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Iovance Biotherapeutics jobs in Philadelphia, PA

- 35 jobs
  • Warehouse Supervisor-Shift: 11/12 Hour Days, Sunday - Wednesday; 7:30am - 8:00pm

    Iovance 4.2company rating

    Iovance job in Philadelphia, PA

    The Warehouse Supervisor is responsible for overseeing the day-to-day operations of the warehouse at the Iovance Cell Therapy Center (iCTC) located in Navy Yard, PA. They allocate necessary resources to meet established deadlines, monitor the productivity of the warehouse staff and when required shift operational focus swiftly when pressing matters arise. The Warehouse Supervisor recommends new strategies to improve efficiencies, compliance, safety and set new internal and external customer service standards to accomplish the desired goals. Shift: 11/12 Hour Day Shift, Sunday - Wednesday; 7:30am - 8:00pm Essential Functions and Responsibilities Schedule daily workloads to warehouse team members, ensuring staffing levels can achieve the expected output for each workstream under predetermined timelines associated with each task, and evaluate demonstrated outputs against key performance indicator targets. Monitoring the flow of goods through the warehouse to ensure orders are processed efficiently and accurately as per defined schedule, advise management of potential gaps or misses and provide resolution efforts to mitigate unexpected delays. Participate in the development of educational curriculum related to all warehouse standard operating procedures and actively train new hires and/or existing employees subject to the acquisition of new skills relevant to their respective job function. Research inventory discrepancies, reconcile within appropriate inventory management system when required and recommend preventive measures or process modifications to prevent future variances. Lead continuous improvement opportunities and lean six sigma projects that drive increased efficiency, lean productivity, improved quality compliance, and innovative safety initiatives. Monitor condition of equipment and facilities to ensure they are effective, safe and secure, update operational procedures and work instructions as necessary to reflect process improvements or corrective actions associated with equipment or facility investigations. Lead audit preparation workshops and subsequent potential audit observations followed by implementation of appropriate corrective actions. Assign 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. Participate in the scheduling of required technical training on relevant SOPs and certifications (i.e. cGMP, HAZMAT, forklift training, etc.). Adhere to all safety warehouse operations and contents, security procedures and protocols. 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 Perform miscellaneous duties as assigned. Required Education, Skills, and Knowledge Minimum of 5 years of related experience with a Bachelor's degree; or 3 years and a Master's degree; or a PhD without experience; or equivalent work experience. Strong communication and interpersonal skills. Ability to collaborate across disciplines. 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. Extensive walking and repetitive physical motion (Squatting, bending, lifting, climbing ladders) is required. Must be able to work well in a team setting. Proficient in MS Word, Excel, Outlook. Ability to operate computers and relevant warehouse management computer software (i.e. ERP/MES). Must have valid driver license. Willingness to work flexible hours, including overtime, weekends, and staggered shifts. Preferred Education, Skills, and Knowledge 7 plus years of experience working in a GMP warehouse setting or in logistics experience in operating material handling equipment preferred. Experience and/or certification in operating material handling equipment preferred (i.e. forklift). 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 work in variable noise levels in both office and warehouse environments. Ability to stand /Sit/walk for long periods of time. Ability to perform heavy physical work, lifting up to 65 pounds. Clarity of Vision Ability to identify and distinguish colors. Must be able to perform activities with repetitive motions. Ability to climb Ladders / Stairs / Scaffolding Ability to operate warehouse equipment/machinery, including trucks & forklifts. Ability to work in variable temperatures, high to freezing. Inside/outside working conditions. 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 primarily work in a warehouse setting exposed to loud noise levels, vibration, chemicals, dust, mechanical hazards, moving objects, forklifts, or other vehicles. This position may be exposed to cold and hot temperatures, inclement weather conditions, chemicals, biohazardous waste, mechanical hazards, and hazardous physical substances and fumes. Employees may interact with staff and/or public and private representatives in interpreting and enforcing departmental policies and procedures. #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-50k yearly est. Auto-Apply 60d+ ago
  • Quality Assurance Document Control Specialist I [Contract to Hire] Wednesday to Saturday from 9am to 8pm

    Iovance Biotherapeutics 4.2company rating

    Iovance Biotherapeutics 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. Auto-Apply 60d+ ago
  • Manufacturing Specialist I-Monday to Friday-2pm-10pm

