What are the responsibilities and job description for the Senior Associate Manufacturing - Training position at BioSpace?
HOW MIGHT YOU DEFY IMAGINATION?
If you feel likeyourepart of something bigger,itsbecause you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, anddeliveringever-better products that reach over10 million patientsworldwide.Itstime for a career you can be proud of.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the AmgenFleXbatch facility will combine the latest insingle usetechnologies with traditionalstainless-steelequipment to allow for maximum flexibility in operations.TheFleXBatch 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 AssociateManufacturing- Training
Live
What Youwill Do
Letsdo this.Letschange the world. In this vital role, you will be a key member of the team thatdevelops andfacilitatestrainingand the Human and Organizational Performance(HOP)philosophyin the Amgen North Carolina Biologics Drug Substance Manufacturing plant.We are looking for a talented Manufacturingteam memberto help deliver opportunities for reliability, efficiency,agilityand differentiation for theANCManufacturing plant.
This individual contributor position reports into the Senior Manager of theMFG TechnicalTraining teamand interacts broadly across the site to implement keytrainingand (HOP)deliverables, quality initiatives.This role will focus on supportingmanufacturing training on and off thefloorand supporting investigations whennecessary. The flexibility tosupport all four shifts covering 24/7 operations is a requirement.
What We Expectofyou
We are all different, yet we all use our unique contributions to serve patients. The collaborative investigator weseekhas abiologicsDrug Substance manufacturing andinvestigationsbackground with strong cross-functional project management and communication skills as well as the below qualifications.
Basic Qualifications
High school diploma / GED and 10 years of Manufacturing or Operations experienceOR
Associates degree and 8 years of Manufacturing or Operations experienceOR
Bachelors degree and 4 years of Manufacturing or Operations experienceOR
Masters degree
Preferred Qualifications
What You Can Expectofus
The annual salary range for this opportunity in the U.S. is [HR to input market pay range].
In Addition To The Base Salary, 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
Objects in your future are closer than they appear. Join us.
careers.amgen.com
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 areprovidedreasonable accommodation toparticipatein 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.
#AmgenNorthCarolina
If you feel likeyourepart of something bigger,itsbecause you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, anddeliveringever-better products that reach over10 million patientsworldwide.Itstime for a career you can be proud of.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the AmgenFleXbatch facility will combine the latest insingle usetechnologies with traditionalstainless-steelequipment to allow for maximum flexibility in operations.TheFleXBatch 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 AssociateManufacturing- Training
Live
What Youwill Do
Letsdo this.Letschange the world. In this vital role, you will be a key member of the team thatdevelops andfacilitatestrainingand the Human and Organizational Performance(HOP)philosophyin the Amgen North Carolina Biologics Drug Substance Manufacturing plant.We are looking for a talented Manufacturingteam memberto help deliver opportunities for reliability, efficiency,agilityand differentiation for theANCManufacturing plant.
This individual contributor position reports into the Senior Manager of theMFG TechnicalTraining teamand interacts broadly across the site to implement keytrainingand (HOP)deliverables, quality initiatives.This role will focus on supportingmanufacturing training on and off thefloorand supporting investigations whennecessary. The flexibility tosupport all four shifts covering 24/7 operations is a requirement.
- Supportingthe development and execution of themanufacturingtraining strategy,ensuringoperational readinessandefficienttime tocontribution.
- Providing trainingexpertiseforMFGarea of responsibility(i.e.cell culture,purification,MFG Services).
- Leading and organizing MFG New Hire Orientation,ensuring content is up to date and relevant.
- Performing Job Task Analysison the floortodeterminewherePerformanceSupportingMaterials(SOP updates, videos,one-slide updates etc.)are needed and thencreating Performance Supporting Materials tocreateabest-in-classtrainingprogram.
- Supporting Manufacturingteamsduring complex investigations andchangecontrols.
- Useoperational Learning Team strategies to promote open collaboration with staff to maximizelearningopportunities andinvestigation findings.
- Support annual requalification programs for manufacturing to ensure training compliance.
- MaintainaccurateTrainingAssignmentProfilesand Assignment Vehiclesfor Manufacturing areas.
- Serve as Learning Management System SME andfirststop forquestions from MFGstaffand management about the training program.
- Present complex topics to large and small groups at various levels and quickly understand and clearly communicate complex issues.
- Build effective relationships across functions.
- Navigate through ambiguity and provide a structured problem-solving approach.
What We Expectofyou
We are all different, yet we all use our unique contributions to serve patients. The collaborative investigator weseekhas abiologicsDrug Substance manufacturing andinvestigationsbackground with strong cross-functional project management and communication skills as well as the below qualifications.
Basic Qualifications
High school diploma / GED and 10 years of Manufacturing or Operations experienceOR
Associates degree and 8 years of Manufacturing or Operations experienceOR
Bachelors degree and 4 years of Manufacturing or Operations experienceOR
Masters degree
Preferred Qualifications
- 5 years related work experience (manufacturing, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility
- Experience in training development and facilitation
- Trainingcontentcreationexpertisein systems
- SOP writing& technical writing skills
- Experience working in Learning Management Systems
- Degree in Science or Engineering
- Experience usingQuality Management Systems (i.e.Track Wiseor Veeva)for Deviation investigations and CAPAs
- Demonstrated project management ability
- Experience presenting to inspectors during regulatory inspections and internal audits.
- Excellent written and verbal communication skills
- Ability to work in a team matrix environment and build relationships with partners
- Strong interpersonal skills
What You Can Expectofus
The annual salary range for this opportunity in the U.S. is [HR to input market pay range].
In Addition To The Base Salary, 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
Objects in your future are closer than they appear. Join us.
careers.amgen.com
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 areprovidedreasonable accommodation toparticipatein 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.
#AmgenNorthCarolina