy for Oncology Sales, Marketing, and Market Access ensuring alignment with business objectives and market evolution. · Design, deliver, and manage all aspects of the Oncology Sales, Marketing, and Market Access and Business Operations training curriculum, including new hire onboarding, product launches, disease state education, and ongoing professional and leadership development. · Partner with Incyte's Director, Employee Development on enterprise-wide development initiatives. · Hire, lead, and develop a high-performing training team responsible for the creation and delivery of training programs. · Partner with Medical, Legal, Regulatory, and Commercial teams to ensure all training materials are accurate, compliant, and up-to-date. · Establish and maintain the LMS to roll out, track, and report on all training activities for the Oncology commercial organization. · Oversee the training budget, optimizing the use of internal and external resources to maximize impact and efficiency. · Regularly assess training effectiveness and implement improvements based on feedback, business needs, and market changes. · Develop and deliver programs focused on both sales effectiveness and leadership capabilities within the Oncology commercial team. · Ensure all training content reflects the latest developments in oncology, including key brands and emerging products. · Submit all training materials through the Medical, Legal, and Regulatory (MLR) review process to ensure compliance with industry standards. Qualifications: · Bachelor's degree required; advanced degree or relevant certifications preferred. · Significant years' experience in leadership development, talent management, or organizational effectiveness · Extensive experience in pharmaceutical/biotechnology industry, with a strong preference for oncology/hematology market knowledge. · Proven track record in Sales and/or Marketing training and development, including leadership roles. · Experience with adult learning principles, instructional design, and e-learning technologies. · Strong organizational, communication, and leadership skills. · Proficiency in Microsoft Office Suite (Word, PowerPoint, Excel, Access). · Ability to manage multiple projects and priorities in a fast-paced environment. · Demonstrated ability to collaborate cross-functionally and influence without authority. · Willingness and ability to travel (15-20%) Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer. We Respect Your Privacy Learn more at: *********** incyte. com/privacy-policy The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate. During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here. You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work. You can learn more about Incyte's data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable). Please contact privacy@incyte. com if you have any questions or concerns or would like to exercise your rights.
    $142k-209k yearly est. 60d+ ago
  • Senior Specialist, Quality Control Lab Technical Support - Analytical

