Director, Pharmaceutical Science

Employer
Celgene
Location
Summit, NJ
Posted
Jun 13, 2018
Ref
1801948
Required Education
Doctorate/PHD/MD
Position Type
Full time

Other Locations:US- NJ- Summit West; US- MA- Cambridge


Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

Summary:

The successful candidate will lead the Pharmaceutical Science group which is responsible for discovery pharmaceutics (discovery support), definition of the preclinical formulations, biopharmaceutical evaluation and support, salt and form selection and evaluation, and support Drug Substance and Analytical Development groups on the final crystallization of the desired crystal form for clinical development. 

  • Discovery Interface:
    • Lead discovery support pharmaceutics team based in Boston MA and San Diego CA.  Provide leadership and mentor scientists supporting discovery groups

    • Work with our medicinal chemistry team to provide them with characterization and formulation support

    • Provide constructive feedback and engage with our discovery colleagues on the developability assessment on candidates in the discovery pipeline


  • Define Preclinical Formulations (Toxicological Formulation):
    • Working with Discovery Scientist and colleagues from the Toxicology and ADME groups define the toxicological formulation to achieve the desired PK coverage in preclinical studies


  • Salt and Form Definition for Development:
    • Working with medicinal chemists, process and analytical colleagues lead the effort to define the most suitable crystal form for clinical development

    • Work internally and with external partners to screen salt and form of the development candidates and provide the patent department with necessary information to protect Celgene's intellectual property

    • Support exhaustive screening on crystal form for the development candidate


  • Biopharmaceutical Support of Formulation Development:
    • Provide bio-relevant in-vitro solubility data

    • Working with ADME and PK scientists support the formulation design and provide simulation support based on animal data (ex. Gastroplus) to understand parameters affecting absorption in animals that may be translatable into clinical setting

    • Work within the broader project team to evaluate if biowaivers are needed for changes in process and formulations during development.


  • Support Crystallization of the Final Solid Form for Development:
    • Working with drug substance and analytical colleagues support the crystallization of the desired form

    • Provide physical form characterization during development of the final crystallization process

    • Provide data on relations between crystal forms (if they exist) to aid the design of the final crystallization (eutectic points, phase diagrams)


  • Material Characterization and Support to Formulation Group:
    • Pharmaceutical Science is imbedded within the broader formulation development group so seamless support can be provided on the design of the formulation and process for the clinic

    • Support solids characterization during formulation and process development


  • Partner with compound leaders (project leaders) to manage budgets, resources and timelines in support of the Pharmaceutical Sciences activities described above.

Qualifications:

This is a leadership role within the Formulations Development group in Celgene.  The successful individual will have a demonstrated experience leading a pharmaceutical science organization in support of small molecule drug product development.  Experience leading and mentoring a team of Ph.D. level scientists as a supervisor is required.  Excellent leadership and communication skills is a must in addition to good problem-solving abilities and good organizational skills.

Education:

Ph.D. in Pharmaceutics, Chemistry, Chemical Engineering or Material Science with 15 years' experience post Ph.D. in small molecule Preformulation and Pharmaceutical Science group.

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Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.