TITLE: Animal Technician
SCHEDULE: Monday through Friday 7am to 3pm, rotating weekends/holidays
DURATION: 12+ Months Contract
Pay rate: $21/hr on w2
This individual will perform daily laboratory animal care duties including animal health monitoring, animal husbandry, and routing cleaning and sanitation. All work assignments will be performed accordance with SOP's and protocol instructions. Must maintain and demonstrate positive working relationships with co-workers, customers, be able to work independently to perform tasks, and have regular attendance.
The essential duties and responsibilities:
• Performs animal husbandry duties to maintain quality and health of research animals to include daily feed/water/enrichment, and cage or room cleaning as required.
• Maintains focus on animal welfare reporting all concerns to management and/or others as required.
• Must ensure animal welfare guidelines are met, building, and equipment are maintained accordingly for internal IACUC inspections and maintenance of AAALAC accreditation.
• Conducts all euthanasia as trained according to AVMA guidelines and completing all documentation associated with the task.
• Cleans assigned animal rooms, isolator environments, animal care equipment, and associated animal facility areas daily.
• Ensures facility areas are maintained and kept clean and orderly daily.
• Assists in maintaining and stocking inventory and communicates when items are needed to be ordered.
• Excellent record keeping skills are required.
• Assists with handling and manipulations as per SOP's and protocols.
• Operates equipment and uses supplies according to safety guidelines, performs general housekeeping, and adheres to safety procedures.
• Able to observe equipment and report of any failures.
• Maintains required attendance level and adheres to work schedule in accordance with required staffing levels to ensure that assigned duties are completed. Weekend and holiday coverage is required on a rotation basis. May be asked to work extended hours occasionally due to workload - Overtime eligible. Being prompt to work and attendance are a must.
• Takes the initiative to complete tasks and anticipates upcoming tasks.
• Must realize the importance of non-contamination process and be prepared to adhere strictly to the procedures.
• Must be conscientious, detail-oriented, self-motivated, and able to work alone.
• Ability to maintain good working relationships with others.
• Excellent communication skills both written and oral.
Job Qualifications
• Education - AA degree required
• Experience - Lab Animal or agricultural experience desired
Ability to lift 50lbs, roll heavy objects, use ladders, working conditions up to 90 degrees or down to freezing temperatures.
Ability to stand for long periods of time.
Must be able to squat, bend, and stoop, as well as twisting and turning.
Manual dexterity and visual acuity are important.
Subject to objectionable odors, aerosols, dust, animal dander, and noise.
Not allowed to own poultry or swine
Multiple showers a day may be required for biocontainment, showering does include washing of hair.
Hair must be able to be completely covered within hairnet for biocontainment purposes.
Nails must be short in length to perform fine motor tasks and avoid risk of injury to oneself, colleagues, or animals.
Work requires use of appropriate personal protective equipment (PPE), including Tyveks, hairnets, respirator or PAPR, gloves, safety glasses, provided uniforms, and shoes.
Personal phones and all forms of jewelry are not allowed in the vivarium.
Thanks & Regards
Mukesh Sharma
Lead Recruiter
O ************
E ************************
$21 hourly 2d ago
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Site Quality Lead
Zoetis 4.9
Zoetis job in Durham, NC
The Site Quality Lead role is responsible for the leadership and oversight of all Quality functions at the site, including Quality Assurance, Quality Control, Quality Operations, and Compliance. This role ensures that product quality and the site's regulatory compliance are maintained at the highest standards, fostering a state of inspectional readiness.
As a champion of the Quality Culture, the site Quality Lead proactively safeguards and strengthens the integrity of quality and compliance across the site. This role ensures the site Quality Policy is understood, implemented, and sustained at every level of the organization, and maintains the independence and authority of the Quality unit. The Site Quality Lead is accountable for developing, coaching, and empowering staff, ensuring systems and processes meet or exceed Zoetis and regulatory requirements, and that the Quality unit is support by adequately trained resources.
A key member of the Site Leadership Team, the Site Quality Lead contributes to defining the strategic direction for both the quality unit and the broader site, while managing day-to-day quality operations. Responsibilities include establishing and maintaining the annual Site Quality Plan, Standard Operating Procedures, and a robust Quality Audit program.
The Site Quality Lead co-chairs the Site Quality Council, driving continuous improvement and compliance objectives, and prioritizing quality initiatives. This role leverages data and metrics to enhance site quality systems and product quality, and is responsible for developing and executing the Site Quality Roadmap. The Site Quality Lead ensures that executive management is informed and engaged in Management Reviews to evaluate the effectiveness of the quality system and it's alignment with the Quality Policy and Quality Plan.
The position reports to the Platform Quality Leader.
POSITION RESPONSIBILITIES:
Establishing / Reinforcing the Quality Culture on the Site.
Maintain Site Inspection Readiness.
Promote Compliance Audit findings/remediation.
Ensure that products are manufactured in compliance with current processes.
Ensure Product Release is done within current quality standards.
Ensuring QC Testing meets within current quality standards.
Proactive Ownership of the Site Risk Assessment process.
Oversee the development and implementation of the Quality Plan / Quality Road Map
Share Leadership of Site Quality Councils and Metrics
Develop metrics to deliver product and process improvement.
Maintain the Supplier Quality program and vendor certification.
Create and be accountable for the Site QA/QC Budget.
Champion Leadership Development for the Site Quality Staff.
Overall Site Product Portfolio Quality Stewardship owner and accountability.
Facilitate agency inspection and notified body audits.
STAFF AND LEADERSHIP RESPONSIBILITIES:
Leadership Development / Coaching of Staff; Creation of Learning Organization
Stewardship of the Quality Culture within the QA Function as well as the Site.
Ensure Training and Development plans are in place for all QA associates.
Development of Site QA operations budget and resource planning for roll up to the Site Quality Budget.
Strong Communication skills written and verbal.
Support the development of Quality goals and targets as part of the organization's strategic plan.
ORGANIZATIONAL RELATIONSHIPS:
Quality Platform Lead
Global QSS
Manufacturing Site Leadership
Corporate Quality Auditing
Site Enabling Functions (ie: Engineering; GMT; Finance etc)
Operational Excellence
VMRA and VMRD
RESOURCES MANAGED:
Financial Accountability
Manage department budget in addition to personnel costs. Responsible for ensuring plant stays in compliance with all applicable entities so as to ensure continuous supply of products.
Supervision
Direct /Indirect: 3 / 2 staff reports
Quality Unit also utilizes approximately 1-2 temporary contract workers (contingent employees)
EDUCATION AND EXPERIENCE:
Bachelor's degree in Science or Engineering required; advance degree preferred.
Proven leadership experience in a Quality function within Animal Health or Human Health Medical Device industries
7-10 years of progressive Quality experience in biological device and/or automation manufacturing environments.
Extensive background in GMP and ISO 9001 regulated operations.
Proficiency in lean manufacturing methodologies
Exceptional communication, problem-solving, and team development skills
TECHNICAL SKILLS REQUIREMENTS:
Leads in Change Management environment, Acts as a Change Agent
Problem solver root cause analysis methodology
Process oriented mindset; data and continuous improvement orientation
Able to work well in complex environment.
Experience in SAP/PLM systems
Facilitate inspections
PHYSICAL POSITION REQUIREMENTS:
Position located in Durham, NC
Minimal off-site travel
Occasional non-core hour work anticipated
Full time RegularColleague
Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.
Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.
Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
$98k-126k yearly est. Auto-Apply 36d ago
Assoc Director, Medical Affairs
Gilead Sciences, Inc. 4.5
Raleigh, NC job
United States - North Carolina - Raleigh Medical Affairs Regular
Lead the implementation of a portfolio of technologies and platforms that enable business process and decision making.