    Iovance Biotherapeutics Inc. 4.2company rating

    Iovance Biotherapeutics Inc. job in Philadelphia, PA

    Iovance Biotherapeutics is a growing, late-stage company focused on the development and commercialization of novel cancer immunotherapies. The Senior Quality Control Analyst, Lab Technical Support-Analytical will support flow cytometry and potency method qualification/validation, method technical transfer, and product release testing at Iovance's integrated Cell Therapy Center (iCTC). This role requires hands-on laboratory experience in at least two (2) of the following areas: cell culture / maintenance and cell count determination (NC-200), cell-based potency methods utilizing various immunoassay platforms (ELISA, ELLA, etc.), and/or identity / characterization / potency methods using multicolor flow cytometry platforms. This position will support the onboarding of new, or updating of existing, methods for the QC analytical team for release testing of cell therapy products. You may be required to work occasional weekends and holidays to complete assigned work. Essential Functions and Responsibilities: * Collaborate effectively with the Iovance Analytical Development (AD) and Analytical Sciences and Technology (ASAT) departments to perform assay qualification, validation, and technical transfer of updated and new methods. * Act as subject matter expert (SME) and train laboratory personnel on new and revised methods. * As needed to support product release, perform GMP laboratory testing with minimal to no errors, while ensuring testing is completed and documented in compliance with all applicable procedures, standards, and GMP/GDP regulations. * Author, review, and approve technical documents including but not limited to protocols, reports, and SOPs. * Contribute ideas for process improvements and technology enhancements in the QC laboratories. * Support thorough GMP investigations for quality events (e.g. deviations, invalid assays, OOS). * Initiate and support quality documents such as deviations, laboratory investigations, CAPAs, and change controls. * Perform technical review of laboratory data and logbooks. * Support Health Authority inspections. * Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations. * Other responsibilities as assigned. Required Education, Skills, and Knowledge * Degree in Biology, Immunology, Microbiology, Molecular & Cell Biology, or related scientific field, with 8+ (Bachelor's), 6+ (Master's) or 3+ (Ph.D.) years of relevant experience. * Minimum of three (3) years of GMP experience in the pharmaceutical industry within Quality Control or related function (e.g. AD or ASAT). * Solid understanding, functional knowledge, and hands-on experience with two (2) or more of the following: multicolor flow cytometry, cell-based potency, or cell culture with cell enumeration (NC-200). * Experienced technical writer (e.g., technical reports, test methods, SOPs, protocols, deviations, CAPAs, change controls) * Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity. * Successfully interface with multi-disciplined teams. * Operate at a consistent and high level of efficiency, producing high quality and accurate results. * Extremely detail-oriented with strong technical laboratory skills. * High level of ownership and accountability. * Demonstrate sense of urgency; ability to recognize time sensitivity. * Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint) * Must adhere to Iovance Biotherapeutics' core values, policies, procedures, and business ethics. Preferred Education, Skills, and Knowledge * Experience with cell therapy products. The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodation may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request accommodation. Physical Demands and Activities Required: * Must be able to wear appropriate lab and clean room attire as well as all Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc. * Able to stand and/or walk 90% (and sit 10%) of the scheduled workday which may include climbing ladders or steps. * Must be able to use near vision to view samples at close range. * Able to crouch, bend, twist, reach, and perform activities with repetitive motions. * Must be able to lift and carry objects weighing 45 pounds. Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines. Work Environment: This position will work in both an office and a manufacturing setting. When in the lab, you may be exposed to various chemicals/biochemical, including latex and bleach. Additionally, there is potential for variable noise levels, equipment hazards, strong odors, and other detergents/sanitizers. #LI-onsite The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time. Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual's race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact *******************. By voluntarily providing information and clicking "Submit Application", you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.
    $50k-68k yearly est. 48d ago
  • Senior Medical Director, US Oncology Medical Affairs

    Incyte 4.8company rating

    Chadds Ford, PA job

    Overview Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value. The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules. Job Summary (Primary function) The Senior Medical Director, US Medical Affairs executes Medical Affairs programs and deliverables through partnership with Medical Science Liaisons, Scientific Communications, Publications, Health Economics and Outcomes Research (HEOR), Clinical Development, and the Commercial Team. The role is accountable for high quality execution of Medical Affairs activities. The Sr. Medical Director plays a key role in the establishment and maintenance of key partnerships and collaborations, and the support of relationships with external experts, both directly, and in conjunction with, the Medical Science Liaison team. Essential Functions of the Job (Key responsibilities) Provide support for planning and execution of the ruxolitinib Medical Affairs program strategy. Expertly deliver scientific and medical information and interpretation of clinical research findings. Provide medical and scientific expertise in a cross-functional environment to field based medical science liaisons as well as internal stakeholders (Medical Affairs functions, Marketing Department, Clinical Development, Clinical Operations, Regulatory Affairs, Biostatistics, and Drug Safety/ Pharmacovigilance Department, Sales Training). Participate in the design, conduct, analysis, and reporting of Medical Affairs led clinical trial and observational studies. Provide scientific review and expertise for independent investigator-sponsored trials (ISTs). Support lifecycle management activities for ruxolitinib. Plan and execute medical advisory boards. Provide Medical expertise to the Commercial organization, including review of promotional materials, sales training, and speaker training for promotional programs. Interface with external experts and health care professionals at major medical conferences, advisory boards, and other external meetings. Maintain high level of expertise in oncology / hematology and serve as key medical resource for the oncology therapeutic area and on specific products. Provision of medical/scientific expertise for relevant marketing materials (including all promotional material) copy review in the Medical-Legal-Regulatory (MLR) Committee. Interact with the Medical Affairs function at Novartis, our partner for activities outside of the U. S. Develop, track, execute and report on goals and objectives. Be accountable for compliant business practices. Qualifications (Minimal acceptable level of education, work experience, and competency) M. D. degree or equivalent. ABIM Board Certified or Board Eligible status in Hematology, Medical Oncology or Internal Medicine (equivalent foreign certification accepted). Pharmaceutical industry work experience of 5+ years preferred. Experience as either Medical Monitor for Industry-sponsored studies or (principal or associate) Clinical Investigator in academia. Medical Affairs, Understanding of Clinical Development and Commercial activities is preferred. Ability to partner effectively with Field Medical staff is required. Solid understanding of Health Economics and Payer environment is preferred. Strong clinical insight, understanding of translational medicine and knowledge of clinical trials, including registries, and successful prior experience in the management of an IST portfolio. Strong business acumen, vision and perspective. Ability to comprehend and combine complex sets of data. Ability to educate internal stakeholders on disease state and/or product/ brand-specific information. Ability to present and discuss complex clinical, medical, biological, or translational data. Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer. We Respect Your Privacy Learn more at: *********** incyte. com/privacy-policy The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate. During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here. You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work. You can learn more about Incyte's data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable). Please contact privacy@incyte. com if you have any questions or concerns or would like to exercise your rights.
    $229k-320k yearly est. 41d ago
  • Associate Quality Control Specialist, Document Control [Contract to Hire]

