Biological E Ltd Job Vacancy for Assistant General Manager

Qualification & Experience: Post Graduation with 12-18 Yrs experience.

Work Location: Shameerpet - Hyderabad

Division: Pharma SGI

Business: Fermentation APIs

Department: Manufacturing DSP Lead

Designation: Assistant General Manager

Technical Competency:

Handling of Down Stream process for Fermentation APIs mandatory

• Experience in handling various DSP equipment's like

o Gravity & High Pressure column Decentrifugation/ continuous centrifuge operation

o Lyophilizer

• Crystallizer

o 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 heal Manager

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"

Job Availables.Com