Establishes and maintains the roadmap for your assigned portfolio by leading the internal idea generation, external benchmarking, and technical evaluation process.
Work collaboratively with the Medical Affairs, Medical Excellence, Medical Governance, and other Medical Affairs Technology leads to help generate meaningful business requirements and design technical solutions that meet those requirements.
Support technology tool maturity by refining processes, delivery templates, and tools with key regional stakeholders based on business needs.
Provide portfolio and project level leadership by managing scope, timelines, communication, testing, and risks associated with the assigned portfolio.
Lead technology implementations with aggressive timelines, broad scope, and high impact according to established business needs while reporting on the project status and budget to the Executive Director of Medical Affairs Technology.
Be the primary source of education and inspiration about ways to leverage technology solutions by being the expert in your assigned platforms and defining new ways it can accelerate Medical Affairs outcomes.
Balance the needs of the platform (performance, scalability, cost, data integrity) with the requests of the business (new functionality, speed to market, integrations) during roadmap planning and while advising on solution design.
Develop creative and effective solutions to address inter- and intra-project priority conflicts, resource constraints and other problems which may impact project goals and deliverables across multiple programs.
Establish and maintain cross-functional communication channels, work practices and processes with internal stakeholders relevant to accomplishing business outcomes.
Advise and/or participate in cross-functional governance, standards and SOPs for global MA technology tools and capabilities.
Balance long-term vision with short-term delivery while making decisions to invest/build/sustain to catalyze the organization to deliver on the business outcomes.
Basic Qualifications
BA/BS and 10 + years of business experience in CRM, Analytics or Technology modernization and LEAN methodology delivery practices
OR
MA/MS and 8 + years of business experience in CRM, Analytics or Technology modernization and LEAN methodology delivery practices
Preferred Qualifications and Strongly Desired
A strong background in Information Technology - ideally a degree or formal training in IT systems, data platforms, or digital tools.
Additional certifications in Veeva, Salesforce, or Business Process Automation
3 - 5 years global/in-market Pharma/Biopharma experience preferable
Experience implementing or upgrading to modern technology platforms inclusive of AI integration/utilization.
Demonstrated practical and technical experience in business case development, planning, implementation, operation, and management of digital and mobile initiatives.
Proven experience articulating and advising on the strategic value of new technology, digital, or operational solutions
Experience shaping end to end field experience delivering creative and simple solutions to complex problems
Excellent communication skills, including the ability to break down complex structures and ideas into consumable concepts for a diverse set of stakeholders, from entry to expert level
Demonstrated excellence in developing effective creative solutions to complex problems
Demonstrated excellence in delivering skilled communications around change management that build system adherence
Demonstrated excellence in building and maintaining relationships with senior leaders
Highly organized with a strong attention to detail, clarity, accuracy, and conciseness
Uncompromising ethical standard and conduct
Able to motivate and foster cross-functional collaboration
People Leader Accountabilities
Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
#J-18808-Ljbffr
$219k-309k yearly est. 1d ago
Intern - BioDevice Training and Support
Zoetis 4.9
Zoetis job in Durham, NC
Durham
The role's primary responsibilities will be to assist the Technical Training & Operational Support Manager in developing and implementing a comprehensive electromechanical training curriculum establishment for Field Service Personnel (FSP) development and advancement for BioDevice and VMD equipment.
Role Overview:
Support in the creation of high impact / value electromechanical scenarios to identify competencies as well as areas of needed improvement.
Assist in the creation of associated documentation to support device processes and field modifications.
Assist in developing electromechanical troubleshooting guides.
Support Technical Training & Operational Support Manager in developing hands-on electromechanical training aides using PLCs, relays, switches, and sensors.
Support Technical Training & Operational Support Manager with in-person or remote training sessions on BioDevice components and sub-systems in both group and individual settings.
Utilizing MS Platform to document and track and trend mechanical issues.
Learn SAP processes to assist in Parts/Consumable orders.
Leverage knowledge of SharePoint designer to update BioDevice Training Site with new/relevant training content.
Work with Technical Training & Operational Support Manager to create relevant work instructions to help global FSPs consistently implement BioDevice related tasks.
Liaise with Engineering to identify solutions from identified problems and create technical bulletins and or alert documents.
Manage Global BioDevice Training Inbox and route issues/messages appropriately.
Engage in training as needed/necessary with FSPs.
Internship Qualifications
Currently pursuing a degree in Electrical Engineering, Mechanical Engineering, Computer Sciences, or a related field.
Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint); experience with process simulation tools is a plus.
Ability to work independently and collaboratively in a team environment.
Enrolled in a degree program during the Spring term preceding internship.
Completion of at least one year of undergraduate studies and a 3.0 GPA or higher.
At least 18 years of age and authorized to work in the U.S.
Successfully pass a background check and drug screen.
Possess strong analytic and statistic skills and have the ability to work independently.
Strong communication, interpersonal, organizational, problem solving & analytical skills.
The following hourly pay rates reflect the anticipated base pay for this position:
If the selected candidate is a student pursuing an Associate-level degree: $16.00 per hour
If the selected candidate is a student pursuing an Undergraduate-level degree: $22.00 per hour
If the selected candidate is a student pursing a Graduate-level degree: $32.50 per hour
If the selected candidate is a student pursuing a Doctorate-level degree: $36.00 per hour
The following hourly pay rates reflect the anticipated base pay for this position if a selected candidate were to be located in California, Connecticut, District of Columbia, Illinois (Chicago area), Massachusetts, New Jersey, New York, Washington (Seattle area):
Student pursuing an Associate-level degree: $17.00 per hour
Student pursuing an Undergraduate-level degree: $24.20 per hour
Student pursing a Graduate-level degree: $36.40 per hour
Student pursuing a Doctorate-level degree: $40.30 per hour
Zoetis is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
$16-40.3 hourly Auto-Apply 6d ago
Associate Manufacturing (Day Shift)
Amgen 4.8
Holly Springs, NC job
**HOW MIGHT YOU DEFY IMAGINATION?** You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
**Associate Manufacturing** **(Day Shift)**
**Live**
**What you will do**
Let's do this! Let's change the world! In this dynamic role, you will be an Associate in the manufacturing organization at Amgen North Carolina (ANC). The initial schedule will be 10 hours shift Mon to Friday 6am to 4pm. The schedule will transition to a 12-hour night shift including every other weekend as business needs dictate. Associates will be completing operations on the floor in our manufacturing services, upstream or downstream area and are responsible for the manufacturing of cGMP (Current Good Manufacturing Practices) drug substance.
Please note; no relocation assistance will be provided for these positions.
With general direction, the Associate will support all floor operations in accordance with cGMP practices.
**Responsibilities will include...**
**Compliance:**
+ Completes work in accordance with established cGMP procedures and policies (Standard Operating Procedures [SOPs], Manufacturing Procedures [MPs], Job Hazard Analysis [JHAs], Code of Federal Regulations [CFR]) with strict adherence to safety and compliance
+ Assure proper gowning and aseptic techniques are always followed
**Process/Equipment/Facilities:**
+ Perform hands-on operations including set-up, cleaning, sanitization, monitoring of equipment and assigned area
+ Run and monitor critical process tasks per assigned procedures
+ Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBRs])
+ Complete washroom activities: cleaning equipment, small to large scale, used in production activities
+ Identify and escalate issues and concerns regarding daily routine functions related to process and tasks; may engage with team on potential solutions
+ Perform documentation for assigned functions (i.e., equipment logs, EBRs)
+ Collaborate as part of a cross-functional team (i.e., QA/QC, F&E (Facilities & Engineering), PPIC, Mfg., PD (Process Development), Regulatory, etc.) in completing production activities
+ Maintain an organized, clean, and workable space
**Win**
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The hard-working professionals we seek are team players with these qualifications.