    Iovance Biotherapeutics 4.2company rating

    Iovance Biotherapeutics job in Philadelphia, PA

    The Associate Quality Control Specialist, Document Control is located at Iovance Cell Therapy Center (iCTC) in Philadelphia, PA. This position requires full-time on-site presence. This position is responsible for supporting the Quality Document Control program at the iCTC facility and ensuring compliance to quality objectives and regulatory standards. The individual must have a strong quality mindset. Shift: Wednesday to Saturday from 9am to 8pm. Essential Functions and Responsibilities Responsible for issuance of logbooks, protocols, and any applicable controlled documents. Maintains the archival of GMP Ensures all GMP documents are complete, well organized, controlled, filed and tracked accurately in trackers and Electronic Document Management System (eDMS), if applicable, and easily retrievable. Independently manage, process, review, and approve the archival of documents in the eDMS. Provides user assistance on eDMS Provides support for internal and regulatory audits and inspections as required. Responsible for basic problem solving related to job responsibilities. Assists with maintaining Quality Assurance Document Control tracking tools for metric purposes. Provides continuous feedback on improvements to Document Control processes. Escalates issues or concerns to Area Management. Must adhere to Iovance Biotherapeutics' core values, policies, procedures, and business ethics. Performs miscellaneous duties required to complete the responsibilities stated in this Job Description (i.e. maintaining inventory of supplies and purchasing, maintaining the work area tidy, etc.). Perform other duties assigned by the area management, which may or may not be associated with projects. Based on business needs, training on document and label issuance for Manufacturing department and, cross-training and assisting other teams within Quality Assurance department may be required. Travel - none required Preferred Education, Skills, and Knowledge Bachelor's degree in Life Sciences discipline is preferred, but not required. Strong computer skills including MS Office Suite. Experience in archival and document change management is preferred, but not required. Must possess a high level of attention to details and have a strong quality mindset. Must be organized Familiarity with cGMP, FDA regulations is preferred, but not required. Highly motivated and a team player. Ability to work effectively on multiple projects simultaneously and able to follow procedures and instructions. Strong interpersonal and communication skills. The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation. Physical Demands and Activities Required Must be able to remain in a stationary position standing or sitting for prolonged periods of time. Able to crouch, bend, twist, reach, and perform activities with repetitive motions. Able to stand and/or walk in a 10-hr day which may include climbing ladders or steps. Must be able to move about inside an office and exert up to 30 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects. Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, safety glasses, etc. Must comply with Safety SOPs and laboratory procedures per the company policy. Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading. This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers. Must be able to communicate with others to exchange information. Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines. Work Environment This job works in a professional office environment and a manufacturing lab setting. Potential exposure to latex, bleach, loud noise, lab equipment hazards, strong odors, and chemical/biochemical is possible. Requires operating standard office equipment and keyboards. #LI-onsite The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time. Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual's race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact *******************. By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.
    $50k-67k yearly est. Auto-Apply 1d ago
  • Sr. Director, Market Access Operations - Dermatology