    Iovance Biotherapeutics 4.2company rating

    Iovance Biotherapeutics job in Philadelphia, PA

    Iovance is an immune-oncology company focused on the development and commercialization of novel cancer immunotherapies based on TIL. The company's lead candidate is an autologous, ready-to-infuse cell therapy, that has demonstrated distinctive efficacy in the treatment of metastatic melanoma. The company has a commercially approved product along with multiple ongoing clinical trials in various phases for squamous cell carcinoma of the head and neck, cervical carcinoma, non-small cell lung cancer, and immunotherapy for solid tumors. The company is currently developing its commercial manufacturing capacity to support development and launch of these assets. This position is currently for regular work week hours -Monday to Friday from 2pm-10pm. Essential Functions and Responsibilities Support documentation, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to accurately reflect current procedures. Lead teams investigating minor, major and critical nonconformances and deviations, including gathering information through structured root cause analysis. Draft and revise deviation reports as needed to assure that deviations are addressed in a timely manner. Own and manage change controls associated with manufacturing areas and equipment. Participate in technology transfer, conference calls and sharing of technical information. Coordination of front-end document requests with supporting departments. Assure that Deviations and CAPAs are addressed in a timely manner, and that Batch Records revisions are reviewed and approved in a timely manner. Continuously seek and support new approaches, practices, and processes to improve the efficiency and efficacy of document review and revision. Adheres to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements. Attends the weekly management meeting to discuss timelines and weekly priorities. Contribute to projects to ensure timely initiation and completion of work. May work on assignments that are moderately complex in nature, where judgment is required to resolve operational issues without negatively impacting manufacturing efforts. Troubleshoot issues and prioritize workload to solve moderately complex problems, including on the floor troubleshooting support as needed. Ability to work in a team environment and independently as required. Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required. Ensure raw data records are accurate, complete, and in appropriate order, and meet protocol specifications and/or GMP requirements. Review data as generated/collected by less experienced technical staff. 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. Perform miscellaneous duties as assigned. Travel May require up to 10% travel, based on business need. Required Education, Skills, and Knowledge Minimum bachelor's degree (B.A./B.S.) in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience. Minimum of 2 years of experience in biopharmaceutical based GMP manufacturing operations. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. Demonstrated strong technical knowledge of aseptic processing in cleanroom environments is a must. Ability to build relationships quickly and credibly. Provide consistent, excellent support to staff, with the ability to influence large teams within the manufacturing department representing a variety of personalities and experience levels. Proactive, results oriented, self-starter with demonstrated strong leadership skills and experience in a complex manufacturing environment. Ability to deal with ambiguity - ready to change gears and plans quickly, with the need to manage constant change. Ability to work successfully in a fast-paced, team-oriented environment. Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations. Excellent presentation skills, both written and verbal. Understands and complies with quality standards and requirements as documented. Must have strong written and verbal communication and organizational skills. Strong computer skills, problem solving and attention to detail. Familiarity with data and sample management required (LIMS/MES) Able to work independently with minimal supervision. Must adhere to Iovance Biotherapeutics core values, policies, procedures, and business ethics. Need to be able to read, write and understand English, and be proficient in Microsoft (Excel, Word, Outlook). 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. Able to stand and/or walk 90% (and sit 10%) 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. 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 cleanroom setting. When in the lab, must be able to work in cleanroom 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.
    $43k-51k yearly est. Auto-Apply 60d+ ago
  • Inventory Control Specialist I

    Iovance Biotherapeutics 4.2company rating

    Iovance Biotherapeutics 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. Auto-Apply 11d ago
  • Quality Control Specialist II, Compliance Investigator (Contract to Hire)-Days-Wednesday to Saturday-9am-7pm.

