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Job DescriptionValidation Specialist Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device IT & Human Resources disciplines in New Jersey. The Validation Specialist performs validation activities primarily to include preparing and executing equipment and CSV protocols and preparing final reports for IQ, OQ and/or PQ of basic cell processing and QC lab equipment. The ideal candidate exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. • Prepare IQ/OQ and /or PQ protocols for various Cell Therapy manufacturing process equipment and QC test equipment such as Flow Cytometers, Cell Separators, Centrifuges, Cell processing equipment, clean utilities, Bioreactors, Automated Control Systems, etc., • Execute IQ/OQ and /or PQ protocols, • Prepare final reports for executed protocols, • Prepare final reports for vendor IQ, OQ and/or PQ protocols, • Review of executed IQ/OQ/PQ protocols and raw data, • Perform periodic review/requalification of validated equipment, systems and cleanrooms, • Manage assigned projects to completion in accordance with established timelines, following-up on review/approval cycles to ensure deadlines are met, • Assembling validation related documents; and filing/archiving approved documents, • Maintaining electronic records.REQUIREMENTS, • BS/BA in engineering or a related Science discipline, • 3-7 + years of validation experience, • Ability to use validation instruments such as Kaye Validator, Tachometer, Multimeter, etc., • Thorough knowledge of cGMP and regulatory requirements, including 21 CFR Part 11., • Excellent protocol and report writing skills, good oral communication skills, detail orientation, problem solving ability and teamwork are necessary., • Ability to comfortably interact and clearly communicate with individuals at all levels of the organization to provide project updates and follow-up communication for review cycle management., • Must be a dedicated self-starter with a high energy level and able to achieve results., • Must have strong problem-solving and critical thinking skills, with a track-record of successful issue resolution., • Good time management skills to manage and meet deadlines., • Strong collaborative and influencing skills and ability to work well in a cross-functional, team environment., • Good computer skills and Microsoft Office knowledge., • Ability to multi-task team is essential., • Flexible and able to adapt to company growth and evolving responsibilities., • Highly organized, detail oriented, and ability to manage multiple priorities., • Ability to perform the job under direct or indirect supervision, • Must have the ability to work in a team-oriented environment and with clients, • Must have the ability to work with specialized equipmentMay occasionally work with pressurized systems. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. This role operates within a professional office environment of a manufacturing operations plant. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Seating is mixed and includes open space seating, cubicle, and office space. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.Ability to work in cleanroom environment for a moderate amount of time.Ability to lift, transfer, or ship validation equipment or related accessories.While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms. The employee is occasionally required to climb or balance; stoop, kneel, or crouch. Must where PPE when appropriate. This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at . Description: The Medical Device Engineer is responsible for leading the design and development activities of new products and improving existing products in compliance with all quality and regulatory requirements. S/he will be responsible for authoring technical documents for the development of medical devices and combination products according to relevant Design Control regulations and standards. The person in this position will also be responsible for providing project-specific support, including technical analysis and review of supplier documentation as required. The position has a scientific focus that includes formulation development, product performance characterization, and implementation including proto-type design and fabrication and data generation through designed experiments. The Medical Device Engineer is expected to aspire for excellence with a bias toward action, willing to roll up their sleeves, get hands-on, and do what’s necessary to move projects forward in a fast-paced environment. They are committed to designing and developing products that dominate the marketplace and improve healthcare by partnering with our customers to drive purposeful innovation, resulting in best-in-class products. The Medical Device Engineer will work with a multidisciplinary team of researchers. This is a multi-faceted job in a highly collaborative environment across multiple functions that will require flexibility as well as an ability to learn about and develop new technologies and explore new techniques in pursuit of product innovation and robustness. Role level is contingent on experience, but this is not an entry level role.. This is a full-time, on-site position, located in Brooklyn, New York. Responsibilities • Create and lead experimentation for exploratory and/or product development research focusing on polymeric materials devices and their use., • Define new product functional requirements (design inputs/user needs) and evaluate the design's overall effectiveness, cost, reliability, and safety., • Lead cross-functional teams to develop new products, address design issues, and maintain existing designs., • Apply strong problem-solving skills to find solutions to complex problems., • Work independently to plan and schedule own activities necessary to meet project timelines., • Work cooperatively with, quality, manufacturing, regulatory, clinical, and marketing to ensure project success., • Lead the creation of design history file documentation through the new product development process., • Develop new implant and instrument designs utilizing Solidworks and modeling/detail design specifications., • Generate technical protocols/reports to support device safety and efficacy., • Invent/create concepts and designs and submit invention disclosures., • Ensure that all design activities adhere to FDA Quality System Regulations and ISO 13485 design control and risk management requirements. Lead material/design/process changes through a design control process, with well-documented research/analyses., • Author protocols and reports including development studies and design verification/validation activities., • Develop and execute test methods to aid in exploratory research, product development, and quality control; conduct chemical and mechanical property evaluation tests to assess the desirability of process or formulation changes., • Exercise technical judgment in the design, execution, and interpretation of experiments within the scope of project responsibilities and ensure the use of professional concepts to solve complex problems in creative and effective ways, in conformance with scientific methods and procedures., • Prepare samples as required for testing, or other evaluations and data analysis, including in voice-of-customer (VOC) labs., • Interface with customers, suppliers, and internal cross-functional team members to develop specifications and coordinate prototype fabrication., • Maintain a laboratory notebook and other technical documentation to required GLP/GMP guidelines., • Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation pertaining to research towards FDA/regulated authority submissions,, • Provide support to marketing and sales team, support the introduction of new technologies with the development of presentations, sales tools, formulations, and applications data, • Communicate results to the scientific community via published papers. Present research at academic/industry symposia as an external representative of the company., • Manage part-time staff as a research leader and mentor for ongoing research projects., • Work with company leadership to evaluate existing research practices and contribute to a culture of ethical, high-quality research operations within the organization., • Provide