    Incyte 4.8company rating

    Chadds Ford, PA job

    Overview Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value. The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules. Job Summary The Senior Director, Market Access Operations is a critical leadership role responsible for developing and executing operational strategy and advanced analytics that enable patient access and payer engagement across the U. S. organization. This individual will oversee HUB, Payer and copay analytics to drive performance, field enablement, and data-driven decision-making. The Executive/Senior Director will partner cross-functionally with Market Access, Product Strategy, Finance, and Sales to deliver market access insights and operational excellence in a dynamic and evolving healthcare landscape. Essential Functions of the Job (Key responsibilities) · Lead, mentor, and develop a high-performing team of market access operations and analytics professionals, fostering collaboration, accountability, and innovation. · Lead performance monitoring across all market access functions and provide regular executive updates on trends, opportunities, and risks. · Oversee all aspects of Market Access operations and analytics, ensuring accuracy, integrity, and compliance with legal, regulatory, and corporate standards. · Design in partnership with market access leadership team KPIs and performance metrics to evaluate Field Access Manager effectiveness, account pull-through activities, access education, and patient case resolution. · Provide integrated, actionable insights to senior leadership and cross-functional stakeholders to shape market access strategy and execution. · Collaborate with Data Management, BIS, and market access vendors to enhance data acquisition, governance, and processing pipelines supporting access operations. · Inform on going access-related brand planning and go-to-market strategies using evidence-based analytics. Qualifications (Minimal acceptable level of education, work experience, and competency) · BA or BS degree or equivalent experience, degrees in mathematical background preferred. · Extensive years of experience in Market Access, Commercial Analytics, or Operations within the pharmaceutical/biotech industry. · Proficiency with market access data sources · Expertise in analytics for Hub services, copay programs, payer dynamics, and field access models (FAMs, PAMs) · Experience in managing and developing direct reports. Proven experience in motivating high performance teams and versed in techniques for effective coaching, communication, and working styles. · Proficient in all aspects of analyzing healthcare sales data and field activities. · Proficient in customer relationship management systems for Market Access teams · Excellent verbal, written and stakeholder management skills to effectively influence and manage expectations with sales management and cross-functional teams. · Strong project management skills. · Willingness to travel up to 20% domestically Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer. We Respect Your Privacy Learn more at: *********** incyte. com/privacy-policy The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate. During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here. You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work. You can learn more about Incyte's data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable). Please contact privacy@incyte. com if you have any questions or concerns or would like to exercise your rights.
    $120k-160k yearly est. 60d+ ago
  • Manager/Sr. Manager, BIS, Business Intelligence - Market Access (Dermatology)

