We are currently looking for a talented R&D CMC Manager. The successful candidate must have proven experience in CMC and formulation development. Knowledge of Inhalation and/or Bioanalytical would be a strong asset. The candidate must have good understanding of the product development process from formulation to registered batches manufacturing, and the regulatory requirements allowing successful registration with the authorities. Given that most of the new developments are targeted for the EU&USA, experience with EMA&FDA requirements is a must.
• Pharmaceutical development, including formulation and analytical aspects, i.e. Chemistry, Manufacturing and Control (CMC)
• Bioanalytical development and analysis
• Liaise with and participate in medical device (inhaler) development (drug-device combinations)
- Undertake the full responsibilities for the CMC activities and for the development of products (planning, coordinating and supervising the activities of products developed by external centres and reporting their progress to the Management, other departments and partners), including all analytical development
- Work closely with key functions, especially within R&D department, to ensure that Aquilon’s project teams have enough information to make appropriate decisions on program milestones and next steps
- Ensure that R&D department meets the timelines and manage delays, negotiate delivery time and cater efficient information flow between internal and external teams
- Negotiate and establish planning for Project budgets, and assess appropriate project scopes
- Ensure proper documentation of the pharmaceutical, (bio)analytical and medical device development to meet the corresponding regulatory and GMP/GLP requirements
- Ensure Contract Development and Manufacturing Organization (CDMO) selection according to each product needs
- Have a global oversight of pharmaceutical activities, including the work of third parties, and ensure proper documentation
- Have a global oversight of the analytical and bioanalytical method development aspects to support pharmaceutical development, as well as nonclinical and clinical development
- Strong educational background (MSc or higher in life science)
- Course in Project Management is appreciated
- At least 4 years’ experience the pharmaceutical industry, specifically in R&D department
- Strong interpersonal skills with the ability to influence others in a positive and effective manner
- Demonstrated ability to contribute to a continuous learning and process improvement environment
- Proven track record in product management or equivalent with knowledge of product management techniques and tools.
- Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies
- Ability to understand and analyse scientific data and results, and review scientific documents including drug development reports, publications and regulatory submissions
- Strategic thinking, strong problem-solving and analytical skills
- Understanding the scientific principles and regulatory requirements
- Communication and motivation skills
- Strong sense of planning and prioritization
- Good understanding of, and respect for, cultural differences, and capacity to work effectively in a multicultural environment
- Fluent in English, both written and oral, French and Dutch are extra assets
The company offers an entrepreneurial and stimulating working environment in an ambitious and dynamic biotech company, working with top entrepreneurs and innovators in the biotech industry.
You will have freedom to shape your work and shape your job.
Next to a competitive salary and benefits package, we offer you the chance to grow and be a team driven by innovation and science to develop new therapies
For more information please contact me at: +31 (0)20 20 44 502 or firstname.lastname@example.org.