    Iovance Biotherapeutics 4.2company rating

    Iovance Biotherapeutics job in Philadelphia, PA

    The , Quality Control Specialist II, Compliance Investigator, will assist the QC Compliance Manager in advancing and closing QC related investigations. Strong technical writing skills are required. Experience in a CAR-T or TIL environment is a plus. The ideal candidate will have experience working in a GMP-regulated laboratory with knowledge of writing investigations. Schedule: Wednesday to Saturday from 9am to 7pm. Essential Functions and Responsibilities Performs root cause analysis and investigations in response to audits, deviations, out of specification/lab investigations, and corrective/preventative actions (CAPA). Work cross-functionally to support deviations and Out of Specification investigations with an emphasis on analytical assays (flow cytometry, ELISA, and other cell-based assays) and Microbiology assays. Support investigations at multiple sites (IOVA-A and ICTC). Represent QC at deviation review board meetings. Perform LIR investigations for OOS events and meet completion timelines. Gather data in support of deviations and maintain a trending database of applicable metrics. Revise Quality documents in support of deviation mitigation and/or CAPAs. Other responsibilities as determined. Required Education, Skills, and Knowledge A minimum of 5 years of related experience with a Bachelor's degree; or 3 years and a Master's degree; or a PhD without experience; or equivalent work experience. 3-5 years of experience in the biopharmaceutical industry within a cGMP Quality Control role. Basic knowledge of biological drug development with respect to Quality Control. Extremely detail-oriented with strong analytical, written, and verbal communication skills. Demonstrate sense of urgency; ability to recognize time sensitivity. Flexible and adaptable style with an eagerness to take on challenges. Must be strong in presenting information to upper management. Preferred Education, Skills, and Knowledge Experience with cell and/or gene therapy products. GMP regulated laboratory experience. Knowledge of investigation writing. 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 accommodation. Physical Demands and Activities Required: Must be able to Sit for an extended amount of time in front of the computer or biological safety cabinet. 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 lab setting. When in the lab, you 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.
    $50k-67k yearly est. Auto-Apply 58d ago
  • Manager, Process Engineering

    Iovance Biotherapeutics 4.2company rating

    Iovance Biotherapeutics job in Philadelphia, PA

    The Manager, Process Engineering is responsible for ensuring that the equipment, utilities, and facility is designed, installed, start-up, commissioned and operates as per specifications in addition to provide engineering support during validation. Incumbent will coordinate with the Facilities, Engineering, Validation, Operations and Quality Control and Quality Assurance Teams to ensure maximum uptime and efficiency of all systems and equipment. Specific Responsibilities Manage the Process Engineering team for a cell therapy manufacturing facility. Develop the scope of proposed future equipment projects for cost and schedule. Implement process improvements including the selection and modification of new equipment and facilities. Author, review, and edit technical documents, including drafting and approval of Equipment Specification, Test Protocols, SOPs, CAPAs, Change Controls, etc. Perform basic revisions as needed to accurately reflect current procedures. Review and edit documents created by other team members for accuracy, clarity, and consistency. Adheres to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements. Ensure that all documentation is compliant with internal requirements, regulatory requirements, including FDA, EMA, and ISO standards. Attends regular management meeting to discuss timelines and priorities. Manage multiple projects to ensure timely initiation and completion of work. Maintain effective communication with project team members, contractors, and vendors. Liaison with the equipment and engineering vendors to support manufacturing and quality control. Create user requirements specifications for new projects. Training maintenance and operative staff when appropriate. Maintain our Engineering documentation and drawings. Oversee contractors when troubleshooting and professional repairs are necessary. Scheduling and Coordinating work in tight deadlines. Present our programs to agency auditors as required. Education and Qualifications BS or MS in Engineering field is required, or equivalent experience. 8 years of related BioPharma/Life Sciences experience required. Prior experience in cell therapy manufacturing is highly desirable. Has comprehensive understanding of principles, theories, concepts, and industry practices and standards and their application. Extensive knowledge of small-scale cell culture processes and techniques is preferred. Experience interfacing with other design disciplines including automation, facility design and mechanical design groups is required. Experience interfacing with CQV and operations teams is required. Experience in scheduling and budgeting Facilities & Process Engineering efforts is highly desirable. Demonstrable experience on cGMP capital, continuous improvement and operating projects. Excellent oral and written communication skills required. Exceptional attention to detail and follow-through. Excellent verbal and written skills in communicating regulatory and technical information. Physical Requirements Stand for long periods of time (2-4 hours). Lift up to 15 lbs. Sit for extended period of time in front of computer (2-4 hour). #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.
    $136k-185k yearly est. Auto-Apply 60d+ ago
  • Senior Maintenance Technician-Days-Monday - Friday, 7am - 3:30pm

    Iovance Biotherapeutics 4.2company rating

    Iovance Biotherapeutics job in Philadelphia, PA

    The Senior Maintenance Technician 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: Monday - Friday, 7am - 3:30pm 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.
    $50k-59k yearly est. Auto-Apply 60d+ ago
  • Senior Specialist, Quality Control Lab Technical Support - Analytical

    Iovance Biotherapeutics 4.2company rating

    Iovance Biotherapeutics 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. Auto-Apply 19d ago
  • Process Development Associate I