other project or product support as needed in order to support Cresilon’s business objective. Required Qualifications • BS in Chemical Engineering, Polymer Engineering, Material Science, Biomedical Engineering, Mechanical Engineering, or related scientific discipline., • A minimum of 4+ years of product development experience is required., • A minimum of 2 years of hands-on experience in new product research and development in a cGMP-regulated industry is required (work experience in the Medical Device field is strongly preferred), • Adept experimentalist with hands-on experience in product development of medical devices and their safety/efficacy characterization in an R&D environment., • Experience gathering user needs, translating them to technical inputs, and developing viable V&V (Design Verification and Validation) plans., • Experience leading complex product development initiatives from concept through release., • Good working knowledge of anatomy and surgical procedures is required., • Demonstrated ability to solve difficult technical problems and deliver practical solutions that meet the application requirements is required. This includes strong analytical, problem-solving, and decision-making skills with the ability to be observant and to think creatively., • Demonstrated ability to design experiments and analyze data with appropriate quality and statistical methodologies., • Demonstrated ability to work independently as well as effectively be a strong team contributor and work cross-functionally to expedite the completion of critical project tasks, • Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency in a timely manner., • Ability to lead directly and by influence, including strong problem-solving, conflict resolution, and analytical skills., • Requires strong leadership skills, excellent written and verbal communication and presentation skills., • Working knowledge of FDA requirements as per 21 CFR 820, • Proficiency in the use of Microsoft Excel, Microsoft Word, and Microsoft PowerPoint is required., • Legal authorization to work in the United States is required. Preferred Qualifications • An advanced degree (MS or Ph.D.) is highly preferred., • Hands-on experience in product development with Class II and Class III medical devices., • Experience developing test methods and protocols/reports for safety and efficacy testing of implant and instrument designs., • Working knowledge of ISO 9001, ISO 13485:2003, and ISO 14971:2007., • Experience with IDE and PMA submissions., • Working knowledge of Good Documentation Practices (GDP), and Good Manufacturing Practices (cGMP), • Good understanding of statistical tools and validation/verification techniques., • Six-Sigma green belt or black belt certification Cresilon is an equal-opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time. Benefits • Competitive annual base salary range of $80,000 - $160,000, depending upon job level and qualifications, • Paid Vacation, Sick, & Holidays, • Monthly MetroCard Reimbursement, • 401(k) & Roth Retirement Savings Plan with company match up to 5%, • Work/Life Employee Assistance Program, • Company Paid Life and Short-Term Disability Coverage, • Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage

Job DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • BA/BS Degree in a Scientific or Engineering discipline, • 8 + years experience computerized system experience with IT compliance/validation/qualification activities., • 8 + years experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise., • 10% travel required.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionAssociate Director, Manufacturing OperationsAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Associate Director, Manufacturing Operations is responsible for efficient utilization of Operations resources to meet customer demand. This role will be responsible for maintaining and overseeing the site Operations scheduling and training capacities for a time period looking ahead to the next 3-6 months. The Associate Director, Manufacturing Operations will understand upcoming needs and constraints and help drive strategy accordingly. This includes the management of all Operations scheduling, training and compliance resources. The Associate Director, Manufacturing Operations is also responsible for assessing the needs of the company to contribute to the big picture by ensuring daily operations run smoothly and as efficiently as possible. This role will also drive individual and team development to ensure a prepared and empowered workforce to become the provider of choice for the industry. • Meeting client process demands through planning, scheduling, manufacture and delivery of clinical cell therapy products according to established procedures, regulations and contracts, • Looking out 3-6 months to ensure capacity and availability of resources (room/equipment/staff) to perform clinical manufacture for processing needs, • Manages all training and compliance activities in the Operations organization, • Responsible for creating, enforcing and measuring Operator training schedules in order to ensure that all production schedules can be carried out, • Creates and maintains a process to ensure that personnel schedules are being accurately and fairly assigned to all Associates, • Supporting and driving special long-term projects and identified and assigned by the PPU Head, • Responsible for creating maintaining and communicating all Operations based KPI’s, • Ensuring department staff compliance with corporate and site-specific HR policies, safety, and business policies and practices, • Approving job specific curriculum for the training and professional development of department staff, • Responsible for streamlining the batch record review process, • Responsible to understand the profit and loss for the PPU’s as well as all related documentation, and how these items impact Operations, • Driving continuous improvement, • Liaison with support groups for short- and medium-term needs – Supply Chain, Training, Quality Systems, Quality Assurance, Quality Control, and others, • Set team expectations and goals and assists in delivering the business direction for the PPU, • Aligning departmental goals, processes and resource allocation with the organizational strategy, • Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws., • Direct reports: Associate Manager Training, Associate Manager, Compliance, Scheduling Associate, Quality Engineer Associates. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. REQUIREMENTS, • Bachelor's degree (i.e. Biology, Biotechnology, Bioengineering, Chemical Engineering)., • 5-10 years of cGMP environment, aseptic processing, mammalian cell culture, monoclonal antibody, cell processing, cryopreservation or similar experience., • 5-10 years of leadership experience or equivalent combination of experience., • Deep Understanding of cGMP and cGLP, • Working knowledge of financial operations and budget development, • Relevant IT skills (able to work with Microsoft Office and corporate scheduling system), • Competencies/Candidate Profile, • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Flexible and able to adapt to company growth and evolving responsibilities, • Accountability, integrity, and strong dedication to regulatory compliance, • Strong business and personnel management acumen, • Strong emotional intelligence, • Ability to think strategically and tactically (detail-oriented), • Strong analytical and problem-solving skills, • Strong written and verbal communication skills, • Drive to create and maintain order in a fluid, technically complex environment, • Continuous improvement mindset, • Ability to multi-task is essential, • Must have the ability to work in a team-oriented environment and with clients, • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.Environment requires gowning, hair net, safety glasses, gloves, and foot coverings.Must be capable of moving, sitting, stretching, stooping, using hands and fingers, reaching with hands and arms, talking and exchanging information, and vision sufficient to read materials.Duties, responsibilities, and activities may change at any time with or without notice