    Incyte 4.8company rating

    Chadds Ford, PA job

    Overview Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value. The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules. The Manager/Sr. Manager, BIS, Business Intelligence - Market Access, part of Dermatology Business Operations, delivers dashboard and reporting solutions in support of key business objectives with a primary focus on market access business initiatives. Reporting to the Associate Director, Business Information Services - Market Access, this role is a key member of a larger team responsible for providing integrated technology solutions across CRM, Business Intelligence (BI), data platforms, and other critical commercial systems. Essential Functions of the Job (Key responsibilities) Serve as lead technical partner to Dermatology Business Unit stakeholders as it relates to business intelligence (BI) solutions such as dashboards and reporting. Lead end-to-end development dashboards/reporting solutions including taking an active role in eliciting, documenting, designing, building, and testing BI and products in support of key customers and business initiatives. Drive BI product development through user experience and interface design, prototyping, development, and continuous improvement. Manage third party vendors through development, testing and support of BI applications. Support Commercial Market Access and Market Access Operations, Product Strategy, Medical Affairs, Finance, Compliance and liaise with Incyte IT as projects or requirements dictate. Manage and maintain source files, data sources, and internal and external data exchanges in support of the US Business Unit. Daily involvement and understanding of data integration and business-rule processing related to Incyte's Master Data Management and Data Warehousing systems. Develop operational procedures and oversee successful execution of data flows and report refreshes to ensure timely, accurate delivery of dashboards to stakeholders Qualifications (Minimal acceptable level of education, work experience, and competency) Bachelor's degree required. Experienced Business Intelligence developer with 5+ years of BI reporting experience. Strong skills with at least one of the major BI tools (Power BI, Qlik, Tableau, etc), Power BI experience preferred. Experience working with pharmaceutical data sets such as IQVIA Xponent data, CRM and Multi-channel engagement data 3 - 5 years of pharmaceutical experience required. Proven ability to work with stakeholders to extract, articulate, and document report requirements. Proven ability to manage third party vendors and internal partners to ensure projects are completed on-time and on-budget. Intermediate level technical understanding of the data warehousing processing specific to the NA Business Unit. Strong sense of customer service; ability to interact with employees spanning all levels of the organization. Expert in Microsoft Office applications (Excel, Access, Word, PowerPoint). Functional knowledge of databases and SQL required. Knowledge of Azure data factories, Databricks, and Synapse Analytics preferred. Excellent organizational skills, written and oral communications. Proven ability to multi-task. Demonstrated ability to manage and/or actively participate in multiple simultaneous projects. Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer. We Respect Your Privacy Learn more at: *********** incyte. com/privacy-policy The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate. During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here. You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work. You can learn more about Incyte's data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable). Please contact privacy@incyte. com if you have any questions or concerns or would like to exercise your rights.
    $102k-128k yearly est. 60d+ ago
  • Senior Manager / Associate Director, Marketing Operations

    Incyte 4.8company rating

    Chadds Ford, PA job

    Overview Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value. The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules. Job Summary: The Senior Manager / Associate Director of Marketing Operations will play a critical role in driving operational excellence across the organization. This position focuses on process improvement through AI, automation, and analytics, ensuring efficiency and scalability in workflows. This position will also oversee the Digital Asset Management (DAM) function, partnering with the DAM contractor to maintain and optimize the reference and digital asset repository within Veeva. Additionally, the role will serve as a backup MLR Manager, supporting the end-to-end promotional review process. Key Responsibilities Process Optimization & Innovation Lead initiatives to streamline marketing operations through AI-driven solutions, automation, and advanced analytics. Identify and implement process improvements that enhance speed, compliance, and quality across marketing workflows. Develop dashboards and reporting tools to provide actionable insights for stakeholders. Digital Asset Management (DAM) Partner with the DAM contractor to manage and optimize the Veeva Vault repository for digital assets and references. Ensure proper tagging, organization, and governance of assets to enable easy retrieval and compliance. Support training and best practices for asset management across teams. MLR Support Serve as backup for the Medical, Legal, Regulatory (MLR) review process, ensuring timely and compliant review of promotional materials. Maintain knowledge of regulatory requirements and internal SOPs to support accurate and efficient review cycles. Cross-Functional Collaboration Work closely with marketing, compliance, IT, and external vendors to ensure seamless integration of tools and processes. Act as a subject matter expert for marketing operations technology and compliance workflows. Qualifications Bachelor's degree in Marketing, Business, or related field; advanced degree preferred. 7+ years of experience in marketing operations, commercial operations, business analytics, or related roles within the pharmaceutical industry. Strong understanding of MLR processes, promotional review requirements, and digital asset management systems (Veeva experience strongly preferred). Proven track record in process improvement, automation, and leveraging AI/analytics for operational efficiency. Excellent project management, communication, and stakeholder engagement skills. Core Competencies Strategic Thinking: Ability to identify opportunities for operational improvement and align initiatives with business objectives. Results Oriented: Ability to deliver actionable results with minimal direction Technical Acumen: Strong understanding of AI, automation tools, and analytics platforms to drive innovation. Collaboration & Influence: Skilled at building relationships and influencing cross-functional teams to achieve shared goals. Problem-Solving: Proactive in diagnosing issues and implementing effective, scalable solutions. Adaptability: Comfortable navigating change and driving adoption of new technologies and processes. Attention to Detail: Ensures accuracy and compliance in all aspects of marketing operations and asset management. Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer. We Respect Your Privacy Learn more at: *********** incyte. com/privacy-policy The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate. During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here. You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work. You can learn more about Incyte's data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable). Please contact privacy@incyte. com if you have any questions or concerns or would like to exercise your rights.
    $95k-125k yearly est. 7d ago
  • Manager, Environment, Health & Safety

