Nature and scope
Responsible for leading day to day activities of formulation and process development activities associated with parenteral drug product development following Quality by Design (QbD) principal. Supports trouble shooting of manufacturing issues, ANDA submission and regulatory response to FDA deficiency. Responsible for training of laboratory personnel in key formulation techniques and basic formulation equipment. The individual will work closely with Manager of R & D to ensure that project timelines are met and also assist in preparation of ANDA documentation and FDA deficiency response.
Essential duties and Responsibilities
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
· Provide technical leadership for the design and execution of Quality by Design (QbD) product development studies and development of scalable manufacturing process for parenteral drugs.
· Manage daily activities of formulation laboratory to ensure that all the assigned projects are completed on time. Ensure that accurate and complete laboratory records are maintained in the group as required by company policy and Good Manufacturing Practices (cGMP) requirements.
· Oversee formulation team in design and execution of laboratory experiments to optimize formulation, study material compatibility and evaluate sterilization options.
· Review and approve R & D study protocols and reports, manufacturing process validation protocols and reports as well as manufacturing batch records.
· Provide R&D oversight for all the validation batch, exhibit batches/ Engineering batches/ site transfer batches
· Support ANDA submission and response to FDA deficiency and product complaints following company's compliance policies.
· Lead formulation activities to support product or process/technical troubleshooting, special investigations and product complaints
· Attend department management team meetings and schedule work to align with department objectives.
· Set and accomplish product development timelines by working closely with R & D manager, analytical chemist/scientist and project management team.
· Responsible for training junior scientists in key formulation techniques and essential formulation equipment.
· Perform any other tasks/duties as assigned by management.
· We all must embrace the QUALITY culture.
Qualifications and Requirements
· Ph.D. in Pharmaceutical Science, Chemistry and Chemical Engineering or equivalent required.
· Minimum of 10 years of experience in parenteral product development.
· Broad knowledge of formulation development following QbD principal, formulation characterization, process development, and scale up of sterile injectable products is essential.
· Strong scientific background and solid understanding of parenteral drug product manufacturing is essential.
· Experience in development of suspension and freeze dried products is a plus.
· Knowledge of pharmaceutical lifecycle management is a plus.