Job DescriptionQuality Control Microbiology SupervisorAllendale, NJ The Quality Control Microbiology Supervisor organizes, and directs staff to meet and exceed cGMP requirements, establish KPI’s, while adhering to quality control-microbiological and technical standards. Provides oversight of day to day activities including adjustment of workflow, test performance, and quality compliance. • Team Leadership - Interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems for the following positions. Directly supervised the following roles: QC Microbiology Associates, • Investigate and document non-confirming events and environmental excursions., • Troubleshoot and recommend process improvements to achieve greater efficiency ad meet quality goals., • Interact with other Microbiology departments on a regularly scheduled basis to discuss and harmonize best practices, procedures and processes between the sites., • Participate in department and cross functional meetings., • Ensure compliance with regulatory agency requirements by enforcing a quality culture throughout the department., • Interact with internal and external customers to ensure proper sampling, reporting, and resolution of questions and concerns., • Author and revise Standard Operating Procedures, Work Instructions, forms and Protocols to reflect current practices., • Perform microbiological and environmental monitoring data review. Compile and issue quarterly and annual Environmental Monitoring trending reports., • Provide staff development through feedback aimed towards performance development and review., • Ability to remain focused and effective in high stress situations., • Builds constructive working relationships characterized by a high level of acceptance, cooperation, and mutual respect., • Able to handle challenging interpersonal relationships., • Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws., • Aseptic Processing StandardsREQUIREMENTS, • BS in Microbiology or relevant field required., • Biotechnology Certificate and/or cGMP experience, • Minimum of 3 years of experience with environmental monitoring or within the biopharmaceutical industry., • Strong knowledge of microbiological test methods, philosophies, method validation and method transfer., • Strong knowledge of quality systems and ability to interpret Quality standards of implementation and review., • Proficient with computer software with MS Office, Excel, and MODA., • Must have ability to work in a team-oriented environment and with vendors., • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen, • Must have the ability to work in the cleanroom environment for extended period of time, • Must have the ability to work with specialized equipment, • Must be able to handle the standard/moderate noise of the manufacturing facility, • The employee must be able to comply with personal hygiene standards as they apply to aseptic processing. The employee must successfully complete sterile gowning training/qualification and aseptic process qualification (personal media fill) as well as annual/semiannual re-qualification as a core competency requirement of their employment in this role., • An individual may exert up to 10 pounds of force occasionally or a negligible amount of force frequently to lift, carry, push, pull, or otherwise move objects., • Must be physically capable to stand, walk, sit, bend, stretch, use hands to handle or feel, reach with hands and arms, and talk or hear., • The employee is frequently required to lift and/or move up to 30 pounds and occasionally move tanks up to 300 pounds (with assistance), • Heavy cryo-gloves must be used when working with liquid nitrogen, • While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noise.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionManager Manufacturing OperationsAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Primary Processing Unit (PPU), Manager, Manufacturing Operations is responsible for efficient capacity utilization of site resources to meet customer demand. They will partner with support functions to deliver on customer demands. This leader is accountable for the management of client projects at the site and for delivery of results within project scope, agreed timelines, contract requirements, revenue targets, as well as compliance and regulatory requirements. The Manager, Manufacturing Operations is responsible for profit and loss within their PPU and will deliver on revenue. This role will also drive individual and team development to ensure a prepared and empowered workforce to become the provider of choice for the industry. • Meet client process demands through planning, scheduling, manufacture and delivery., • of clinical cell therapy products according to established procedures, regulations and contract., • Ensures manufacturing documentation is closed out in a timely manner in accordance with applicable regulations and per contract., • Ensures capacity availability of resources (room/equipment/staff) to perform clinical manufacture for clients per contract., • Ensures process hours are charged - tracked to meet contract and revenue targets., • Accountable for maintaining a mechanism to work with clients to troubleshoot problems, suggests improvements and determines & advocates for value-add projects., • Assures manufacturing space is kept in a clean, validated state in compliance with company procedures, GMP and applicable regulations, • Ensures on the job training program and resources for new associate (proficiency) training and cross training of existing staff., • Ensures a safe work environment for employees., • Ensures department staff compliance with corporate and site-specific HR policies, safety and business policies and practice., • Approves job specific curriculum for the training and professional development of department staff., • Holds regular staff and 1:1 meetings to emphasize corporate culture, maintain morale, and provides a forum for staff development and discussion., • Responsible for the profit and loss for the PPU, • Deliver on revenue, • Assures compliance with budget, • Liaison with support groups – supply chain, training, quality systems, and business development, • Partners with clients along with Project Management and team leadership; drives the account management and liaison with the clients, • Sets team expectations and goals and delivers the business direction for the PPU, • Sets KPIs & ROIs targets and assures PPU metrics are maintained and tracked monthly., • Coordinates with PPU leadership and team meetings and determines PPU strategy development, • Accountable for driving the spirit of continuous improvement, • Collaborates with Business Development to ensure compliance and contract requirements, • Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Directly supervises the following roles: Associate Manager, Manufacturing, Manufacturing Associates, Lead Manufacturing Associates, Production Support Associates, Technical Trainers, Compliance InvestigatorsREQUIREMENTS, • Bachelor's degree (ie Biology, Biotechnology, Bioengineering, Chemical Engineering)., • 5-7 years of cGMP environment, aseptic processing, mammalian cell culture, cell processing, cryopreservation experience., • 5-7 years of leadership experience or equivalent combination of experience., • Strong business acumen, • Deep understanding of cGMP and cGLP, • Working knowledge of financial operations and budget development, • Relevant IT skills (Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Meeting management/facilitation skills/teamwork, • Ability to multi-task team is essential, • Flexible and able to adapt to company growth and evolving responsibilities, • Drive to create and maintain order in a fluid technically complex environment, • Integrity, accountability and strong dedication to regulatory compliance, • Continuous improvement mindset, • List required training that must be completed by incumbent in order to fulfill the responsibilities for this role. Examples can include aseptic techniques, gowning qualifications, manager training, GMP, etc., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays and as required by the company, • May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids, • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen, • Must have the ability to work in the cleanroom environment for extended period of time, • Must have the ability to work with specialized equipment, • May work with hazardous materials and chemicals, • Environment requires gowning, hair net, safety glasses, gloves, and foot coverings.