**Basic Qualifications:**
+ High School/GED + 2 years manufacturing and/or other regulated environment experience
Or
+ Associate's Degree + 6 months manufacturing and/or other regulated environment experience
Or
+ Bachelor's Degree
**Preferred Qualifications:**
+ Completion of NC BioWork Certificate Program
+ Experience in a regulated industry such as biotechnology or pharmaceutical
+ Basic understanding and process experience in a cGMP manufacturing facility
+ Excellent verbal and written communication
+ Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems
+ An ability to demonstrate desire and drive to learn and grow their understanding of operations and processes
**Thrive**
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
+ Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
+ A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
+ Stock-based long-term incentives
+ Award-winning time-off plans and bi-annual company-wide shutdowns
+ Flexible work models, including remote work arrangements, where possible
+ No relocation assistance will be provided for these positions
**Apply now**
**for a career that defies imagination**
Objects in your future are closer than they appear. Join us.
**careers.amgen.com**
**\#AmgenNorthCarolina**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
$26k-35k yearly est. 10d ago
Senior Manager Quality Assurance - Incoming Quality Raw Materials /Disposition
Amgen 4.8
Holly Springs, NC job
**Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
**Senior Manager Quality Assurance - Incoming Quality Assurance Raw Materials /Disposition**
**What you will do**
Let's do this! Let's change the world!
In this vital role, you will lead a team of Quality professionals supporting the Disposition and Incoming Quality operations at our North Carolina site. You will provide technical quality leadership and oversight of Disposition and Incoming Quality, partnering closely with cross-functional teams to build, enhance and sustain compliant commercial operations.
**Specific responsibilities include but are not limited to:**
+ Lead, manage, and motivate a high-performing team of Quality professionals across key areas, including QA support for Disposition and Incoming QA, and their applicable quality systems (e.g., Document Management, Change Control, and Deviations).
+ Ensure team members are properly trained and qualified to perform their duties in accordance with cGMP and regulatory requirements.
+ Oversee workload distribution, resource planning, and departmental budgeting, including forecasting and monitoring.
+ Own the development, implementation, and continuous improvement of the site's inspection readiness program and overall Quality Management System (QMS), ensuring compliance with Amgen standards, cGMP, and applicable regulations.
+ Ensure timely review, approval, and tracking of key cGMP processes, documents, and records, including deviations, CAPAs, Change Controls, validation protocols, and assays.
+ Lead cross-functional investigations of deviations, ensure appropriate documentation, and assess changes for potential product quality impact.
+ Stay current with regulatory developments and quality trends to maintain a compliant and forward-thinking quality program.
+ Represent the Quality unit during internal and external audits and regulatory inspections.
+ Alert senior management to significant quality, compliance, supply, or safety risks, using sound judgment and cross-functional coordination when needed.
+ Manage hiring, succession planning, and performance development to ensure organizational capability and talent pipeline.
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients! The Manager Quality Control professional we seek is a strong leader with these qualifications.
**Basic Qualifications:**
+ High school diploma / GED and 12 years of Quality and Manufacturing support industry experience OR
+ Associate's degree and 10 years of Quality and Manufacturing support industry experience OR
+ Bachelor's degree and 8 years of Quality and Manufacturing support industry experience OR
+ Master's degree and 6 years of Quality and Manufacturing support industry experience OR
+ Doctorate degree and 2 years of Quality and Manufacturing support industry experience
**Preferred Qualifications:**
+ Educational background in Life Science and/or Engineering
+ Proven experience in Quality oversight of Incoming, Warehouse, and Disposition, with a strong focus on quality systems.
+ In-depth knowledge of cGMPs, regulatory requirements, and pharmaceutical processing, with demonstrated ability to apply compliance principles in practice.
+ Hands-on experience with Disposition, Incoming, and Quality Systems-particularly investigations, corrective actions, and audit readiness.
+ Experience managing and interacting with regulatory and internal auditors.
+ Demonstrated leadership of Quality teams, with strong team development, collaboration, and mentoring skills.
+ Effective risk management, negotiation, and cross-functional collaboration abilities.
+ Excellent written and verbal communication, facilitation, and presentation skills in both English and Spanish.
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
+ A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
+ A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
+ Stock-based long-term incentives
+ Award-winning time-off plans
+ Flexible work models, including remote and hybrid work arrangements, where possible
**Apply now and make a lasting impact with the Amgen team.**
**careers.amgen.com**
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
$102k-132k yearly est. 9d ago
Associate Engineer, Process Development - Downstream
Amgen 4.8
Holly Springs, NC job
**Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. The Amgen FleX batch facility combines the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility not only features the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities but also integrates sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
**Associate Engineer, Process Development**
**What you will do**
Let's do this. Let's change the world. In this vital role you will be a part of the Process Development Drug Substance Technology group at Amgen's FleX Batch Biologics Manufacturing Facility. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility, which includes collaborating with other drug substance teams across our network. Additionally, the Process Development Associate will use out-of-the-box thinking to contribute to technology development and will demonstrate the desire to expand and develop expertise in downstream protein purification, thereby further contributing to the integrated group.
+ Apply a fundamental understanding of Downstream (Purification) Bioprocessing to support biologics technology transfer, process validation, and plant start-up
+ Support continuous process verification, process monitoring, optimization, complex investigation, and product life cycle management
+ Ensure safety and compliance of process development activities
+ Provide process on floor process support as required
+ Provide support for regulatory filing, inspection, and other CMC activities
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The scientific professional we seek is a leader with these qualifications.
**Basic Qualifications:**
+ High school diploma / GED and 6 years of Chemical, Biomedical, or related Engineering; Life Sciences; or other relevant sciences' experience OR
+ Associates and 4 years of Chemical, Biomedical, or related Engineering; Life Sciences; or other relevant sciences' experience OR
+ Bachelor's degree
**Preferred Qualifications:**
+ Master's degree in Chemical, Biomedical, or related Engineering; Life Sciences; or other relevant sciences
+ Some experience in a technical role supporting biotechnology processes within regulated environments (i.e., cGMP)
+ Understanding of protein purification/separation principles
+ Understanding of process scale-up, technology transfer, troubleshooting, and complex investigation
+ Strong oral and verbal communication skills, interact effectively with diverse internal and external stakeholders
+ Familiarity in statistical analysis, analytical methods, and product quality attributes related to biological processing
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
**Apply now and make a lasting impact with the Amgen team.**
**careers.amgen.com**
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
$68k-82k yearly est. 58d ago
Manufacturing Procurement Site Lead
Amgen 4.8
Holly Springs, NC job
**Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Manufacturing Procurement Site Lead
**What you will do**
Let's do this. Let's change the world. We are seeking an individual who thrives in ambiguity and is capable of driving procurement outcomes in a manufacturing operations environment with strategic vision and precision. In this vital role you will oversee the operations and management of manufacturing procurement at one of Amgen's world class global manufacturing sites. This position will play a key role in ensuring procurement deliverables support effective and efficient site-based manufacturing activities, while maintaining compliance with regulatory requirements, and driving continuous improvement in manufacturing operations. Reporting to the Manufacturing Site Lead within Internal & External Manufacturing, you will also act as the lead procurement business partner for the Site Head and their functional and cross-functional leadership team, connecting procurement outcomes to strategic business objectives at the site.
**Roles & Responsibilities:**
+ Drive continuous improvement Procurement initiatives by identifying inefficiencies, recommending solutions, and implementing changes to enhance manufacturing performance, speed, and delivery.
