Warehouse Supervisor (Materials Management)
United Therapeutics Corporation job in Raleigh, NC
California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.
United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension( PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).
The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create bio-artificial organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.
Who You Are
You are a natural leader who thrives on building structure from the ground up. You're passionate about creating efficient processes, mentoring a team, and driving operational excellence in a fast-paced, highly regulated environment. You take pride in ensuring accuracy, compliance, and quality at every step-from receiving GMP materials to shipping finished products. With a keen eye for improvement and a hands-on approach, you're ready to implement innovative solutions, lead automation projects, and set the standard for a world-class warehouse operation. If you're energized by the challenge of shaping something new and making a lasting impact, this is your opportunity to lead and grow.
The Warehouse Supervisor, Dry Powder Inhalation (DPI) is responsible for overseeing incoming GMP material receipts, expensed supplies and material receipts, control and issuance of materials, and final preparation of product shipments. This role is also responsible for personally training, mentoring, and leading warehouse operations staff in supporting a cGMP warehouse operation in accordance with UT policies and procedures. A key responsibility of this role is to guarantee that their team adheres to UT corporate policies and procedures, with focus on proper non-exempt time management. Ensure warehouse team is completing daily tasks in a timely manner and in compliance with UT standards while looking for ways to improve these processes. Lead in the development and implementation of updated warehouse automation projects.
* Oversee warehouse team in the prioritization of warehouse tasks and activities for completion of inbound material processing and outbound product shipment requirements
* Direct and manage direct reports to include responsibilities for training, goal setting & achievement, performance evaluations/management, coaching, mentoring, career development and provide support for recruitment process (as needed)
* Oversee the receiving process of GMP and expensed materials according to SOPs
* Supervise outbound product shipments in support of the distribution schedule, including but not limited to booking carriers, preparing bills of lading, and obtaining receipt confirmations
* Enter and oversee warehouse material control transactions in SAP
* Track GMP and expensed material stock levels
* Perform as well as oversee disposal of hazardous, non-hazardous, and general waste materials according to SOPs
* Ensure that the warehouse and all material storage areas are maintained in a clean and orderly fashion
* Oversee inventory and ensure shipping supplies are ordered to meet distribution requirements
* Coordinate with Quality Assurance department to ensure that materials are tested and released in a timely manner
* Oversee and ensure GMP materials are staged according to pick list requirements for production and packaging operations
* Assist in the completion of year end physical inventory count
* Coordinate with EHS to repot any potential safety issues
* Ensure that non-inventoried ancillary supplies are always on hand and that we are sourcing these items from the best vendors for our needs
* Coordinate the material flow between multiple RTP warehouses
* All other duties as assigned
Minimum Requirements
* H.S. Diploma or General Education Degree (GED)
* 9+ years of warehouse experience in a regulated manufacturing environment with a H.S. Diploma/GED OR 7+ years of warehouse experience in a regulated manufacturing environment with an Associate Degree
* Knowledge and understanding of cGMPs for warehouse operations, manufacturing, and material control
* Previous experience with operation of mechanical warehouse equipment
* Previous experience with SAP/ERP systems
* Training and experience with the handling and storage of hazardous materials
* Ability to execute a work plan and adapt to schedule changes
* Good organizational skills
* Ability to train and mentor teammates in processing GMP material control tasks for inbound and outbound requirements
* Ability to communicate effectively with other departments within the company
Preferred Qualifications
* Associate Degree
* Ability to author and edit warehouse SOP's
Job Location
United Therapeutics requires this candidate to be on-site at our Durham, North Carolina location 100% of the time.
Physical Demands
This position will require frequent standing and walking, as well as pushing and pulling up to 300 pounds. There may be occasional lifting and carrying up to 50 pounds of weight.
At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.
Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit ******************************************************
United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
Auto-ApplyPharmaceutical Packaging Technician I
United Therapeutics Corporation job in Raleigh, NC
California, US residents click here. The job details are as follows: Who we are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.
United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).
The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.
Who you are
We are seeking a detail-oriented Pharmaceutical Packaging Technician I to join our team at the RTP facility. In this role, you will be responsible for setting up, operating, and cleaning pharmaceutical packaging equipment, including bottle lines, blister lines, cartoning lines, and manual kitting operations. Under direct supervision, you will support packaging and kitting operations, perform in-process checks, equipment adjustments, yield calculations, and batch reconciliations-ensuring strict adherence to company SOPs, MBRs, cGMPs, and safety regulations. If you have a keen eye for accuracy, a commitment to compliance, and a passion for pharmaceutical packaging, we'd love to hear from you!
For this role you will need
Minimum Requirements
* H.S. Diploma or General Education Degree (GED)
* Basic computer skills
Preferred Qualifications
* Associates Degree
* 1+ years of hands-on experience in a pharmaceutical manufacturing, packaging or warehouse environment (will consider commensurate experience and/or combination of education and experience)
* Ability to navigate sophisticated HMI control systems on automated pharmaceutical packaging equipment
* Experience with GMP documentation requirements and have experience with completing batch packaging records, reading and understanding SOPs, and working with packaging machinery
Job Location
United Therapeutics requires this candidate to be on-site at our Durham, North Carolina location 100% of the time.
At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.
Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit ******************************************************
United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
Auto-ApplyIntern - Human Resources - HR Shared Services
Raleigh, NC job
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance our company's mission but will allow you to gain real world experience at one of the most innovative organizations in the world. You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs.
**Key Responsibilities will include, but are not limited to the following:**
+ Perform all assigned tasks accurately, efficiently and in accordance with applicable policies and procedures
+ Work closely with members of assigned team to develop subject matter knowledge
+ Attend company/department/team trainings and meetings as appropriate
+ Maintain accurate and updated employee records in accordance with company policies and government regulations
+ Provide answers to employee questions and problem-solves as needed
+ Assist in the development and improvement of HR processes and procedures
+ Compose competent employee communications regarding HR information and process changes
+ Prepare HR-related reports and surveys
+ Showcase your work with a final presentation (PPT) near the conclusion of your internship
**Required Qualifications:**
+ Must be at least 18 years old
+ Must have a minimum GPA of 2.8
+ Authorized to work in the United States without Sponsorship now or in the future or CPT/OPT through your University.
+ Must be currently enrolled as a full-time student in a Bachelor's/Masters/MBA/PhD program at an accredited US based university or college
+ Must be a Rising Sophomore, Junior, or Senior in undergrad or a Graduate or Doctoral Student
+ Must be enrolled full-time in the Fall Semester at an accredited university/college after the completion of the internship
+ Must be able to complete a 10-12 consecutive week internship between May and August
+ Must be able to relocate if necessary and work at the designated site for the duration of the internship
**Preferred Qualifications** **:**
+ Preferred Degree qualification: master's or undergraduate in fields of mathematics or business administration
+ Proficiency with MS Office Suite
+ Ability to identify issues and seek solutions
+ Ability to work both independently and collaboratively
+ Demonstrated commitment to inclusion and diversity in the workplace
+ Efficient, organized, and able to handle short timelines in a fast-paced environment
+ Good analytical skills with attention to detail
+ Ability to maintain high standards of confidentiality
+ Show strong passion for building a career in Human Resources
+ Workday or ServiceNow knowledge a plus but not required
**Gilead Core Values:**
+ Integrity (Doing What's Right)
+ Inclusion (Encouraging Diversity)
+ Teamwork (Working Together)
+ Excellence (Being Your Best)
+ Accountability (Taking Personal Responsibility)
The expected hourly range for this position is $19.00 - $55.00.
Gilead considers a variety of factors when determining base compensation, including education level and geographic location. These considerations mean actual compensation will vary.
Benefits include paid company holidays, sick time, and housing stipends for eligible employees.
**For jobs in the United States:**
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' (********************************************** poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (*********************************************************
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
Scientist - Matrix Biology
United Therapeutics Corporation job in Raleigh, NC
California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.
United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).
The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.
How you'll contribute
We are looking for our missing puzzle piece, an extracellular matrix (ECM) enthusiast who is looking to apply that expertise to a scale with impact that could change the world? This position will advance progress towards the generation of a functional engineered lung, with a specific focus on the role of the lung scaffold during cellular repopulation, including cell-matrix interactions, matrix changes during culture, and the impact of matrix properties on cellular repopulation. Interested? We can't wait to meet you - let's chat soon!
* Characterize the stability of matrix components, identify relevant degradation profiles, and mitigate degradation of key components, as appropriate
* Identify potential process changes or storage conditions to mitigate stability concerns, and contribute to the evaluation and implementation of changes to process or storage conditions
* Analyze recellularization outcomes to understand the role of the ECM scaffold in the biology of regeneration in engineered lung constructs
* Evaluate and optimize scaffold ECM stability from decellularization through recellularization and terminal pulmonary function assessments
* Determine the proper chemical conditions for ECM stability, ECM component supplementation and adsorption, and ECM-cell interactions
* Analyze matrix composition, turnover, and cell-derived matrix deposition in engineered tissues, interpret these findings, and provide insightful and actionable methods to improve or stabilize the function of the engineered tissues which may include supplementation with bioactive matrix or matrix-associated molecules
* Assess the mechanical function of the scaffold at the organ (pulmonary mechanics) and tissue (interstitial, alveolar, and microvascular integrity) levels and develop methods to promote the proper organization and function of the matrix molecules to achieve optimal regeneration of native organ function
* Evaluate the consistency of findings between in vitro assays and large-scale recellularization studies, adjusting or developing new assays as necessary
* Independently integrate analyses from experiments across multiple sub-teams to determine key factors which drive outcomes, as needed
* Develop new techniques, laboratory procedures, and/or protocols to support lung scaffold recellularization and characterization efforts, as needed
* Proficiently perform complex scientific tasks and independently make complex technical or scientific decisions
* Proficiently analyze data, potentially utilizing sophisticated or in-depth analyses, and through such analyses, identify novel data trends
* Evaluate new technologies or methods, applying scientific insights to the process. Coordinate tech transfer with academic & industrial collaborators.
