Manager, Manufacturing

1 month ago

Albany, New York, United States Amgen Full time

HOW MIGHT YOU DEFY IMAGINATION?

Youve 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 missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Manager Manufacturing

Live

What you will do

Lets do this. Lets change the world. In this role you will be managing and leading all aspects of either a small manufacturing production area, or a section of a larger production area in a Packaging facility. Responsibility includes maintaining production in full cGMP compliance. Supervises, hires, and develops staff and ensures production schedules are completed in a shift.

Specific responsibilities include but are not limited to:

Compliance:

Evaluate and approve reports and protocols.Ensure cGMP and CFR compliance of operating areas.Revise, update, and review proceduresManage the development and revision of SOPs.Evaluate current operating procedures and recommend changes to management to optimize production.Assure all corporate change control procedures are followed, and Regulatory and QA are made aware prior to the changes.Interact with the FDA.Ensure Amgen policies are followed Process/Equipment/Facilities: Ensure maintenance and re validation of systems.Collaborate with cross-functional teams (i.e. QA/QC, PPIC, Clinical Mfg, PD, Regulatory, etc.) in completing production activities.Develop, implement and assess solutions for problems.Responsible for resolving problems during operation.Coordinates set up of critical new manufacturing processes. Staff Supervision Responsible for selection, training, evaluation, staff relations and development of staff.Ensure training programs are maintainedEnsure scheduling of production and maintenance activities.Interacts with management in optimizing organizational structure and responsibilitiesEnsure plant safety through auditing and evaluations. Administrative: Interacts with management in planning, developing and maintaining budget.Assist in developing and maintaining department goalsWinWhat we expect of you We are all different, yet we all use our outstanding contributions to serve patients. The professional we seek will possess these qualifications. Basic Qualifications:Doctorate degree or Masters degree and 3 years of experience in the pharmaceutical, medical device or biotechnology industryor Bachelors degree and 5 years of experience in the pharmaceutical, medical device or biotechnology Associates degree and 10 years of experience in the pharmaceutical, medical device or biotechnology High School Diploma/GED and 12 years of experience in the pharmaceutical, medical device or biotechnology industry.And In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above Preferred Qualifications:Educational background in Science, Engineering or Business AdministrationAvailability to work on a 12-hour PM shiftStrong Managerial skillsNon-Conformance and CAPAEnsure that all Non-conformance are triage within the established goal.Leadership and team buildingVerbal communicationWritten Communication including technical writing skillsConflict ResolutionAnalytical Problem SolvingProject ManagementCoaching, Mentoring and CounselingAbility to be flexible and manage changeRegulatory requirementsSchedulingPresentation SkillsThriveWhat 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 planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleApply nowfor a career that defies imagination Objects in your future are closer than they appear. Join us. 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.

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