Associate Director - Analytical Development R&D

The leader of this section will be in the leadership team at Analytical Development and will work with products in the early ideation stage all the way trough development and transfer to production. A close collaboration within the department as well as across R&D will be needed. Given that it is a group of 6 to 10 persons to manage including a research manager, principal scientists and senior scientists, there will be both strategically leadership, a substantial part of operational responsibilities and budget responsibility included in the role. It is expected that the person can lead a product development team and or work as an analytical lead in a product development team.

The accountabilities include analytical work to support early ideation, innovation, all the way through transfer of the products to production. Development and validation of methods, stability testing, specifications and the analytical work needed for release of products to clinical studies are major parts of your accountabilities.

Compliance in terms of cGMP, EHS and support to our chromatography data system and other AD related IT systems are also in scope. Across the sections experts are working, why more in depth investigations to resolve issues is also part of the work. As a highly skilled department we deliver answers to questions.

Documentation skills are important since you will write and or review/approve a number of reports. Another responsibility is to deliver our parts of CTA's, MAA's and NDA's.

The current main focus from a product perspective is Digestive Health but since we work closely together across the sections the work is unlikely limited to one therapy area. The NPD projects are global in scope why a broad knowledge of worldwide requirements for analytical methods, specifications and stability testing is a merit.

Business: McNeil AB

City: Helsingborg

Job type: Full time

Deadline for applications: 2014.02.28

More information: Camilla Wern at Proffice Life Science, 0733-436098

Qualification:

The person we are looking for has preferably at least 5 years of experience within the pharmaceutical industry as a people manager and is well acquainted with cGMP requirements. A Ph D within a relevant chemistry area is a merit but not a requirement; otherwise achieved scientific skills will be valued equally. Since the NPD product portfolio is broad in terms of formulations in-depth knowledge on both cGMP as well as medical device requirements is a merit. Knowledge and understanding of requirements and analysis of different formats such as tablets, sprays, nasal and inhaled products is also a merit.

You should be able to communicate in Swedish but since we are working in an international organisation good verbal and written English is a prerequisite. Experience from documentation in general and writing registration files and or response to registration files are important skills that will be valued. The ability to grasp, understand and translate complex problems into explicit work packages will be needed.

The applicant should apply at Proffice Life Science website www.profficelifescience.se. The application should include a personal letter describing why you are the right person for this position, a curriculum vitae and references.

Organization/Business description:

Johnson & Johnson is a globally operating health care company employing approximately 129 000 people in more than 250 companies in 60 countries. Our worldwide headquarters is in New Brunswick, New Jersey, USA. McNeil AB is part of the Johnson & Johnson Family of Companies and the largest industry in Helsingborg with around 630 employees. We develop and manufacture OTC drugs and amongst our brands Nicorette is the largest and also the world-leading product for smoking cessation. We encourage our employees to an active, healthy and tobacco free lifestyle - our premises are tobacco free. www.mcneilab.se