Job Detail

Job Description

JOB PURPOSE:

This person is responsible for coordinating manufacturing activities across 1 BMC,  5 shifts and support departments.  Cross-shift and cross-functional communications will be a daily focus of this position.  Additionally, this person will be responsible for the management of projects and coordination of validation exercises.  This position requires excellent interpersonal skills as well as the ability to multitask, and effectively communicate issues and resolutions to Manufacturing personnel and management.  Thorough understanding of the manufacturing processes and ability to accurately review GMP documentation including validation protocols is required.  This person will also be expected to represent the area manager on teams such as tech. transfer and other inter-departmental teams as well as to provide on-floor supervision to Manufacturing Associates as required.

MAIN ACCOUNTABILITIES:

1. Coordinates manufacturing activities with other departments as well as other sites; provides adjustments to production schedulers and works closely with quality, materials management, manufacturing science, validation, facilities, Process engineering, Maintenance etc,     


2. Co-assist MFG supervisors on floor based on business needs  (working shifts & week end might be required to support occasionally MFg teams)
   Provides input for performance evaluations / career development and goal setting


3. Coordinates CQV activities, ensuring proper and timely execution of validation protocols


4. Works collaboratively as part of either an upstream processing or downstream processing team to provide support and troubleshooting, Identifies continuous improvement projects continually invest in efficiency gains to drive down cost of goods, and oversee their implementation in close collaboration with GTS and process Engineering.


5. Provides support and manufacturing expertise during URS definition and new equipment installation.


6. Ensures cGMP compliance and safety procedures ensuring manufacturing documentation is updated and revised accordingly,


7. Acts as an SME during internal/ external audits


8. Act as deputy for Associate director

Qualifications

EDUCATION REQUIRED:

• Biotech or pharmaceutical BS degree or other relevant educational background from chemical industry, food industry, pharmaceutical or biotech industry.

REQUIRED SKILLS:

• Min. 8 years experience within MFG in Biotech/Pharma environment


• Manufacturing decision-making 


• Highly detailed oriented with excellent documentation skills and exceptional troubleshooting abilities


• Solid knowledge of business and manufacturing processes to support manufacturing operations 


• Solid understanding of the basic QA and cGMP principles 


• Solid understanding of the roles of various functional groups within the company and ability to influence


• Fundamental knowledge of change control, validation  processes


• Solid Project management skills


• Ability to influence audience and demonstrate cross functional leadership