Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
Plant Purchasing Supervisor
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:
* Career development with an international company where you can grow the career you dream of.
* Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
* An excellent retirement savings plan with a high employer contribution
* Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
* A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
* A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
This position works out of our Altavista, VA location in the Abbott Nutrition division. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands - including Similac, PediaSure, Pedialyte, Ensure, and Glucerna - to help them get the nutrients they need to live their healthiest lives.
Altavista, Va., is one of Abbott's largest nutrition manufacturing plants equipped with advanced technology to ensure efficient production. Working here will make you feel like you're part of a family that works together to make a difference and help nourish millions of families around the world.
The Purchasing / Stockroom Supervisor leads the onsite MRO (maintenance, repair, and operations) warehouse. The warehouse, or "parts room", contains critical spare part and consumable items used in the manufacturing operation. In addition, the position leads the administration of site indirect procurement (non-raw materials).
What You'll Work On
* Manage the overall inventory process and system, including hours of operation, procedures for check-outs and returns, inventory and cycle counts, new add-to-stocks, master data (safety stocks, vendor lead time), etc…
* Act as lead for Plant Purchasing (including issuance of site purchase orders in both Maximo(front for SAP) and Ariba, maintenance of price/quantity changes, and vendor maintenance).
* Ensure all processes and systems comply with safety, quality, and finance procedures.
* Lead and develop warehouse team members, including annual goal setting and performance reviews.
* Be the site subject matter expert for the inventory software (Maximo).
* Own the program for parts that get repaired and the kitting of parts used collectively in one job.
* Partner with vendors on vendor management inventory.
* Partner with Engineering and Maintenance teams on part obsolescence.
* Manage operation with defined budget.
* Achieve all applicable key metrics (stockout %, obsolescence %, blocked invoice aging, etc… ).
* Assist with supplier selection.
* Manage SOWs/RFI's/Ordering documents.
* Manage day to day supply issues.
* Communicate pertinent information to both internal customers and suppliers to keep apprised and to prevent problems.
* Drive savings outcomes. Collaboration with functions.
* Seek and support business relationships with diverse suppliers.
* Communicate with appropriate departments to clarify request and obtain appropriate supporting documentation for the purchase using p-card.
* Assure team members are trained and understand duties, responsibilities, and performance against established expectations.
* Provide timely coaching, counseling and feedback.
* Develop all line personnel by securing appropriate training, providing mentoring and assigning progressively challenging stretch responsibilities within the scope of the team and department accountabilities.
* Execution of on time performance reviews for direct reports
You'll be accountable for meeting our compliance standards including FDA, OSHA and Abbott policies and procedures.
Required Qualifications
* Bachelor's degree in accounting, business, science, food technology, engineering or equivalent combination of education and experience
* Demonstrated leadership skills
* Knowledge of project planning tools and experience using them
* Proven plant financial understanding
* Drive Continuous Improvement within the scope of work
Preferred Qualifications
* Previous experience working in a regulated manufacturing work environment with preference being for food, pharmaceuticals, medical devices, cosmetics, etc.
* Experience utilizing project planning and execution tools
* Green Belt Certification
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: **********************
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer and a Military/Veteran friendly Employer, committed to employee diversity.
Connect with us at *************** on Facebook at ************************ and on Twitter @AbbottNews.
The base pay for this position is $61,300.00 - $122,700.00. In specific locations, the pay range may vary from the range posted.
$61.3k-122.7k yearly Auto-Apply 5d ago
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Point of Care Solution Specialist - Hospital Sales - Raleigh, NC
Abbott 4.7
Abbott job in Raleigh, NC
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.JOB DESCRIPTION:
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:
Career development with an international company where you can grow the career you dream of.
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
An excellent retirement savings plan with a high employer contribution
Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
Abbott Point of Care (APOC) is a global leader in providing critical medical diagnostic and data management products for rapid blood analysis that are intuitive, reliable, and cost-effective. Our i-STAT System is an advanced, portable diagnostic tool that provides real-time, lab-quality results within minutes to accelerate patient-care decision-making. The i-STAT System has the industry's most comprehensive menu of tests in a single, with-patient platform, including tests for blood gases, electrolytes, chemistries, coagulation, hematology, glucose, and cardiac markers. By delivering lab-quality results in minutes, our i-STAT System fosters a collaborative, patient-centered environment while driving improved operational performance.