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at . The R&D Formulation Manager/Principal Scientist will lead the design, development, and implementation of novel formulations and polymer materials for use in medical devices, ensuring all activities meet quality and regulatory standards. This role involves providing expertise in formulation development, building and optimizing internal capabilities to deliver innovative and efficient solutions, and ensuring alignment with the company’s long-term technical vision to create a strong pipeline of customer-focused innovations. Key responsibilities include developing and characterizing formulations, recruiting and onboarding talent, managing technical collaborations with external suppliers and vendors, and integrating formulations into scalable manufacturing processes, whether in-house or through CDMOs. This role operates in a collaborative, cross-functional environment, requiring flexibility, a strong focus on scientific formulation, and a drive to explore new technologies and techniques in pursuit of robust, innovative materials and products. The R&D Formulation Manager/Principal Scientist is expected to be a subject matter expert in areas including polymer material science, formulation strategies, analytical chemistry, and biomaterial interactions with biological systems. They are responsible for ensuring high standards in research practices. They are responsible for leading the creation of documentation required for regulatory submissions, developing strategies for grants and publications, and securing non-dilutive funding through grant opportunities. They will report to the Vice President Technology. This is a full-time, on-site position, located in Brooklyn, New York Responsibilities • Lead, staff, and manage formulation development teams and their efforts across multiple parallel product development opportunities, to launch new commercially successful products., • Provide sound scientific leadership, monitoring and coaching through the initiation, planning and execution their team’s overall activities., • Create and lead experimentation for exploratory and/or product development research with focus on polymeric materials and their use., • Exercise technical judgment in the design, execution, and interpretation of experiments within the scope of project responsibilities and ensure the use of professional concepts to solve complex problems in creative and effective ways, in conformance with scientific methods and procedures., • Lead material/design/process changes through design control process, with well-documented research/analyses., • Review and author protocols and reports including development studies and design verification/validation activities., • Develop and implement investigations into new technologies and capabilities, partnering with business development, that advance research team and company objectives., • Lead efforts in chemical and mechanical property evaluation to assess the desirability of process or formulation changes. Develop test method capabilities to support R&D (exploratory research, product development) and production test requirements., • Develop unique, proprietary (and ideally patentable) intellectual property that yields competitive advantage., • Lead and participate in voice-of-customer (VOC) labs and influence go-to-market strategies., • Interface with customers, suppliers, and internal cross-functional team members to develop specifications and coordinate prototype fabrication., • Work as part of a cross-functional team to develop, verify, and validate product designs through bench, in-vitro, and in-vivo testing and other assessments., • Ensure an effective documentation system is in place and utilized throughout the development process inclusive of R&D lab notebooks, design reviews, test methods, and test reports., • Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation pertaining to research towards FDA/regulated authority submissions,, • Act as research liaison between R&D and Quality Control to define product specifications., • Maintain active dialogue with Manufacturing to ensure successful technology transfer and process development, including the review of research-related documents, • Provide guidance and support to commercial teams, support introduction of new technologies with development of presentations, sales tools, formulations and applications data., • Communicate results to the scientific community via published papers. Present research at academic/industry symposia as an external representative of the company., • Work with company leadership to evaluate existing research practices and contribute to a culture of ethical, high-quality research operations within the organization. Required Qualifications • Master’s degree in Chemistry, Materials Science, Chemical Engineering, Polymer Science, or a closely equivalent discipline., • A minimum of 10 years of research experience in developing and utilizing polymeric materials, biomaterials, or other complex materials toward product/application development and their manufacture., • A minimum of 2 years of direct management experience., • Adept experimentalist with hands-on research experience with polymers, coagulation chemistry, and materials science of complex systems, including the development of structure-property performance relationships in designing and characterizing these materials., • Demonstrated ability to solve difficult technical problems and deliver practical solutions that meet the application requirements, along with a fundamental understanding of the chemistry that drives the performance required. This includes strong analytical, problem-solving, and decision-making skills with the ability to be observant and to think creatively., • Direct experience in new product development from concept to regulatory approval through launch., • Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies is required., • Excellent verbal and written communication skills, with the ability to lead in a dynamic and collaborative environment is required., • Highly organized and detail-oriented, with the ability to extract key facts from complex information and create/present clear and concise technical documentation is required., • Demonstrated ability to lead and inspire teams and develop and mentor individuals, and allocate resources strategically and according to the portfolio priorities., • Requires strong leadership and organizational skills with a strong attention to detail and multi-tasking skills while simultaneously keeping overall “big picture” view of projects, priorities, and strategies., • Experience working under pressure with tight timelines, with the ability to maintain a sense of priorities, focus, urgency, and delivery., • Strong working knowledge of Microsoft Office., • Legal authorization to work in the United States. Preferred Qualifications • Ph.D. in a relevant discipline is strongly preferred., • Experience developing and commercializing products in a highly regulated environment, • Medical device development experience., • Demonstrated expertise in the use, development, and qualificication of material characterization techniques, including rheological, thermal, mechanical, spectroscopic, microscopic, and other chemical compositional methods., • Strong understanding of medical device regulatory requirements for Class II and III medical devices (e.g., 21 CFR Part 820), cGLP/cGMP, and related standards (e.g., ISO 13485)., • Strong understanding of cGMP, ICH guidelines, • Six sigma green belt or black belt certification., • Experience with executing a grant and publication submission strategy, knowledge of and strong track record with SBIR submissions to multiple agencies, including NIH and DOD is strongly preferred., • Demonstrated experience in Project Management and Product Lifecycle Management practices, and the ability to lead multiple projects simultaneously., • Excellent problem-solving skills and a proactive approach to addressing formulation challenges. Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time. Benefits BENEFITS • Competitive annual base salary range of $130,000 - $180,000, depending upon qualifications., • Paid Vacation, Sick, & Holidays, • Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage, • Company Paid Life and Short-Term Disability Coverage, • Work/Life Employee Assistance Program, • Monthly MetroCard Reimbursement, • 401(k) & Roth Retirement Savings Plan with company match up to 5%