+ Champion a multi-year pipeline of savings and value plans across the manufacturing site that alignment with category and business strategies delivered against Finance's annual budget plan
+ Be a trusted advisor across the Site Leadership Executive teams - ability to grow and maintain influence of Sourcing Agenda and delivered through strategic business partnership
+ Be a Procurement leader with strong financial competence, experienced with accountability to site Executives and cross-functional leaders
+ Lead with a commitment to continuous improvement in sourcing processes, tools and operating model; Develop goals and prioritize impact to site work among multiple initiatives; Courage to provide performance feedback across the category and sourcing teams
+ Connect the dots and translate central functional programs into site based deliverables and outcomes
+ Champion supplier relationship management for critical suppliers at the site level
+ Identify and mitigate supply risk while ensuring Procurement deliverables adhere to regulatory requirements (e.g., GLP, GMP, ISO) and implement quality control systems, including audits, inspections, and compliance-related activities.
+ Monitor and report on Procurement performance metrics, making necessary adjustments to meet organizational goals and identifying opportunities for cost savings and process improvements.
+ Evaluate and implement, through Procurement, process improvement, environmental sustainability, and automation initiatives to enhance operational efficiency and support long-term goals.
+ Maintain up-to-date knowledge of industry standards and best practices, sharing innovative procurement solutions within the global manufacturing operations network.
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is an individual with these qualifications.
**Basic Qualifications:**
Doctorate degree and 2 years of Procurement, Supply Chain, Manufacturing or Operations (preferably in a regulated industry) experience
**Or**
Master's degree and 4 years of Procurement, Supply Chain, Manufacturing or Operations (preferably in a regulated industry) experience
**Or**
Bachelor's degree and 6 years of Procurement, Supply Chain, Manufacturing or Operations (preferably in a regulated industry) experience
**Or**
Associate's degree and 10 years of Procurement, Supply Chain, Manufacturing or Operations (preferably in a regulated industry) experience
**Or**
High school diploma / GED and 12 years of Procurement, Supply Chain, Manufacturing or Operations (preferably in a regulated industry) experience
**Preferred Qualifications:**
+ In-depth knowledge of procurement best practices across manufacturing, capital, equipment, and technologies.
+ Familiarity with industry standards and regulations (e.g., GLP, GMP, ISO, OSHA).
+ Proven track record to drive value in a procurement environment supporting manufacturing
+ Strong analytical skills to monitor performance metrics, optimize procurement deliverables, and ensure compliance.
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $145,239 to $170,803. Actual salary will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
+ A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
+ A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
+ Stock-based long-term incentives
+ Award-winning time-off plans
+ Flexible work models, including remote and hybrid work arrangements, where possible
**Apply now and make a lasting impact with the Amgen team.**
**careers.amgen.com**
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
**Application deadline**
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
**Sponsorship**
Sponsorship for this role is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
$145.2k-170.8k yearly 60d+ ago
Senior Associate Facilities Maintenance
Amgen 4.8
Holly Springs, NC job
**Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
**Senior Associate Facilities Maintenance**
**What you will do**
Let's do this. Let's change the world. In this vital role, you will be part of the Facilities organization within the Facilities & Engineering (F&E) team at Amgen's newest manufacturing site in North Carolina!
+ System Owner responsibilities for facilities and utilities infrastructure systems including Building Shell & Core, Fire Protection & Suppression, Fire Alarm, Domestic Water, Sewer, etc, and supporting operations at the site.
+ Provide engineering support for design, construction, startup, commissioning and qualification of new or modified systems.
+ Support day-to-day logistics and overall coordination within the department and with project team. Attendance to whiteboard meetings, support and communication with the team.
+ Ability to support end-to-end process for the creation of the Master Maintenance Packages including, but not limited to:
+ Construction inspection walks
+ Commissioning documentation
+ Develop equipment/instrument maintenance programs, ensure the availability of spare parts, and coordinate maintenance execution as necessary to ensure systems are in proper working order.
+ Asset Creation / Preventive Maintenance Creation / Job Plan creation and overall ownership of systems within the Computerized Maintenance Management System (CMMS)
+ Define spare parts' list, responsible for assessment with regards to criticality of spares
+ Develop and assist in redlining and workflow process for SOP's relevant to the Facilities department
+ Collaborate with peers to streamline or construct efficient Workflows/Business Practices
+ Support of field walks, and general activities leading up to and at startup of systems; which includes but it is not limited to inspection field walks, punch list items generation, and inspection of equipment for Mechanical Completion
+ Work with technicians and system owners to develop the scope of work, resource requirements, and parts requirements to complete preventive and corrective maintenance tasks in a safe, compliant, efficient, and effective manner
+ Write clear, concise, and accurate Job Plan steps within the CMMS for corrective and preventive maintenance work orders
+ Review turnover documentation and observe/document required spare parts for commissioning runs and future state operations
+ Ensure systems are installed and operating safety and comply with pertinent environmental health/safety practice, rules and regulations.
+ Collaborate with integrated facilities management team and craft groups to schedule maintenance activities as required to support site operations
+ Support maintenance activities to allow efficient labor utilization of F&E crafts while minimizing the interruption to customer operations. Identify and coordinate contractor resources as needed to effectively complete tasks
+ Overall Facilities Compliance:
+ Owner for Facilities Standard Operating Procedures
+ Responsible for reviews, updates and administration of SOP's for Facilities Department
+ Owner of change controls - end to end process
+ Owner of deviations and corrective actions
+ Assist with Procurement and Invoicing for the department
+ Provide technical support and issue resolution with 24x7 on-call support of Utility systems on a rotational based frequency (Support may be required outside of normal working hours including nights, weekends, and holidays).
+ Data verification of GMP information for pest control compliance
+ Delegate for Facilities Sr Manager during period of absence
+ Day-to-day management of communication and any other tasks/projects assigned as per manager's request
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a collaborative partner with these qualifications.
**Basic Qualifications:**
+ High School Diploma / GED and 6 years of Work Order Administration, Mechanical Maintenance, Facilities/Utilities Operations, or Engineering experience OR
+ Associate's Degree and 4 years of Work Order Administration, Mechanical Maintenance, Facilities/Utilities Operations, or Engineering experience OR
+ Bachelor's Degree and 2 months of Work Order Administration, Mechanical Maintenance, Facilities/Utilities Operations, or Engineering experience OR
+ Master's Degree
**Preferred Qualifications:**
+ Experience with regulated environments (i.e., cGMP, OSHA, EPA) including detailed understanding of current Good Manufacturing Practices
+ Strong customer service skills, written and verbal communication skills, and the ability to work with minimal direction
+ Demonstrated ability to function within cross-functional teams and embrace a team-based culture
+ Ability to use Microsoft Excel, Word, PowerPoint, SharePoint, Smartsheet, and various database querying tools
+ Good understanding of CMMS systems (Maximo, SAP, Blue Mountain, ETC.)
+ Familiar with Root Cause Analysis and LEAN methodology
+ Excellent facilitation, organizational and planning skills
+ Proactive, self-starter with the ability to take on several projects at one time
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
**Apply now and make a lasting impact with the Amgen team.**
**careers.amgen.com**
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
$73k-95k yearly est. 4d ago
Associate Scientist, Process Development (Process Validation & Business Strategy)
Amgen 4.8
Holly Springs, NC job
**Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
**Associate Scientist, Process Development** **(Process Validation & Business Strategy)**
**What you will do**
Let's do this. Let's change the world. In this vital role you will be a part of the Process Development Drug Substance Technology group (PD DST) at Amgen's FleX Batch Biologics Manufacturing Facility. This position is part of the Process Validation & Business Strategy (PBS) team within PD DST. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility, which includes process development operation support, developing digital tools to support business processes, and support commercial development of Amgen's pipeline.
The role will be responsible for ensuring PD business strategy operations have appropriate digital tools to track operational metrics for safety, training, compliance, support business processes improvements, and the commercial development of the Amgen's pipeline. In addition, the role will be responsible for supporting tech transfer activities as needed.