The Opportunity
We are hiring a Point of Care Solutions Specialist in our Abbott Point of Care (APOC) Division selling to hospitals in E. North Carolina. The Point of Care Solution Specialist works independently within an assigned territory leading commercial execution to increase market share and drive sustainable growth. Working in a collaborative environment, the Sales Specialist will partner with internal support team members to identify opportunities and create strategies that move sales cycles forward. The position reports to the District Manager and requires up to 50% travel to provide customer-focused service and effectively support business goals.
What you will work on
Achieve sales targets through efficient and effective sales cycle and territory management.
Maintain sales base while closing new business in both new and existing accounts.
Efficiently navigate complex sales environments with multiple stakeholders and dynamic decision-making criteria, while also building relationships.
Develop and execute sales strategies, while anticipating potential risks and proactively developing and implementing mitigation plans.
Utilize available resources effectively.
Ensure that all administrative tasks (i.e., training modules, expense reports, sales forecasts, etc.) are completed promptly and accurately.
Travel within assigned territory is up to 50% and will provide customer-focused service and effectively support business goals. some regional, overnight travel is required.
Understands and complies with all applicable EHS policies, procedures, and guidelines.
Responsible for implementing and maintaining the effectiveness of the Quality System.
Required Qualifications
Bachelor's degree
4+ years of relevant sales experience or 0-3 years of experience with a Clinical background (BSN, MLT, CLS, RT, Cardiac Tech, etc.)
Must reside in the territory and be able to travel up to 50% in assigned territory and other business locations (as necessary).
Preferred Qualifications
Documented history of being a consistent sales overachiever (i.e., President's Club winner).
Consistently ranks among the top 20% in peer sales group.
Diagnostics, point of care (POC), lab, or capital equipment sales experience.
Has established contacts at IDN's and Hospital Systems within assigned territory.
Possesses strong MS Office (Excel, PowerPoint, and Word) skills.
Highly proficient at using the Salesforce.com, or similar, CRM platform.
Attended multiple sales training courses (e.g., Challenger, Miller Heiman, etc.), and is an active user of one or multiple effective sales methodologies.
Learn more about our benefits that add real value to your life to help you live fully: **********************
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at *************** on Facebook at *********************** and on Twitter @Abbott News and @AbbottGlobal.
The base pay for this position is
$66,700.00 - $133,300.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Sales ForceDIVISION:APOC Point of CareLOCATION:United States of America : RemoteADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:Yes, 50 % of the TimeMEDICAL SURVEILLANCE:NoSIGNIFICANT WORK ACTIVITIES:Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day), Driving a personal auto or company car or truck, or a powered piece of material handling equipment Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: ************************************************************ EEO is the Law link - Espanol: ************************************************************
$66.7k-133.3k yearly Auto-Apply 31d 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
SummaryJob Description
We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of healthâ„¢ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us.
The Project Manager, Solution Deployment provides direct oversight and management of projects within the RxA business within BD's Pharmacy Automation portfolio, including new product installations, customer-to-customer sales, relocations, removals, upgrades, conversions, inspections, and training. Customers include health systems, independent retailers, institutional facilities, and retail chains. These projects are complex and require strong cross-functional leadership to ensure successful outcomes and positive customer experiences.
The Project Manager will lead implementations for vial-filling product lines, pouch and blister packaging solutions, pouch inspection devices, inventory management and workflow solutions, software platforms, and other product lines as needed. Occasional cross-training with other solutions and platforms, such as the Dispensing business, may be required.
This role is responsible for managing all aspects of implementation and service projects for the RxA business. The Project Manager collaborates with customers and leads implementation teams in planning, scheduling, and executing all deliverables within the defined project scope.
**Home-based position with regional travel. Candidate can be located anywhere in the US.
Job responsibilities:
Lead and Coordinate Projects: Drive day-to-day activities to ensure projects are completed on time, within scope, and aligned with organizational goals, departmental policies, and contractual terms.
Develop and Manage Project Plans: Create and maintain detailed project plans with clear milestones, timelines, and task assignments.
Scope and Risk Management:
Effectively manage project scope, prioritize customer needs, and escalate issues or risks as appropriate.
Proactively identify potential risks to project success and develop effective action plans to mitigate or resolve them.
Customer Engagement:
Maintain clear, professional, and consistent communication with customers to ensure engagement and alignment throughout the project lifecycle.