* Develop and implement novel, impactful, and/or complex experimental plans. Generate insightful complex hypotheses and conclusions. Apply scientific knowledge and literature evidence to experimental planning.
* Prepare and present regular reports on research strategy and progress
* Independently contribute to focused research areas through maintenance and continued development of knowledge using past and current scientific literature as well as collaborative thinking
* Commit to supporting individual, group, and departmental goals to achieve key objectives
* Appropriately document performance and methods
* Help maintain smooth operations of the lab, including maintaining lab supplies, monitoring equipment and providing lab support
* Perform other duties as assigned
For this role you will need
Minimum Requirements
* Masters degree with 6+ years of related industry or academic faculty-level experience or a PhD with 2+ years of related industry or academic faculty-level experience
* 5+ years of experience and comfort developing, optimizing ,and performing analytical assays, evaluating and interpreting data, and optimizing and troubleshooting analytical assays
* Experience includes proficiency with at least 4 of the following analytical tools in support of research efforts: histology, immunohistochemistry, image analysis, SEM/TEM, biochemistry, ELISA, Western Blot, and/or proteomics/glycomics, mechanical testing
* Experience with statistical analysis utilizing JMP, GraphPad Prism, R or other comparable program
* Proficiency and experience developing, optimizing ,and performing analytical assays, evaluating and interpreting data, and optimizing and troubleshooting analytical assays
* Proficient in applying Design of Experiments (DOE) principles and advanced statistical methods for experimental planning and data interpretation
* Familiarity with material and device biocompatibility evaluation and associated regulatory requirements
Preferred Qualifications
* Doctor of Philosophy (PhD) in protein/cell biology, biomaterials, biotechnology, biomedical engineering, biomechanics, or related field
* Performs and interprets results of uniaxial mechanical testing
* Experience with MatLab and/or Python
* Comparative Proteomic Quantitation/Comparative Analysis Program(s)
* Previous regenerative medicine or tissue engineering experience involving cellular and matrix or scaffold interactions
* Experience/knowledge in one or more of the following: - Mechanical characterization of biomaterials, Chemical modifications of extracellular matrix, - Immunological techniques (IHC, ELISA), - Accelerated degradation study of biomaterials, product or prototype characterization of proteins, and/or - Protein detection, western blot or ELISA especially as applied to ECM component or degradative products
* Contribution to regulatory filing(s) in support of clinical candidate development
Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit ******************************************************
United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
Auto-ApplyPatient Navigator, Patient Support Operations
United Therapeutics job in Morrisville, NC
California, US residents click here (******************************************************************************************************************************************* . **The job details are as follows:** Who we are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.
United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).
The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.
Who you are
You are someone who believes in delivering "best in class" customer service. You are a calm and patient listener and love to research issues and find compliant and helpful solutions. You are excited to work for a company that is passionate, inspiring and always patient-centric.
The Patient Navigator, Patient Support Operations, plays a pivotal role in educating customers about our PAH and PH-ILD products, while also providing essential services that streamline patient access to therapy. Compliantly adhering to FDA and other regulatory guidelines, the Patient Navigator takes ownership of the patient journey, expertly guiding individuals through the complexities of obtaining prescribed medication. By acting as a bridge between patients, caregivers, and healthcare providers (HCPs), this role effectively eliminates non-clinical barriers to therapy. The Patient Navigator has a strong sense of ownership, adept problem-solving abilities, and provides compassionate, patient-centered care from case initiation to closure. Moreover, the Patient Navigator uses exceptional interpersonal skills to provide support and education to patients regarding their disease state, understanding of medical and pharmacy benefits, as well as thorough product education and service explanations. The objective of our overall Patient Support Program is to ensure patients have the knowledge, resources, and logistical support necessary to help effectively manage their conditions and adhere to treatments as prescribed by their HCP.
This role will contribute to our overall Patient Support vision by:
+ Providing a "Best in Class" customer experience for our patients, prescribers and caregivers
+ Removing non-clinical barriers to therapy
+ Operating in compliance with FDA and Standard Operating Procedures
+ Supporting a culture that ignites passion.
Minimum Requirements
+ Associates Degree in life sciences, business, or a related field with 4+ years of relevant experience in case management, customer service, or patient experience management or,
+ Bachelor's Degree with 2+ years of relevant experience in case management, customer service, or patient experience management.
+ Strong sense of ownership, adept problem-solving abilities, exceptional interpersonal skills and ability to offer compassionate, patient-centered care, support and education
+ Professional telephone etiquette; effective verbal and written communication skills
+ Strong communication and interpersonal skills, with the ability to effectively engage on the phone or in person with patients, healthcare professionals, and cross-functional teams
+ Empathy, compassion, and a patient-centric mindset to provide the "best in class" customer service
+ Adaptive, anticipating the needs of the business and patients, while being open to feedback.
+ Ability leading without authority, possessing a drive for results
+ Excellent problem solving, time management and organization skills
+ Candidate must be able to work onsite M-F from 10:00 a.m. - 7:00 p.m. ET
Preferred Qualifications
+ Bachelor's Degree in life sciences, business, or a related field
+ Strong proficiency with Microsoft Office suite
+ Experience working in an SOP environment
+ Prior case management ownership of a territory
+ Experience utilizing CRM (e.g. Health cloud, Salesforce) to carry out patient support related activities
+ Experience working with patient support programs, case management, and adherence program designs
+ Rare disease and / or complex therapy administration experience
+ Experience with text or chat HIPAA compliant communication methods
+ Bilingual Spanish
Job Location
This position will be located at our Morrisville, NC office. Currently this job is a fully onsite role.
At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.
Learn more about United Therapeutics Cares: ************************************
Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit ******************************************************
United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
_We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success._
_We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work._
Sr. IT Organizational Change Management Specialist
Raleigh, NC job
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
**Sr. IT Organizational Change Management Specialist** **(Cork, Ireland or Raleigh, North Carolina, USA)**
In IT Customer Success and Enablement (CSE), we drive internal customer success and technology enablement across Gilead to minimize disruption, enhance productivity and improve the employee experience. We bridge the gap between technology and people by raising awareness and fostering engagement with IT offerings, initiatives, platforms and services. We drive for excellence by measuring adoption and satisfaction and ensuring continuous improvement.
We are seeking a subject matter expert to plan and implement organizational change management, communications and learning activities in support of the adoption and satisfaction with enterprise wide IT change initiatives and technology offerings.
This role focuses on the impact of change on end users, including changes to business processes, systems and technology. Collaborates with IT and business stakeholders, people leader and peers on the development and implementation of plans that drive business value and expected outcomes. Follows department standard operating procedures (SOPs) and guidelines to ensure quality and on time delivery.
We are considering candidates for either the Cork Ireland or Raleigh, North Carolina locations.
**Job Responsibilities**
+ Supports change management strategies and work plans for multiple internal technology projects and product offerings in IT as required.
+ Promotes the organizational change management discipline and work plans for project initiatives. Supports the application of related processes and procedures to implement Organizational Change Management strategies, as well as implementation of various related tactics (readiness assessments, targeted surveys, early adopters program, targeted communications), to ensure a structured methodology and approach for completion of plans/deliverables.
+ Creates Communications strategy, plan and timeline. Collaborates with leader, peers and IT point of contact to ensure messages align with strategic intent for the initiative or product offering. Writes, reviews, and delivers communications outlined in the IT CSE plan.
+ Identifies potential risks and anticipated points of resistance, and works with leaders, peers and/or stakeholders to develop specific plans to mitigate or address the concerns.
+ Supports the development of a set of actionable and targeted change management plans - including communication, sponsor roadmap, management coaching plan, learning plan, listening and measurement and any other areas as required.
+ Maintains systems to track adoption, utilization, and proficiency of changes. Contributes to ongoing improvements to tracking systems and tools.
+ Creates, recommends, and encourages and enables reinforcement mechanisms and celebrations of success.
+ Responsible for other duties as assigned to support the IT CSE team's deliverables.
**Basic Qualifications**
For EU-Cork, IR candidates:
Bachelor's degree and relevant years of organizational change management, project management and communications experience in a technology function.
For US-Raleigh, NC candidates:
Bachelor's degree and extensive experience in organizational change management, project management and communications experience in a technology function.
**Preferred Qualifications**
+ Knowledge of how change and change processes impact an organization, as well as external client environments.
+ Experience and knowledge of change management principles and methodologies, especially change management tools such as ADKAR and Prosci certification is preferred.
+ Exceptional communication skills - both written and verbal.
+ Ability to work effectively at all levels in an organization.
+ Strong analytical and decision making abilities.
+ Must be a team player and able to work with and through others.
+ Proficiency with M365 Suite including Copilot and other AI tools.
**Equal Employment Opportunity (EEO)**
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
Case Manager
Raleigh, NC job
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
Customer Management
Job Sub Function:
Customer Service Operations
Job Category:
Business Enablement/Support
All Job Posting Locations:
Orlando, Florida, United States of America, Phoenix, Arizona, United States, Pittsburgh, Pennsylvania, United States of America, Raleigh, North Carolina, United States
Job Description:
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at *******************/innovative-medicine
We are searching for the best talent for a Case Manager located in Pittsburgh, PA; Raleigh, NC; Orlando, FL; or Phoenix, AZ.