    Iovance 4.2company rating

    Iovance job in Philadelphia, PA

    The Process Development Associate I will provide process and analytical support to Tumor Infiltrating Lymphocyte (TIL) clinical and commercial development projects as part of the late-stage process development team. The successful candidate will have prior cell culture, process or method development, and cGLP/cGMP knowledge and experience. This role is a lab-based position, based in the Iovance Cell Therapy Center (iCTC) in Philadelphia, PA. Specific Responsibilities Lead / support process development experiments involving a variety of protocols and techniques related to TIL expansion and characterization. Make detailed observations and record them in a timely and relevant fashion. Analyze and interpret experimental results, including graphing and statistical analysis Organize results for team presentation and discussion. Lead / support write-up of protocols and associated reports. Provide support related to data and records management Ensure training is up to date on new processes and analytical methods. 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 Perform all other related duties as assigned Education and Qualifications Bachelor's degree (B.S./B.A.) in a life science or STEM-related discipline 1+ years cell culture / cell therapy/biotechnology/life science industry experience Proficiency in Microsoft Office Suite is required Proficiency in Graph Pad, MiniTab, and FACS DIVA software is desirable Must be able to comprehend regulations and guidance documents Must be analytical and able to apply critical thinking skills Effective Communication Skills, both written and oral Must be organized, able to multi-task Team player Preferred Education, Skill, and Knowledge Experience with cell therapy process development is a plus Prior experience with cell therapy manufacturing equipment such as NC-200, Miltenyi Prodigy, LOVO, CRF is a plus Experience with JMP software is desired Analytical skills with flow cytometry and experience with cell therapy assays including apoptosis, ELISA/ELLA is preferred 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 move about the office and lab as needed. Must be able to remain in a stationary position, standing or sitting, for prolonged periods of Must be able to lift up to 15 pounds multiple times a day Wear proper personal protective equipment when in a laboratory setting, e., safety glasses, lab coats, and closed-toed shoes 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 laboratory setting. When in the lab, there may be a risk of exposure to hazardous or biological waste within the environment through receipt, transport, storage, preparation, dispensing, administration, cleaning, and/or disposal of contaminated areas and waste. #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-51k yearly est. Auto-Apply 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. 4d 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. 40d 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 34d ago
  • Senior Lab and Endpoint Support Analyst

    Iovance Biotherapeutics 4.2company rating

    Iovance Biotherapeutics 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. Auto-Apply 11d ago
  • Contract Facilities Technician

    Iovance Biotherapeutics 4.2company rating

    Iovance Biotherapeutics job in Philadelphia, PA

    The Contract Facilities Technician plays a crucial role in ensuring smooth operations within Iovance Biotherapeutics' workplace environments. This position requires a proactive, detail-oriented individual who can manage multiple tasks related to facilities administration, communication, and technology. The coordinator will contribute to creating a productive and positive workspace, while adhering to Iovance Biotherapeutics' core values, policies, procedures, and business ethics. This position will provide direct administrative support to Facilities Operations that focus on the Philadelphia region as well as back-up support coverage for other facilities in the portfolio. Essential Functions and Responsibilities Administer and provide level 1 support for the Corporate Facilities Helpdesk. Manage Corporate Facilities communication channels and software applications. Oversee the Virtual Front Desk and provide exceptional service. Administer site access control as a lead or backup as required. Monitor pantry and office supplies, including inventory management and ordering. Support Corporate Facilities procurement, contract administration, and vendor relations. Analyze and report data on occupancy, attendance, and workplace utilization. Collaborate in budget creation and ensure adherence to financial guidelines. Organize and manage catering logistics (ordering, setup, and breakdown). Assist in planning and supporting company events. Travel between sites to provide facilities support as needed. Perform miscellaneous duties and manage projects independently to completion. Maintain knowledge of workplace technology and collaborate effectively with IT teams. Adherence to Iovance Biotherapeutics' core values, including professionalism, integrity, and teamwork, is essential for success in this role. Education and Experience Bachelor's degree or 2 to 5 years of relevant professional experience. Technical Skills Proficiency in Microsoft Office suite applications. Familiarity with workplace technology and facilities software applications. Experience in data analysis and reporting (preferred). Professional Skills Excellent customer service skills with a professional demeanor and positive attitude. Strong organizational skills and attention to detail. Proven ability to manage multiple projects independently. Exceptional communication skills (interpersonal, oral, and written). Comfortable working in a fast-paced environment with minimal direction and changing priorities. Additional Requirements Consistent attendance and punctuality. Ability to work collaboratively with cross-functional teams. Willingness to travel between sites as needed. Sound judgment in handling sensitive and confidential information. 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 move to and from the office to the lab located on separate floors and move about the office and lab as needed. Must be able to travel in between sites in the Philadelphia region and on occasion travel to other facilities in the US. Must be able to remain in a stationary position standing or sitting for prolonged periods of time. Wear proper personal protective equipment when in a laboratory setting, i.e., safety glasses, lab coats, and closed-toed shoes. 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 laboratory setting. When in the lab, there may be a risk of exposure to hazardous or biological waste within the environment through receipt, transport, storage, preparation, dispensing, administration, cleaning, and/or disposal of contaminated areas and waste. #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-51k yearly est. Auto-Apply 60d+ ago
  • Med. Info. Content Dev. Manager/Sr. Manager

