Senior Manager Manufacturing

Amneal Pharmaceuticals LLC; Ahmedabad District; Presencial; INR 2.500.000 - 4.000.000; Jornada completa

Descripción de la vacante

Amneal Pharmaceuticals LLC in Ahmedabad seeks a senior professional to lead upstream and downstream mammalian cell culture operations, ensuring robust manufacturing and process validation.

The role requires extensive hands-on experience with bioreactors, chromatography, TFF, virus filtration, and QMS/SOP processes to support batch manufacturing.

Formación

• Education: Life science graduate or postgraduate (MSc/BE/BTech/MTech (Biotechnology/Microbiology))
• 15–18 years of experience in mammalian/cell culture process development/manufacturing
• Experience in upstream and downstream manufacturing operations
• Hands-on exposure to bioreactors, TFF, chromatography and virus filtration

Responsabilidades

• Responsible for Upstream Process for Mammalian/Cell culture.
• Should have exposure to Cell Culture techniques such as Single use Bioreactors, shake flasks and perfusion technology.
• Lab equipment handling such as microscope, cell counter, osmometer and biochemical analyzer.
• SOP preparation, QMS, Qualification and validation of equipment in the initial stage and then responsible for Batch manufacturing.
• Handling the entire Suite manufacturing Operations
• Responsible for Downstream Process for Mammalian/Cell culture.
• Should have exposure to Protein purification Techniques like chromatography, TFF and virus filtration.
• Handling of Chromatography systems (Cytiva/Sartorius).
• Performed Column Packing/Unpacking & Column Qualification.
• New Equipment introduction & Suite qualification.
• Preparation of QRM, change control, SOP preparation, Vendor and CFT follow up for Introduction and qualification of downstream equipment’s.
• Handling the entire Suite manufacturing Operations

Conocimientos

Upstream cell culture

Bioreactors

Chromatography

TFF

Virus filtration

SOP drafting

Equipment validation

QMS

Educación

Life science degree (BSc/MSc/BE/BTech/MTech)

Herramientas

Cytiva/Sartorius systems

Descripción del empleo

Job Description

Following are the Details of the Job.

• Education: Life science Graduate / Postgraduate ( M.Sc./B.E./B.Tech/M.Tech (Biotechnology/Microbiology)
• Total Years of Experience: 15 - 18 Years
• Job Location: Ahmedabad

Departments Are As Follows

Upstream

• Responsible for Upstream Process for Mammalian/Cell culture.
• Should have exposure on various Cell Culture techniques such as Single use Bioreactors, shake flasks and perfusion technology.
• Lab equipment handling such microscope, cell counter, osmometer and biochemical analyzer.
• SOP preparation ,QMS, Qualification and validation of equipment in the initial stage and then responsible for Batch manufacturing.
• Handling the entire Suite manufacturing Operations

Downstream

• Responsible for Downstream Process for Mammalian/Cell culture.
• Should have exposure to Protein purification Techniques like chromatography, TFF and virus filtration.
• Handling of Chromatography systems (Cytiva/Sartorius).
• Performed Column Packing/Unpacking & Column Qualification.
• New Equipment introduction & Suite qualification.
• Preparation of QRM, change control, SOP preparation, Vendor and CFT follow up for Introduction and qualification of downstream equipment’s.
• Handling the entire Suite manufacturing Operations

Qualifications

Education: Life science Graduate / Postgraduate ( M.Sc./B.E./B.Tech/M.Tech (Biotechnology/Microbiology)

Requirements: