Principal Scientist Small Molecule Formulation Development

Posted 31 Jan 2019

Billerica, Massachusetts - United States

Req Id 187753

Details

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.


Your role:

The Principal Scientist is responsible for developing and implementing new and optimized procedures for preclinical CMC activities of new chemical entities (NCE) with a focus on candidate characterization and feasibility assessments for first in man (FIM) formulation development.

 

The selected candidate conducts both miniaturized formulation development as well as analytical characterization and control of small scale stability studies. They will prepare decision making on CMC strategy for the first clinical drug product, as well as develops and maintains cohesive relationships with local and global partners, including external contract research organizations.

 

  • Within the Pharmaceutical Technologies team, the selected candidate translates strategies for CMC related activities 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, leads discovery CMC teams and represents the Chemical & Pharmaceutical Development department in discovery 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-projects and activities in preclinical research and compound characterization reports. 

 

Who you are:

  • Ph.D. in Pharmaceutical Sciences or related field with 5 plus years of pharmaceutical formulation experience, MS with 10 plus years of experiences strongly preferred
  • Bachelor’s degree with 8 plus years of experience, master’s degree with 3 plus years of experience, or PhD degree in Pharmaceutical Sciences or related field required
  • 3 plus years of managerial experience preferred
  • Expert knowledge of pre-formulation for small molecules
  • Expert knowledge of small molecule pharmaceutical analytics, including liquid chromatography, mass spectrometry, stability assessments
  • Additional knowledge of biologics formulation and analytics is desired
  • Comprehensive understanding of the functional areas of research, development, manufacturing, analytics, characterization, sourcing and quality assurance in a pharmaceutical development and/or manufacturing environment
  • Demonstrated ability to collaborate with strong team-oriented skills
  • Proven ability to manage activities on multiple complex projects in parallel
  • Dedicated team player and customer orientation
  • Strong knowledge of quality systems for non-regulated research
  • Excellent communication skills
  • Fluent in English
  • Able to quickly establish and maintain excellent interpersonal relationships. Maintains positive, professional relationships with external contacts.
  • Able to operate independently. Manages time well, follows through on commitments and pays attention to details. Able to work on several complex projects simultaneously
  • Able to demonstrate unquestionable integrity, credibility and character. Has demonstrated high moral and ethical behavior
  • Able to work in uncharted areas. Challenges conventional wisdom when required. Strong project orientation


What we offer: With us, there are always opportunities to break new ground. We empower you to fulfill 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.

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