Our client is a world leading contract development and manufacturing organization of pharmaceutical products. Located in France, the USA, Brazil, and China, we provide comprehensive innovation & development services to fulfil every aspect of contract pharmaceutical manufacturing needs. They specialize in unit dose manufacturing and our expertise includes an extensive range of unit dose packaging, such as Blow-fill-seal (BFS). In addition, we also manufacture preservative-free multidose, pharmaceutical bottles, sprays, tablets, tubes, suppositories and pessaries.
Performs method validation and development from design to execution independent of supervision. Manages complex, multi-disciplinary projects with minimum input. Implements improvements to lab quality systems. Provides analytical support commercial products and Manufacturing. Provides technical resource for QA laboratories..
Solutions that Minimize Commercial Lab & Manufacturing Downtime
- Conducts incident investigations to determine root cause. Assesses product impact.
- Works with the appropriate discipline to identify corrective/preventative measures necessary for each observation made for improvement and to align processes to consistently manufacture quality products.
- Coordinates documentation required at the completion of investigations; pulls all materials together into a concise summary that thoroughly documents the conclusions of the investigation.
- Collaborates with internal groups to determine and implement preventative measures to reduce/eliminate repetitive deviations.
- Identifies, offers, and implements plans to prevent and overcome analytical issues and performs method trouble shooting.
- Provides analytical leadership and consultation internally.
- Serves as analytical lead for customer and government regulatory agency site inspections.
Methods for New Products & Product Transfers
- Coordinates work of lab personnel to support on-time delivery of analytical data to projects.
- Functions as Analytical Services representative and SME on project teams.
- Provides consultation regarding new test methods as required.
- Performs analytical method development, validation and project support from design to execution.
- Provides scientifically sound, clearly written analytical data packages/reports suitable for submission.
- Writes protocols and reports. Reviews and checks analytical data generated by peers and maintains integrity of data.
- Internal Analytical Support
- Provides analytical solutions to manufacturing troubleshooting, process development and improvements.
Efficiency Improvements to Existing Methods
- Evaluates regulatory changes to existing methods: i,e PhrEU and USP monograph changes.
- At customer request, investigates new technologies and analytical approaches for utilizing existing in-house instrumentation to improve test efficiency/effectiveness.
- Investigates and recommends analytical instrumentation purchases for cost improvements and operational efficiencies.
- Proactively participates in activities in support of process changes. Suggests and leads process improvements to refine current systems and improve efficiencies.
Laboratory Training Program
- Builds systems that translate training and development needs into appropriate, cost-effective learning and development interventions that support the effectiveness of the individual and the Labs.
- Develops methods to transfer information and techniques from training sessions to actual on-the-job performance.
- Evaluates training effectiveness by using pre-test and post-test measures, interviews, and examining various records and reports; and recommends modifications to training as appropriate.
- Delivers one-on-one or group training to individuals on assigned processes that includes not only information on the process, but the opportunity to practice.
- Distinguishes between training and non-training needs and works with Supervisor/Manager to recommend an appropriate solution to performance problems.
- Bachelor's degree in life science or closely related discipline AND 10+ years of experience
- Master's degree in life science or closely related discipline AND with 7+ years of experience
- Ph.D life science or closely related discipline AND with 5+ years of experience
- 2+ year in Regulated Industry, Pharm preferred
- Must have previous experience in cGMP environment
- Proven success in method development and validation
- Familiarity/competency in following areas with in-depth knowledge of at least 3: HPLC, GC, GC/LC-MS, FTIR, UV/Vis, SEM, CE, Chiral Separations, dissolution
- Experienced in regulated development process & regulatory requirements
- Statistical data evaluation to include experimental design a plus.
- Basic Outlook and PowerPoint skills, Intermediate MS Word and MS Excel skills