Job Description Territory Sales Executive - Bronx, NY Bronx, NY, USA Job Description Medical Diagnostic Laboratories, LLC (MDL) is a CLIA certified clinical laboratory with multiple state licensing, specializing in state of the art, automated DNA based molecular analysis of a variety of chronic and infectious illnesses. MDL specializes in and performs a large menu of Polymerase Chain Reaction (PCR) testing. Our main theme of research extends to the field of Gynecology, Infectious Diseases, Infectious Arthritis, Tick-borne Diseases, and Mycology. MDL is looking to expand its sales force throughout the U.S. We are seeking a high-energy, self-motivated individual to join our sales team. As a Territory Sales Executive, you will be responsible for bringing in new business as well as maintaining and growing a client base of both hospital and physician customers for MDL. The territory goal is to achieve 2000 specimens per month. Responsibilities: • Responsible for achieving annual sales and profit objectives for a defined territory., • Obtain new business as well as grow client base revenues., • Exceed annual territory sales budget each year by presenting new test information, up selling and seeking out new sources of revenues from clients., • Develop and present personalized sales presentations to professional audiences (physicians, laboratory staff, clinics and group practices); demonstrate how MDL's technical features and services could benefit the practice and help medical personnel provide quality patient care., • Establish positive long-term client relations through scheduling and conducting visits with clients., • Develop and maintain a full business pipeline of prospective clients and assume all territory management in an assigned geographic region., • Provide timely and accurate reporting of pipeline, account plans and territory management activities as required., • Work closely with Regional Manager to identify client concerns and assist in the development and implementation of client retention strategies., • Work closely with Regional Manager to develop assigned territory in line with company's objectives., • Maintain knowledge of competitors and their presence in assigned territory., • Educate and train clients, research problems and coordinate solutions between the laboratory and client., • A bachelor's degree preferred but not required, or two years sales experience, or any similar combination of education and experience., • Well-developed multi-tasking, organizational skills, and detail orientation are key to success., • Energy, motivation, enthusiasm, and integrity., • Excellent written and verbal communication skills., • Must demonstrate sound judgment and decision making ability., • Computer proficiency in MS Office, Excel, e-mail and internet functions., • Must be able to travel within the coverage area and occasionally nationwide. We Offer: • Competitive Salary, • Company Car, • Medical, Dental & Vision Insurance, • Short and Long Term Disability, • Life Insurance, • Dependent Care Flex Spending Account, • Voluntary Policies (Accident, Hospital Indemnity, Critical Illness & Supplemental STD), • Identity Theft Protection, • 401(k) Plan, • Paid Vacation & Holiday Medical Diagnostic Laboratories, LLC is an equal opportunity employer. Job Details Pay Type Salary Hiring Rate 50,000 USD Company DescriptionGenesis Global Group is a privately held collection of vertically integrated domestic and international companies that delivers deep expertise, objective solutions, customized products and unparalleled service spanning the sectors of biotechnology, health care, manufacturing, real estate, and hospitality.Genesis Global Group is a privately held collection of vertically integrated domestic and international companies that delivers deep expertise, objective solutions, customized products and unparalleled service spanning the sectors of biotechnology, health care, manufacturing, real estate, and hospitality.

Job Description Territory Sales Executive - Queens, NY Bayside, Queens, NY, USA• Fresh Meadows, Queens, NY, USA• Flushing, Queens, NY, USA• College Point, Queens, NY, USA• Astoria, Queens, NY, USA Job Description Medical Diagnostic Laboratories, LLC (MDL) is a CLIA certified clinical laboratory with multiple state licensing, specializing in state of the art, automated DNA based molecular analysis of a variety of chronic and infectious illnesses. MDL specializes in and performs a large menu of Polymerase Chain Reaction (PCR) testing. Our main theme of research extends to the field of Gynecology, Infectious Diseases, Infectious Arthritis, Tick-borne Diseases, and Mycology. MDL is looking to expand its sales force throughout the U.S. We are seeking a high-energy, self-motivated individual to join our sales team. As a Territory Sales Executive, you will be responsible for bringing in new business as well as maintaining and growing a client base of both hospital and physician customers for MDL. The territory goal is to achieve 2000 specimens per month. Responsibilities: • Responsible for achieving annual sales and profit objectives for a defined territory., • Obtain new business as well as grow client base revenues., • Exceed annual territory sales budget each year by presenting new test information, up selling and seeking out new sources of revenues from clients., • Develop and present personalized sales presentations to professional audiences (physicians, laboratory staff, clinics and group practices); demonstrate how MDL's technical features and services could benefit the practice and help medical personnel provide quality patient care., • Establish positive long-term client relations through scheduling and conducting visits with clients., • Develop and maintain a full business pipeline of prospective clients and assume all territory management in an assigned geographic region., • Provide timely and accurate reporting of pipeline, account plans and territory management activities as required., • Work closely with Regional Manager to identify client concerns and assist in the development and implementation of client retention strategies., • Work closely with Regional Manager to develop assigned territory in line with company's objectives., • Maintain knowledge of competitors and their presence in assigned territory., • Educate and train clients, research problems and coordinate solutions between the laboratory and client., • A bachelor's degree preferred but not required, or two years sales experience, or any similar combination of education and experience., • Well-developed multi-tasking, organizational skills, and detail orientation are key to success., • Energy, motivation, enthusiasm, and integrity., • Excellent written and verbal communication skills., • Must demonstrate sound judgment and decision making ability., • Computer proficiency in MS Office, Excel, e-mail and internet functions., • Must be able to travel within the coverage area and occasionally nationwide. We Offer: • Competitive Salary, • Company Car, • Medical, Dental & Vision Insurance, • Short and Long Term Disability, • Life Insurance, • Dependent Care Flex Spending Account, • Voluntary Policies (Accident, Hospital Indemnity, Critical Illness & Supplemental STD), • Identity Theft Protection, • 401(k) Plan, • Paid Vacation & Holiday Medical Diagnostic Laboratories, LLC is an equal opportunity employer. Job Details Pay Type Salary Hiring Rate 50,000 USD Company DescriptionGenesis Global Group is a privately held collection of vertically integrated domestic and international companies that delivers deep expertise, objective solutions, customized products and unparalleled service spanning the sectors of biotechnology, health care, manufacturing, real estate, and hospitality.Genesis Global Group is a privately held collection of vertically integrated domestic and international companies that delivers deep expertise, objective solutions, customized products and unparalleled service spanning the sectors of biotechnology, health care, manufacturing, real estate, and hospitality.