    Iovance Biotherapeutics 4.2company rating

    Iovance Biotherapeutics job in Philadelphia, PA

    The Senior Manager, Environment, Health & Safety role is responsible for providing compliant EHS programs to all departments at the IOVA-A facility. Integrates EHS programs into daily operations to assure regulatory compliance, achieves continuous performance improvement, meeting EHS performance objectives. Partners with operations to develop objectives to achieve these goals in alignment with site business goals and values. Provides technical leadership to ensures the biological safety programs adhere to federal, state, and local EHS regulations. Manages the day-to-day requirements and activities of the EHS incident management and reporting system. Essential Functions and Responsibilities Serves as the site subject matter expert regarding general safety, chemical hygiene, biosafety (BSL 2), and environmental management. Implements new and improves existing EHS programs to ensure compliance with federal, state, and local environmental, safety, medical surveillance and sustainability laws, regulations, codes, rules, and consensus standards. Provides and executes programs, policies, procedures, and trainings as the site SME for high-risk work programs including but not limited to working from heights, electrical safety, hot work, confined space entry, lockout tagout, and contractor safety. Completes hazard assessments, coordinates IH monitoring, process hazard analysis, life safety reviews, incident investigations, environmental reports, and permit applications as needed. Participates in and supports EHS operational and tier discussions, safety committees and teams, self-assessments, and audits. Reviews processes, facilities, procedures, and management of change documents to assure conformance to recognized EHS regulations, standards, and guidelines. Provides support to staff in completing injury/illness investigations, additional training, data analysis, and addresses specific concerns as they are raised. Participates in regulatory inspections and assists in addressing noted concerns and citations. Reviews site data for the EHS reporting system (Enablon); manages user permissions; identifies data gaps and other concerns; generates output reports and dashboards using the appropriate BI tools; tracks and communicates EHS score card metrics. Perform miscellaneous duties as assigned. Travel May require up to 5% domestic travel. Required Education, Skills, and Knowledge Bachelor's degree in Occupational Safety, Industrial Hygiene, Chemical Engineering, Process Safety Management, or a related technical discipline required. Minimum 8 years relevant EHS work experience required. Technical working knowledge of federal, state, and local regulations as well as CDC, NIH, BMBL guidelines, and other regulations and consensus standards required. Preferred Education, Skills, and Knowledge RBP, CBSP, CIH, and/or CSP certification preferred. Working knowledge of six-sigma and operational excellence a plus. Experience with GMP environments and biotechnology processes preferred. Demonstrated ability to quickly interpret complex regulatory issues and provide recommended course of action. Strong written and verbal communication skills with the ability to communicate clearly to all levels of the organization. Self-motivated, flexible, creative, able to prioritize, and work in a fast-paced, dynamic environment and effectively deal with conflicting and changing priorities. Strong working knowledge of computers and programs including Microsoft Office, SharePoint, Teams, Enablon, etc. Excellent interpersonal, relationship management, and organizational skills. Physical Demands and Activities Required: Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc. Must meet requirements for and be able to wear a half-face respirator. Able to stand and/or walk 90% (and sit 10%) of a 10-hr day which may include climbing ladders or steps. Able to crouch, bend, twist, reach, and perform activities with repetitive motions. Must be able to lift and carry objects weighing 45 pounds. The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation. Work Environment: This position will work in both an office and a manufacturing lab setting. When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach. Able to work in cleanroom with biohazards, human blood components, and chemicals. Potential exposure to noise and equipment hazards and strong odors. #LI-Onsite The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time. Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual's race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact *******************. By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.
    $61k-79k yearly est. Auto-Apply 60d+ ago
  • Shipping Logistics Specialist I

