Technical Operations Analyst

Immuneel Therapeutics Private Limited is a pioneering start-up company leading the charge in cell therapy and personalized immunotherapy for patients in India. For more details, please refer www.immuneel.com

We Pursue, with Purpose, to serve our Patients (3 Ps) by Connecting within, Collaborating globally and Creating (3 Cs) solutions. Our flexible, diverse, and vibrant team is bringing together best practices and innovations in the field of cell and gene therapy.

Working at Immuneel promises the excitement of an agile start-up on a critical mission. Proudly Indian in solutioning, yet global in outlook, we are keen to collaborate. We value diversity including in experience and perspectives. We value work-life balance and believe that having fun on the job is integral to achieving the right results. We pride ourselves on providing an open environment and our mission resonates with humanity everywhere. At Work, we are:

1. Passionate in driving patient outcomesWe are passionately committed to doing the RIGHT thing to achieve the best outcomes for our patients through innovation, agility and performance orientation. We put the impact on the patient above all else.
2. Responsible and accountableWe demonstrate ownership and accountability for our actions. We make timely and well-informed decisions, learning from our performance.
3. Transparent, honest, and supportive in how we work togetherWe insist on integrity and respect for the individual. We demand excellence. Our performance management is focused on excellence through timely and constructive feed-forward.
4. Inclusive and flexibleWe are full of life and embrace all opportunities to collaborate and work together. We are excited about the collective knowledge and expertise that we share. “Being and thinking different” is valued.

Immuneel prides itself as an organization that is keeping pace with best practices in organization design. Our role-based organization incorporates global trends in human capital that promote focus on work and greater nimbleness. Our role-based structure allows you to be cherished by the work you do and bring value to your work rather than designations, our organization is simplified into a flat, non-hierarchical, millennial, organization where you may fully inherit the role you play in the organization and are recognized by the accountability you take and the work you deliver.

Immuneel’s employees are integral to our quest to develop and deliver high quality engineered cell therapies in India. We believe that our culture provides an environment for employees to excel and find purpose. The strength of our team is every bit as important as our cutting-edge technology and we invest in clear compensation and comprehensive benefits for our employees. People for us, are not resources, but our capital.

If you are a talented professional, an out-of-box thinker with a zeal to help change, and passionate about healthcare, we invite you to join us and be a part of a historic initiative in India.

Interested to be a part of the next revolution in cancer treatment? Send your resume to careers@immuneel.com

1. Role Title:

Analyst Technical Operations

2. Department/Function:

Product Operations

3. Reporting Structure:

• Reports to: Technical Operations and Inventory
• Direct Reports: Individual contributor

4. Role Summary:

This position must implement and execute the operating guidelines for the cleanroom facility. It should also be able to support the technical operations by anticipating the demand and arranging supply for all cleanroom requirements. Implementation of the strategy to keep cleanrooms operationally sound and maintain the standards necessary for smooth operations.

5. Key Responsibilities:

• Supervise daily site operations
• Supervising lab technicians in their day-to-day activity
• Recording of all the required daily annexures to monitor temperature and cleaning requirements

Tracking of the instrument AMC

• PR creation for all the instrument AMC and utility vendors

Liaising between internal stake holders and vendors for calibration/ AMC/ breakdown and maintenance of instruments

• Coordinating with utility vendors for timely delivery of material like liquid nitrogen, gas cylinders.
• Assisting QC in environmental monitoring and monitoring trends
• Recording and disposing of Biomedical waste
• Filling up and maintenance of daily records pertaining to relevant SOPs
• Maintain all areas in audit ready conditions.
• Generate and review GMP documentation such as Standard Operating Procedures, non-conformance reports, deviations, CAPA and update to reporting manager
• To maintain and track performance measures for the Manufacturing and operations that may be used as key indicators for the area
• Perform routine stock checks to maintain levels of critical stock consumables, re-stock gowning garments and critical consumables in the clean area as required.
• Provide training and mentoring to ensure good understanding of the tasks allocated to lab technician
• Provide guidance and assistance to the Labtech team concerning work methods, the use of equipment and techniques
• Ensure that company policies/ SOP’s are followed and understood by all lab technician
• Health and Safety – be responsible for ensuring all laboratory staff are aware of identified hazards within the work area and understand the implications of not adhering to standards and procedures
• Ensure all users of the lab are wearing the appropriate Personal Protective Equipment (PPE)
• To participate in any other tasks that are deemed a priority for the site by Management

6. Primary Objectives:

1. Efficient and compliant clean room operations
2. Monitoring and training to Lab tech for their routine work
3. Any time audit readiness and compliance with required procedures

7. Competencies Required:

1. Technical Competencies:Inventory control and management
2. Operations in ERP system (SAP)
3. Material inspection

1. Soft Skills: Quality commitment
2. Collaborative
3. Ethical
4. Self-confident
5. Results-oriented
6. Analytical
7. Detail-oriented
8. Enthusiastic
9. Hard-working

8. Qualifications:

1. Bachelor's degree in Science, three+ years of related experience in relevant areas of lab operation and clean room area in pharmaceutical, working effectively and collaboratively across departments and functions
2. Prior experience working with GMP systems
3. Enterprise Resource Planning (ERP) system knowledge
4. Strong written and oral communication skills with the ability to present ideas and plans to team members and other departments and functions
5. Strong Mathematics and Microsoft Excel skills

9. Working Conditions:

• Role Type: Full Time and Onsite
• Work Hours: 9:00 AM to 6:00 PM for the General Shift and 2:00 PM to 11:00 PM for the Post-Noon Shift (on a rotational basis). There will be two days off each week, which may not necessarily fall on a Saturday or Sunday.
• Travel Requirements: No
• Base Location: Immuneel Therapeutics Private Limited, 8th Floor, Mazumdar Shaw Medical Center, Narayana Health City, Bommasandra Industrial Area, Bangalore - 560099