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Lead Chemist, Pat
2 weeks ago
Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.
**THE OPPORTUNITIES**
- The Lead Chemist PAT role provides drug substance and/or drug product PAT (Process Analytical technology) development and testing support for all manufacturing processes manufactured on site including providing technical expertise in the area of PAT to support manufacturing activities on site and transferring of manufacturing activities to other facilities. The Lead Chemist PAT demonstrates advanced skills in developing PAT method and validating methods, implementation strategy and supports investigations involving PAT, as well as providing PAT solutions for process robustness issues and process related investigations for manufacturing processes on site. The Lead Chemist PAT performs all activities in compliance with all regulations, policies and procedures on site.
**WHAT YOU WILL DO**:
- Utilizes technologies that include but are not limited to spectroscopic techniques, PAT-adapted analytical technology such as online HPLC, online MS, Raman, FTIR Spectroscopy as well as multivariate modelling of process data, as well as further expanding on the PAT tool set to include at line analysis, for eg, conductivity, pH, refractive index etc
- Leads and advises others on experimental design and execution, statistical analysis, analytical method development and validation
- Has an understanding of the pertinent regulatory guidance applicable to PAT. Lead contributions to regulatory filings and internal scientific as well as internal quality/GMP documents regarding PAT. Act as primary lead of regulatory inspections of PAT installations for the site.
- Supports routine supply manufacture by providing on going PAT technical support to the IPT and proactively monitoring the performance of equipment module(s) or unit operation(s) during manufacturing and cleaning using PAT. Proposes and implements new PAT solutions to support manufacturing, understand shifts and trends and process robustness issues.
- Provides training and coaches/mentors the PTO Engineers/Chemists in PAT related equipment’s.
- Leads collaboration and sharing the best practices with internal/external SMEs (eg CPDC, PCT, ADC, CMSE and other groups within the GSTC network) so as to build PAT and analytical capabilities for PTO.
- Complies with all divisional and site-specific policies, guidelines and procedures. Making safety adherence as a prerequisite to employment. Demonstrates and promotes safety, health & environment (EHS) leadership behaviors, ensuring that all activities are carried out in accordance with EHS requirements.
- Where applicable, develops and reviews SOPs, gap analysis and Job Aids for PAT within PTO Subsystems in compliance with divisional and corporate policies and guidelines.
- Demonstrate leadership behaviour in alignment with our Leadership standards
- Practice inclusion as the How and our Production Systems (MPS)
- Leads personal career development with manager assistance using myCareer and career mapping (development plan, self-assessment).
- Any other duties as assigned by the Supervisor.
**ABOUT YOU**
- Bachelor, Master or PHD in related technical field, including Chemical or Mechanical Engineering, Chemistry or Pharmaceutical Sciences
- Minimum 4 years technical experience in pharmaceutical manufacturing industry
- Expert knowledge of core technology/unit operations relevant to active pharmaceutical ingredients, Biotech and/or Non-Sterile drug product manufacturing.
Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high quality, reliable supply to customers and patients on time, every time.
**Who we are **
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
**What we look for**
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization.
We ar