Handle customer expectations for products and services, ensuring satisfaction.
Governance and Compliance: Utilize governance tools (scope documents, status reports, risk/change logs, tollgates) to maintain control and transparency.
Revenue Forecasting: Accurately forecast current and future quarterly revenue for assigned projects and maintain alignment with backlog management processes.
Cross-Functional Collaboration: Work effectively across multiple departments (e.g., CSC, Sales, Finance) and participate in pre-sales activities when required.
Team Leadership: Provide coaching, mentoring, and training to project teams and peers; contribute constructive feedback through peer reviews.
Project Closure: Ensure complete project closure, including customer acknowledgment, equipment reconciliation, and transition to Service & Support and CSM teams.
Professional Competence:
Apply industry-recognized project management methodologies to ensure structured and efficient project execution.
Demonstrate strong professional and interpersonal skills to lead projects effectively and foster collaboration among stakeholders.
Education and Experience required:
Bachelor's degree, or a combination of relevant experience and education will be considered.
3 years of professional experience implementing and supporting healthcare IT software solutions, including proven experience in project management and leading medium to large-scale projects.
Knowledge and Skills required:
Demonstrated ability to lead and build effective project teams, including matrixed staff, using servant leadership principles.
Expertise in managing complex projects with significant impact on customer workflows, including multi-site implementations.
Strong leadership, interpersonal, and customer-facing skills to build trust and maintain engagement.
Effective verbal and written communication skills to engage customers, project teams, and leadership professionally.
Proficiency in forecasting, backlog management, and driving cross-functional collaboration.
Ability to proactively identify risks and develop actionable mitigation plans.
In-depth knowledge of industry-recognized project management methodologies and best practices.
Strong understanding of healthcare IT operations and implementation governance processes, including scope management, tollgates, and risk/change management.
Skilled in negotiation, conflict resolution, and decision-making with a customer-focused approach.
Demonstrated growth mindset, adaptability, and professional soft skills essential for success in dynamic environments.
Proficient with MS Office suite Word, Excel, Outlook, Teams, etc.
Must possess and maintain a valid driver's license and a past clean driving record for a minimum of 3 years, as well as meet BD's auto safety stand
Ability to travel up to 20% with the flexibility to work some nights and weekends as needed.
Preferred qualifications:
Specific knowledge of BD RxA or BD Dispensing Business.
Experience with medication management or pharmacy automation workflows.
Familiarity with hospital systems and procedures that integrate with BD products.
Understanding of supply chain dynamics and capital equipment models.
Salesforce, CRM, and SAP experience (preferred).
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit **********************
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.
Required Skills
Optional Skills
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Primary Work LocationUSA NC - Durham - Roche DriveAdditional LocationsWork Shift
$88k-117k yearly est. Auto-Apply 9d ago
Principal Clinical Specialist
Abbott Laboratories 4.7
Abbott Laboratories job in Raleigh, NC
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
Principal Clinical Specialist
About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to:
* Career development with an international company where you can grow the career you dream of.
* Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
* An excellent retirement savings plan with high employer contribution.
* Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
* A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
* A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
In Abbott's Electrophysiology (EP) business, we're advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.
What You'll Work On
Working under limited supervision, provides advanced engineering, sales, educational and technical support in response to more complex field inquiries from physicians, health care professionals, patients, and field sales staff, involving EP products. Performs work that involves a high degree of independence and will be perceived as a proven leader/mentor in the region. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises independent judgment in planning, organizing and performing work; monitors performance and reports status to manager. Technical proficiencies and performance are at the highest level of all Clinical Specialists in the region.
* Acts as the most senior clinical interface between the medical community and business.
* Demonstrates ability to build and sustain credible business relationships with customers and shares product expertise accordingly.
* Identifies reports and advises of customer needs, product performance and potential sales opportunities to sales representatives / directors and/or management to influence sales growth and service of accounts.
* Provides engineering, sales, education and clinical support in response to the most complex field inquiries on a 24-hour, on-call basis. Demonstrates a thorough command of all EP products, related product and technical knowledge, trends and players.
* Develops, leads and/or facilitates trainings and other programs on EP products to healthcare professionals
* Provides insight, guidance, and feedback to management on market feedback and components of next generation of products
* Provides regional EP implant case coverage to defined accounts, and the accounts typically have EP share higher than national average.
