Hovione is an international company with over 55 years’ experience in the development and compliant manufacture of Active Pharmaceutical Ingredients and Drug Product Intermediates. With four FDA inspected sites in Portugal, the U.S., Ireland and China, Hovione offers integrated API, particle design, formulation development and GMP manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services.
To reinforce our team we are looking to fill the following position at our New Jersey site:
Analytical Development Chemist (US)
The Analytical Development Chemist will provide analytical support to all projects guaranteeing that development analytical tasks are accomplished within the time frame defined and according with the scope and GMP requirements.
The successful candidate provides high quality support, duly integrated as defined in internal procedures, quality agreements and internal guidelines, in order to guarantee the requirements of clients, both internal and external. This position is responsible for contributing to the success of each project by meeting the requirements of the project team and supplying the necessary analytical chemistry knowledge in technical transfer and/or validation of the analytical methods. Provide the analytical results and adequate pro-active interpretation to help enrich the team's understanding of the project. A qualified candidate will demonstrate an understanding of the theoretical principles of the main technologies in use at Hovione and/or show knowledge in new analytical technologies.
- Provide Analytical support to new projects, activities related to analytical development, validation and/or transfer work for projects;
- Coordinate priorities with area head, designee, or project manager to ensure the analytical portion of project timelines is maintained;
- Ensure that technical transfer analytical tasks are accomplished within the timeframe defined and in accordance with the scope and cGMP requirements;
- Generate documentation to support the introduction of new products from external customers (protocols, reports, methods, and specifications);
- Maintain all laboratory notebooks and records as per GMP and in accordance with the Quality System in place;
- Review work generated by Analytical Development group when required and ensures all procedures are properly followed;
- Calibrate and maintain designated laboratory instruments;
- Train staff on laboratory work, techniques, and instrumentation;
- Improve knowledge in Analytical Chemistry area in terms of new technologies and new methodologies;
- Propose changes for continuous improvement, either in safety or general efficiency;
- Highlight any deviations or non-conformance's in testing or work practice;
- Liaise with other departments and external customers;
- Adhere and ensure all safety requirements and expectations are met;
- Interpret analytical results and resolve technical and/or operational problems and provide technical advice and support to analysts
- Bachelors degree in Chemistry or related field with a minimum or 4 years of industrial experience in a GMP regulated chemistry laboratory or a Masters degree in Chemistry or related field with a minimum of 2 years of industrial experience in a GMP regulated chemistry laboratory or a PhD in Chemistry with 1 year of industrial experience in a GMP regulated chemistry laboratory;
- Must be hands-on in method development/validation as well as operation/maintenance of analytical instruments;
- Excellent knowledge of GC, HPLC, UPLC, MS;
- Good knowledge or wet chemistry, Karl Fisher, FTIR, particle size analysis is desirable;
- Excellent Communication skills both written and oral
- Results driven, positive attitude, team player, able to deal with multiple projects/tasks simultaneously;
- Demonstrates a high level of integrity at all times;
- Analytical skills and ability to make decisions under pressure;
- Flexibility is essential (willingness to work shift patterns as required by business needs);
- Ability to work on own initiative;
- Excellent computer skills e.x. MS Word, Excel, Outlook;
- Experience with LIMS and Empower is desirable;
- Pragmatic, resilient, proactive, creative, innovative and with high ethical standards.
- Exciting full time opportunity in a growing Company, using continuous manufacturing technology under a Quality by Design approach in an innovative setting
- Competitve salary and benefits commensurate with the job function and candidate’s relevant experience;
- Excellent work environment, with a strong focus on quality.