Purpose:
The Case Manager is a client-facing role responsible for responding to inquiries about patient programs, referral status, benefits verification, and financial assistance for Patient Service Center (PSC). They serve as the primary contact for Healthcare Providers (HCPs), patients, internal and external teams, ensuring clear communication, efficient case navigation, and access to therapy.
Responsibilities:
* Act as the primary point of contact and case manager for client, provider and customer inquiries and escalations.
* Support patients and providers with program enrollment, benefits verification and referral to specialty pharmacies.
* Conduct initial patient onboarding calls and ongoing support outreach.
* Maintain regular communication to update all parties on case status and next steps.
* Process PAP (patient assistance program) requests and re-approvals promptly.
* Refer patients to external programs as appropriate
* Identify and document adverse events and product complaints timely.
* Independently manage an assigned territory making timely decisions for case resolution.
* Demonstrate the ability to prioritize and balance the needs of patients, HCP offices utilizing program business.
* Provide concierge-level service resolve issues efficiently and escalate when necessary.
* Collaborate with field teams, manufacturer reps, providers, and internal/external teams to resolve complex cases.
* Maintain accurate, compliant documentation and communication to support program goals.
* Uphold patient privacy laws and foster collaborative team relationships.
* Other duties as assigned.
Required Qualifications:
* High school diploma or equivalent.
* Minimum of 4 years of working experience with at least 2 years' experience in customer service, call center, or insurance roles preferably within a healthcare or pharmacy setting.
* Ability to work assigned 8 hr shift between program operating hours of 8am-8pm EST.
* Strong communication and interpersonal skills with a focus on customer service.
* Proven ability to manage a case load, prioritize tasks, and build relationships.
* Ability to efficiently navigate multiple screens and systems to perform work.
* Ability to proficiently use Microsoft programs.
Preferred Qualifications:
* Undergraduate degree
* Certified Pharmacy Technician (CPhT)
* Bilingual Spanish speaking and writing
* Knowledge of benefit verification, foundation programs, plan types, and insurance structures.
#Li-Remote
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Accountability, Communication, Customer Support Operations, Customer Support Trends, Detail-Oriented, Inquiry Handling, Issue Escalation, Process Oriented, Service Excellence
Auto-ApplyPrincipal Controls Engineer, Operational Technology
United Therapeutics Corporation job in Raleigh, NC
California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.
United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).
The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.
Who You Are
You're a well-rounded expert in controls engineering and automation with an eye towards the future. We're counting on you to help guide our Operational Technology teams strategy as we expand operations and eventually look to explore new technologies including the expanded use of Machine Learning and Generative AI in support of our packaging, manufacturing and building automation needs. The Principal Controls Engineer will provide expert knowledge, guidance, and leadership in the design, implementation, and support of complex distributed control systems, manufacturing and packaging automation systems, and environmental monitoring systems including Schneider EcoStruxure, AVEVA (WW) Archestra, Delta V, and Elpro in a regulated, validated environment.
* Provide leadership and guidance to the Operational Technology Automation team
* Participate in and lead projects as a subject matter expert in automation systems for upgrades and/or new implementations. Provide expert support of distributed control systems, manufacturing and packaging automation systems, and environmental monitoring systems.
* Troubleshoot and maintain PLCs, HMIs and field devices under strict change control. Perform preventative maintenance procedures on systems and/or equipment as required. Perform network troubleshooting, database troubleshooting, and code troubleshooting and revisions.
* Collaborate with engineering, manufacturing, information technology, and validation teams on system configuration, network architecture, software requirements, graphics, programming, and sequence of operations
* Review automation system specifications, programming standards and implementation plans. Verify standards are met; ensure GAMP/cGxP procedures and testing are followed.
For this role you will need
Minimum Requirements
* Associate Degree in information technology or engineering or Bachelor's Degree in information technology or engineering
* 12+ years of automation experience including PLC programming and connectivity, Industrial Networking and Schneider EcoStruxure, Wonderware Archestra, Delta V, and Elpro Environmental Monitoring with an Associate's Degree or 10+ years of automation experience including PLC programming and connectivity, Industrial Networking and Schneider EcoStruxure, Wonderware Archestra, Delta V, and Elpro Environmental Monitoring with a Bachelor's Degree
* Prior experience working in an FDA regulated pharmaceutical manufacturing environment
* Prior experience working on construction projects
* Organizational skills including, but not limited to, the ability to handle multiple demands and assignments, the ability to prioritize tasks effectively and efficiently, and the ability to effectively manage resource procurement and utilization
* Superior database maintenance / development experience
* Computer hardware / software validation and change control experience
* PLC programming and connectivity
* Industrial Networking
* Schneider EcoStruxure, AVEVA (WW) Archestra, and Delta V
* Experience working in small, fast paced project teams; ability to work under pressure and adhere to deadlines
Preferred Qualifications
* 2+ years of supervisory experience
* Certified Project Management Professional (PMP)-PMI
Job Location
United Therapeutics requires this candidate to be on-site at our Durham, North Carolina location 100% of the time. Approximately 15% travel is expected for this position.
At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.
Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit ******************************************************
United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
Auto-ApplySenior Specialist, Marketing
Raleigh, NC job
**Reporting to the CFA Strategy and Operations Lead, the Customer Facing Application (CFA) Strategy and Operations Senior Specialist executes the strategic roadmap for US Commercial customer-facing applications, including the evolution of Veeva and Veeva Account Management.**
**Through a deep understanding of customer-facing roles, including that of the Field Sales Representative and Key Account Manager, this individual will partner closely with internal stakeholders across business and technical teams, as well as external providers to evolve our strategic customer engagement model. The CFA senior specialist will directly contribute to the transformation to a bi-directional engagement model through our Veeva capabilities and processes for field representatives.**
**The individual will condense the desired changes or strategic platform enhancement requests into consumable artifacts for distribution/sharing with impacted stakeholders to address both long and short-term issues facing field sales. The individual will represent the field facing channel to drive an omnichannel experience with our customers. The individual will triage and address operational issues that arise related to capability modifications. These capabilities align to key field sales competencies, namely, customer activity reporting, product promotion and business acumen.**
**Success in this role will require strong project management skills and an effective partnership across many functions including Sales Leadership, Account Executive Leadership, US Market Operations, Technical, Training, Compliance and Communications teams.**
**This role will ensure:**
**Realization of the US Commercial CFA roadmap**
**Drive an omnichannel experience with our customers representing the field facing channel**
**CFA capabilities are functioning as intended**
**Related business processes are executed to ensure capabilities continue to be fully realized**
**Processes are aligned with compliance requirements**
**Core strategic platform upgrades are prepared for from a business perspective**
**Operational issues are triaged and addressed in a manner that meets the needs of the business**
**Responsibilities and deliverables include, but are not limited to:**
**Drive creation of planned approach, identify expert stakeholders for engagement and contribution to scope of work**
**Facilitate close collaboration with US Market Operations, Sales Operations, Communication and other critical stakeholder teams to execute against planned approach**
**Engage with legal, compliance, and other similar bodies to seek guidance and alignment on new/novel approaches for customer interactions with the field**
**Communicate with senior Sales and Account Leadership to align on approach, share progress, and for risk mitigation**
**Partnering with technical and/or strategic partners to lead the implementation of capabilities**
**Define and execute against a plan to measure success**
**Required Education:**
**Bachelor's degree**
**Required Experience and Skills:**
**Strong project management skillset**
**Business analysis, problem solving, understanding of sales and marketing strategic priorities**
**Minimum 3 years' experience in Sales/Marketing Operations, field sales, or account management**
**Demonstrated ability to collaborate, plan and execute**
**Experience in the development or implementation of capabilities (e.g., requirements definition, user acceptance testing)**
**Communication and cross-functional collaboration**
**Business process design/re-design**
**Strategic thinking, business acumen, problem solving, understanding of sales and marketing**
**Ability to negotiate and influence key stakeholders, and lead without authority**
**Strong verbal and written communication skills**
**High Compliance IQ: A strong understanding of field sales policy and compliance priorities within a pharmaceutical organization, including the ability to apply to a variety of real-world scenarios.**
**Ability to articulate customer-facing challenges or opportunities to simplify and improve processes to a large matrix cross functional team**
**Leadership Skills including:**
**Entrepreneurship: Having patient and customer orientation; placing a high priority on the internal or external customer's perspective when making decisions and taking action; implementing service practices that meet the customers' and own organization's needs.**
**Ownership and Accountability: taking ownership; setting high standards of performance for self and others; assuming responsibility and accountability for successfully completing assignments or tasks; self-imposing standards of excellence rather than having standards imposed**
**Execution Excellence: taking prompt action to accomplish work goals, per compliance standards; taking action to achieve results beyond what is required; being proactive.**
**Strategic Planning - prioritizing and planning; establishing an action plan for self and others to complete work efficiently and on time by setting priorities, establishing timelines, leveraging resources**
**Change Catalyst: demonstrating adaptability; maintaining effectiveness when experiencing major changes in work responsibilities or environment (e.g., people, processes, structure, or culture); adjusting effectively to change by exploring the benefits, trying new approaches and collaborating with others to make the change successful**
**Preferred Experience and Skills:**
**Experience working in Veeva**
**Passion for working with technology products and solving consumer needs**
**Knowledge/experience with the US marketplace**
**Understanding of launch products and timelines**
**Required Skills:**
Account Management, Account Management, Adaptability, Agile Methodology, Animal Health Sales, Business Acumen, Business Management, Business Processes, Communication, Company Due Diligence, Creative Campaign Development, Customer Engagement, Entrepreneurship, Interpersonal Relationships, Marketing, Marketing Budget Management, Marketing Data Analysis, Marketing Management, Marketing Strategy Implementation, Market Research, Pricing Strategies, Product Lifecycle Management (PLM), Product Roadmap, Project Management, Strategic Customer Development {+ 5 more}
**Preferred Skills:**
Current Employees apply HERE (*****************************************************
Current Contingent Workers apply HERE (*****************************************************
**US and Puerto Rico Residents Only:**
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (******************************************************************************************
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (**********************************************
**U.S. Hybrid Work Model**
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
The salary range for this role is
$114,700.00 - $180,500.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** .
