Biotechnologist III Upstream

Purpose:

• Performs functions associated with cGMP manufacturing operations for the Manufacture of clinical and bulk drug substance per safety regulatory and operational requirements
• Uses sophisticated programs (such as LIMS SAP automated control systems etc. for executing and monitoring operations
• Complete batch documentation accurately and thoroughly while adhering to the required quality and safety standards and in a productive costeffective manner.

Key Responsibilities:

Operations & Technical

• Adhere to cGMP and safety requirements
• Ensure good housekeeping of associated production facilities so that they are kept in good operational order
• Identify areas for improvement and participate in continuous improvement projects to enhance operational effectiveness and efficiency
• Participate in commissioning and qualification activities as required
• Carry out other related duties as assigned by the Lead or Supervisor
• Assigned as incharge by process/operations area to provide guidance/leadership to ensure processes are completed reliably

Training & Development

• Ensure that he/she is trained/qualified in the current effective SOP and OJT in accordance with the assigned training curricula prior to commencing operation.
• Proactively engage N1 to discuss personal development and follow up on agreed development plan.
• To provide guidance and support to new joiner ensuring his/her smooth transition to the new environment
• To develop oneself as a process SME
• Guide junior employees to ensure knowledge transfer for business continuity.
• Conduct classroom and onthejob (OJT) training as assigned.

Quality

• Comply with all relevant SOP/Batch record requirements.
• Perform timely review of documentation and make necessary corrections.
• Have good quality mindset and integrity to ensure products are manufactured with the highest quality
• Participate in deviation investigation process (Process Environmental Maintenance/Equipment QC) and implementation of Corrective and Preventive Action (CAPA)
• Participate in cGMP selfinspections to ensure compliance with internal SOPs and regulatory requirements

Reporting & Documentation

• Operate key computer applications related to production function
• Ensure that batch record checklist and logbooks are correctly recorded cGMP complied and maintained
• Maintain clear communication with N1 and fellow colleagues providing clear feedback of any items pertaining to safety quality and efficiency
• Participation in development and generation of production checklist SOPs validation protocols and the regular review and updates of these documents
• Perform VS review of completed documentation to ensure adherence to GDP
• To lead design/drafting of working instruction to ensure that it is user friendly to improve GDP 

Technical Transfer

• Participate in new technology and/or new process transfer

Security/Safety/Environment

• Awareness and adherence to site safety procedure.
• Ensure safe operations on the field
• Identify and report all potential safety issues (personal protection requirement equipment protection way of working etc).
• Ensure proper housekeeping of assigned production areas to minimize safety hazards
• Participate in Safety Inspections
• Participate in Workplace Risk Assessment

Interface with crossfunctional teams

• Coordination with department colleagues to ensure timely supplies of materials and buffers calibration/maintenance activities are supported.
• Open communication on sampling requirements to QC department
• Establish good working relationship with QA QC maintenance calibration to ensure smooth operations.

Qualifications :

• Bachelors Degree in Science Engineering or equivalent 
• Up to 3 years of relevant experience working in Biologics Production facility 
• Proven problemsolving skills and the ability to adapt to new requirements
• Strong working knowledge of Microsoft and other software packages SAP LIMS Atlas systems preferred 
• Experience with cGMP documentation and record maintenance preferred 
• Excellent attitude towards work and keen willingness to learn and perform handson work 
• Excellent team player with strong troubleshooting and analytical skills 
• Willingness and ability to perform shift work required

Additional Information :

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion.  It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.

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Work :

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