162 days ago on roche.com

Head Pharmaceutical Development Small Molecules

Roche AG

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Head Pharmaceutical Development Small Molecules

Head Pharmaceutical Development Small Molecules

Switzerland, Basel-Town, Basel

The Head Pharmaceutical Development Small Molecules leads a department comprising Formulation Research & Development, Process Development, Operations and Compliance, and GMP Manufacturing for small molecules from entry into human through transfer to commercial manufacturing and support of New Drug Applications / Marketing Authorizing Application. The department is responsible for developing formulations to support clinical studies, commercial launch and significant post-market modifications and the production of supply for clinical studies as well as performing characterization & validation studies supporting Quality by Design & writing and regulatory filings. The department then transfers formulations, technical knowledge, and processes to commercial sites while providing ongoing support where appropriate. Also, the department develops new technologies & innovative approaches supporting these efforts and enabling future products.

Specific responsibilities of the Head Pharmaceutical Development Small Molecules include:

  • Provide vision and leadership to establish clear goals and expectations of the department in alignment with portfolio and corporate objectives. Is a member of the Small Molecule Development leadership team
  • Develop, implement, and monitor practices, policies and strategies for the department to support the small molecule portfolio. Ensure that projects receive necessary resources and scientific support. Efficiently partner with other departments locally and globally
  • Develop and implement short, mid, and long term strategies to ensure scientific excellence, state-of-the-art technologies, and regulatory compliance. Ensure balanced investments (internal and external collaborations) for formulation development technologies to enable the Roche portfolio
  • Initiate and promote technical relationships to develop technical networking in maintaining knowledge of industry practices and communicate and/or applies new advances in the field. Influence evolving regulatory standards through participation in professional and trade organizations
  • Ensure and monitor laboratory compliance with current Good Manufacturing Practices (cGMPs), Standard Operating Procedures (SOPs) and regulatory requirements for development and line-extension projects. Ensure technical training of personnel is current and that laboratories are using current and state-of-the-art methods in accord with industry and regulatory standards.  Ensure proper qualification, validation, and maintenance of all equipment
  • Provide professional development opportunities for all personnel. Manage performance and provide opportunities for personnel/professional growth
  • Manage a portfolio of projects and apply broad knowledge of drug product development to decision making and problem solving while managing expense, capital, and grant budgets to ensure smooth operation of the department
  • Who you are
    You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

    The successful candidate will meet the following qualifications:

    • Ph.D degree in scientific / engineering discipline, or equivalent with a minimum of 15 years of pharmaceutical industry experience
    • Proven track record of leading a major technical organization. Strong knowledge and experience in leading drug product and process development
    • Demonstrated skills and knowledge in drug development with thorough knowledge of GLP, cGMP, and regulatory requirements
    • Ability to manage multiple projects and a multidisciplinary scientific staff
    • Extensive experience in relevant QIMPD, IND, and NDA regulatory documentation
    • Proven skills in recruiting and developing world class staff and building effective teams
    • Demonstrated ability to lead innovation and change and drive for results
  • Who we are
    Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 8,500 people from approximately 90 countries work in Basel, which is one of Roche`s largest sites. Read more.

    Roche is an equal opportunity employer.
  • Job facts
    • Location Switzerland, Basel-Town, Basel
    • Function Production & Manufacturing
    • Subfunction Management Production
    • Schedule Full-time
    • Job level Manager with Direct Reports
    • Job type Regular Employee
    • Division Roche Pharmaceuticals
    • Date 2016/06/28
    • Job-ID 2524157007
  • Get in touch
    Lisa Zelmel+41 61 687 96 49
    Work place: Basel