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Discovery & Pre-Clinical/Clinical Development

Associate Director in Solid State Sciences & Characterization

  • Titolo Associate Director in Solid State Sciences & Characterization
  • Funzione Discovery & Pre-Clinical/Clinical Development
  • Sottofunzione Pharmaceutical Product R&D
  • Categoria Senior Manager, Pharmaceutical Product R&D (PL8)
  • Località Beerse, Antwerp, Belgium
  • Data di pubblicazione
  • Riferimento 2406176813W
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Descrizione

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.
  • Providing and overseeing solid state support, which implies polymorph studies, salt or co-crystal screenings and solid form recommendation for new small molecule drug candidates.
  • 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.
  • 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) to create new opportunities within Pharmaceutical & Material Sciences.
  • Using your global network to set up collaborations with external partners.

Qualifiche

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

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

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 will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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