A career with EMD Serono is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.
The Scientist Parenterals is responsible for driving preclinical CMC activities on new biological entities with a focus on candidate characterization feasibility assessments for first in human formulation development.
The selected candidate will conduct comprehensive miniaturized formulation development activities including control of stability studies and analytical characterization to drive evidence-based decision making on CMC strategy for the first clinical drug product. Careful assessment of stability data, drawing conclusions and presentation to CMC stakeholders in close partnership with their manager is required.
Development activities will address the current and future needs. Developing and maintaining trustful relationships at both local and global interfaces including partner lines such as protein and cell science and non-clinical safety is essential. Management of relationships with external contract research organizations or collaboration in academic partnerships may also be required.
Within the Parenterals Team, the selected candidate translates strategies for CMC related activities for biologics into implemented processes.
- Responsible for day-to-day internal and external pre-formulation, formulation and analytical development activities.
- Ensures a strong network with the local and global interfaces such as Discovery CMC teams and represent CMC in Development project teams.
- Maintains efficient, innovative and GRP-compliant internal and external CMC processes which provide fast path to decision points without compromising on quality and regulatory requirements.
- Active contribution to CMC-activities in preclinical research and candidate characterization reports.
Who you are:
- A Bachelor’s degree with 3 plus years or Master’s degree Pharmaceutical Sciences or related field required
- Advanced degree with 2 plus years of biopharmaceutical formulation experience strongly preferred
- Expert knowledge of biotherapeutic pre-formulation for injectables
- Expert knowledge of bio-pharmaceutical analytics, including liquid chromatography, electrophoresis and biophysical assessment of aggregation
- Understanding of the functional areas of Research and Development, good research practice in a pharmaceutical development environment
- Demonstrated ability to collaborate with strong team-oriented skills
- Proven ability to manage activities on multiple complex projects in parallel
- Written and verbal communication skills to facilitate information exchange with department and project stakeholders
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at come2emd.com
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.