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Senior Scientist for Analytical Development (NCE) (all genders)

Your role:

You take over project responsibility as analytical development expert in CMC teams for new chemical entities (NCE) from phase 0 to clinical phase III. You work within a GMP environment, assess the quality of drug substance and drug product intended for use in clinical trials and act as “Head of Quality Control” according to German and EU legislation. Furthermore you develop quality relevant specifications for drug substances and products, be responsible for structure elucidation of impurities, setup and monitoring of stability studies. You coordinate and drive the scientific strategy for the analytical method development of new drug substances and drug products. Application and continuous development of  the QbD concept during the product design phase as described in ICH Q8 and ICH Q11 as overarching paradigm of the product lifecycle. You assure a comprehensive understanding of the chemical and physical nature of the individual active substance(s) and excipients, and of the way their attributes interact in the formulation and how they are impacted by the manufacturing process. You cooperate within interdisciplinary and international teams, especially with other functions of chemical and pharmaceutical development and global pharma operations. You collaborate closely with contract manufacturing organizations (CMOs): Evaluate capabilities of CMOs and manage projects in cooperation with CMOs. Review and contribute to regulatory documents intended for submission to Health Authorities. You ensure launch readiness for all analytical activities including transfer of methods to commercial organizations.

 

Who you are:

- Scientific degree (pharmacy, chemistry or similar) with an emphasis on analytical science preferably with PhD

- Broad expertise in analytical technologies and their field of application for testing of NCEs (drug substance and drug product)

- Ideally 2-3 years of experience in the pharmaceutical industry

- Demonstrated knowledge in application of ICH Q8, Q9, Q10, and Q11 concepts in Pharmaceutical Development

- Knowledge of current quality and regulatory requirements relevant for NCE development

- Very good communication skills, both written and oral in English and German

- Excellent organizational skills, reliable teamplayer

- Highly motivated and results-orientated, willingness to take on responsibility

 

Job Requisition ID:  196853
Location:  Darmstadt
Career Level:  C - Professional (1-3 years)
Working time model:  full-time

US Disclosure
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 their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


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