+ Lead and develop the Process Development safety, training, and compliance monitoring operation
+ Holistic Lab Execution Environment (HLEE) champion for the process development lab
+ Develop digital tools to improve business process efficiencies and identify bottlenecks within the process development operation
+ Develop digital tools to support process validation and process monitoring activities
+ Support and develop the Amgen North Carolina (ANC) PD DST knowledge management ecosystem, alignment of ANC PD business process to network practice, and optimizing the ANC PD business process.
+ Provide process floor or lab support as required
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The experienced scientific professional we seek is a leader with these qualifications.
**Basic Qualifications:**
+ Bachelor's degree and 3 years of Process Development or Scientific experience OR
+ Master's degree and 1 years of Process Development or Scientific experience
**Preferred Qualifications:**
+ 2 - 4 years of experience in a Biotech/Pharma Process Development, MFG, QC, or laboratory role.
+ Knowledge in broad aspects of biologics processing, for example cell culture, purification, analytical methods, or product quality attributes
+ Familiarity in operational aspects of process development lab or commercial biopharma manufacturing
+ Experienced with software such as Holistic Lab Execution Environment (HLEE), Tableau, MS PowerBI, spotfire, and/or databricks
+ Able to apply digital tool skills to solve business process issues and evaluate opportunities for process improvements
+ Excellent written and verbal communication
+ Be a self-starter with the ability to take on several projects at one time.
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
**Apply now and make a lasting impact with the Amgen team.**
**careers.amgen.com**
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
$57k-82k yearly est. 9d ago
Senior Associate Warehouse Systems
Amgen 4.8
Holly Springs, NC job
**Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
**Senior Associate Warehouse Systems**
**What you will do**
Let's do this. Let's change the world. In this role, you will be part of the Supply Chain team, and you will participate in multiple cross-functional initiatives for Amgen North Carolina (ANC) warehouse. You will serve as warehouse Subject Matter Expert and as site representative on various cross-functional task forces and teams to ensure that consistent and well-integrated practices are developed throughout the organization. The focus of the Sr. Associate is to support warehouse process and systems, including floor support, gemba walks to ensure adequate safety and housekeeping practices, procedures drafting and approval, staff training and quality systems records, as well as warehouse equipment ownership. This position works close with Warehouse operations and Procurement to manage warehouse capacity actions.
+ Represent ANC Supply Chain in interdisciplinary system-related projects/initiatives and possibly lead work streams within such projects (e.g., process mappings with manufacturing) **.**
+ Own Warehouse Safety Program, investigations and actions.
+ Manage initiatives to support warehouse capacity constraints.
+ Conducts warehouse walks and tracks actions to completion.
+ Support Operational Excellence initiatives in Supply Chain processes, including data analysis and business case development.
+ Identify and manage warehouse risks.
+ Owns change control and deviations records if applicable.
+ Involvement in test process for new functionality.
+ Serve as first point of contact for Key Users in case of warehouse related issues
+ Own relevant Supply Chain procedures and conduct required periodic reviews
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The Supply Chain professional we seek is a leader with strong strategic problem solver with these qualifications.
**Basic Qualifications:**
+ High school diploma/GED and 4 years of operations, business, or supply chain experience OR
+ Associates Degree and 2 years of operations, business, or supply chain experience OR
+ Bachelor's degree and 6 months of operations, business, or supply chain experience OR
+ Master's degree
**Preferred Qualifications:**
+ Supply Chain & Logistics Management, Information Technology, or Engineering educational background.
+ Supply Chain experience with a focus on warehouse operations and systems
+ Basic knowledge of ERP (SAP) and SAP Warehouse Management (WM)
+ Good understanding of Warehouse Master Data and SAP
+ Knowledge of Information Technology, Supply Chain processes, and Operational Excellence
+ Good understanding of current Good Manufacturing/Distribution Practices
+ Quick process understanding, insight and visualizing
+ Experience in managing projects or work streams (cross functional)
+ Availability to support non-standard shift organization with the flexibility to work extended hours.
+ Good organizational and communications skills
+ Continuous improvement mentality.
+ Experience working in a global environment, ability to collaborate closely/communicate effectively at different management levels.
+ Proficient user of software applications (Excel, PowerPoint, Smartsheet, Skype, Tableau).
+ Consistent and strong communication within Supply Chain and throughout all of Amgen and across all sites.
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
**Apply now and make a lasting impact with the Amgen team.**
**careers.amgen.com**
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
$37k-46k yearly est. 4d ago
Senior Instrument Technician
Amgen 4.8
Holly Springs, NC job
**Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
**Senior Instrumentation Technician**
**What you will do**
Let's do this. Let's change the world. In this vital role, you will provide technical expertise and guidance supporting the start-up of the plant and daily operations.
During Construction Phase:
+ The initial focus of this role for the majority of 2024 will be to work closely with the Capital Project Delivery team providing technical support associated with the start-up, commissioning, and qualification of the wide variety of equipment and systems used in Manufacturing, Laboratories, Utilities, and other areas at the site.
+ Support the implementation of the Metrology program meeting all Good Manufacturing Practices (GMPs) and safety requirements, local/ global regulations, and Amgen Maintenance excellence standards.
+ Support the development, writing and implementation of the Metrology program documentation including Standard Operating Procedures (SOP), Change Control (CCMS), Non-Conformance (NC), Work Orders (WO), Job Plans (JP), Hazard Risk Assessments (HRA), Job Hazard Assessments (JHA), etc.
+ Ensure safety of all staff during plant construction and start-up operations and metrology activities.
Post-Construction completion and continued operations. In this key role within the Facilities & Engineering team, under limited supervision, the Senior Instrument Technician is responsible for:
+ Performing calibration, repair, installation, troubleshooting and documentation / logs of instruments used on process control systems and building systems.
+ Completing quality and safety documentation and completing the work in a safe, compliant, and timely manner according to planning and predefined schedules with minimal impact to production while aligning with GMPs, SOPs and Amgen policies and regulations.
+ Work in a highly productive and efficient manner to maximize the quantity of activities completed with focus on maintenance excellence.
+ Ensure work is appropriately communicated to system operators and key stakeholders.
+ Ensure work order documentation is completed accurately.
+ Reviewing and technically approving maintenance reports, forms, plans and records.
+ Identify waste, work-flow interrupters, and other opportunities for improvement, recommend solutions, and assist with implementation.
+ Identify opportunities to learn new skills and actively participate in development that will improve overall team performance.
+ Represent Maintenance team in discussions and meetings with peers and other site functions.
+ Provide facility and manufacturing support as needed with on-call rotation - this may be outside of normal working hours including nights, weekends and holidays.
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The maintenance professional we seek is a dynamic team-player with these qualifications.
**Basic Qualifications:**
+ High school diploma / GED and 6 years of Maintenance experience OR
+ Associate's degree and 4 years of Maintenance experience
**Preferred Qualifications:**
+ Experience in mechanical maintenance with an emphasis on sanitary processing equipment and systems.
+ 3+ years knowledge of pneumatic, mechanical, and hydraulic systems and ability to effectively perform associated maintenance activities.
+ Knowledge and experience working in a highly regulated function - cGMP.
+ Experience executing and documenting maintenance work orders in a computerized maintenance management system.
+ Ability to interpret P&ID's.
+ Ability to work with minimum direction.
+ Ability to effectively communicate issues and status of tasks in a timely manner.
+ Ability to interact constructively with peers/teams.
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
**Apply now and make a lasting impact with the Amgen team.**
**careers.amgen.com**
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
$89k-117k yearly est. 4d ago
Network Architect - Manufacturing
Amgen 4.8
Holly Springs, NC job
Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
**Specialist Network Engineer - Manufacturing**
**What you will do**
Let's do this. Let's change the world. In this vital role you will lead the design, implementation, and optimization of industrial IO and IoT network infrastructure across our manufacturing sites. This role is pivotal to advancing our Industry 4.0 strategy, enabling scalable, secure, and intelligent connectivity for smart devices, sensors, and edge platforms.
