A Pharmaceutical Technology Specialist is primarily responsible for transfer and validation of new products/processes into production. The major objective is to assure successful new product transfer to commercial manufacturing organizations and proper training of production personnel in any new process and/or technology platform. Key functional roles include troubleshooting and reformulation of problem products, providing technical expertise and support to Production Investigations, and writing product development reports in support of registration activity. Other key objectives include generation, execution, and reporting of product, cleaning, and equipment validation protocols. Other objectives would include assessment of new production equipment and selection or evaluation of new systems for both laboratory and commercial manufacturing; rework evaluation of rejected batches and new/existing raw material evaluation.
1. Primary responsibility is to coordinate the scale-up batches of new products and processes to enable commercialization of new and life- cycle management projects. Carries out responsibilities in accordance with the organization's policies, procedures and state, federal and local laws. 2. Responsible for identifying potential product/process improvements of existing commercial dosage forms. Will present proposals to optimize formula and product flow. Will implement changes after management approval. 3. Interfaces with Quality Assurance and Research and Development (R&D) on process requirements for new and current products and assists with on-site transfer projects and product scale-up activities. 4. Provides troubleshooting assistance in manufacturing and packaging areas and recommends improvements in manufacturing and change control systems. 5. Assures that protocols are approved through proper channels. Also executes validation protocols per related SOPs and assures that acceptance criteria related to validation protocols are met. 6. Writes and revises validation protocols to ensure technical objectives and functional performance goals of studies are achieved. Also writes product development (P2 and ICH Q8) reports in support of regulatory submissions as well as deviation reports required upon failures to meet protocol acceptance criteria. 7. Assures that all test data are gathered and recorded in accordance with cGMP requirements. Also analyzes data to ascertain compliance of results to acceptance criteria. 8. Provides support in investigations and leads other troubleshooting activities of the cross-functional team. Coordinates the documentation process to establish quality standards that are rugged and robust for highly regulated products. 9. Complies with all GXP and safety requirements, SOP's and Company policies and procedures. Also assumes primary responsibility for quality excellence in products that the company develops and introduces into commercial operations.10. Responsible for compliance with Controlled substance documentation and accountability procedures while maintaining high alert to diversion and theft possibilities.
Educational Requirements Minimum Qualifications: BS/MS in chemistry or engineering with 5 plus years of experience in generic pharmaceutical environment preferred.
Required Experience & Technical Requirements
SPECIFIC KNOWLEDGE, SKILLS, LICENSES, CERTIFICATIONS ETC: Knowledge of:
- Current Good Manufacturing Practices (cGMP), Code of Federal Regulations (21 CFR), Food and Drug Administration (FDA), OSHA, EPA and other regulatory requirements. - Pharmaceutical dosage forms and manufacturing principles, especially on the science of technology transfer. - Instrumental/pharmaceutical analysis and concepts of equipment qualification, calibration and cleaning validation. - Mathematical/statistical computations in process scale up, e.g. concepts for process improvement and quality by design (QBD), Six-Sigma, quality engineering, etc. Also able to effectively utilize computer tools in the workplace. - Good technical writing skills for moderately complex reports; good verbal and communication skills. - Ability to prepare all types of pharmaceutical documentation with proper guidance. - Multi-tasking, good decision-making, ability to function in a high performance and a cross-functional team environment. - Establishes and maintains good relationships with team and other functional groups. - Complies with company policies, practices and procedures, including safety rules and regulation.
Ms. Deborah Miller Shell Recruiter
Purdue Pharma - 10 months ago
Purdue Pharma helps bring patients relief from pain. The company specializes in developing, manufacturing, and marketing prescription and...