Mgr Manufacturing

Mgr Manufacturing

Reporting to the Director Manufacturing, LC Manufacturing, this position is primarily responsible for the supervision and development of manufacturing staff. In addition, the manager is responsible for dispensing and warehouse operations related to production at AC7, including but not limited to inventory management, material movement, process order generation and fulfillment and batch reconciliation. This includes ensuring dispensing and warehouse operations are safe and maintained in full cGMP compliance through observation and direction.

Specific Responsibilities:
Selection, training, supervision (performance appraisals) and development of 5-7 staff members
Responsible for compliance with cGMP and Safety requirements. Ensures plant/site safety programs and goals are supported
Functional responsibility for dispensing and warehouse equipment, processes and procedures, including but not limited to SAP/WERUM training, and forklift certification/training.
Responsible for material management at AC7, including raw material staging/kitting, miscellaneous order fulfillment, consumables, drug substance movement, and bulk material system transactions.
Ownership of Lock-out/Tag-out program for manufacturing
Ensure schedule adherence for tasks including but not limited to dispensing and area maintenance. Adjust schedule as necessary to accommodate changes and rework.
Ensure staff are fully trained and proficient on tasks performed
Ensure SOPs, batch records and completed documentation are accurate and up to date. This includes timely review of documents and coordination with other organizations to ensure accurate and complete documentation
Investigation and troubleshooting of equipment and the process.
Utilize appropriate systems for job responsibilities (SAP, QMTS, MES/WERUM, MAXIMO, etc)
Interact with internal and external regulatory agencies (FDA, EMEA etc). Primary presenter during walkthrough of the warehouse and dispensing areas.
Interact with various support departments to assist with scheduling of services performed in the warehouse and dispensing areas.
Identification and implementation of process improvements and application of Lean Principles
Managers must ensure that all work is completed in accordance with requirements including but not limited to CFR's, cGMPs, SOPs, Amgen policies and department performance standards.

NOTE: Shift work and weekends may be required

Basic Qualifications
Doctorate degree

OR

Master's degree and 3 years of directly related experience

OR

Bachelor's degree and 5 years of directly related experience

OR

Associate's degree and 10 years of directly related experience

OR

High school diploma / GED and 12 years of directly related experience

AND

Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications
Bachelor's degree in Science or Engineering and 5 years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (i.e. laboratories, engineering, utilities/facilities, quality).
OR
Associate's degree in Science or Engineering and 8 years experience in a biotech/pharma manufacturing or /manufacturing support role (i.e. laboratories, engineering, utilities/facilities, quality)
OR
10 years of directly related experience in a biotech/pharma manufacturing environment
AND
SAP and WERUM system expertise
Strong leadership skills and decision making abilities.
Demonstrated ability to work under minimal direction.
Able to adapt to changing business needs and operational requirements.
Excellent written and verbal communication skills.
Knowledge of applicable regulatory requirements.
Resolve issues and influence across support organizations.
Ability to pull together and interpret a large amount of data.
Development of processes that will support staff and department evaluation and growth.
2+ years of supervisory experience