R&D - Downstream

Hi,

We are hiring for the Executive / Sr Executive R&D - Downstream role

Experience -

Location - Hinjewadi phase 2

Key Responsibilities:

1. Planning & Scheduling: Prepare monthly experimentation plans, ensuring the availability of resources such as manpower, raw materials, consumables, and equipment.

2. Team Leadership: Lead a small team, ensuring optimal utilization of processes, equipment, and consumables. Provide training and guidance to team members

Key Responsibilities:

1. Problem-Solving & Troubleshooting: Proactively identify and resolve issues in experimentation, batch processing, and equipment operation in the PDL and Pilot Plant section.

2. Safety & Compliance: Ensure strict adherence to cGMP, GLP, and EHS protocols, maintaining compliance in all operations.

3. Employee Development: Conduct gap analysis and competency mapping for training needs. Focus on on-the-job training (OJT) for continuous development of staff skills.

4. Documentation: Prepare and maintain process development, scale-up, and technical documentation. Ensure accurate and timely record-keeping in compliance with GDP.

5. Cross-Functional Coordination: Collaborate with Engineering, QC, and other departments for effective execution of plans and implementation of new technologies, including equipment modifications and cGMP requirements.

Key Requirements:

• Experience: 6+ years in R&D or biopharma-related downstream processes with hands-on experience in upstream/fermentation/recovery.

• ACTA Expertise: Proficiency in using ACTA, especially in the R&D context, for process optimization and data management.

• Technical Knowledge: Strong understanding of QBD-guided process development, scale-up, and technology transfer for biotherapeutics.

• Leadership & Team Management: Proven ability to lead, train, and mentor a small team while managing day-to-day operations.

• Process Optimization: Experience with process optimization and technology evaluation to enhance production efficiency and product quality.

• Compliance & Safety: Knowledge and adherence to cGMP, GLP, and EHS standards, with the ability to resolve non-compliance issues.

• Problem-Solving: Analytical skills to identify and address process gaps, deviations, and inconsistencies in a timely manner.

• Documentation Skills: Strong documentation skills for preparing technical reports, SOPs, and batch records.

• Cross-Department Collaboration: Ability to work effectively with internal teams (Engineering, QC, etc.) and external vendors/partners to integrate new technologies and ensure process success.

• Process Monitoring: Ensure equipment operation, training, and process standards are maintained and continuously improved.