**Key Responsibilities**
+ Architect and deploy robust IO and IoT network solutions for manufacturing environments, including edge-to-cloud integrations.
+ Collaborate with cross-functional teams (OT, IT, DevOps, Engineering) to define requirements and deliver scalable network solutions.
+ Develop and maintain documentation for network configurations, security policies, and deployment blueprints in line with Gartner's IoT Reference Model
+ Provide technical leadership in troubleshooting, risk mitigation, and continuous improvement of network operations.
+ Support IoT platform rollouts, including wireless sensor architecture and enterprise edge node deployments
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The professional we seek will have these qualifications.
**Basic Qualifications:**
Doctorate degree
OR
Master's degree and 2 years of Computer Science, Electrical Engineering, or related field experience
Or
Bachelor's degree and 4 years of Computer Science, Electrical Engineering, or related field experience
Or
Associate's degree and 8 years of Computer Science, Electrical Engineering, or related field experience
Or
High school diploma / GED and 10 years of Computer Science, Electrical Engineering, or related field experience
**Preferred Qualifications:**
+ Strong expertise in industrial network architecture, standards governance, and multi-site rollout strategy.
+ Hands-on experience with Rockwell Stratix switches, Cisco IE platforms, and configuration tools such as Studio 5000, Cisco Industrial Network Director, or equivalents.
+ Proven ability to design and manage networks using PRP, DLR, and other redundancy and fault-tolerance protocols.
+ Deep understanding of routing, switching, VLANs, and segmentation in mixed OT/IT environments.
+ Familiarity with industrial protocols such as MQTT, OPC-UA, Modbus, and LoRaWAN.
+ Practical knowledge of industrial cybersecurity principles, including ISA/IEC 62443, network zoning, access control, and anomaly detection.
+ Experience in Layer 2/3 diagnostics, packet capture analysis, and bandwidth optimization within industrial networks.
+ Ability to work in high-performance cross-functional teams and manage vendor engagements across global sites.
+ Strong communication, collaboration, and documentation skills.
What you can expect from us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
+ A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
+ A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
+ Stock-based long-term incentives
+ Award-winning time-off plans
+ Flexible work models, including remote and hybrid work arrangements, where possible
Apply now and make a lasting impact with the Amgen team.
**careers.amgen.com**
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
$95k-119k yearly est. 60d+ ago
Specialist Manufacturing: NPI, Upstream Process Owner
Amgen 4.8
Holly Springs, NC job
Career CategoryManufacturingJob DescriptionJoin Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
Specialist Manufacturing: NPI, Upstream Process Owner
What you will do
Let's do this. Let's change the world. In this vital role you will communicate and interface between the GMP manufacturing teams in the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and Process Development scientific groups. As part of ANC's Manufacturing Support team, this position is responsible for ensuring new products are successfully introduced into ANC's biologics manufacturing facility and ownership of upstream unit operations. It is a highly visible role across the site with the core responsibility of hosting cross-functional meetings to drive to timelines to support the tech transfer of the program into the facility as well as process ownership for some upstream process unit operations.
New Product Introduction (NPI) lead coordinating with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, as well as Quality to introduce new Drug Substance products and/or advanced technologies into the plant using project management tools (i.e. Smartsheet).
Upstream biologics drug substance technical expert who leads or participates in projects, including aiding in commissioning and qualification and training staff on equipment and processes
Support Manufacturing in troubleshooting, problem solving and RCAs. Support CAPA development to prevent error recurrence.
Owns New Product Introduction Change Controls and collaborates with stakeholders to drive on-time completion. Responds to regulatory questions and/or audit findings.
Ensures that manufacturing production documents (e.g. Standard Operating Procedures) are accurate and up to date.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The manufacturing professional we seek has a biologics Drug Substance Upstream manufacturing background with strong cross-functional project management and communication skills as well as the below qualifications.
Basic Qualifications:
High school diploma / GED & 10 years of biotechnology operations experience OR
Associate's degree & 8 years of biotechnology operations experience OR
Bachelor's degree and 4 years of biotechnology operations experience OR
Master's degree in chemistry, biology, or engineering & 2 years of biotechnology operations experience OR
Doctorate degree
Preferred Qualifications:
Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry
Excellent cross-functional project management, meeting facilitation, and technical writing skills
Experience in Upstream GMP manufacturing operations
Strong technical knowledge of Upstream drug substance processing (media preparation, cell culture, harvest) and a broad understanding of related disciplinary areas in bioprocessing.
Ability to organize, analyze and interpret technical data through trend analysis, forecasting, modeling, etc.
Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
Ability to coach, mentor and/or cross train colleagues within core technical areas
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now and make a lasting impact with the Amgen team.careers.amgen.com
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.
Salary Range
112,977.00 USD - 139,179.00 USD
$60k-82k yearly est. Auto-Apply 55d ago
Manager Manufacturing, New Product Introduction (NPI)
Amgen 4.8
Holly Springs, NC job
**Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
**Manager Manufacturing,** **New Product Introduction**
**What you will do**
Let's do this. Let's change the world. In this vital role you will act as the Manager for the New Product Introduction (NPI) Team in GMP Drug Substance Supply. This position is within Amgen North Carolina (ANC) Manufacturing and GMP Supply - Manufacturing Support organization.
ANC is a dynamic environment and an important supply facility for Amgen's pipeline products. The GMP DSS plant manufactures drug substance for clinical trials and commercial supply through GMP production using both stainless steel and single-use equipment platforms. This NPI team is a key communication and technical interface between the GMP manufacturing operations teams in the plant and Process Development, Drug Substance Technologies & Engineering, Supply Chain, Facilities & Engineering, and Quality.
+ Directly manage a team of NPI leads responsible for introduction of new products and/or advanced technologies into the plant. Includes hiring, training, oversight, performance evaluations, and development.
+ Proactively assess the NPI team capabilities to meet the evolving drug substance supply needs (ex. resources, platform technical understanding, cross-functional alignment).
+ Lead team meetings and drive alignment in business processes across the team.
+ Coordinate with PD, DSTE, Supply Chain, Planning, Facilities and Engineering, Quality as well as Manufacturing for the introduction of new products, process changes and improvements and/or advanced technologies into the plant.
+ Champions Lean Transformation and OE initiatives, facilitates the drive towards continuous improvement in the plant and tracks progress on a plant level.
+ Collaborate with Regulatory and Quality partners to ensure compliance of team change control records/documents and respond to regulatory questions and/or audit findings.
+ Drive a culture of inspection readiness across the team by ensuring NPI change controls are kept up to date and supporting staff with audit or regulatory response strategy.
+ Interacts with management in planning, developing, and maintaining budget
+ Assist in developing and maintaining department goals
+ Interact with regulatory agencies as needed
+ Responsible for engaging staff and building relationships of trust and respect while driving team performance and continuous improvement
+ Responsible for selection, training, evaluation, staff relations and staff development
+ Mentor and coach staff members to live by the Amgen Values
+ Develop and implement trainings plans and programs, to ensure staff are prepared and compliant
+ Other functional responsibilities may be assigned
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.