Job Description Territory Sales Executive - Northern Manhattan/Washington Heights/Harlem, NY 116 E 125th St, New York, NY 10035, USA ● Harlem, New York, NY 10027, USA ● Washington Heights, New York, NY, USA Medical Diagnostic Laboratories, LLC (MDL) is a CLIA certified clinical laboratory with multiple state licensing, specializing in state of the art, automated DNA based molecular analysis of a variety of chronic and infectious illnesses. MDL specializes in and performs a large menu of Polymerase Chain Reaction (PCR) testing. Our main theme of research extends to the field of Gynecology, Infectious Diseases, Infectious Arthritis, Tick-borne Diseases, and Mycology. MDL is looking to expand its sales force throughout the U.S. We are seeking a high-energy, self-motivated individual to join our sales team. As a Territory Sales Executive, you will be responsible for bringing in new business as well as maintaining and growing a client base of both hospital and physician customers for MDL. The territory goal is to achieve 2000 specimens per month. Responsibilities: • Responsible for achieving annual sales and profit objectives for a defined territory., • Obtain new business as well as grow client base revenues., • Exceed annual territory sales budget each year by presenting new test information, up selling and seeking out new sources of revenues from clients., • Develop and present personalized sales presentations to professional audiences (physicians, laboratory staff, clinics and group practices); demonstrate how MDL's technical features and services could benefit the practice and help medical personnel provide quality patient care., • Establish positive long-term client relations through scheduling and conducting visits with clients., • Develop and maintain a full business pipeline of prospective clients and assume all territory management in an assigned geographic region., • Provide timely and accurate reporting of pipeline, account plans and territory management activities as required., • Work closely with Regional Manager to identify client concerns and assist in the development and implementation of client retention strategies., • Work closely with Regional Manager to develop assigned territory in line with company's objectives., • Maintain knowledge of competitors and their presence in assigned territory., • Educate and train clients, research problems and coordinate solutions between the laboratory and client., • A bachelor's degree preferred but not required, or two years sales experience, or any similar combination of education and experience., • Well-developed multi-tasking, organizational skills, and detail orientation are key to success., • Energy, motivation, enthusiasm, and integrity., • Excellent written and verbal communication skills., • Must demonstrate sound judgment and decision making ability., • Computer proficiency in MS Office, Excel, e-mail and internet functions., • Competitive Salary, • Medical, Dental & Vision Insurance, • Short and Long Term Disability, • Life Insurance, • Dependent Care Flex Spending Account, • Voluntary Policies (Accident, Hospital Indemnity, Critical Illness & Supplemental STD), • Identity Theft Protection, • 401(k) Plan, • Paid Vacation & Holiday Medical Diagnostic Laboratories, LLC is an equal opportunity employer. Company DescriptionGenesis Global Group is a privately held collection of vertically integrated domestic and international companies that delivers deep expertise, objective solutions, customized products and unparalleled service spanning the sectors of biotechnology, health care, manufacturing, real estate, and hospitality.Genesis Global Group is a privately held collection of vertically integrated domestic and international companies that delivers deep expertise, objective solutions, customized products and unparalleled service spanning the sectors of biotechnology, health care, manufacturing, real estate, and hospitality.

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Job DescriptionDescriptionPrecision Neuroscience is pioneering a brain implant, known as a brain-computer interface (BCI), to restore communication and independence for people with neurological conditions. Our cutting-edge technology is designed to empower people with paralysis to control digital devices—such as computers and smartphones—with their thoughts alone, opening new possibilities for daily life. Precision’s multidisciplinary team brings together leading experts in diverse fields such as neurosurgery, artificial intelligence, machine learning, microfabrication, electrical engineering, and more. We are committed to turning breakthrough scientific advancements into real-world solutions for people affected by conditions such as spinal cord injury, stroke, and ALS. As a Precision employee, you will be joining one of the fastest moving and best-capitalized companies in the emerging field of BCI. Since our founding in 2021, Precision has secured over $155 million in funding, developed and validated our technology, and initiated human trials in collaboration with some of the nation’s top hospitals. We are seeking a dynamic and experienced Vice President of Commercial Strategy & Operations to develop the foundational strategies and build the operational infrastructure necessary to bring our life-changing therapy to patients. This role will lead across multiple functions, including market access, marketing, revenue strategy, and commercial operations. This is a unique opportunity to build a world-class commercial organization and define the go-to-market model for a new category in medical technology. This position is on-site at our Manhattan or Santa Clara office. To be eligible for this role, you must currently be based in the United States, and have working rights. Key Responsibilities • Develop and execute a comprehensive go-to-market strategy, including physician targeting, market segmentation, and competitive positioning., • Refine and expand the assessment of the addressable market for our initial indication and develop the strategic roadmap for future applications and product pipeline expansion., • Lead the evaluation and selection of core commercial systems, including CRM, and outline the plan for a commercial analytics function to drive data-informed decisions., • Drive the development of our revenue generation strategy, including pricing, reimbursement, and revenue cycle management., • Develop a comprehensive reimbursement strategy., • Design the commercial organization roadmap, mapping out the necessary roles, responsibilities, and structure to scale effectively., • Define and build the field support operations model to support healthcare providers and patients, • 10+ years of progressive experience in commercial roles within the medical device, biotechnology, or pharmaceutical industry., • Proven track record of success in commercial strategy, product launches, and market development, preferably with novel technologies or in specialty markets., • Deep experience in one or more of the following areas: market access/reimbursement, marketing, sales operations, or health economics., • Demonstrated ability to build and lead high-performing teams and to operate in a player-coach capacity in a fast-paced, startup environment., • Exceptional analytical and financial modeling skills; able to translate complex data into actionable strategic insights., • Experience managing external agencies and vendors and negotiating contracts., • Strong understanding of the legal and regulatory compliance environment for medical devices., • Excellent communication and presentation skills, with the ability to influence and align stakeholders at all levels, from the Board of Directors to cross-functional teams., • Bachelor’s degree required; MBA or other advanced degree strongly preferred. Diverse workforces create the best culture, company, and products. We at Precision are committed to an inclusive culture that celebrates the uniqueness and contributions of everyone. As an equal opportunity employer, Precision does not discriminate on the basis of sex, race, religion, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Job DescriptionCompany Description Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application! At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients. Our mission and culture at Sobi North America get us excited to come to work every day, but here are a few more reasons to join our team: • Competitive compensation for your work, • Generous time off policy, • Summer Fridays, • Opportunity to broaden your horizons by attending popular conferences, • Emphasis on work/life balance, • Collaborative and team-oriented environment, • Making a positive impact to help ultra-rare disease patients who are in need of life saving treatmentsJob Description The Clinical Account Manager (CAM) acts as the primary customer contact for sales demand creation by executing marketing strategy and promoting Sobi products as lead by the Regional Sales Director. In this strategic role, the CAM provides current and comprehensive clinical knowledge of Sobi’s products and effectively communicates the on-label clinical benefits of the products. As a sales leader, the CAM is expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages to customers, representing Sobi at local meetings, and achieving or exceeding sales targets. *Please note this is a remote position but candidate must reside within the territory (New York City) • Responsible for representing Sobi’s products and services to a defined customer base, generating and growing sales and consistently achieving or exceeding sales goals within a specific geographic area and actively promotes the appropriate use of Sobi products to healthcare professionals in accordance with all Corporate, PhRMA, and OIG guidelines, • Comprehensive understand of Sobi and competitor products in their therapeutic area, and an in-depth knowledge of the disease states., • Develops and implements a territory business plan to meet customer needs and achieve sales goals and weekly analysis of territory sales data to help prioritize physician targeting and ensure accurate reporting of physicians, • Strict compliance with all regulatory agencies, state, and federal law is required., • Prepares territory budget plans for customer contacts, local symposia, and other miscellaneous external expenditures, • Assists in the identification and resolution of issues and opportunities and communicates proactively to sales and marketing management., • Reports all adverse events to Sobi’s Drug Safety department as appropriate per required guidelines, • Performs all administrative functions require of the position, including reporting call activity and customer information into the appropriate call reporting system in a timely manner, submitting expenses, etc.Qualifications, • Located within the territory, • BA/BS in business or science, • Minimum of 5 years’ with dedicated hospital selling experience in the Pharmaceutical or Biotechnology industry, with minimum of 3 years’ specialty sales experience in the Pharmaceutical or Biotechnology industry, • A CAM will have a minimum of 3 years’ of biologics sales experience that will utilize a specialty pharmacy or 8 years with dedicated hospital selling experience. Experience with a transition of care/patient journey process from the hospital to the outpatient setting, • Demonstrated history of high sales performance, • Experience with single source pharmacies, reimbursement programs, managed care, and formulary, • Strong work ethic, ability to develop priorities, and manage time appropriately in a large, assigned geography., • Travel within the assigned territory, including overnights, which could be as high as 40-50% in some cases. Must be based in, or located near given geographic territory (relocation will not be provided), • This individual will also be responsible for accurately performing all administrative functions require of the position, including reporting call activity and customer information into the appropriate call reporting system in a timely manner, submitting expenses, etc., and travel within the assigned territory, including overnights, which could be as high as 40-50% in some cases. Must be based in or located in close proximity to given geographic territory (relocation will not be provided). Additional Information Compensation and Total Rewards at Sobi At Sobi, we are dedicated to providing our employees with a comprehensive and industry-competitive total rewards package. Our compensation philosophy is designed to recognize and reward talent, ensuring that your contributions are valued and reflected in your overall rewards. Your total compensation at Sobi goes beyond just your base salary and annual bonus. It also includes a robust suite of benefits, such as: • A competitive 401(k) match to support your financial future., • Tuition and wellness reimbursements to invest in your personal and professional growth., • A comprehensive medical, dental, and vision package to prioritize your health and well-being. All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease. Why Join Us? We are a global company with over 1,700 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you. We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff. Sobi Culture At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them. As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth. An Equal Opportunity Employer Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate. Sobi is an affirmative action and equal opportunity employer. Disabled/Veterans. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to COVID-19 Policy For the safety of our employees and all individuals with whom we interact professionally, Sobi North America requires all new hires in the U.S. to be fully vaccinated for COVID-19 with proof of vaccination status. We will consider requests for reasonable medical or religious accommodations, as well as any state-specific exemptions, as required by applicable law.