* Provides additional back-up support to EP Sales Representatives in the following areas:
* Sales support;
* Regional training seminars;
* Clinical studies/data collection;
* Trouble Shooting; and,
* New product in-service training to physicians, nurses and sales representatives.
* Mentors and provides leadership to EP clinical support roles.
* Continuously develops engineering, sales and technical skills relative to the overall Arrhythmia Management strategy, including learning opportunities via Sr. Sales personnel and management.
* Assists Training and Education departments with advanced educational seminars, and the preparation of educational materials.
* Assists Sales with advanced product demonstrations to visiting physicians and sales personnel.
* Remains current on developments in field(s) of expertise, regulatory requirements, and a good working knowledge of company and competitor products, markets, and objectives as well as industry trends.
* Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence.
* Performs related functions and responsibilities, on occasion, as assigned.
Required Qualifications
* Minimum of 6 years of clinical experience (internal or external).
* Prior industry/competitive experience, if external.
* Solely dedicated to EP.
* Must be in Sr. EP CS role for 2 years.
* 1 of last 2 performance ratings must be exceeds expectations.
* IBHRE EP certified.
* Ability to perform the most complex EP cases solo.
* Ability to mentor and train EP CS roles and CA CS roles on complex mapping cases.
* Ability to conduct complex customer education events to sell the value proposition of the full ABT portfolio.
* Revenue/case higher than national average.
* Performs in top 1/2 of number of cases completed across clinical group at time of promotion in defined Region/Area.
* Verification that you will satisfy all vendor credentialing requirements, which may include vaccination for COVID-19. If you require a medical or religious accommodation from these requirements or if you would like to understand more about these requirements, please advise HR so that we can provide additional information and if needed, we can explore any needed accommodation(s).
Apply Now
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: **********************
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at *************** on Facebook at *********************** and on Twitter @AbbottNews and @AbbottGlobal.
and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is $86,700.00 - $173,300.00. In specific locations, the pay range may vary from the range posted.
$86.7k-173.3k yearly Auto-Apply 38d ago
Associate Manufacturing (Day Shift)
Amgen 4.8
Holly Springs, NC job
Career CategoryManufacturingJob Description
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.
.
Salary Range
75,618.00 USD - 89,473.00 USD
$26k-35k yearly est. Auto-Apply 10d ago
Manufacturing Procurement Site Lead
Amgen 4.8
Holly Springs, NC job
Career CategoryProcurementJob 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.
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.
.
Salary Range
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$145.2k-170.8k yearly Auto-Apply 60d+ ago
Process Development Senior Associate I
Amgen 4.8
Holly Springs, NC job
Career CategoryScientificJob 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.
Process Development Senior Associate
What you will do
Let's do this. Let's change the world. In this vital role you will work in a team environment to contribute to drug substance process development
Execute mammalian cell culture experiments at different scales in shake flasks and bioreactors
Execute purification experiments, mainly filtration and chromatography, at bench and pilot scale as needed
Document experimental data in lab notebooks
Communicate findings through oral presentations and written documentation (technical reports as well as GMP documents to support regulatory filings)
Contribute to technology development projects to seek continuous improvement in reliability and efficiency
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The scientist professional we seek is a self-starter with these qualifications.
Basic Qualifications:
High school diploma / GED and 6 years of life sciences industry experience OR
Associate's degree and 4 years of Quality Control experience OR
Bachelor's degree and 2 years of Quality Control experience OR
Master's degree
Preferred Qualifications:
Degree in Chemical Engineering, Biochemistry, Biotechnology, Bioengineering, Biomedical engineering, or Bioprocessing field or relevant experience in the pharmaceutical or related industry preferred.
Relevant hands-on lab experience in cell culture or protein purification.
Proven ability to identify and tackle problems by applying scientific and engineering principles, preferably in a process development environment
Experience in Design of Experiments and statistical analysis is a plus.
Good oral and written communication skills.
Strong communication and interpersonal skills, and the ability to work flexibly in a dynamic and collaborative environment with diverse team members
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
86,613.00 USD - 104,742.00 USD
$68k-82k yearly est. Auto-Apply 10d 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. 10d ago
Senior Production Scheduler, CVRM (Holly Springs)
Genentech 4.5
Holly Springs, NC job
** Pharma Technical Manufacturing (PTM) is responsible for managing all aspects of end-to-end drug substance and drug product manufacturing and supply. From the raw material to the final medicine, we contribute to deliver Roche's ground-breaking therapies to more than 120 million patients around the world. We make our medicines at 9 sites around the world and coordinate all aspects of production of Roche medicines in all disease areas and dosage forms.
To ensure readiness for a step-change in the standard of care that Roche delivers in the area of Cardiovascular, Renal and Metabolism (CVRM), PTM will construct a new manufacturing site in the U.S. in Holly Spring, North Carolina. The new site will focus on large volume low cost Drug Product manufacturing (Component Prep & Compounding, Liquid PFS Filling, Automated Inspection, Autoinjector Assembly, Packaging/Finished Products).
**The Opportunity**
We're looking for a highly skilled Master Production Scheduler/Senior Production Scheduler to join our team. In this role, you'll be responsible for developing and maintaining the master production schedule, ensuring we meet customer demand while optimizing our production resources. You'll be a key player in our supply chain, bridging the gap between sales, operations, and procurement.
As part of plant start-up you will act as the Materials Management PLAN main functional contact for the SAP ERP deployment; responsible for the timeline, deliverables, and adherence to the global template processes.
Initially, you will perform a mix of remote and onsite work (first at the General Planner's office, later at construction site/plant). You will transition to local full time on-site work once the site buildings are built and equipment delivered. Travel of up to 30% of the time is expected during the project phase.
+ You will create and maintain a feasible Master Production Schedule (MPS) for key finished goods and components, balancing customer demand with production capacity. Use inputs from the sales forecast, customer orders, and inventory targets to drive the schedule.
+ You will assess and manage production capacity, identifying and resolving any bottlenecks. Work closely with production managers to ensure the MPS is achievable.
+ You will partner with the procurement team to ensure timely availability of raw materials and components needed for production. Monitor inventory levels and adjust the MPS as needed to prevent stockouts or excessive inventory.
+ You will utilize SAP S/4HANA for planning and execution, and OMP for advanced planning and scheduling. You'll need to be proficient in these systems, generating reports, analyzing data, and making informed decisions.
+ You will serve as the primary liaison between sales, operations, finance, and procurement. You'll communicate changes to the schedule, manage expectations, and facilitate a smooth production flow.
+ You will monitor and report on key performance indicators (KPIs) such as production attainment, schedule adherence, and inventory accuracy. Use this data to identify areas for continuous improvement.
+ You will apply standard APICS (Association for Supply Chain Management) principles and best practices in all aspects of master scheduling. A strong understanding of planning, scheduling, and inventory management concepts is essential.
+ You will lead site function activities for SAP deployment fit-to-template, design, test, SOP development, go-live, and hypercare
**Who You Are**
You hold a Bachelor's degree in Supply Chain Management, Operations, Business, or a related field with 8-10 years in a master production scheduler or similar supply chain planning role..
+ You have proven experience with ERP planning processes and software (eg. SAP S/4HANA and OMP) is required.
+ You have strong analytical and problem-solving abilities, with the capacity to analyze complex data and make data-driven decisions.
+ You have excellent communication and interpersonal skills, with the ability to effectively collaborate with various teams and stakeholders.
Preferred
+ You have a CPIM (Certified in Planning and Inventory Management) or CSCP (Certified Supply Chain Professional) certification
+ You have an advanced degree (eg. Masters, MBA)
+ You have experience with the implementation of large scale ERP projects a plus
The expected salary range for this position based on the primary location for this position of Holly Springs, North Carolina $91,070 - $169,130. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. Relocation benefits are provided.
Link to Benefits (****************************************************
Relocation benefits are provided
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants (***************************************************************************************************** .
$60k-74k yearly est. 60d+ ago
Director/Senior Director, Global Process Owner - Sterility Assurance QMS
Eli Lilly and Company 4.6
Raleigh, NC job
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Company Overview:
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Organization Overview:
Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is working to build a stronger Sterility Assurance function and capability to provide increased technical capacity across the network.
Position Brand Description:
The Director/Senior Director, Global Process Owner for Sterility Assurance, as a leader within the Technical Service, Manufacturing Sciences, Sterility Assurance team, will establish and maintain the global quality system procedural requirements for a Level 2 Process related to Aseptic Processing controls inclusive of Aseptic Process Simulations, Barrier System Management, Cleaning and Disinfection, Aseptic Technique, and Aseptic Training. They will provide strategic oversight and expertise for global Aseptic Processing Programs, including Quality Management System Sterility Assurance standards, practices, business processes, implementation tools and associated IT systems. Additionally, the Global Process Owner will lead an Aseptic Processing Program Community of Practice, including Global Process Leads and Area Process Owners. They will lead key global projects and priorities within the Sterility Assurance Level 1 Program.
