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Pharmaceutical & Material Sciences is, within the Pharmaceutical Development & Supply (PPDS) organization of the Pharmaceutical Companies of Johnson and Johnson, responsible for preformulation & biopharmaceutics, solid state form selection and understanding, and material selection and qualification.
In Belgium (Beerse) there is a vacancy for a Director in Solid State Sciences & Particle Engineering . Within this role you and your team will provide expert scientific leadership in the solid state area, ensuring that we have the capabilities to perform to a world class standard.
The overall mission of the position is together with your team to work with discovery and process chemists, analytical chemists, formulators, quality assurance and regulatory to select, develop, understand and control the Active Pharmaceutical Ingredient (API) solid state form and form attributes and drug product solid state for each phase of development. Both for conventional and enabling formulations (e.g. amorphous solid dispersions, nano-systems). You will be responsible to develop the right API and drug product control strategy.
Selection of a proper API solid state form, form attributes and physical properties is the key to:
- Drug product performance including PK profile as defined in target product profile
- A stable formulation
- A robust drug product manufacturing process
- A stable API
- A robust and reproducible API manufacturing process
Additional key elements of the function are: innovation, partnership, international networking and building up scientific knowledge and expertise, networking and establishing partnerships, strategy setting and benchmarking.
Your key responsibilities:
- Leading the Solid State Sciences and Characterization group which is an interdisciplinary team working together with chemical development, analytical development and drug product development. The group provides solid state support for projects at all stages of the product life cycle starting at the preclinical stage up to filing and launch.
- Providing solid state guidance and insights including polymorph studies, salt or co-crystal screenings and solid form recommendation for new synthetic molecule drug candidates.
- Acting as an authority in physical chemistry, towards phase behaviour, thermal behaviour, crystallization processes for active pharmaceutical ingredients (API’s) and formulation development.
- Mapping the API morphology tuning potential in the early phases of development and co-driving particle engineering efforts in alliance with the crystallization process development activities. Understanding how API form attributes impact the drug product manufacturing process and co-drive particle engineering efforts in the right direction.
- Supporting both conventional and enabling formulation development through examining and understanding the behaviour of the solid state form of the API in the drug product.
- Develop the solid state control strategy for both API and drug product, which includes developing, validating and transferring appropriate solid state methods.
- Writing and reviewing reports, including relevant CMC documentation to support both clinical and marketing applications
- Follow-up on solid state developments (i.e. Scientific and Regulatory literature) in order to build new opportunities within Pharmaceutical & Material Sciences.
- Using your global network to set up strong partnerships and innovation.
We would love to hear from YOU, if you have:
Must haves: to be considered for this role, please ensure the minimum requirements are evident on your resume
- A Ph.D. in Chemistry, Physics, Pharmaceutical Sciences or a related science combined with proven experience and leadership in a Pharmaceutical Sciences environment.
- Experience and profound knowledge in solid state sciences and characterization of API’s and drug product, both related to version and form selection as well as form attributes and particle engineering for API and physical form stability of conventional and enabled formulations such as amorphous solid dispersions.
- Strong connect to academic and industry network in this field. Strong networking skills.
- Knowledge and experience with both current and new technologies used in solid state development.
- Demonstrated people leadership and talent development, including technical and non-technical coaching and mentoring.
- Demonstrated strategic thinking and the ability to help define a vision for the future.
- Good understanding of the drug development process from early through late development and an appreciation of how Pharmaceutical & Drug Product Development contributes to R&D.
- A consistent track record of analyzing and interpreting complex situations to provide clear direction to others .
- Good communicator with experience of effective collaborations and interactions, building strong relationships with partners and customers.
- Demonstrate a high degree of personal accountability.
About Janssen, the Pharmaceutical Companies of Johnson & Johnson
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Ready to be part of something great? Don't forget to apply. We want YOU!