Chief Manager Research & Development (FRD) | Indian Immunologicals | Hyderabad

Job Description

Roles and Responsibilities:

To lead a team that will be involved in the development of various formulations covering both human and animal health Portfolios. Should have thorough knowledge in the development of Oral, mucosal, and parenteral formulations. To develop newer platform technologies and evolve novel advancements in current technologies, focusing on current customer needs

Should have a thorough knowledge of various aspects of formulation development with specific reference to biologicals and vaccines including the technologies like micro/nanoemulsions, liposomal, freeze-dried, and spray-dried formulation techniques.

• To Plan and execute formulation development activities as per the project plan and timeline.
• Preparation of tech transfer documents related to Product Tech. transfer process equipment, Lot processing records, and Development reports.
• Scientific presentations in both internal and external meetings
• To develop consistent and cost-effective processes for different projects in formulation development (Drug product).
• Coordinate with inter-departments and associates on process, testing, and R&D-QA to meet the compliance requirement.
• Ensure to complete the work plan online, maintain for lab/workplace as per the GLP requirement and face the internal audits as per schedule, and provide in-time CAPA associated with the observations.
• Investigate, develop, and characterize vaccines, therapeutics, and biologicals and prepare technical reports, communicate findings internally and externally, and present in cross-functional meetings

Collect and share relevant academic literature, leverage external consultants/SMEs, and establish new collaborations with internal groups. Optimize current processes to ensure a robust manufacturing

Desired Candidate Profile:

• Experience in vaccine formulation and process development.
• Exposure to newer drug delivery devices
• Experience in defining dosage forms and driving projects in early and late-stage development is desired.
• Exposure to analytical techniques including UV, Fluorescence, HPLC, LCMS, CE, GC, NMR, KF, IR, and DSC.
• Effective communication skills and the ability to write detailed technical reports.
• Solid foundation in Formulation, analytical, chemistry, material science, and antigen-adjuvant characterization.
• Exposure to various biophysical and light scattering techniques (DLS, NTA, Coulter Counter, etc.).
• Should have good managerial skills and communication skills. Good proficiency in English is required.
• Good Knowledge of regulatory, documentation and report-writing skills
• Good teamwork, leadership and interpersonal skills
• .