The Global Process Owner will consult with Lilly manufacturing facilities, Global and Site Quality and other functions to educate on the Sterility Assurance program requirements, and proactively ensure compliance of the Lilly Sterility Assurance program with various country agency standards, industry trends and scientific principles.
Key Objectives/Deliverables
The Director/Senior Director, Global Process Owner for Sterility Assurance Level 2 Processes is responsible to:
* Establish and maintain the global quality system for Aseptic Processing Programs to drive standardization globally.
* Own the Global Standards, Processes, Practices, Trainings, and implementation tools and ensure they are designed according to regulatory, industry and company expectations.
* Provide governance, lead the implementations of improvement initiatives and foster a robust compliance mindset.
* Ensure processes are executed consistently across the organization and monitor signals to drive continuous improvement.
* Act as the leader and SME to ensure supporting IT applications and analytical tools are configured and maintained to support the business needs and facilitates accurate reporting and analytics.
* Define a common set of global effectiveness and efficiency metrics to drive end-to-end performance.
* Monitor performance metrics, report and provide insights to inform decision making to drive further improvements.
* Develop, lead, mentor and maintain a community of cross-functional SMEs to collaborate on proposed improvements and deepen the knowledge of the associated processes & tools.
* Actively collaborate with enterprise-wide teams on standardized global business processes.
* As the subject matter expert, ensure inspection readiness, directly interact with Health Authorities during inspections and draft responses to observations as needed.
* Actively engage in external organizations and industry organizations to monitor policy changes for regulatory / external environments and advocate / influence quality related policies and regulatory requirements related to Aseptic Processing requirements inclusive of Aseptic Process Simulations, Aseptic Technique and Barrier system (e.g. Isolators/RABs) management.
* Provide overall guidance and leadership as related to Aseptic Process Simulation Program Design and Implementation, Aseptic Controls and Practices including Cleaning & Disinfection, Barrier System Controls, and Aseptic Technique
Basic Requirements:
* 10+ years' experience in the pharmaceutical industry in roles across commercial manufacturing and or quality in a manufacturing, validation, and/or Quality roles supporting aseptic product manufacturing
* 7+ years' experience in parenteral manufacturing sterility assurance control systems - development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment.
* Bachelor's degree in Natural Science, Engineering, Pharmacy, or other Life Science-related field.
* Candidate will have previous experience implementing and leading global Sterility Assurance programs which can include Aseptic Training, Aseptic Process Simulations, and Isolator Controls and Management.
* Strong technical understanding of sterility assurance, from a science and compliance perspective. Current in technological and compliance developments across the parenteral manufacturing industry (e.g. filling technology, contamination control, Annex 1 interpretation)
* Strong written and oral communication skills
* Understanding of cGMP's, policies, procedures, and guidelines relating to sterility assurance
* Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals
* Approximately 25% travel
Additional Preferences:
* Proven ability to work in a matrixed organization leading diverse teams and influencing areas not under direct control.
* Experience leading a major multi-site or global functions improvement initiative.
* Strong strategic thinking capability with a focus on the ability to execute strategic decisions while balancing conflicting priorities.
* Proficiency in addressing operational challenges through structured approaches and innovative solutions.
* Ability to drive process improvements and strategic decisions by analyzing and interpreting complex data.
* Demonstrated change agility in anticipating and leading others through change and ambiguity.
* Excellent teamwork, interpersonal, and communication skills, with the ability to communicate and collaborate at all levels through various formats.
* Expertise in developing scalable and standardized processes across global operations to improve efficiency and reduce complexity.
* Demonstrated influential leadership expertise and experience engaging with senior-level functional leads.
* Strong leadership capability to make and act on decisions while balancing speed, quality, and risk to deliver value-added business results.
* Strong capabilities in establishing governance structures and proactively addressing quality and regulatory risks.
* Demonstrated people management experience.
* Expertise in navigating and ensuring adherence to global regulatory standards and frameworks.
* Experience leading a major multisite improvement initiative or driving multisite standardization.
