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Senior Formulation Development Manager
hace 2 semanas
Your mission
The Senior Formulation Development Manager will be responsible to lead and manage all the formulation and process development activities within the Pharmaceutical Development Department.
As Senior Formulation Development Manager you will lead a team of Senior Scientists in the formulation development of new products (New Chemical Entities) and reformulation of products already marketed.
Responsibilities
- Lead, coordinate, and manage the formulation development team, composed for five people (scientists and technicians), in carrying out drug development activities, from pre-formulation, selection, optimization, and scale-up to the industrial plant, in order to ensure the proper progress of projects.
- Hands-on scientific and technical knowledge applied to excipients, formulation and manufacturing processes for the proper identification of CMAs (critical material attributes) and CPPs (critical process parameters).
- Ensure that formulation development activities are conducted in accordance with ICH Q8 (Quality by Design), ICH Q9 (Risk Assessment), and ICH Q10 (Quality Control) guidelines, as well as internal standard operating procedures, current good manufacturing practices, and health and safety requirements.
- Guarantee that formulation development data generated during development are enough for regulatory filings of NDA/ANDA in USA and also EU and current regulatory guidelines. Write or review formulation and manufacturing development sections for the regulatory filings.
- Ensure that Pilot Plant facilities and equipment are adequate, qualified/calibrated as needed, and safe. Ensure that all the staff is adequately trained and updated.
- Control the schedule and planning of formulation development activities with defined deadlines, ensuring that resources are allocated effectively and that formulation tasks are completed on time.
- Work closely with the Analytical Development Team on key aspects of the pharmaceutical development.
- Lead, supervise and collaborate with other involved areas of the company, in all the activities related to ensure the correct progress project.
Why Ferrer?
- Make a positive impact in society
- Participate in volunteering activities
- Grow in a culture of trust, responsibility, and constructive feedback
- Enjoy a flexible working model & collaborative office experience to enable innovation and teamworking
- Make a real difference to the team and to yourself
- Take advantage of opportunities for development & learning
- Discover a range of benefits to support your physical, emotional and financial wellbeing
- Customize your remuneration and benefit
What you'll need to succeed
You will rock at this company if you are a person with empathy, humility, curiosity and optimism and you want to fight for Social Justice.
You will rock at this role if you match with:
Background and experience:
- MS/PhD degree in Pharmaceutical Sciences or equivalent.
- At least, 15 years of experience in formulation development activities from early development to late scale.
- At least 7 years of leadership experience at the formulation departments and/or larger team level, including recruiting/coaching high performing teams.
- Proven Leadership ability.
- Strong background in formulation and process development, specially of solid oral dosage forms, liquid formulations (solution and suspensions) and injectables. Highly valuable hands-on experience with poorly soluble compounds and modified release technologies.
- Proven track record of successful formulation development and Innovation skills.
- Working understanding of GMP and regulatory guidelines applicable to the products development.
- Experience with EMA and other regulatory Agencies in regulatory filings, deficiencies letters and clarifications.
Skills and competencies:
- Proven ability to manage different projects simultaneously.
- Good and clear communication skills, verbal and written.
- Teamwork and collaboration.
- Able to work in a dynamic environment.
- Flexibility and adaptability to changes.
- Efficiency and optimization mindset.
- Highly motivated, creative and curious scientist interested in implementing and explore new technologies, innovation mentality.
If this great challenge matches your profile, then we are waiting for you
At Ferrer, we guarantee equal treatment and opportunities in recruitment, avoiding prejudices and stereotypes for any reason in the processes of access to the company, assessing only objective criteria such as professional and academic skills and work experience.
