layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

LAYIQ - Front Line Manufacturing Manager (Bulk Drug Substance - Upstream) - Night Shift at Amgen

Compliance: Ensure safe working environment for all
Ensure Amgen policies are followed, including cGMP and CFR (Code of Federal Regulations) compliance of assigned areas
Evaluate and implement process improvements and optimizations, partnering with Quality, compliance, and EHSS (Environmental, Health, Safety and Sustainability) on change controls
Interact with regulatory agencies as needed
Assure proper gowning and aseptic techniques are followed
Staff Supervision: Responsible for engaging staff and building relationships of trust and respect while driving team performance and continuous improvement
Responsible for selection, training, evaluation, staff relations and staff development
Mentor and coach staff members to live by the Amgen Values
Develop and implement trainings plans and programs, to ensure staff are prepared and compliant
Ensure adherence to production schedule and maintenance activities
Interacts with management in optimizing organizational structure and responsibilities
Ensure plant safety through auditing, evaluations, and cross functional walks
Process/Equipment/Facilities: Demonstrate technical mastery of manufacturing processes
Collaborate with cross-functional teams (i.e., QA/QC, F&E (Facilities & Engineering), PPIC, Mfg, PD (Process Development), Regulatory, etc.) in completing production activities
Develop, implement, and assess CAPAs (Corrective Action Preventive Action) and solutions to complex problems
Responsible for elevating and resolving problems during daily operations
Oversees set up, execution, and completion of critical manufacturing processes/tasks
Administrative: Interacts with management in planning, developing, and maintaining budget
Assist in developing and maintaining department goals
Other functional responsibilities may be assigned
Basic Qualifications
Doctorate degree
OR
Master’s degree and 3 years of Manufacturing and/or operations experience
OR
Bachelor’s degree and 5 years of Manufacturing and/or operations experience
OR
Associate degree and 10 years of Manufacturing and/or operations experience
OR
High school diploma / GED and 12 years of Manufacturing and/or operations experience
AND
Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

Bachelor’s degree in Life Sciences or Engineering
Experience in biotechnology or pharmaceutical plant start up
Basic understanding of upstream and/or downstream operations
Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources
Knowledge and experience within a cGMP or other highly regulated environment
5 years process experience in a cGMP manufacturing facility
3+ years of experience in a production Area Lead, Specialist or Manager role
Strong leadership and teambuilding skills (coaching, mentoring, counseling)
Experience with performance management including performance reviews
Conflict Resolution, analytical problem solving, and project management skills
Thorough understanding of regulatory requirements
Excellent verbal and written communication (technical) skills
Excellent computer skills with Microsoft, EBR/MES, Delta V, Electronic quality systems
Thrive
Some of the vast rewards of working here
As we work to develop treatments that look after others, we also work to care for our teammates’ professional and personal growth and well-being.
Full support and career-development resources to expand your skills, improve your expertise, and improve your potential along your career journey
A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor
Apply now for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
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Front Line Manufacturing Manager (Bulk Drug Substance - Upstream) - Night Shift

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