You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
**San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
**Search Firm Representatives Please Read Carefully**
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
**Employee Status:**
Regular
**Relocation:**
No relocation
**VISA Sponsorship:**
No
**Travel Requirements:**
10%
**Flexible Work Arrangements:**
Remote
**Shift:**
1st - Day
**Valid Driving License:**
No
**Hazardous Material(s):**
N/A
**Job Posting End Date:**
12/17/2025
***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.**
**Requisition ID:** R377014
Senior District Manager, Advanced Oral Dermatology
Raleigh, NC job
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
Pharmaceutical Sales
Job Sub Function:
Sales - Immunology (Commission)
Job Category:
People Leader
All Job Posting Locations:
Camden, New Jersey, United States, Charleston, West Virginia, United States, Horsham, Pennsylvania, United States of America, Philadelphia, Pennsylvania, United States, Pittsburgh, Pennsylvania, United States of America, Raleigh, North Carolina, United States, Washington, District of Columbia, United States of America
Job Description:
Johnson & Johnson Innovative Medicine is recruiting for a Senior District Manager, Immunology-Dermatology, to support the Mid-Atlantic Advanced Oral team which includes Pittsburgh, PA, Charleston, WV, Philadelphia, PA, Raleigh, NC, Camden, NJ, Washington, DC, Wilmington, NC, Lancaster, PA, and Columbia, SC.
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Our Immunology team leads in the development of transformational medicines for immunological disorders and illnesses. You can influence where medicine is going by restoring health to millions of people living with immune diseases.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at *******************/innovative-medicine
The Sr. District Manager (SDM) is a field-based role reporting to a Region Business Director. As a Sr. DM, you will:
* Lead a diverse group of sales professionals to foster a culture of high performance, engagement and talent development
* Manage and coach team to develop and execute high impact territory business plans for leading products and win for the patients
* Continuously develop and demonstrate business, clinical and access acumen to compliantly guide the team to capitalize on opportunities in a highly competitive, dynamic environment
* Connect and collaborate with internal and external customers to identify challenges/opportunities/solutions
Required Qualifications:
* A minimum of a Bachelor's degree is required
* At least two (2) years of successful management and/or supervisory experience.
* Five (5) or more years of documented successful pharmaceutical, biologic/biotech, or medical device sales experience in a competitive environment.
* A valid Driver's License in one of the 50 United States
* Ability to travel up to 60%
* Reside within the geography or be willing to relocate to it
Preferred Qualifications:
* Knowledge of the Immunology/Dermatology field
* Knowledge of Institutions in the district
* Knowledge of access and fulfillment processes for biologic therapies
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers and internal employees contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
The anticipated base pay range for this position is :
$141,000-$243,800
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. *********************************************
Auto-ApplyTechnician Maintenance (SkillBridge)
Durham, NC job
**Job Requirements** Technician is a skilled technician with a moderate level of industry experience, responsible for performing routine operational and maintenance activities within an assigned suite or area. This role requires proficiency in mechanical and technical tasks, adherence to current Good Manufacturing Practices (cGMP), and a commitment to environmental, health, and safety (EH&S) standards. The Technician O2 works with moderate supervision, demonstrates mechanical aptitude, and actively contributes to team performance and process improvements.
**Key Responsibilities**
+ **Operational Proficiency:**
+ Fully qualified to independently operate within the assigned suite or area
+ Performs all routine operational activities and preventative maintenance tasks independently.
+ Demonstrates mechanical aptitude and executes basic repairs for assigned equipment;
+ **Compliance and Documentation:**
+ Takes ownership of cGMP compliance, ensuring adherence to Standard Operating Procedures (SOPs), maintenance task lists, and proper documentation.
+ Proactively identifies and resolves compliance issues in the assigned suite, escalating to higher levels when necessary.
+ Maintains 100% training status without requiring coach input.
+ **Business Systems Proficiency:**
+ Proficient in business systems such as SAP, SAP Mobile, DeltaV, and other relevant platforms, performing tasks and transactions independently with minimal assistance.
+ **Problem Solving and Process Improvement:**
+ Recognizes operational and technical problems, using established procedures to assess and implement solutions.
+ Performs routine troubleshooting for assigned equipment or systems, escalating complex issues to higher-level technicians (O3/O4) as needed.
+ **EH&S and Team Accountability:**
+ Contributes to maintaining positive EH&S performance in the assigned area, actively identifying and resolving potentially unsafe conditions.
+ Demonstrates inclusion principles, collaborates with team members, and actively participates in team meetings, including Tier discussions.
+ Complies with safety and environmental regulations and guidelines.
+ **Work Management and Prioritization:**
+ Works independently to meet timeframes set by others, demonstrating reliability and follow-through on commitments.
+ Acts with urgency for emerging issues as directed by leadership.
+ **Leadership and Communication:**
+ Provides and receives timely, constructive one-on-one feedback to improve performance.
+ Listens, collaborates, and supports team decisions to meet collective goals.
+ **Additional Duties:**
+ Communicate with other departments, contractors, or disciplines
+ Assists with automation, validation, and additional testing as required.
+ Contributes to Continuous Improvement of existing processes
+ Complies with safety and environmental regulations and guidelines.
+ Other tasks that may be assigned by leadership
**Work Experience**
+ **Minimum 3 years of plant maintenance or technical experience.**
+ Proficiency in **one** of the technical craft skills, including instrumentation, electrical, plumbing, or advanced mechanical systems.
+ Familiarity with regulatory requirements in accordance with cGMP manufacturing operations or other regulated industry.
+ Effective communication skills, both written and oral.
+ Ability to work with moderate supervision in non-routine situations.
+ This is a Skillbridge opportunity; candidates must be active duty military and eligible for Skillbridge opportunities.
**Requisition ID:** P-100948
Supervisor, Bulk Manufacturing (Dry Powder Inhalation)
United Therapeutics Corporation job in Raleigh, NC
California, US residents click here. The job details are as follows: What We Do We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation.
We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.
Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of "medicines for life". We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan diseases.
How you'll contribute
United Therapeutics supplies Dry Powder Inhalation (DPI) medicines from the RTP, NC facility. This Supervisor is responsible for overseeing the setup, operation, and cleaning of all Bulk manufacturing operations equipment, ensuring that all machines within the supervised area(s), run efficiently and meet operations targets. The Bulk Supervisor will also lead a team of technicians, assigning tasks, monitoring performance, coaching and mentoring, and ensuring the smooth flow of operations across different workstations.
* Provide leadership and guidance to technicians assigned to a given operations area, including but not limited to: performing and documenting all start-up checks, in-process checks, equipment adjustments, and batch reconciliations
* Effectively direct and manage direct reports to include responsibilities for training, goal setting & achievement, coaching, mentoring; provide input to performance evaluations, and support career development, retention, and recruitment process. Promote open communication, address concerns promptly, and foster a positive and collaborative work environment while ensuring an uninterrupted operations flow.
* Responsible for scheduling of operations personnel based on daily deliverables and personnel constraints
* Effectively communicate operations needs and/or issues with leadership
* Coordinate with warehouse staff for components needed for each operation; with QA staff for batch record issuance, room clearances and batch record checks as required; with manufacturing staff to issue labels and manage additional staffing needs; with maintenance staff for equipment troubleshooting and preventative maintenance
* Ensure all operations completed in full compliance with company SOPs as well as GMPs. Ensure batch documentation as well as all cleaning records and labels are complete and accurate. Participate in resolving any non-conformance events; responsible for strict adherence to all OSHA and Company Safety Policies.
* Author SOPs, batch documents and investigation reports
* Perform all other duties as assigned
For this role you will need
Minimum Requirements
* H.S. Diploma or General Education Degree (GED)
* 9+ years of hands-on experience in a cGMP manufacturing, packaging or warehouse environment with a H.S. Diploma/GED or
* 7+ years of hands-on experience in a cGMP manufacturing, packaging or warehouse environment with an Associates Degree or
* 5+ years of hands-on experience in a cGMP manufacturing, packaging or warehouse environment with a Bachelor's Degree
* Must have (or be willing and able to obtain) a valid Passport
* Ability to navigate sophisticated equipment control systems on semi- and fully automated pharmaceutical equipment
* Familiarity with the use and operation of in-process test equipment such as scales, balances, torque tester, and count checker
* Experience with GMP documentation requirements
* Must possess excellent written and oral communication skills
* Ability to interact with other departments effectively
* Ability to review work performed by other personnel, communicate problems and deficiencies, elicit corrections, and enforce company policy and procedures as they relate to manufacturing requirements
* Ability to write and contribute to the development of SOP's and standard work instructions
* Ability to work either a 24/5 or 24/7 work schedule
Preferred Qualifications
* Associates Degree or Bachelor's Degree in a relevant field
* 2+ years of experience as an Operations Supervisor or equivalent
* Knowledge of complex products and processes in a drug manufacturing facility
At United Therapeutics, you'll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients.
Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit ******************************************************
United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
Auto-ApplyResearch Associate I - HLA/SLA
United Therapeutics job in Morrisville, NC
California, US residents click here (******************************************************************************************************************************************* . **The job details are as follows:** **Who We Are** We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.
United Therapeutics (Nasdaq: **UTHR** ) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease ( **PH-ILD** ) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis ( **PF** ).
The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.
**Who You Are**
The Research Associate I - HLA/SLA (Xeno/RMO) is responsible for assisting developing, validating, and performing immunogenetics testing to support xenotransplantation research and regulatory milestones. This role focuses on performing assays to characterize swine leukocyte antigen (SLA) and human leukocyte antigen (HLA) compatibility, optimizing crossmatch and antibody screening assays, and ensuring high-quality, reproducible data to guide clinical and preclinical decision-making. The position plays a key role in advancing translational research by collaborating with multidisciplinary teams to refine protocols, analyze results, and support regulatory submissions.
+ Perform routine and complex immunogenetics testing (e.g., PCR-based typing, Next-Generation Sequencing, Luminex/Intelliflex assays) on human and porcine samples
+ Assist in development, validation, and optimization of assays for histocompatibility testing (HLA/SLA)
+ Isolate, culture, and prepare PBMCs, endothelial cells, and other relevant cell populations for compatibility testing
+ Troubleshoot technical issues, maintain assay performance, and document deviations or corrective actions
+ Maintain and calibrate laboratory equipment, ensuring readiness for regulated testing and audits
+ Contribute to scientific manuscripts, abstracts, and conference presentations
+ Stay current with relevant literature, technologies, and regulatory guidelines in HLA/SLA testing and xenotransplantation research
+ Document all laboratory activities in compliance with GLP, CLIA, CAP, EFI, and/or FDA regulatory requirements
+ Assist in writing, reviewing, and updating SOPs, validation protocols, and quality records
+ Participate in internal audits, CAP inspections, and regulatory reviews
+ Assist in training junior staff and collaborators in proper laboratory techniques and assay workflows
+ Collaborate with clinicians and R&D scientists to design experiments and refine donor-recipient matching strategies
Minimum Requirements
+ Bachelor's Degree in a related field
+ 1+ years of histocompatibility experience
+ Proficiency in laboratory techniques (pipetting, cell handling, molecular assays, flow cytometry)
+ Capacity to participate in multiple projects with competing timelines in a fast-paced research and clinical environment
+ Effective problem-solving skills to troubleshoot assay failures and identify root causes
+ Competence with electronic laboratory notebooks (ELN), LIMS systems, and basic bioinformatics workflows
+ Ability to work flexible hours including evenings and weekends on an ad hoc basis.
Preferred Qualifications
+ ABHI - American Board of Histocompatibility and Immunogenetics Certified Histocompatibility Technologist (CHT) or Supervisor (CHS)
+ Strong understanding of immunogenetics, including HLA and SLA systems, antigen presentation, and transplant immunology
+ Familiarity with xenotransplantation models, including swine genetics, immunobiology, and donor-recipient matching considerations
+ Working knowledge of cell culture techniques, including PBMC and endothelial cell isolation and maintenance
+ Knowledge of crossmatch methodologies (CDC, flow cytometry) and interpretation of cytotoxicity/antibody binding data
+ Excellent technical documentation skills for SOP writing, assay reports, and regulatory submissions
Job Location
This job is an Onsite role requiring 5 days per week in the Morrisville, NC location.
At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.
Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit ******************************************************
United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
_We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success._
_We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work._
Rare Disease Account Specialist - Raleigh, NC
Raleigh, NC job
Who We Are:
At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs.
What We Do:
Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (
*in collaboration with AbbVie
)
About the Role:Expert on the practices, delivery networks, and patient populations within their territory. Call on healthcare providers representing a first-in-class new treatment for rare CAH disease in a unique patient population. Responsible for positioning the company as a leader in the Endocrine space and maximizing sales in their territory. Provides education and approved support to their customers from diagnosis through rare disease management. Represent Neurocrine in the communities we serve as we strive toward transforming the lives of those living with Rare Disease. Playing an integral role in identifying and building collaborative relationships with COE's, key academic institutions, health systems, physicians and clinics, the RAS embraces and executes marketing and sales strategies. They will master brand messaging, clinical information, targeting, and digital technology to deliver persuasive, high-impact customer experiences tailored to distinct user segments while maintaining the highest ethical standards.
_
Your Contributions (include, but are not limited to):
Leads the implementation for our patient-centric model which will include physicians, their staff, clinics, and applicable hospitals
Develop and maintain strategic long-term relationships with COEs, Academic Teaching Institutions, key Health Systems, and relevant IDNs
Serve as the authority on the various tools and resources Neurocrine offers to support physicians, pharmacists, and other health care providers in advocating for Rare Disease patients
Create, maintain and execute strategic business and account plans reflecting a thorough understanding of brand plan and the local market conditions
Master targeted disease states which include a deep understanding of patient journeys, standards of care and treatment drivers
Leverages in-depth disease and therapeutic clinical, and scientific knowledge to effectively execute local disease education and promotional programs for therapeutic area
Provides a high level of product expertise and customer service to all targeted accounts and appropriate stakeholders
Continuously expand expertise of all treating and referring physicians, as well as payers, hospital systems, pharmacies, labs, and other components of the care continuum; maintain awareness and remain attentive to the dynamics between different stakeholders that influence patient treatment decisions
Navigates complex hospital setting (academic and community) to access targeted HCP and other key stakeholders
Maintain strong relationships within the payer landscape to ensure providers are informed on coverage and reimbursement status; collaborate with the payer access team to ensure all relevant stakeholders are working with the most-up-to-date information to maximize access for patients using Neurocrine products
Foster strong relationships with patient advocacy groups to support appropriate patient education and disease state awareness activities in the community
Engage with providers managing patients with rare CAH disease and provide high-level clinical education around disease state and product
Compliantly assist with steps to provide access to therapies for patients. This may include proper testing procedures, site of care determination and reimbursement process education
Provide educational support to an underserved patient community
Collaborate with patient advocacy to support the patient and rare disease community
Outstanding communication and interpersonal skills, with expert aptitude in networking, problem solving, negotiation and building relationships
Keep abreast with industry and market trends and best practices, provide feedback loop during initial stages of launch
Performs other job related duties as assigned
Requirements:
BS/BA degree AND 8+ years of sales experience in biotech/pharmaceutical sales industry, including 5+ years of relevant work experience calling on prescribers of specialized, high value products. Proven launch experience in highly complex and competitive environments. Experience with business systems, salesforce automation platforms, and other business intelligence tools (e.g., Salesforce.com, Oracle database, SAP, Business Objects, COGNOS, QlikView, Veeva etc.) Proven sales performance as evidenced by % to quota, ranking reports, and recognition awards in specialty pharmaceutical or biotech markets. OR
Master's degree preferred AND 6+ years of experience as show above. OR
PhD AND 4+ years of experience as show above
The ideal candidate will embody Neurocrine's core values
Candidates must demonstrate a consistent track record of sales success including quantifiable/documented sales accomplishments and awards
Experience in rare diseases preferred
Prior experience calling on Key Accounts, COE's and academic institutions
Previous start-up, market development experience desirable
Endocrine experience is strongly preferred
Experience with products in specialty pharmacy distribution/Hub Model
Demonstrated ability to plan, analyze and interpret sales data to identify and address business opportunities
Demonstrated proficiency with a Sales Force Automation application and basic business software
Well organized with the ability to multitask, prioritize, and manage shifting responsibilities in a dynamic, cross-functional teamwork environment
Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity
Strong interpersonal and organizational skills and excellent verbal and written communication skills are required
Passion for Patient and Caregiver Programs
Thorough understanding of industry standards, multiple customer segments, specialty product distribution and market access fundamentals
Proven ability, as supported by superior product/portfolio performance, to set and achieve challenging business objectives
Demonstrated self-leadership ability that inspires peers to achieve high performance result
Thrive in an environment driven by ownership and accountability with high ethical standards
Demonstrated ability successfully navigate complex and challenging accounts in highly varied sites of care
Challenge the status quo with intellectual curiosity and entrepreneurial spirit
Derive great job satisfaction through purposeful work
Strong understanding of healthcare regulatory and enforcement environments
Demonstrated ability to work cross-functionally
Ability to identify and hire an exceptional sales team
Ability to work independently
This position requires frequent driving, therefore a valid driver's license, clean driving record, and ability to operate a motor vehicle are required as part of the job responsibilities
Neurocrine Biosciences is an EEO/Disability/Vets employer.
We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description.
_
The annual base salary we reasonably expect to pay is $132,600.00-$183,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position is eligible participate in the Company's quarterly incentive compensation plan, which provides the opportunity to earn additional compensation based on individual performance results. This position is also eligible to participate in our equity based long term incentive program.
Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.
Auto-ApplyLead Site Auditor
Durham, NC job
The Quality Associate Director/GMP Lead Site Auditor will have leadership responsibility for the site internal audit program, encompassing the full scope of site operations. Collaboration is required with site leadership, regional compliance leadership and Divisional Quality Assurance to elevate site audit program to achieve excellence and ensure program is effective. The position requires ability to lead and perform the operational aspects of the audit program, apply risk-based principles, communicate results to stakeholders, and evaluate/verify CAPA closure. Position requires risk communication related to the totality of audit and inspection findings at the site. Ability to lead an audit program that is focused on early detection and robust remediation of observation across the site. Ability to play a lead role in hosting Health Authority inspections and Divisional Audits at the site.
**Position Responsibilities:**
+ Actively manage, mentor, and support site auditors to ensure performance of auditors contributes to the effectiveness of the site audit program
+ Function as a change agent related to culture and audit program performance
+ Lead change and process improvement initiatives related to Auditing, Inspections, CAPA, and other compliance topics
+ Perform routine risk communication pertaining to audits/inspection to Site, Regional, and Divisional Management
+ Mentor new auditors to ensure comprehensive training and full understanding of auditor roles and responsibilities
+ Achieve and maintain auditor qualification status through robust training and continuing education
+ Lead training/orientation for new Quality Auditing staff
+ Ensure preparation of annual audit schedule, using risk-based approaches
+ Schedule and perform assigned audits for site program.
+ Ensure timelines and quality of content for audit execution (audit pre-work, conducting audit, issuance of audit report, CAPA review and verification) meet established expectations.
+ Perform, lead, and mentor other auditors during site audits; participate in opportunities to audit at regional sites
+ Review, and approve Audit Reports
+ Actively monitor, report and trend observations/CAPAs, along with standard site audit metrics to Quality Council and Management
+ Actively participate and take a leadership role in the Auditor Community of Practice and Guest Auditor Program
+ Review and ensure CAPA responses to Audits and Inspections are robust
+ Perform a risk-based verification and effectiveness check on key CAPAs from audits and inspections
+ Recommend and lead implementation of improvements to the Audit and Inspection Management programs based on new regulations, guidance documents, and industry standards
+ Lead company and site preparation activities for support of regulatory and customer inspections
+ Provide compliance advice to site, development and commercial product teams
+ Supports and continually enhance the ongoing site Permanent Inspection Readiness status
+ Obtain and maintain cutting-edge knowledge and auditing techniques across applicable technical/Quality topics
**Education Minimum Requirement:**
+ Bachelor's degree in engineering, Biology, Chemistry or related field
**Required Experience and Skills:**
+ Minimum of five (5) years of manufacturing, technology, laboratory, and/or quality operations experience within GMP environment
+ GMP Compliance knowledge and proficiency in interpreting and applying domestic and international regulatory requirements
+ Knowledge of Quality Systems within a GMP environment
+ Demonstrated ability to establish and maintain collaborative relationships with key stakeholders
+ Ability to work independently with limited supervision
+ Ability to build relationships and influence across disciplines and all levels
**Preferred Experience and Skills:**
+ GMP Audit experience in the pharmaceutical industry (CQA or other certification preferred)
+ Experience with leading effective audits and obtaining meaningful audit observations
+ "Subject Matter Expertise", including knowledge and demonstrated application in one or more of the following areas, based on site activities; Medical Device/Combination products, Biologics, Vaccines, API's or Non Sterile or Sterile Drug Product
+ Specific technical knowledge in areas pertaining to the hiring site (e.g, Quality Systems, Manufacturing, Testing/Stability, Microbiology testing, Packaging, Distribution, Data Integrity, Automation)
+ Knowledge of QBD development & submission requirements, as applicable to site
+ Ability to lead, motivate, develop and mentor other auditors
+ Knowledge of and experience in Quality Risk Management methods
+ Knowledge of US and European cGMP guidelines, ICH and other international regulatory requirements, as applicable
+ Experience with hosting or participating in Health Authority inspections and/or Divisional audits
+ Highly motivated, flexible, and have excellent organizational and communication skills
+ Excellent verbal and written communication skills
+ Ability to prioritize and balance work from multiple projects in parallel
**Required Skills:**
Accountability, Accountability, Aseptic Processing, Audit Management, Biological Sciences, cGMP Training, Customer-Focused, Detail-Oriented, Driving Continuous Improvement, Ethical Standards, GMP Compliance, Immunochemistry, Internal Auditing, IS Audit, Management Process, Medical Devices, Molecular Microbiology, Quality Auditing, Quality Control Documentation, Quality Control Management, Quality Management Systems (QMS), Quality Metrics, Quality Risk Assessment, Quality Risk Management, Regulatory Compliance Consulting {+ 5 more}
**Preferred Skills:**
Current Employees apply HERE (*****************************************************
Current Contingent Workers apply HERE (*****************************************************
**US and Puerto Rico Residents Only:**
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (******************************************************************************************
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (**********************************************
**U.S. Hybrid Work Model**
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
The salary range for this role is
$126,500.00 - $199,100.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** .
You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
**San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
**Search Firm Representatives Please Read Carefully**
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
**Employee Status:**
Regular
**Relocation:**
Domestic
**VISA Sponsorship:**
No
**Travel Requirements:**
10%
**Flexible Work Arrangements:**
Hybrid
**Shift:**
1st - Day
**Valid Driving License:**
No
**Hazardous Material(s):**
N/A
**Job Posting End Date:**
12/24/2025
***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.**
**Requisition ID:** R375871
Neuroscience Sales Specialist - Durham, NC
Durham, NC job
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
Pharmaceutical Sales
Job Sub Function:
Sales - Neuroscience (Commission)
Job Category:
Professional
All Job Posting Locations:
Durham, North Carolina, United States
:
Neuro Sales Specialist - Durham, NC
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************/.
Johnson & Johnson has entered into an agreement to acquire Intra-Cellular Therapies, Inc, a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders. With a differentiated commercialized therapy and promising clinical-stage pipeline that complements our current areas of focus, this acquisition brings us one step closer to achieving our ambition of becoming the #1 neuroscience company worldwide.
Intra-Cellular Therapies, a Johnson & Johnson company, is on the path to be the #1 leader in neuroscience. With an exceptional suite of products and a commitment to transforming patient lives, we are expanding our CAPLYTA medical team to support our growing impact in psychiatry.
The Neuroscience Sales Specialist-II, has overall responsibility for meeting or exceeding sales expectations within their assigned geographies in an ethical and compliant manner. The sales specialist is responsible for understanding and identifying customer needs, aligning marketing resources and supporting pull-through activities. They are also accountable for embodying and communicating Intra-Cellular's corporate vision of improving the lives of patients suffering from neuropsychiatric disorders.
The Neuroscience Sales Specialist-II will develop superior product and disease state knowledge that allows them to compliantly engage in in-depth clinical dialogue with healthcare professionals. Additionally, they will have responsibility for the creation of local strategic and tactical plans, differential resource allocation, and accountability for effective application of budget and expense management within their assigned territory.
We are looking for sales professionals who have a passion for patients, tenacity for results, ability to adapt and evolve, entrepreneurial thirst for working in an energizing and winning culture.
Job Responsibilities
* Following compliance guidelines, drives sales performance to ensure sales forecasts are met or exceeded within assigned territory by calling on HCP offices and Mental Health Community Centers both in-person and virtually.
* Effectively uses assigned budgets to achieve territory objectives. Customizes discussions and client interactions based on customer's needs in a compliant and ethical manner
* Maintains current understanding of local market, practice structures, evolving customers, and key influencers. Routinely shares such information with relevant internal Intra-Cellular stakeholders.
* Provides input into resource allocation decisions across customers/region. Identifies and selects programs/resources available and appropriate for each customer, practice, and/or system.
* Works with Regional Business Manager and key stakeholders to develop a local business plan that ensures achievement of all business objectives. Capitalizes on formulary approvals and other business opportunities through effective implementation of the strategic plan.
* Collaborates with other Neuroscience Sales Specialists on common objectives and sharing of best practices.
* Accountable for providing timely and accurate administrative management of work hours, sales call data, customer objectives, communication responses, synchronization, sample and expense reporting.
* Effectively inform and build a business plan based on depth and breadth of customer business needs, resources and products.
* Complete all company and job-related training as assigned within the required timelines.
* 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 Requirements
* 2+ years of previous sales experience in pharmaceuticals, biologics, or medical device sales required; 3+ years of sales experience in specialty pharmaceuticals preferred
* Launch, antipsychotic, and/or bi-polar sales experience highly preferred.
* Must have Bachelor's degree from an accredited college or university as well as a valid driver's license and safe driving record.
* Must have strong desire and passion for improving the lives of patients and their caregivers. Ideal candidate emulates patient-centricity.
* Must act with high integrity and always in accordance with the Company's Compliance policies and procedures.
* Must have strong sense of self-motivation, initiative, and entrepreneurial thirst, excellent decision-making judgment, strong teaming/collaboration and cross-functional skills
* A proven track record of success in learning and adapting to an evolving environment such as Covid-19 in order to overcome obstacles and challenges
* Must have ability to be agile and adapt to the changing telemedicine/virtual environment.
* Ability to analyze data/metrics to assess progress against objectives as well as diagnose performance issues and identify new opportunities.
* Experience establishing new customer relationships and communicating technical information to a diverse customer audience.
* Work hours may include meetings scheduled outside of normal working hours.
* Territories may require some overnight travel depending on geography.
* Some domestic travel to corporate headquarters, training and sales meetings will also be required on a periodic basis.
* Must be able to perform all essential functions of the position, with or without reasonable accommodation.
#ITCIBuild2025
Salary range for this position: $98,000 - $155,000
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************/.