* Prior demonstrated experience managing aseptic processing programs including global procedural requirements and training.
* Work closely with senior technical staff in the parenteral network TSMS group to provide full oversight to new and existing facilities. Be available to help with inspection readiness and inspection preparation at each site, particularly the new sites. Provide guidance to investigations and ensure root cause, CAPA are quickly developed.
* Support the establishment of a sterility assurance network or hub in global TSMS
* Support inspection preparation and execution during health authority on-site or remote inspection as an expert in Sterility Assurance
Education Requirements:
BS/MS in a biological science (or equivalent work experience) or engineering discipline (Microbiology-preferred, Biology, Chemistry, Mechanical Engineering, Biomedical Engineering, etc.), preferably Microbiology.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$151,500 - $264,000
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
$151.5k-264k yearly Auto-Apply 60d+ ago
Senior Associate Maintenance Planner
Amgen 4.8
Holly Springs, NC job
Career CategoryMaintenanceJob 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.
Sr 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!
During Construction Phase:
System Owner responsibilities for facilities and utilities infrastructure systems including Building Shell & Core, Fire Protection & Suppression, Fire Alarm, Domestic Water, Sewer, etc.
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
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
Post-Construction Completion and Continued Operations:
System Owner responsibilities for key facilities and utilities systems including, but not limited to: Building Shell & Core, Fire Protection & Suppression, Domestic Water, Sewer, etc.
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
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
Assist with Procurement and Invoicing for the department
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.
.
Salary Range
-
$73k-95k yearly est. Auto-Apply 9d ago
Senior Instrument Technician
Amgen 4.8
Holly Springs, NC job
Career CategoryMaintenanceJob 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 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.
.
Salary Range
89,926.00 USD - 111,678.00 USD
$89k-117k yearly est. Auto-Apply 4d ago
Senior Manager Quality Assurance - Incoming Quality Raw Materials /Disposition
Amgen 4.8
Holly Springs, NC job
Career CategoryQualityJob Description
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.
.
Salary Range
154,692.00 USD - 188,725.00 USD
$102k-132k yearly est. Auto-Apply 10d ago
Specialist Manufacturing: NPI, 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 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.
Specialist Manufacturing: NPI, 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 downstream 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 downstream 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).
Downstream 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 Downstream 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 Downstream GMP manufacturing operations
Strong technical knowledge of drug substance processing (harvest, chromatography, filtration, buffer preparation) 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 56d ago
Associate Principal, Business Analyst
Astrazeneca 4.6
Durham, NC job
Are you ready to play a pivotal role in transforming demand forecasting within BioPharma ClinOps? As an Associate Principal, Business Analyst, you'll be at the forefront of developing, testing, and implementing FTE demand algorithms using PLANIT, our enterprise project management tool. Collaborate closely with stakeholders across BioPharma ClinOps to ensure alignment with organizational productivity initiatives and drive impactful changes in ways of working.
Accountabilities:
In this dynamic role, you'll deliver value by managing the BAU process for ongoing review and refinement of functional FTE demand algorithms. You'll develop and manage a roadmap of planned deliveries, ensuring alignment with scorecard objectives and functional needs. Your expertise will ensure that FTE BioPharma ClinOps demand in PLANIT (PLANISWARE Enterprise project management tool), aligns with the current organizational structure and is driven by reliable forecast algorithms. You'll also ensure the impact of productivity initiatives is realized in our demand forecasting, while delivering documentation, communication, and training to support ongoing changes.
Essential Skills/Experience:
University degree at Bachelor level, in a scientific or business discipline
5-10 years of project/portfolio/resource management, in a Clinical Development environment
Broad drug development experience in a matrix environment
Minimum 5 years of working experience and understanding of business planning and capacity management process
Ability to look for and champion more efficient and effective methods/processes
Goal oriented and ability to drive performance
Experience in converting organizational needs into demand algorithms
Experience in developing demand algorithms for Clinical Development
Strong data modelling skills and the ability to transform data into forms easily understood by others
The ability to balance tact, patience and persistence with the need to move improvements at speed
Strong organizational skills to move multiple functions through the improvement processes at different speeds based upon their level of understanding and complexity of their business
Expert knowledge of PLANIT (PLANISWARE Enterprise project management tool), and demand algorithms
Desirable Skills/Experience:
Advanced degree
Business relationship management skills
Accredited/Certified in Project Management tools/systems
Proven ability with enterprise project management systems
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
At AstraZeneca, you'll be part of a team that tackles complex challenges head-on, empowered to innovate and experiment. With access to extensive capabilities and a comprehensive pipeline, you'll engage in diverse projects across the drug development process. Our supportive yet challenging environment fosters continuous learning and improvement, driving us towards groundbreaking solutions that make a tangible difference in patients' lives.