    Iovance Biotherapeutics Inc. 4.2company rating

    Iovance Biotherapeutics Inc. job in Philadelphia, PA

    The Shipping Logistics Specialist is responsible for the preparation, routing, and management of internal shipments derived from the Iovance Cell Therapy Center (iCTC) located in Navy Yard, PA and from Research and Product Development entities within the business unit as well as external shipments originating through affiliates associated with Iovance Biotherapeutics, Inc. The Shipping Logistics Specialist duties include reviewing shipment materials before distribution, collaborating with transportation systems to ensure prompt and accurate shipment pick-ups and deliveries, and monitoring shipment costs and productivity processes. Tuesday to Saturday - 8 hour day shift Essential Functions and Responsibilities: * Assist with the planning and scheduling of shipments including documentation, physical preparation of packaging, pick-up and delivery arrangements, routing information, shipping instructions, and customs clearance procedures (if applicable) to ensure deliveries arrive on time and to their correct location, using a variety of transportation methods such as trucking companies, railroads, airlines, and/or shipping lines. * Track goods in real time while enroute to their destination ensuring any problems that arise are resolved immediately to avoid potential delays; communicate issues to management that may hinder on time deliveries. * Serve as primary point of contact for external Supply Chain Logistics team when handling inbound and outbound patient samples, tumors, and final product out of iCTC; ensure documentation, pick-up and delivery arrangements are scheduled and communicated to appropriate personnel involved in the shipment. * Participate in the selection of best suited products or materials to estimate quantities or weight of shipments and type of container required for compliant storage and transport. * Liaise with Finance for the preparation of invoices ensuring shipping costs are calculated accurately and passed onto respective departmental cost center. * Negotiate rates with carriers and insurance agencies, and prepare tariffs for oversea shipments, ensuring approved budget targets are achieved as directed by the company. * Interact with insurance companies to settle claims for damaged or lost items. * Maintain a shipment database such as goods shipped, addresses, contact information, courier used, transportation method, shipment results, etc. that supports optimization efforts on future shipments. * Create reports for senior management on various shipping metrics such as tracking shipments and costs, compile statistics about shipping volume and rates, monitor courier performance, and participate in continuous improvement opportunities with recommendations to enhance shipping efficacy and accuracy, while lowering costs. * Performs other duties as assigned by leader. Required Education, Skills, and Knowledge * 5+ years warehouse experience in a high-volume cGMP production or manufacturing environment. * Working knowledge of MRP/ERP systems, APICS Certification is an asset. * Proficient in MS Word, Excel, Outlook. * Experience and/or certification in operating material handling equipment preferred (i.e. forklift). * Ability to collaborate across disciplines. * Strong interpersonal and team-building skills, effective communication (both written and verbal), proactive problem-solving and analytical skills. * Possess the ability to bridge relationships between various departments, levels of the organization, supplier and customer organizations. * Excellent organization skills and an ability to prioritize effectively to deliver results within reasonably established guidelines. * Must be comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities with a strong attention to detail. * Willingness to work flexible hours, including overtime and weekends. Preferred Education, Skills, and Knowledge * Experience with cell therapy products. The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation. Physical Demands and Activities Required: * Must be able to wear appropriate lab and clean room attire as well as all Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc. * Able to stand and/or walk 90% (and sit 10%) of the scheduled workday which may include climbing ladders or steps. * Must be able to use near vision to view samples at close range. * Able to crouch, bend, twist, reach, and perform activities with repetitive motions. * Must be able to lift and carry objects weighing 45 pounds. Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines. Work Environment: This position will work in both an office and a manufacturing setting. When in the lab, you may be exposed to various chemicals/biochemical, including latex and bleach. Additionally, there is potential for variable noise levels, equipment hazards, strong odors, and other detergents/sanitizers. #LI-onsite The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time. Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual's race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact *******************. By voluntarily providing information and clicking "Submit Application", you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.
    $42k-52k yearly est. 22d ago
  • Associate Director, MSL Training, IAI

