Biologics Production - Executive

2-5 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: Biologics Production - Executive
Experience: 2-5 years
Location: Hyderabad
Employment Type: Full-Time

Company Overview:

Promea Therapeutics Pvt Ltd is a leader in the development and manufacturing of biologic drugs. We are seeking a skilled and dedicated Biologics Production Executive to join our team. In this role, you will be responsible for ensuring the efficient, compliant production of biologics, adhering to quality standards, safety regulations, and production schedules.

Job Summary:

The Biologics Production Executive will play a critical role in manufacturing biologic drugs by overseeing upstream and downstream processes, ensuring compliance with cGMP guidelines, and collaborating with cross-functional teams to optimize production processes. You will contribute to the continuous improvement of production efficiency, maintain proper documentation, and troubleshoot technical issues as they arise.

Key Responsibilities:

Manufacturing Operations:
- Execute and oversee the production of biologic drugs, including upstream and downstream processes, purification, and formulation.
- Ensure compliance with cGMP and SOPs throughout all production activities.
Documentation & Compliance:
- Prepare and review production documents, batch records, and production reports to ensure accuracy and compliance with regulatory standards.
- Collaborate with teams to troubleshoot issues and optimize production processes.
Data Monitoring & Analysis:
- Monitor production data, yield trends, and KPIs to identify improvement areas and implement corrective actions.
- Support investigations of deviations, OOS results, and non-conformances, implementing CAPAs as necessary.
Technology Transfer & Process Improvements:
- Participate in technology transfer activities, including process scale-up, process validation, and equipment qualification.
- Contribute to continuous improvement initiatives, suggesting enhancements, process optimizations, and cost-saving measures.
Cross-Functional Collaboration:
- Collaborate with process development, quality control, and engineering teams to address technical issues and improve production quality.
Regulatory & Industry Awareness:
- Stay updated on industry trends, regulatory requirements, and technological advancements, applying relevant improvements to the production process.

Qualifications and Skills:

Education: Bachelor’s or Master’s degree in Biotechnology, Biochemistry, or a related field.
Experience: Solid understanding of biologics production processes, including cell culture, fermentation, purification, and formulation.
Technical Skills:
- Familiarity with cGMP guidelines and regulatory requirements specific to biologics manufacturing.
- Experience with bioreactors, chromatography systems, filtration technologies, and other equipment used in biologics production.
- Knowledge of process optimization, scale-up, and technology transfer in biologics manufacturing.
Analytical Skills: Strong problem-solving ability and attention to detail for analyzing complex data sets.
Time Management: Excellent organizational and time management skills to meet production deadlines and manage multiple priorities.
Communication: Effective communication and interpersonal skills for working in cross-functional teams.
Software Proficiency: Proficiency in using manufacturing execution systems (MES) and other related software.
Flexibility: Willingness to work in shifts, including weekends and holidays, as required in a biologics production environment.

This structured format clearly defines the role’s responsibilities, qualifications, and skills, ensuring clarity for prospective candidates.

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