Required Skills:
Preferred Skills:
Business Behavior, Clinical Experience, Coaching, Competitive Landscape Analysis, Cross-Functional Collaboration, Cultural Competence, Customer Centricity, Data Savvy, Developing Partnerships, Market Knowledge, Neuroscience, Pharmaceutical Industry, Pharmaceutical Sales Marketing, Problem Solving, Product Knowledge, Sales, Sales Enablement, Sales Trend Analysis, Strategic Sales Planning
The anticipated base pay range for this position is :
$98,000-$155,000
Additional Description for Pay Transparency:
Auto-ApplyAssociate Director, Thought Leader Liaison - Neuroscience - Carolinas
Raleigh, NC job
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
Medical Affairs Group
Job Sub Function:
Professional Medical Education
Job Category:
Professional
All Job Posting Locations:
Atlanta, Georgia, United States, Charleston, South Carolina, United States, Fayetteville, Georgia, United States, Fayetteville, North Carolina, United States, Georgia (Any City), Greenville, North Carolina, United States, Greenville, South Carolina, United States, North Carolina (Any City), Raleigh, North Carolina, United States, South Carolina (Any City), Winston Salem, North Carolina, United States
:
We are recruiting for an Associate Director, Thought Leader Liaison - Neuroscience to support the Carolinas (GA, NC, SC) region. This is a field-based position, with preference for the candidate to be in a major metropolitan market with easy access to a national airport.
This is a field based role available in North Carolina, South Carolina and Georgia. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************/.
Johnson & Johnson has entered into an agreement to acquire Intra-Cellular Therapies, Inc, a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders. With a differentiated commercialized therapy and promising clinical-stage pipeline that complements our current areas of focus, this acquisition brings us one step closer to achieving our ambition of becoming the #1 neuroscience company worldwide.
The Associate Director, Thought Leader Liaison -Neuroscience, will be responsible for leading the CAPLYTA Key Opinion Leader (KOL) engagement strategy, as well as contributing significantly to the overall KOL strategy across the Neuroscience franchise in close collaboration with the brand team. This territory includes GA, NC, SC.
Job Responsibilities
* Lead the development and execution of Regional KOL engagement strategy, marketing education strategy and faculty development. This includes oversight of regional peer to peer marketing plans, health care compliance training for faculty, and other related activities as needed.
* Serve as a key member of the CAPLYTA Brand team by providing local market insights and feedback to craft future strategies for the Neuroscience franchise in close collaboration with sales leaders, key business partners, and medical teams to elevate brand advocacy.
* Build trusting relationships with academic and community KOLs, and other key partners to achieve above-brand priorities.
* Maintain pulse on regional trends and closely coordinate regional marketing education and engagement plans with cross functional partners to ensure heightened KOL and customer engagement strategies that are fully aligned to the Brand strategic imperatives.
* Partner with coordinated analytics team to better understand regional variations in treatment patterns to advise peer to peer and insight program placement.
* Attend conferences and serve as onsite host for product theatres
* Facilitate, participate, and attend advisory boards where appropriate
* Coordinate executive engagements with KOLs and commercial leadership
* Closely supervise the regional marketing budget and provide continuous feedback on business planning.
* Assist in crafting future innovative educational platforms including national and regional recommendations to tailor our education to local needs and creating innovative solutions in further engaging KOL's at all regional and national medical congresses.
* Leadership of the overall neuroscience strategy inclusive of mapping, framework development, innovative engagement planning for current brands and future launches, inclusive of marketing operations for KOL strategy and planning including agency management, champion materials through CAC, Totality, MRC.
Job Requirements
* BA/BS Degree Required; advanced degree preferred.
* Minimum 6 years of experience in marketing, key account management, medical, sales leadership, sales training, or field sales engaging with KOLs/Influential HCPs and professional healthcare organizations.
* Deep understanding and experience working cross functionally with various key internal & external partners with a strong ability to innovate, collaborate and deliver results with desired outcomes.
* Demonstrated understanding of key industry trends and ability to develop strategies to stay ahead of the competition and improve patient outcomes.
* Demonstrated ability to build and manage relevant and lasting customer relationships with strong focus on patient impact and outstanding customer centricity.
* Travel can be up to 65%; this includes internal meetings, advisory boards, medical meetings, congresses, and select program attendance.
* A Valid Driver's license issued in the United States.
Preferred:
* Minimum 5 years of experience in neuroscience.
* Previous cross-functional industry experience in pharma or biotech engaging with KOLs and professional healthcare associations is preferred.
* Deep medical/scientific knowledge/experience with a firm understanding of the psychiatry marketplace is preferred.
* Experience leading through change and transformation, product launches, and exceptional communication and leadership skills is preferred.
* Complete all company and job-related training as assigned within the required timelines.
* Must be able to perform all essential functions of the position, with or without reasonable accommodation.
* 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
#NeuroTLLBuild
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Brand Marketing, Channel Partner Enablement, Digital Strategy, Global Market, Learning Materials Development, Medical Affairs, Medical Communications, Mentorship, Organizing, Process Improvements, Program Management, Sales Enablement, Sales Presentations, Strategic Sales Planning, Strategic Thinking, Technical Credibility, Training People
The anticipated base pay range for this position is :
$137,000.00 - $235,750.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
* Vacation -120 hours per calendar year
* Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
* Holiday pay, including Floating Holidays -13 days per calendar year
* Work, Personal and Family Time - up to 40 hours per calendar year
* Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
* Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
* Caregiver Leave - 80 hours in a 52-week rolling period10 days
* Volunteer Leave - 32 hours per calendar year
* Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - *********************************************
Auto-ApplySpecialist, Engineering
Durham, NC job
Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.
The Maurice R. Hilleman Center for Vaccine Manufacturing is located in Durham, NC. This state-of-the-art facility established in 2004, manufactures our Company lifesaving vaccines in bulk and finished forms. Due to the importance of this facility in our Company Vaccine Manufacturing network, the facility has seen rapid growth in production volumes and new employees over the last several years; currently Durham employs 1,000+ people.
Durham's Technology Transfer Specialist will be an energetic, technical leader with strong interpersonal, communication, and collaboration skills responsible for implementation of technology transfer process knowledge, post approval support, and post commercial process enhancements activities for pipeline vaccine programs. This is position will support vaccine drug substance site readiness and technology transfer focusing on either upstream, downstream, and/or culture media/support systems.
Off-shift and weekend coverage will be required based on business unit needs and specific assignments.
**Responsibilities may include but are not limited to:**
+ Maximum of travel 25% of the time, as needed.
+ Provide technical/team support and leadership for commercial technology transfer, and qualification studies associated with the development and implementation of processes, systems and facilities related to vaccine drug substance and key intermediates e.g. buffers, media and cleaning solutions.
+ Actively participate on cross-functional manufacturing teams to advance projects goals and deliverables related to the vaccine process
+ Lead technical studies and author documentation associated with site commercialization efforts
+ Participate in the equipment specification, selection/procurement, and qualification phases of vaccine capital projects
+ Provide deep SME knowledge for manufacturing investigations support (Product and process deviations and complex material-related)
+ Authoring deviation investigations
+ Collaborate with internal/external partners, e.g. Our Company sites, Procurement, Raw Material & Component Suppliers
+ Develop effective data analytics methodologies, including statistical process control, deepening process understanding
+ Author, review, and/or edit technical documents to support regulatory filings including technical reports and risk assessments
+ Author or approve Change Control documentation for complex process, validation, analytical, equipment, facility/utility and/or automation changes. Managing on-time implementation and close-out to meet project, production and supply timelines.
+ Lead aspects of regulatory inspections by presenting and defending technical documentation, investigations, and change controls
+ Evaluate and develop innovative process technologies, continuous process improvements and post launch process enhancements
+ Provide shop floor hypercare supporting during manufacturing
+ Provide post approval support and subject matter expertise support to ongoing manufacturing activities.
**Education Minimum Requirement:**
+ Bachelor of Science Degree in Chemical Engineering, Biochemical Engineering, Bioengineering, or related life science field with a minimum of two (2) years of relevant experience or a Master of Science Degree.
**Required Experience and Skills:**
+ Experience in vaccine or biologics manufacturing within a cGMP environment
+ Experience authoring technical documentation within a cGMP context
+ Proven leader with influence and outstanding communication (written & presentation) skills
+ Experience with project strategic plan development and management
+ Ability to foster a collaborative work environment focused on mentorship, coaching, and Subject Matter Expert development
**Preferred Experience and Skills:**
+ Experience in manufacturing support processes including weigh and dispense, media/buffer, and sterile supply
+ Experience with single-use component qualification
+ Experience with technology transfer methodologies for introduction/launch of a cGMP product
+ Experience with on-the-floor cGMP manufacturing support including providing immediate responses on the shop floor to deviations and supply chain interruptions
+ Authored complex process change control
+ Authored complex deviation investigations
+ Experience with validation documentation and execution
+ Experience with SAP
+ Experience with Manufacturing Execution Systems (MES)
+ Experience with Delta V
+ Ability to provide scientific mentorship and guidance to technical colleagues
+ Ability to read Piping and Instrumentation Diagrams
+ Lean Six Sigma belt certification
+ Experience with process risk assessment tools
+ Experience with responding to regulatory questions with multiple agencies (e.g.FDA, EMA)
+ Experience with face-to-face presentation of technically complex subjects to regulatory inspectors
**Required Skills:**
Adaptability, Adaptability, Biodesign, Change Control Management, Chemical Engineering, Collaborative Communications, Continuous Process Improvement, Data Analysis, Equipment Troubleshooting, Good Manufacturing Practices (GMP), Lean Manufacturing, Manufacturing Support, Personal Initiative, Process Innovation, Process Optimization, Process Technologies, Procurement, Professional Integrity, Project Management, Risk Control Assessment, Root Cause Analysis (RCA), Strategic Procurement, Technical Writing, Technology Transfer, Vaccine Manufacturing {+ 1 more}
**Preferred Skills:**
Current Employees apply HERE (*****************************************************
Current Contingent Workers apply HERE (*****************************************************
**US and Puerto Rico Residents Only:**
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (******************************************************************************************
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (**********************************************
**U.S. Hybrid Work Model**
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
The salary range for this role is
$85,600.00 - $134,800.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** .
You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
**San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
**Search Firm Representatives Please Read Carefully**
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
**Employee Status:**
Regular
**Relocation:**
No relocation
**VISA Sponsorship:**
No
**Travel Requirements:**
10%
**Flexible Work Arrangements:**
Hybrid
**Shift:**
1st - Day
**Valid Driving License:**
No
**Hazardous Material(s):**
N/A
**Job Posting End Date:**
12/25/2025
***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.**
**Requisition ID:** R377263
Eng Process Engineering
Wilson, NC job
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
Supply Chain Engineering
Job Sub Function:
Process Engineering
Job Category:
Scientific/Technology
All Job Posting Locations:
Wilson, North Carolina, United States of America
:
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine.
J&J is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J&J's significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations.
The GET (Global Engineering & Technology) organization operates as one integrated team in the delivery of Engineering, Maintenance and Execution Systems solutions. We operate in a standard, coordinated and consistent manner in support of the current and future requirements of our Manufacturing and Manufacturing Science and Technology (MSAT) and in partnership with key internal/external network.
Apply now for this exciting opportunity located in Wilson, NC !
Support the deployment of the MTO aspiration "to innovate to safely supply quality products and services competitively, faster, always". Responsible for providing engineering design and start-up of GMP large molecule biologics manufacturing facility systems, and equipment. Provide integrated equipment, utility, and facility engineering expertise with an operational focus in support of technology transfer and manufacturing projects to support 'right first time' execution and start up.
Drive innovative solutions in engineering support, and process technology. Coordinate with Technical Operations platform to ensure project alignment with technology standards and engineering specifications for manufacturing technology. This is intended to be a general job description and should not be construed as all-inclusive.
Key Responsibilities:
* Extensive interaction with external partners (A&E, construction firms, equipment vendors) to develop, organize and execute project plans as SME and process systems owner. The incumbent should demonstrate the following: detail and goal oriented, teamwork, customer-focus, thorough understanding of GMPs and regulatory requirements.
* Serve as Process Engineering Expert to develop business based technology solutions and provide integrated equipment, utility, and facility engineering expertise with an operational focus to support execution of strategic and key CAPEX manufacturing projects, driving 'right first time' start up and execution.
* Provide system ownership for bioprocess manufacturing equipment including review or URS, P&ID, C&Q, automation and architectural drawings and documentation.
* Explore and understand Technology and Manufacturing challenges and synthesize business needs, manufacturing requirements, engineering elements, and technology inputs, etc. into business solutions.
* Provide technical leadership of multi-functional teams on many projects/ process improvements and resolves inter-functional issues.
* High degree of collaboration with internal (manufacturing, quality, engineering) to develop standards and define project needs and priorities; as well as recruiting project team members.
* The incumbent must also have a thorough understanding of business requirements, effective communication skills, leadership, and interdependent partnering, conflict and risk management
Qualifications
Education:
* Minimum of a Bachelor's or equivalent University Degree in Chemical, Mechanical, Bioprocess Engineering or related field; required
* MS/MBA/Ph.D. PE Certificate preferred
Experience and Skills:
Required:
* Preferably two (2)+ years of process/plant engineering experience in GMP MFG large molecule biologics facilities.
* The ability to lead and/or support multiple projects simultaneously
* Track record of successful program execution and team outcomes
Preferred:
* FPX certification and Six Sigma and/or Lean experience are a plus
Other:
* Ability to travel up to 10%; international and domestic
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit *********************
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Auto-ApplyRegional Medical Scientific Director (Medical Science Liaison) - GI Immunology - Mountain West (MT, WY, UT, CO, NM) (Remote)
Raleigh, NC job
Responsibilities** + The Regional Medical Scientific Director (RMSD) is a credentialed (i.e., PhD, PharmD, DNP, MD) therapeutic and disease expert who engages in bidirectional exchange of scientific or medical information with Scientific Leaders (SLs). This MSL-type role provides balanced, factual, scientific information about non-product areas of interest to the Company and replies to scientific questions from SLs, including questions about Company products. The work of an RMSD is aligned to: Scientific Exchange, Research, Scientific Congress Support, and Scientific Insights.
+ RMSDs liaise between the scientific community and the Company to enhance the comprehension of scientific foundations and goals for approved, in-development, and active Company-sponsored trials and/or investigator-sponsored research studies. The RMSD serves as a role model for other field medical team members in ways that include on-boarding and/or sharing of therapeutic expertise.
+ This position will support our Company's Gastrointestinal (GI) Immunology program
**Location details:** This role covers MT, WY, UT, CO, & NM. Candidates **must** reside within the territory; preference for the Denver and Salt Lake City areas. Travel up to 50% within the territory.
**Responsibilities** **and Primary Activities**
**Scientific Exchange**
+ Develops professional relationships and engages with national and regional SLs to ensure access to company-approved medical and scientific information on areas of therapeutic interest and Company products
+ Conducts peer-to-peer scientific discussions and maintains a reliable presence with those SLs to ensure they have a medical contact within the company
+ Addresses scientific questions and directs SL inquiries on issues outside of RMSD scope (e.g., grants) to appropriate company resources consistent with applicable policies
+ Maintains current knowledge and comprehension of dynamic scientific and clinical environment in the Company's Areas of Interest (AOI) for the RMSD's specific therapeutic area.
**Research**
+ Upon request from Global Center for Scientific Affairs (GCSA),
+ Initiates discussions with SLs and/or potential investigators that include scientific/data exchange within our AOI to determine the alignment with our research strategies, studies concepts, scientific merit, and qualifications for a specific compound or trial
+ Enhances the comprehension of the scientific foundations and goals of investigator-sponsored research
+ Identifies barriers to patient enrollment and retention efforts to achieve study milestones
+ Upon request from Global Clinical Trial Operations (GCTO),
+ Recommends study sites and identifies potential investigators to participate in phase II-IV clinical development programs, conducts Site Initiation Visits (SIVs), and detects barriers to patient enrollment and retention efforts to achieve study milestones.
+ Protocol lead responsibilities in collaboration with GCTO
+ Addresses questions from investigators and provides information regarding participation in Company-sponsored clinical studies
**Scientific Congress Support**
+ Engages in scientific congresses and medical meetings, facilitates scientific and data exchange for both Company and competitor data.
**Scientific Insights**
+ Gathers feedback, data, or information during routine activities that can help the company better comprehend medical or scientific needs, priorities, or concerns of SLs and/or patients
**Inclusive Mindset and Behavior**
+ Demonstrates eagerness to contribute to an environment of belonging, inclusion, equity, and empowerment
+ Leads by example and serves as a role model for creating, leading, and retaining a diverse and inclusive workforce
**Required** **Qualifications** **, Skills, & Experience**
**Minimum**
+ PhD, PharmD, DNP, DO, or MD
+ Proven competence and a minimum of 3 years of relevant therapeutic area experience beyond that obtained in the terminal degree program
+ Ability to conduct doctoral-level discussions with key external stakeholders
+ Dedication to scientific excellence with a strong focus on scientific education and dialogue
+ Excellent stakeholder management, communication, and networking skills
+ A thorough comprehension of FDA, OIG, HIPAA, and other ethical guidelines, laws, and regulations relevant to the pharmaceutical industry and its customers
+ Ability to organize, prioritize, and work effectively in a constantly changing environment
+ Strong working knowledge of Microsoft Office Suite (Word, PowerPoint, Excel, Teams, OneNote)
+ Familiarity with virtual meeting platforms
+ Desire to contribute to an environment of belonging, engagement, equity, and empowerment by:
+ Working to transform the environment, culture, and business landscape
+ Leveraging diversity and inclusion to ensure business value, per global diversity and inclusion strategy
+ Ensuring accountability to drive an inclusive culture
+ Strengthening the foundational elements of diversity
+ Consistent adherence to field and corporate policies and Global Medical Scientific Affairs (GMSA) strategy, including field standard operating procedures (SOPs), Good Clinical Practice (GCP) guidelines, and administrative/operational responsibilities
**Preferred**
+ Field-based medical experience
+ Research Experience
+ Demonstrated record of scientific/medical publication
\#eligiblefor ERP
**Required Skills:**
Clinical Research, Clinical Trials, Gastroenterology, Gastrointestinal Disease, Medical Affairs, Medical Relations, Pharmaceutical Medical Affairs, Stakeholder Engagement
**Preferred Skills:**
Current Employees apply HERE (*****************************************************
Current Contingent Workers apply HERE (*****************************************************
**US and Puerto Rico Residents Only:**
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (******************************************************************************************
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (**********************************************
**U.S. Hybrid Work Model**
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
The salary range for this role is
$187,000.00 - $294,400.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** .
You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
**San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
**Search Firm Representatives Please Read Carefully**
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
**Employee Status:**
Regular
**Relocation:**
No relocation
**VISA Sponsorship:**
No
**Travel Requirements:**
50%
**Flexible Work Arrangements:**
Remote
**Shift:**
Not Indicated
**Valid Driving License:**
Yes
**Hazardous Material(s):**
n/a
**Job Posting End Date:**
12/13/2025
***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.**
**Requisition ID:** R364045