**Basic Qualifications:**
+ High school diploma / GED and 12 years of Manufacturing or Operations experience OR
+ Associate's degree and 10 years of Manufacturing or Operations experience OR
+ Bachelor's degree and 5 years of Manufacturing or Operations experience OR
+ Master's degree and 3 years of Manufacturing or Operations experience OR
+ Doctorate degree
**Preferred Qualifications:**
+ Degree in Chemical Engineering, Industrial Engineering, Biology or Biochemistry
+ Experience leading/managing a team of direct reports
+ Experience with PAS X, Werum software
+ Experience in GMP operations, including New Product Introduction (NPI)
+ Strong technical knowledge of drug substance processing (cell culture, harvest, chromatography, filtration, buffer compounding) and a broad understanding of related disciplinary areas in bioprocessing
+ Ability to organize, analyze and interpret technical data through trend analysis, forecasting, modeling, etc.
+ Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
+ Ability to coach, mentor and/or cross train colleagues within core technical areas
+ Background in lean manufacturing methodologies and operational excellence
+ Experience in cross functional Project Management
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
**Apply now and make a lasting impact with the Amgen team.**
**careers.amgen.com**
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
$98k-129k yearly est. 53d ago
Senior Medical Science Liaison- Autoantibody Pipeline-South
Johnson & Johnson 4.7
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:
Medical Science Liaison
Job Category:
Scientific/Technology
All Job Posting Locations:
Nashville, Tennessee, United States, Raleigh, North Carolina, United States
Job Description:
Johnson & Johnson Innovative Medicine is searching for the best talent for a Senior Medical Science Liaison- Autoantibody Pipeline for the South region. This is a field-based position located in the South region, the preferred location is the Raleigh, NC or Nashville, TN area. The territory covers Louisiana, Arkansas, Mississippi, Kentucky, Tennessee, North Carolina, South Carolina, and Virginia.
About Immunology
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 Senior Medical Science Liaison (Sr. MSL) is responsible for providing fair balanced, objective, scientific information and education to opinion leaders (OLs), health care professionals, and to internal partners as required by scientific and business needs. The Sr. MSL is considered an established scientific and clinical knowledge lead on current and future J&J Innovative Medicine products per Therapeutic Area (TA) alignment. Sr. MSL is responsible for staying abreast of current scientific and treatment landscape trends in their therapeutic areas of interest. Sr. MSL provides research support for company and investigator-initiated research. The Sr MSL will function with high integrity and follow credo values.
Sr. MSL is responsible for building external relationships with identified OLs and health care providers (MD, DO, PhD, PA, NP, RN, Pharm.D., bio coordinators) and developing and managing a geographical territory. These relationships and engagements can include both virtual & in-person, with a prioritization of in-person engagements when appropriate.
The Sr. MSL is responsible for developing and maintaining a territory strategic plan, which includes educational activities with identified OLs, HCPs, institutions, and community practices.
The Sr. MSL role is one that requires a level of competency and experience in the disease state. The Sr. MSL is expected to possess foundational competencies in the areas of Influence & Results Focused, Communication, Stakeholder Engagement, Product & Therapeutic Area Knowledge, and Data Insights & Dissemination.
The Sr. MSL will be expected to rapidly identify and compliantly collaborate with field-based partners to ensure support of the Healthcare Providers, which will positively impact the patients that they care for.
The Sr. MSL will continue to enhance their skills in agility, applying the competencies of Change Management, Time Management and Innovation.
The Sr. MSL is responsible for conducting all activities in accordance with current regulatory and health care compliance guidelines.
This is a field based clinical position which required travel, primarily throughout assigned geography, with infrequent meeting travel outside of assigned geography. Travel for this role is estimated at 70%.
Responsibilities:
Consistently demonstrate strategic territory planning and ability to build strong relationships within the territory.
* Responsible for developing and maintaining a field strategic plan.
* Responds in a timely manner to unsolicited scientific inquiries of HCPs/investigators/health care systems/academic medical centers and population health decision makers integrating scientific data including real world evidence into real life practice to meet customer needs.
* Presents data and information in a manner appropriate to the audience and request.
* Execute plans regarding reactive and proactive outreaches as approved via the legal/HCC exceptions process.
* Integrates scientific data into real life practice to meet customer/audience needs, adapting interpersonal style to particular situations and people.
* Anticipates the responses of various individuals and teams based on their vantage point and perspective.
* Prioritize franchise customer-based initiatives and field responsibilities, while balancing administrative duties and project responsibilities.
* Executes Research Initiatives:
* Leverages knowledge of standards of care and Janssen company/investigator sponsored clinical trials and competitor landscape to facilitate external-internal research communication.
* Engages with external investigators regarding unsolicited research inquiries and act as liaison to R&D, Medical Affairs and operations teams.
* Provides clinical trial support to identify potential sites, resolve issues with enrolled sites, and participate in meetings as appropriate, including site initiation visits and investigator launch meetings.
* Effectively leads at least one scientific or strategic Immunology project, exhibits strategic identification of educational gaps and elevates team acumen.
Consistently demonstrates strong scientific acumen.
* Actively participate in team calls, trainings, & journal clubs through scientific dialogue, understanding of current standard of care, and regularly sharing of scientific news.
* Attends and provides leadership at scientific conferences to gather and understand new scientific information relevant to the company and the external scientific community.
* Medical insights: Actively listens for, documents, and shares medical insights. Proactively synthesize data and medical insights for MSL team and other partners
* Sets aside time for self-driven learnings on current scientific landscape.
* Role includes representing and supporting JNJ at relevant scientific or other key stakeholder meetings including congresses, symposia, advisory boards and investigator meetings.
* Role includes representing JNJ at speaking engagements at relevant scientific or other key stakeholder meetings.
Continuous support Department Operations and Internal Partners:
* Performs all administrative requirements in a timely, accurate and compliant manner (e.g. expense reports, documentation of activities)
* Maintain focus and composure in uncertain circumstances with minimal direction.
* Provide regional and local support to enhance sales training initiatives and improve competencies of field personnel in partnership with Sales Learning and Development
* Communicates and collaborates with all field-based partners, and other Immunology MSL teams on a routine basis.
* Demonstrate the ability to partner with others to lead or participate in large scale projects.
* Maintains thorough understanding and competence in the following areas (regulatory and health care compliance guidelines; corporate policies on appropriate business conduct and ethical behavior; Medical Affairs SOPs and guidelines.
Qualifications
Required:
A PharmD, PhD, MD, w/ 3+ years relevant hematology, immunology and/or auto/alloimmune disease experience
Minimum 3 years MSL experience, and/or 2-3 years relevant work exp (clinical or research experience)
Must be familiar with Microsoft Word, Excel, PowerPoint, and utilization of computers and remote technologies.
Ability to travel up to 70 %.
Preferred:
Launch experience in rare disease is highly preferred.
Significant experience giving presentations is highly preferred.
Must be familiar with Microsoft Word, Excel, PowerPoint, and utilization of computers and remote technologies.
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.
#LI-Remote
Required Skills:
Preferred Skills:
Analytics Dashboards, Clinical Research and Regulations, Clinical Trials, Consulting, Customer Centricity, Data-Driven Decision Making, Digital Culture, Digital Literacy, Medical Affairs, Medical Communications, Medical Compliance, Mentorship, Product Knowledge, Relationship Building, Research and Development, Strategic Thinking, Tactical Planning, Technical Credibility
$90k-126k yearly est. Auto-Apply 5d ago
Senior Manufacturing Systems Engineer: Automation - DeltaV
Amgen 4.8
Holly Springs, NC job
**Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
**Senior Manufacturing Systems Engineer: Automation - DeltaV**
**What you will do**
Let's do this. Let's change the world. As a Senior Manufacturing Systems Engineer, you will provide automation technical leadership to a group of automation engineers who are responsible for building and maintaining various automation systems and platforms that support the GMP Drug Substance Plant Operations.
In this vital role as a member of the Facilities & Engineering (F&E) Automation team you will work hand in hand with the capital project team to deliver robust **process automation systems** to operate the new plant.