    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 Medical Information and Content Development Manager/Sr. Mgr. is responsible for providing accurate, timely, unbiased, and up-to-date medical information to internal and external customers. The position will be responsible for the creation and maintenance of written scientific content, including medical information response letters (MIRLs), frequently asked questions (FAQs), and product dossiers regarding Company marketed products, investigational compounds, and related disease states. The individual will also serve as the primary medical reviewer of promotional and sales training materials. The position will also be responsible for the development of US Medical Affairs scientific exchange materials for field-based US Medical Affairs staff, advisory board materials, medical congresses, and other relevant projects and programs. The position will report directly to the Executive Director, Medical Information and Content Development. Essential Functions of the Job (Key responsibilities): • Oversee, develop, and maintain written scientific information for use in responding to unsolicited customer requests; explore opportunities to leverage AI solutions. o Manage external vendors involved in scientific content development. • Creation of medical information standard response letters, product dossiers, and frequently asked question (FAQ) documents • Serve as an active member on cross-functional teams (e. g. , promotional materials review committee, core medical team, scientific materials review committee). • Provide medical literature surveillance for Medical Affairs; communicate pertinent updates in a timely manner. • Support medical conference activities, including execution of pre- and post-conference deliverables, insights generation, and staffing of medical/scientific booth. • Collaborate with cross-functional partners (eg, Research & Development, Publications & Medical Communications); assist with development of scientific exchange materials for emerging therapeutic areas. • Develop and maintain expertise in relevant hematology and oncology therapeutic areas, including disease states, treatment landscape, and ongoing research strategies. • Assist Medical Information Leadership with key projects, as needed. • Comply with all guidelines, policies, legal, regulatory, and compliance requirements. Qualifications (Minimal acceptable level of education, work experience, and competency): • Healthcare Professional (PharmD, MD, RPh, PhD in related field) with 2-5 years' experience working in a Medical Information/Medical Affairs capacity for a pharmaceutical or medical device company, or equivalent clinical experience, is required. • Knowledge of FDA regulations regarding the dissemination of Medical Information, drug promotion, and adverse event and product quality complaint reporting, is required. • Experience creating scientific content, including medical information response letters and clinical slide presentations, is required. • Ability to query scientific literature (via PubMed, Embase, Scopus, etc. ) and identify and summarize pertinent findings is required. • Excellent oral and written communication skills are required. • Excellent project management skills, including the ability to plan, prioritize, and execute multiple projects are required. • Experience in hematology/oncology is strongly preferred. • Approximately 15% travel commitments. 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.
    $71k-95k yearly est. 54d ago
  • Vice President Commercial 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. Position Overview The Vice President (VP) of Commercial Operations for Dermatology will lead all strategy, operations, analytics, and executional support functions enabling the success of the Dermatology business unit. Reporting directly to the General Manager, this individual will serve as a key member of the Dermatology Leadership Team, driving operational excellence, commercial performance, and cross-functional collaboration across Sales, Marketing, Market Access, and Medical Affairs. The VP will oversee a multidisciplinary team covering commercial insights, forecasting, sales operations, incentive compensation, CRM and BI systems, marketing operations, and data science. This role requires a visionary and pragmatic leader who can translate business strategy into operational plans, build scalable capabilities for future launches, and drive data-driven decision-making throughout the organization. Key Responsibilities Strategic Leadership • Partner with the General Manager and brand leads to define and execute the Dermatology franchise commercial strategy. • Serve as the primary liaison between corporate functional centers (Finance, IT, Data Science, Market Access) and the Dermatology BU to ensure aligned priorities and seamless execution. • Develop and operationalize strategic plans for commercial readiness, lifecycle management, and portfolio expansion through 2026 and beyond. Commercial Operations & Enablement • Oversee the planning and execution of all commercial operations functions, including: o Sales Operations: Incentive design, field alignment, targeting, and sample operations. o Market Access Operations: Payer analytics, contracting operations, patient services, and access reporting. o Marketing Operations: Meeting planning, convention execution, digital operations, and marketing logistics. o Forecasting & Insights: Business analytics, forecasting, and performance reporting. • Drive operational rigor through KPI development, business reviews, and performance dashboards. Data, Systems, and Analytics • Lead the integration of advanced analytics, CRM, and BI systems (in partnership with BIS and Data Science) to enable real-time insights and predictive modeling. • Embed AI tools and capabilities into key processes and workflows to improve efficiency, decision-making, and business outcomes. • Ensure high-quality, compliant, and harmonized commercial data infrastructure across the Dermatology organization. • Champion data literacy and analytical decision-making across the commercial team. People Leadership • Lead, coach, and develop a team of senior directors and managers across functional disciplines, fostering a high-performance and collaborative culture. • Drive organizational design and workforce planning for evolving commercial needs (e. g. , open and 2026 roles in Insights, Sales Ops, Market Access Ops, and BI). • Build succession plans and talent pipelines for future leadership growth. Qualifications • Bachelor's degree required; MBA or advanced degree preferred. • 15+ years of experience in commercial operations, business insights, or related functions within the pharmaceutical or biotechnology industry. • Proven track record of building and leading multi-functional operations teams in support of specialty or rare disease franchises. • Deep understanding of field force effectiveness, forecasting, CRM systems (e. g. , Veeva, Salesforce), data strategy, and market access analytics. • Exceptional communication, influencing, and stakeholder management skills across senior leadership levels. • Demonstrated ability to balance strategic vision with hands-on operational execution. Leadership Attributes • Strategic Integrator: Connects insights, analytics, and operations into a unified commercial execution model. • Enterprise Collaborator: Navigates complex matrix environments and aligns cross-functional teams toward shared goals. • Change Leader: Anticipates business evolution and proactively designs scalable systems and processes. • Talent Developer: Inspires, mentors, and empowers a high-performing, diverse team. 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.
    $161k-227k yearly est. 4d ago
  • 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 26d 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. 13d ago
  • Process Engineer I

