Sr Executive / Asst Manager

3-8 years

Not Disclosed

Hyderabad

10 Feb. 10, 2025

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Sr. Executive / Assistant Manager - Biologics Production
Experience: 3-8 years
Location: Hyderabad
Employment Type: Full-Time

Company Overview:

Promea Therapeutics Pvt Ltd is dedicated to the manufacturing and production of biologic drugs. We are seeking a Sr. Executive / Assistant Manager for our Biologics Production Department. The ideal candidate will oversee the efficient, compliant production of biologics, ensuring adherence to quality standards, safety regulations, and production schedules.

Job Summary:

The Sr. Executive / Assistant Manager will be responsible for batch planning, execution, and dispatch, supervision of documentation, shift planning, and ensuring compliance with Good Manufacturing Practices (GMP). The role will involve overseeing validation studies, performing risk assessments, troubleshooting equipment, and training staff on GMP processes.

Key Responsibilities:

Batch Planning & Execution:
- Plan and execute batches for biologic production.
- Dispatch drug substances efficiently.
Documentation Supervision:
- Oversee all production-related documentation to ensure accuracy and compliance.
Shift Planning & Manpower:
- Plan shift schedules, manage manpower, and ensure timely material availability.
- Ensure cleanliness of facilities and manage material and personnel movement across the site.
Cross-Functional Coordination:
- Collaborate with cross-functional departments for validation studies.
- Perform risk assessments and root cause analysis.
- Coordinate with the Engineering and Quality Assurance teams for equipment IQ, OQ, and PQ.
Process & Equipment Management:
- Manage change control processes across departments.
- Oversee troubleshooting and breakdown resolution in coordination with respective utilities.
- Supervise reprocessing activities for Albumin and IVIG, ensuring set yields and quality.
Facility Maintenance & Equipment Care:
- Schedule fumigations, CIP of vessels, and preventive maintenance activities.
- Ensure low levels of BET in products and equipment.
- Manage equipment calibrations for Chrom Skid pH & Conductivity meters as required.
Training & Personnel Management:
- Train junior staff on technical aspects of columns, TFF, centrifuges, and filtration systems.
- Manage and coordinate manpower effectively, ensuring smooth operations.
Vendor Coordination:
- Plan and coordinate with vendors for the AMC of Chrom Skids, Columns, TFF, and other equipment.

Qualifications & Skills:

Education: Bachelor’s degree in Pharmacy, Pharmaceutical Science, Life Sciences, or a related field. A B.Sc. in Chemistry is also acceptable.
Experience: Minimum of 3-8 years of relevant experience in biologics production or a similar field.
Key Skills:
- Ability to multitask and prioritize in a fast-paced environment.
- Strong understanding of GMP, CGMP, GDP, documentation, and audits.
- Excellent communication skills (written and oral).
- Proven ability to work effectively in a team, especially with senior leadership.
- Good articulation skills for clear communication across teams.

This structured format outlines the responsibilities and qualifications for the role of Sr. Executive / Assistant Manager in Biologics Production, helping potential candidates understand the expectations and requirements clearly.

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Sr Executive / Asst Manager

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