**Site design, construction, start-up, and operational readiness**
+ Collaborate with key stakeholders and end-users to understand and synthesize key process requirements, and to develop solutions using Amgen standard automation platform for process automation systems
+ Support design phases to ensure design aligns with Amgen specifications, incorporates the latest technology, and meets safety requirements
+ Support vendor FAT to ensure that control strategy and software code meet Amgen requirements
+ Develop and maintain engineering and maintenance documentation, and associated procedures for delivered solutions and processes
+ Collaborate with cross-functional teams to develop a robust commissioning and qualification plan and/or qualification strategy
+ Support commissioning and qualification including Automation Installation Verification/Automation Check Out (IV/ACO)
+ Support QA partners in performing computerized systems validation in a GxP environment
+ Perform Data Integrity Assessments (DIA) in accordance with the current Amgen and industry standards
**Site Operations**
+ Own and drive to completion Change Controls, CAPAs, and Deviations
+ Lead and support technical root cause analysis, incident investigations, and troubleshooting
+ Lead and support functional area projects focused on improving process equipment, utilities, and facilities as well as large capital projects to integrate new drug substance manufacturing technologies into the facility
+ Drive continuous improvement for process automation systems to improve operational workflows, safety, reliability, efficiency, and sustainability
+ Support day-to-day operations including rotational on-call support
+ Perform and maintain Data Integrity Assessments (DIA) in accordance with the current Amgen and industry standards
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The automation professional we seek is an engineer with these qualifications:
**Basic Qualifications:**
+ High School diploma/GED and 10 years of engineering experience OR
+ Associate's degree and 8 years of engineering experience OR
+ Bachelor's degree and 4 years of engineering experience OR
+ Master's degree and 2 years of engineering experience OR
+ Doctorate degree
**Preferred Qualifications:**
+ Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field
+ Direct knowledge of automation system design
+ Experience in programming, installation and lifecycle management of automation and field instrumentation technologies
+ Experience in automation of GMP biopharmaceutical equipment and systems such as buffer prep and hold, chromatography, single use mixing vessels, depth filtration, and solution prep
+ Experience in integrating various OEM automation software
+ Experience in programming, design, installation and lifecycle management of manufacturing process controls, and automation and field instrumentation technologies.
+ Experience with Emerson DeltaV DCS system and ability to perform advanced troubleshooting, and system integration using OPC, Foundation Fieldbus, and Profibus technologies
+ Ability to interpret and apply GAMPs and GMPs, and familiarity with documentation in a highly regulated environment with requirements such as 21 CFR Part 11, ASTM 2500, S88 and S95
+ Self-directed team player able to work cross-functionally
+ Strong leadership, technical writing, and communication skills
+ Ability for domestic and international travel
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
**Apply now and make a lasting impact with the Amgen team!**
**careers.amgen.com**
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
$77k-100k yearly est. 59d ago
Sr Mgf Systems Engineer
Amgen 4.8
Holly Springs, NC job
Additional Information
All your information will be kept confidential according to EEO guidelines.
$85k-105k yearly est. 9h ago
Engineering, Project Manager
Amgen 4.8
Holly Springs, NC job
Career CategoryEngineeringJob DescriptionJoin Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
Engineering - Project Manager
What you will do
Let's do this. Let's change the world. This role is responsible for the strategic planning, implementation, and oversight of complex, high-impact facilities projects. The individual will ensure that all initiatives are completed on schedule, within budget, and in alignment with organizational standards for safety, quality, and operational excellence. The position requires strong leadership, technical expertise, and the ability to drive multi-functional collaboration to deliver projects that support Amgen's mission to change the world through innovation and excellence.
Lead and oversee the execution of multiple facilities engineering projects from initiation through completion, ensuring alignment with organizational goals and objectives.
Develop comprehensive project plans, including scope definition, timelines, budgets, and resource allocation strategies.
Coordinate and collaborate with internal stakeholders, external contractors, and consultants to ensure all project requirements, specifications, and deliverables are met.
Provide leadership and direction to multi-functional project teams, encouraging accountability, technical excellence, and effective communication.
Monitoring and evaluating project performance, identifying risks and implementing corrective actions to maintain schedule and budget adherence.
Ensure all projects align with applicable regulatory requirements, industry codes, and company standards for safety and quality.
Prepare, maintain, and present detailed project reports, status updates, and performance metrics to senior management and key collaborators.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The project management professional sought for this role will exemplify these values and possess the qualifications outlined below.
Basic Qualifications:
High school diploma / GED and 10 years of engineering project management experience OR
Associate's degree and 8 years of engineering project management experience OR
Bachelor's degree and 4 years of engineering project management experience OR
Master's degree and 2 years of engineering project management experience OR
Doctorate degree
Preferred Qualifications:
Demonstrated success in managing and delivering complex, large-scale projects within scope, schedule, and budget parameters.
Leadership and team management capabilities, with the ability to empower and guide cross-functional teams toward successful outcomes.
Exceptional communication, presentation, and interpersonal skills, with a focus on collaboration and stakeholder engagement.
Strong ability to perform effectively under pressure, manage challenging priorities, and meet tight deadlines.
Proficiency in project management methodologies, software, and analytical tools.
Project Management Professional (PMP) certification or equivalent credential preferred.
Prior experience within the pharmaceutical, biotechnology, or regulated life sciences industry strongly desired.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now and make a lasting impact with the Amgen team!careers.amgen.com
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.
Salary Range
122,112.00 USD - 147,362.00 USD
$98k-123k yearly est. Auto-Apply 60d+ ago
Senior Engineer, Process Development (Downstream)
Amgen 4.8
Holly Springs, NC job
Career CategoryEngineeringJob DescriptionJoin Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
Senior Engineer, Process Development (Downstream)
What you will do
Let's do this. Let's change the world. In this vital role you will advance Amgen latest bioprocessing platform and technology, delivering high quality of medicine to patients around the world.
The Sr. Engineer will be part of the Process Development-Drug Substance Technology at Amgen's FleX Batch facility, focusing on technology transfer, process support, and optimization. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility, which includes collaborating with other drug substance teams across our network.
Responsibilities include but are not limited to:
Support technology transfer, process validation, and plant start-up
Provide technical leadership in Downstream (Purification) Bioprocessing for process monitoring, optimization, yield improvement, complex investigation, and product life cycle management
Partner with cross-functional teams to resolve complex problems while meeting quality, schedule, and cost objectives
Provide on-the-floor process support as required
Ensure safety and compliance of process development activities
Collaborate with other site-functions and network drug substance teams in delivering plant goals
Support regulatory filing, inspection, and other CMC activities
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The inspiring professional we seek is a strong team-player with these qualifications.
Basic Qualifications:
High school diploma / GED and 10 years of biologics process development or commercial-scale technical support experience OR
Associate's degree and 8 years of biologics process development or commercial-scale technical support experience OR
Bachelor's degree and 4 years of biologics process development or commercial-scale technical support experience OR
Master's degree and 2 years of biologics process development or commercial-scale technical support experience OR
Doctorate degree
Preferred Qualifications:
Master's degree in Engineering or Science discipline
5+ years of experience in a technical role supporting biotechnology processes within regulated environments (i.e., cGMP)
In-depth expertise in biologics process purification processes
Experience in process scale-up, technology transfer, process validation, process optimization, troubleshooting, and complex investigation
Strong oral and verbal communication skills, interact effectively with diverse internal and external stakeholders
Able to apply engineering principles and statistical analysis in resolving complex issues
Knowledge in regulatory filings and inspections
Knowledge in broad aspect of biologics processing, for example cell culture, analytical methods, or product quality attributes
Familiarity in operational aspects of commercial biopharma manufacturing (e.g. process automation, equipment, single use)
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now and make a lasting impact with the Amgen team.careers.amgen.com
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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Salary Range
119,195.00 USD - 147,867.00 USD