Manufacturing Manager (Mfg Support & Doc) - Shire

Job Reference: HH100
Employer/Agency: Shire
Location: Singapore
Experience:
Salary/Package: On application
Job Sector: General Management & Consulting
Date Posted:
Closing Date:

% of Time
Job Function and Description
60%
Leading the Manufacturing Support department including all subgroups (including buffer preparation, equipment preparation, documentation and weighing/dispensing group)
Accountable for manufacturing support day-to-day operations fulfillment of all Quality/ current Good Manufacturing Practice (cGMP) systems and policies
Accountable for shift operations in routine
Manage the release of product by ensuring documents are reviewed, MRP transactions are complete and events/change controls are closed in a timely manner
Responsible to ensure the fulfillment of all legal and EHS requirements during day-to-day operations
To liaise with other departments to ensure smooth operation and fulfillment of production goals
Ensure the continuous improvement of all processes and workflows to enable lean and efficient manufacturing and business processes as well as organizational structure
Inculcate a culture of Right First Time for all manufacturing operations
Ensure that the production and storage fulfills all quality requirements and specifications and is appropriately documented
Ensure that the appropriate controls and approval mechanisms are in place to ensure the fulfillment of all internal and external requirements
Ensure that the appropriate validations are completed and that the production environment and storage areas are controlled and monitored
Review the production schedule and monitor/adjust production output according to demands
20%
Ad-hoc activities including
Responsible for preparation and updating the department goals/ objectives/ budget and fulfillment of the targets
Managing of projects for the department
Manage ownership of common GMP areas
To liaise with other Manufacturing plants to harmonize processes and operations
To represent the department and the plant in all internal and external audits inclusive of maintaining audit readiness
Review and approve required SOPs and documents to ensure compliance
Participate in site or above site initiatives
20%
Team Development and Management
Accountable for the hiring and training of new workforce
Develop the manufacturing support team into a high performing team, ensuring good team dynamics based on efficient and lean operations
Communicate key messages and policies to ensure understanding and alignment
Cultivate a culture that embodies Shire’s principles and site operational goals
Carry out performance reviews and talent reviews
Mentor Senior Manufacturing Supervisors and other team members
Lead teams in creating a culture that embodies the Shire Leadership Behaviors
Ensure team succession is identified, planned and executed
Responsibility to adhere to any applicable EHS requirements.
Commitment to a fair and respectful relationship to others and behavior in accordance with Shire’s Code of Conduct.
Any other duties as assigned by supervisor.
Education in a relevant discipline, preferably in Biomedical Sciences/Chemical Engineering/Bioengineering/Bio-processing related
Possess minimum 7 - 12 years of relevant experience in the biotechnology, pharmaceutical or chemical processing industry.
With at least 5 years of management or leadership experience
Key Skills and Competencies
Leadership experience with management responsibilities
Excellent knowledge of pharmaceutical/biopharmaceutical plant and unit operations
Understanding of manufacturing enterprise systems, electronic batch management and have a broad overview of site level interactions
Knowledge of Lean and/or Six Sigma methodologies
Experience with multi-product operations
Excellent trouble shooting, problem solving and communication skills
Demonstrates high commitment to cGMP, EHS and people development
Good interpersonal skills and ability to work in a team environment
Knowledge of technical and biologics operations
Business acumen
Proven organizational and time management skills
Demonstrates appropriate level of adaptability, maintains positive outlook, and demonstrates composure under pressure.
Able to manage ambiguity and drive for results
Able to work in a matrix environment
Ability to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes
Ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas.

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