    Incyte 4.8company rating

    Chadds Ford, PA job

    Overview Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value. The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules. Job Summary (Primary function) The Associate Director, Medical Affairs Training, Dermatology/IAI composes, designs, and executes a training plan in accordance with Medical Affairs strategy that drives scientific expertise and related business acumen. The incumbent is responsible for the management of the training framework, inclusive of both scientific and non-medical curricula, training documentation, and creation of related medical content with the objective of aligning training priorities with business and employee needs. This position will report to the Director, Medical Communications - Dermatology/IAI. Essential Functions of the Job (Key responsibilities) · Designs and implements a training plan in alignment with Dermatology/IAI Medical strategic goals and objectives with input from appropriate subject matter experts to support the scientific and non-medical training needs of the Medical team · Establishes effective working relationships with Medical Directors and cross-functional colleagues in Development, Global Medical Affairs, Legal, Regulatory, Compliance and Commercial at Incyte, as well as external opinion leaders, in support of ensuring comprehensive training for the Medical team · Creates scientific training materials, including clinical Q&As, product/disease state backgrounders, and slide decks · Supports the creation and maintenance of an internal LMS platform, including access, content, and routine updates · Assesses effectiveness of training program and identifies skill gaps; ensures implementation of innovative training initiatives that effectively address these issues · Formulates training curriculum for new field Medical hires and assists field leadership in establishing expectations and the certification process. Provides hands-on coaching to support both new hire and ongoing strategic education · Ensures that appropriate employee assessments are in place and conducted on a regular basis through routine field visits (~10 per year) and communicates feedback and recommendations to field leadership · Partners with leadership to implement soft-skills trainings to develop leadership and business acumen of Medical Affairs personnel to achieve the technical, medical, and interpersonal competencies of their roles · Sources, evaluates, and selects vendors to implement robust and cost-effective training courses, and leads development of agendas for training programs in Medical Affairs as required · Leads cross functional competitive readiness activities, including maintaining current competitive landscape documents and organizing pre- and post-conference training. Collaborates with field Medical on monthly journal clubs and competitive insights reporting · Ensures the appropriate documentation and tracking of training activities to ensure all legal, regulatory, and compliance requirements are met Qualifications (Minimal acceptable level of education, work experience, and competency) · Qualified candidates will have advanced degrees (MD, PharmD, PhD) with a minimum of 5 years' Medical Affairs experience within the pharmaceutical industry. Prior experience as MSL or Medical Trainer is strongly preferred · Knowledge/familiarity with dermatologic/immunologic conditions is preferred · Certification in education and knowledge of adult learning principles, including the ability to appraise needs, problem-solve and select alternative methods to support a variety of learning styles is strongly desired · Excellent written, verbal, presentation, interpersonal communication, and leadership skills · Flexible, with a positive attitude, strong ability to multitask, prioritize projects effectively and communicate at all levels within the company · Strong negotiation, strategic influencing, and planning skills. Must demonstrate initiative, project management skills, analytical and critical thinking skills · Proven ability to perform successfully under stringent timelines while delivering desired results · Excellent computer skills: Excel, Word, Power Point, Microsoft, Outlook/Office · Ability to collaborate with multidisciplinary teams to ensure the execution of deliverables successfully · Ability to work as a collaborative team member in a dynamic environment · Must be knowledgeable on pharmaceutical regulations (PhRMA), guidelines (ACCME, OIG, FDA) ensuring consistent best practices across all activities · Up to 20% of domestic travel required, including field visits Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer. We Respect Your Privacy Learn more at: *********** incyte. com/privacy-policy The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate. During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here. You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work. You can learn more about Incyte's data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable). Please contact privacy@incyte. com if you have any questions or concerns or would like to exercise your rights.
    $123k-161k yearly est. 60d+ ago

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