Manufacturing Manager (Device Assembly & Packaging) - New Albany, OH
Manufacturing Manager (Device Assembly & Packaging) - New Albany, OH
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$ 133764 - 133764
1 Vacancy
Job Description
Our award-winning culture is collaborative innovative and science based. If you have a passion for challenges and the opportunities that lay within them youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Manager Manufacturing- Second Shift (8 hours M-F)
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 an Inspection and Packaging facility. Responsibility includes maintaining production in full cGMP compliance. Supervises hires and develops staff and ensures production schedules are completed.
Specific responsibilities include but are not limited to:
Compliance:
Evaluate and approve reports and protocols.
Ensure cGMP and CFR compliance of manufacturing areas.
Revise update and review procedures
Coordinate the development and revision of SOPs.
Evaluate current manufacturing 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 maintained
Ensure scheduling of production and maintenance activities.
Interacts with management in optimizing organizational structure and responsibilities
Ensure plant safety through auditing and evaluations.
Administrative:
Interacts with management in planning developing and maintaining budget.
Assist in developing and maintaining department goals
Shift:
This position will be supporting Second Shift 2:30pm until approximately 11:00pm. Second shift will start in May/June of 2025 and the incumbent will work a M-F first shift until that time.
Additional Qualifications/Responsibilities
What 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 industry
or
Bachelors degree and 5 years of experience in the pharmaceutical medical device or biotechnology industry.
or
Associates degree and 10 years of experience in the pharmaceutical medical device or biotechnology industry.
or
High School Diploma/GED and 12 years of experience in the pharmaceutical medical device or biotechnology industry.
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 Administration
Availability to work on a third (3rd shift)
Strong Managerial skills
Non-Conformance and CAPA
Ensure that all Non-conformance are triage within the established goal.
Leadership and team building
Verbal communication
Written Communication including technical writing skills
Conflict Resolution
Analytical Problem Solving
Project Management
Coaching Mentoring and Counseling
Ability to be flexible and manage change
Regulatory requirements
Scheduling
Presentation Skills
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 well 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
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
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.
Salary Range
114259.00 USD - 133764.00 USD
Required Experience:
Manager
Employment Type
Full Time