Ready to take on this exciting challenge? Apply now and be part of our journey to transform healthcare!
Date Posted
02-Jan-2026
Closing Date
30-Jan-2026
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
$120k-148k yearly est. Auto-Apply 52d 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
**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 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.
$88k-108k 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. 1d ago
Principal Clinical Specialist
Abbott 4.7
Abbott job in Raleigh, NC
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.JOB DESCRIPTION:
Principal Clinical Specialist
About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to:
Career development with an international company where you can grow the career you dream of.
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
An excellent retirement savings plan with high employer contribution.
Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
In Abbott's Electrophysiology (EP) business, we're advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.
What You'll Work On
Working under limited supervision, provides advanced engineering, sales, educational and technical support in response to more complex field inquiries from physicians, health care professionals, patients, and field sales staff, involving EP products. Performs work that involves a high degree of independence and will be perceived as a proven leader/mentor in the region. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises independent judgment in planning, organizing and performing work; monitors performance and reports status to manager. Technical proficiencies and performance are at the highest level of all Clinical Specialists in the region.
Acts as the most senior clinical interface between the medical community and business.
Demonstrates ability to build and sustain credible business relationships with customers and shares product expertise accordingly.
Identifies reports and advises of customer needs, product performance and potential sales opportunities to sales representatives / directors and/or management to influence sales growth and service of accounts.
Provides engineering, sales, education and clinical support in response to the most complex field inquiries on a 24-hour, on-call basis. Demonstrates a thorough command of all EP products, related product and technical knowledge, trends and players.
Develops, leads and/or facilitates trainings and other programs on EP products to healthcare professionals
Provides insight, guidance, and feedback to management on market feedback and components of next generation of products
Provides regional EP implant case coverage to defined accounts, and the accounts typically have EP share higher than national average.
Provides additional back-up support to EP Sales Representatives in the following areas:
Sales support;
Regional training seminars;
Clinical studies/data collection;
Trouble Shooting; and,
New product in-service training to physicians, nurses and sales representatives.
Mentors and provides leadership to EP clinical support roles.
Continuously develops engineering, sales and technical skills relative to the overall Arrhythmia Management strategy, including learning opportunities via Sr. Sales personnel and management.
Assists Training and Education departments with advanced educational seminars, and the preparation of educational materials.
Assists Sales with advanced product demonstrations to visiting physicians and sales personnel.
Remains current on developments in field(s) of expertise, regulatory requirements, and a good working knowledge of company and competitor products, markets, and objectives as well as industry trends.
Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence.
Performs related functions and responsibilities, on occasion, as assigned.
Required Qualifications
Minimum of 6 years of clinical experience (internal or external).
Prior industry/competitive experience, if external.
Solely dedicated to EP.
Must be in Sr. EP CS role for 2 years.
1 of last 2 performance ratings must be exceeds expectations.
IBHRE EP certified.
Ability to perform the most complex EP cases solo.
Ability to mentor and train EP CS roles and CA CS roles on complex mapping cases.
Ability to conduct complex customer education events to sell the value proposition of the full ABT portfolio.
Revenue/case higher than national average.
Performs in top 1/2 of number of cases completed across clinical group at time of promotion in defined Region/Area.
Verification that you will satisfy all vendor credentialing requirements, which may include vaccination for COVID-19. If you require a medical or religious accommodation from these requirements or if you would like to understand more about these requirements, please advise HR so that we can provide additional information and if needed, we can explore any needed accommodation(s).
Apply Now
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: **********************
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
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The base pay for this position is
$85,300.00 - $170,700.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Support ServicesDIVISION:EP ElectrophysiologyLOCATION:United States of America : RemoteADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:Yes, 50 % of the TimeMEDICAL SURVEILLANCE:YesSIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Driving a personal auto or company car or truck, or a powered piece of material handling equipment Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: ************************************************************ EEO is the Law link - Espanol: ************************************************************