    Iovance Biotherapeutics Inc. 4.2company rating

    Iovance Biotherapeutics Inc. job in Philadelphia, PA

    Iovance Biotherapeutics is seeking a Process Engineer to join the team. This engineer is responsible for providing oversight and review of design and construction work related to process improvements within a cGMP manufacturing facility. Incumbent will support the startup, CQV (Commissioning, Qualification and Validation) of process equipment as well as the development of process technical transfer documents. This role will Interface with senior leadership to develop long term strategic planning consistent with operational strategies as it relates to process, facility engineering and controls. Essential Responsibilities * Implement process improvements including the selection and modification of new equipment and facilities. * Write, review, and edit technical documents, including drafting and approval of Equipment Specification, Test Protocols, SOPs, CAPAs, Change Controls, etc. Perform basic revisions as needed to accurately reflect current procedures. Review and edit documents created by other team members for accuracy, clarity, and consistency. * Participate in technology transfer, conference calls, and sharing of technical information. * Adheres to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements. * Ensure that all documentation is compliant with internal requirements, regulatory requirements, including FDA, EMA, and ISO standards. * Attends the weekly management meeting to discuss timelines and weekly priorities. * Manage projects to ensure timely initiation and completion of work. Education and Qualifications * BS or MS in Chemical, Mechanical, Biochemical Engineering or related degree is required. * 2+ years of related BioPharma Life Sciences experience required. Preferred experience includes process simulation, preparation and checking of process deliverables, participation in design safety reviews and HAZOPs. Both owner and A&E firm experience will be considered equally. * Experience with GMP procedures is desired, including change controls, deviation management and CAPAs. * Extensive knowledge of small-scale cell culture processes and techniques is preferred. * Prior experience in cell therapy and aseptic manufacturing is highly desirable. * Experience interfacing with other design disciplines including automation, facility design and mechanical design groups. * Experience interfacing with CQV and operations teams is required. * Excellent oral and written communication skills required. * Must have strong analytical, communication, presentation, and interpersonal skills. * Exceptional attention to detail and follow through. * Effective technical presentation skills. * Excellent verbal and written skills in communicating regulatory and technical information. 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 10-hr day 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 deadline. 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.
    $56k-70k yearly est. 43d 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. 39d ago

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