Associate Director in Solid State Sciences
il y a 4 semaines
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 an **Associate Director in Solid State Sciences & Characterization **. 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 function 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 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, customer focus, teamwork, international networking and building up scientific knowledge and expertise, strategy setting and benchmarking.
As an Associate Director, **you will be responsible for**:
- People leadership of about 8 - 10 people within the Solid-State Sciences and Characterization group which is an interdisciplinary team interfacing between 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. This includes issue resolution for life cycle management programs.
- Acting as an expert in physical chemistry, towards phase behaviour, thermal behaviour, crystallization processes for active pharmaceutical ingredients (API’s) and formulation development.
- Defining and understanding the API morphology tuning potential in the early phases of development and co-driving particle engineering efforts in synergy 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.
- Follow-up on solid state developments (i.e. Scientific and Regulatory literature) to create new opportunities within Pharmaceutical & Material Sciences.
- Using your global network to set up collaborations with external partners.
**Qualifications**:
**Qualifications**:
- A Ph.D. in Chemistry, Physics, Pharmaceutical Sciences, or a related science combined with relevant 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
- 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 valuable asset
- A proven record of analyzing and interpreting complex situations to provide clear direction to others
- Good communicator with experience of effective collaborations and cross functional interactions, building strong relationships with stakeholders and customers
- Good team player and networking skills
- Demonstrate a high degree of personal accountability
- Demonstrate the ability to deliver under pressure.
About Johnson & Johnson
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and w
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