Job Description About PharmaEssentia: It’s not often you get the chance to make a real impact on the lives of others, while expanding your own possibilities. You’ll find that rare opportunity at PharmaEssentia. Join us, and let’s transform lives, together. PharmaEssentia Corporation is a rapidly growing biopharmaceutical innovator. We are leveraging deep expertise and proven scientific principles to deliver effective new biologics for challenging diseases in the areas of hematology and oncology, with one product approved and a diversifying pipeline. We believe in the potential to improve both health and quality of life for patients with limited options today through the combination of rigorous research and innovative thinking. Founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today we are listed on the Taiwan Stock Exchange (TWSE: 6446) and are expanding our global presence with operations in the U.S., Japan, Singapore, South Korea, and China, along with a world-class biologics production facility in Taichung. Position Overview: PharmaEssentia is seeking an experienced Hematology Account Manager with a strong patient focus and a passion for driving results for its commercial product, BESREMi®. This position is responsible for all sales activities in an assigned geographical area and will be expected to maximize sales achievement through promotion of PharmaEssentia products to approved, targeted customers and distribution channels. You will build and execute strategic territory plans across stakeholders involved in patient care in order to educate customers about BESREMi® and address the various needs along the treatment adoption process. Customers include hematologists/oncologists, nurses, pharmacists, pharmacy and therapeutics groups, teaching institutions, hospitals and formulary committees. Key Responsibilities: Customer Focus • Communicate the clinical profile of BESREMi®, describe pivotal trial data and address clinical and non-clinical barriers in a clear and impactful manner to key customers involved in hematology oncology patient care, • Partnering with cross-functional commercial partners such as market access and medical teams to provide comprehensive solutions for customers, • Contribute to a culture of continuous learning and going the extra mile for patients by sharing knowledge across teams, investing in personal skill development, and striving to keep abreast of changing clinical and business dynamicsResults Focus, • Build, maintain and apply clinical and business expertise within the hematology oncology marketplace to develop territory business plans designed to address the needs of various customers within the geography as it relates to BESREMi®, • Developing specific account/prescriber action plans that provide a clear line-of-site to achieving established goals within a specific timeframe, using analytics to understand trends and track progress against goals, • Meet and exceed business objectives through thoughtful planning, collaboration with partners and utilization of tools and resources for flawless execution of strategic directionEntrepreneurial Expertise, • Becoming a true subject matter expert on all key topics that impact the success of the business – disease state knowledge, clinical acumen, product expertise, competitive intelligence, market dynamics, customer needs across segments, local market access, etc., • Being a creative, resourceful problem solver with a “no job is too big or too small” attitude that is essential for success in a startup environment, • Growing one’s knowledge and capabilities (clinical, marketplace, competitive), trying new approaches to persistent challenges, continually raising the bar on performanceBusiness Acumen, • Using data and sound judgement to continually evaluate plans and make changes as necessary to course correct and address evolving landscape and business dynamics, • Utilizing CRM as a strategic tool for assessing and tracking customer status and progressing sales plans, • Completing of sales administrative requirements (T&E, compliance SOPs, Sunshine reporting, etc.)Qualifications and Experience:, • 5+ years of experience within the pharmaceutical or biotechnology industries including experience in the hematology, solid tumor, or rare disease space, • Bachelor’s degree required, • A consistent track record of hematology oncology sales experience in academic and community-based institutions, • Existing relationships with key customers are highly valued (e.g., KOLs, key account leadership), • Experience in new product launches is required, • Experience in and understanding of other commercial functions (e.g., marketing, market access, sales operations, sales training, insights/analytics, business development, etc.) is preferred, • Experience working in a start-up company environment is preferred, • Specialty pharmacy knowledge is preferred, • Track record of performance and a passion for making a difference for patients, • Ability to understand all facets of the sales cycle including patient identification, building clinical conviction, understanding and overcoming access and reimbursement barriers, and navigating distribution, • Ability to think creatively and seek solutions to access customers and support business needs, • Excellent interpersonal, oral and written communication skills and a strong leadership presence, • Demonstrated ability to adapt to changes in the work environment. Able to maintain a big picture view in the face of frequent change, delays, unexpected events, or uncertainty/ambiguity involved in new product launches with maturity and professionalism, • Must consistently act with high ethical standards and always keep the patient at the forefront, • Strong critical thinking and strategic problem-solving skills, • Demonstrates a strong sales hunter mentality. Able to develop new leads and drive for results, • Advanced business acumen and granular account acumen management skills, • Successful experience covering large geographical territories autonomouslyThe expected base salary range for this position is $180,000 to $200,000. Salary offers are based on a wide range of factors including relevant skills, training, experience, education and geographical location. Market and organizational factors are also considered. In addition to base salary and a competitive benefits package, successful candidates are eligible for short-term and long-term incentives. Benefits of working with our team: PharmaEssentia USA strives every day to improve the lives of patients as well as our employees. As a valued member of PharmaEssentia USA, you will enjoy the following benefits: • Comprehensive medical coverage, • Dental and vision coverage, • Generous paid time-off, • 401(k) retirement plan with competitive company match, • Medical & Dependent Care Flexible Spending Account, • Monthly cell phone reimbursement PharmaEssentia does not accept unsolicited agency resumes. Staffing agencies should not send resumes to our HR team or to any PharmaEssentia employees. PharmaEssentia is not responsible for any fees related to unsolicited resumes from staffing agencies. At PharmaEssentia, our goal is to treat as many people with cancer as possible. That means challenging the status quo with better science that leads to better lives. By joining our team, you will not only expand your own possibilities, but you will contribute to expanding options for people with cancer. Powered by JazzHR PcJk171CLZ