Head of Analytical & Formulation Development Transdermal Deliver Job in Monheim am Rhein, Germany

Head of Analytical & Formulation Development Transdermal Deliver Job Description

Our challenge. Your impact.

We aspire to be the Patient Centric global biopharmaceutical leader transforming the lives of people with severe diseases and need exceptional individuals to achieve this goal. We are looking for enthusiastic and talented professionals who thrive on challenge and change, who want to make a difference and deliver results.

We are currently seeking a Head of Transdermal Center of Expertise (m/f) as part of our Pharma Sciences Organization who can lead and support the colleagues in this unit as soon as possible.

Nature and Scope of this function and Transdermal Center of Expertise (TCE):

 

• Manage the TCE, as part of the Pharma Sciences Organization (PS).
• TCE has the primary responsibility for analytical and formulation development in the field of transdermal delivery systems.
• TCE is also in charge of all commercial product support required to maintain a high quality supply of the products to the patients.
• TCE should be developed as integrated function within Pharma Sciences for other CMC development activities as well.

• Ensure successful management of the TCE through staff performance management, including updating of position descriptions, performing objectives setting, conducting performance reviews (mainly for excempt coworkers) and ensuring training in the necessary quality environment.
• To maintain and develop appropriate competence and resources, and to support career development and coaching for the staff, especially to fulfill their roles as members of the technical satellite teams.
• To facilitate and enable the achievement of targets and milestones of projects assigned to TCE, to support the establishment of new projects in TCE, and contribute in establishing longterm plans for PS
• Budget management (OPEX and CAPEX) in order to maintain financial control of the TCE budget and to achieve PS objectives.
• To support the analytical teams in TCE in order to take accountability for the development and validation of robust and efficient test methods, performing release and stability of drug substance and drug product, and supporting drug product development activities. The analytical teams are also responsible for establishing improvements in analytical technology to provide a better understanding of the products and processes, for transferring methodology, technology, and data, and for preparing regulatory submissions with its business partners.
• To enable the formulation team in TCE in order to take accountability for the development of appropriate formulations, products and processes, for appropriate manufacturing of formulations and products internally and externally, and for supporting validation and transfer of the manufacturing process according to agreed objectives, plans, procedures and quality standards.
• To support the preparation of technical documents in line with authorities requirements and interacting with regulatory affairs and regulatory agencies to drive successful applications.
• Driving and ensuring the support of departmental needs such as SOP writing, trainings, KPI tracking, CAPA tracking, introduction of new software systems, qualification and validation of equipment etc., and to deliver according to the PS Balance Score Card.
• Working with the Quality Division to ensure compliance with all appropriate regulations and SOPs and with HSE to ensure application of all necessary safety regulations.

Head of Analytical & Formulation Development Transdermal Deliver Job Requirements

Your qualifications for this position:

• You are a Pharmacists or Chemist by training with profound expertise in pharmaceutical development (both analytical development and drug product development)
• Strong experience in a GMP regulated environment, experience in both R&D and commercial areas of the pharmaceutical industry desirable.
• Highly knowledgeable in regulatory and technical requirements of the pharmaceutical industry.
• Experience in interacting directly with global regulatory agencies and with regulatory review staff on submission issues is desirable.
• Expertise in analytical testing of drug substance and drug product for clinical release, stability testing and pharmaceutical development.
• Experience in formulation development activities.
• Expertise in outsourcing.
• Solid management experience to lead larger and interdisciplinary teams (25-50 co-workers). Ability to evaluate staffing and equipment needs versus project workload is essential. Ability to build and lead larger teams.
• Ability to manage multiple high-level priorities and relationships. Must have demonstrated ability to delegate efficiently. Requires the ability to validate decisions taken at lower levels by utilizing strong analytical, troubleshooting and problem solving mindset.
• High administrative / organizational skills and actively following up on routine administrative tasks.
• Excellent interpersonal, verbal, and written communication skills are required, with ability to balance multiple priorities, provide leadership and prioritization, and work with minimal supervision.

Head of Analytical & Formulation Development Transdermal Deliver Application Information

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Head of Analytical & Formulation Development Transdermal Deliver Summary

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