Job Description
Job Description
Summary :
This position is responsible for all aspects of product development for oral liquids and parenteral dosage forms including formulation development, scale-up, technology transfer and manufacturing of registration batches, and provide scientific leadership and technical expertise in formulation development and drug product manufacturing, to support PAIs portfolio comprising of 505 (j) and 505(b)(2) drug products.
Responsibilities :
- Lead formulation and process development and scale up work
- Design and conduct formulation development, process development and optimization of oral liquids and parenteral formulations
- Design and develop robust and scalable formulation and manufacturing process for oral liquids and parenteral formulations
- Evaluate and present results to R&D management
- Write and review compounding and packaging batch records, protocols, SOPs and reports to support development of PAIs product portfolio
- Participate in technology transfer and manufacturing of registration batches both internally and externally
- Maintain formulation development laboratory including instruments and equipment
- Provide technical support to identify the root cause and solve formulation, process and analytical related issues including out-of-specification
- Work with cross functional departments such as manufacturing, AR&D, validation, QC / QA and regulatory affairs to meet critical milestones of the projects
- Generate product development documents in support of regulatory submissions
- Provide technical justifications / responses and lead activities to address regulatory deficiency (IR’s, DRL’s and CRL’s).
Requirements :
- M.Sc. / Ph.D in Pharmaceutical Sciences or related.
- Minimum 5 years’ experience in pharmaceutical industry, with experience in oral and parenteral dosage forms
- Should demonstrate excellence in independently designing and conducting experiments and analyzing data.
- Should be fully conversant with advanced principles of pharmaceutics, physical and organic chemistry, thermodynamics, and materials science
- Should be experienced with Quality by Design (QbD) principles and applying statistical approaches to design and analysis of experiments
- Ability to perform complex scientific work independently with no supervision
- Ability to work in a cross-function environment under aggressive timelines
- Should have strong verbal and written communication skills
To perform this job successfully, an individual must be able to perform the essential job functions satisfactorily. PAI is an Equal Opportunity Employer.
In compliance with the Americans with Disabilities Act, PAI will provide reasonable accommodations to qualified individuals with disabilities and encourages both prospective and current employees to discuss potential accommodations with the employer. PAI uses E-Verify.
EEO Employer / Veteran / Disabled
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