Biological E Ltd Job Vacancy For Post Graduate
Qualification & Experience: Post Graduation with 12-18 Yrs experience.
Work Location: Shameerpet-Hyderabad
Division: Pharma SGI
Business: API Fermentation -
Department: Manufacturing DSP Lead
Designation: Assistant General Manager
Technical Competency:
Handling of DSP process for Fermentation APIs Experience in handling various DSP equipment's like
Gravity & High Pressure column
Decentrifugation/ continuous centrifuge operation o Lyophilizer Crystallizer
Rising film evaporators and various others o Solvent Recovery operations
Leads, develop and mentor the DSP/ purification team.
Long and short-term strategic plan for Downstream manufacturing to ensure uninterrupted operations.
Manufacturing of commercial batches of high quality as per its intended use.
Preparation of OPEX budget and plan to in line with approved OPEX. Maintenance of manufacturing facility as per cGMP compliance
To coordinate work with other functions/departments to achieve company set goals.
Additional Requirements:
Experience in start-up of new green field project to project commissioning to commercial production,
Exposure to USFDA/EU GMP Audit.
Build team capabilities for taking Technology Transfer, Scale-up/DMF Validation Batches
manufacturing Set specific goals for self and team. Create specific metrics to measure team performance
Lead team/ Create Quality documents
To assist Facility validation, process validation and equipment qualification complying to
QMS Manufacturing of Exhibit batches for Regulatory approvals.
• All Time readiness for Audits Risk Identification, Risk assessment and Risk mitigation plan of processes
SAFETY
Percolate EHS practices down to his team for the compliance and inculcate culture that
promotes an environment, occupational health and safety (EHS) mind set as well as the
highest standards of quality, integrity and compliance Provide oversight and leadership for process operational excellence and safety.
Interested candidates please share your Profile to kishore.dodda@biologicale.com please mention mail subject as "FDSP-1218"
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