Associate Scientist Downstream Process Development

Posted 22 Jun 2017

Billerica, Massachusetts - United States

Req Id 164180

Details

A career with EMD Serono is an ongoing journey of discovery: our 50,000 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 Protein Science / Late Stage Downstream Processing (DSP) group, a core function that develops purification processes for late stage and produces drug substance for pre-clinical GLP Tox studies, is seeking motivated and experienced scientists to join our antibody discovery program at EMD Serono. Candidates will be primarily responsible for DSP production of GLP Tox drug substance but also for developing purification processes for a variety of therapeutic candidate proteins including monoclonal antibodies and Fc fusion proteins. Scope of work will include, but are not limited to, protein purification, biochemical and biophysical characterization of proteins, novel purification technologies, purification process development, data analysis and project reporting. Candidates should have experience in writing technical documents for process transfer to manufacturing. The candidate is expected to have excellent time management skills, with the ability to adapt to rapid changes in projects priorities and meeting aggressive timelines. These individuals should enjoy working in a team setting and be able to work well with research scientists, the manufacturing group as well as external collaborators.

Main Interfaces

Internally: The candidates will interact with other members of the Protein and Cell Sciences group as well as members of the Early discovery organizations and downstream process development manufacturing groups.

Externally: Candidates will foster relationships with non-EMD Serono personnel specialized in all aspects of protein expression/ purification under the guidance of the manager. Candidates will prepare and communicate results at external meetings, and in scientific publications.

Key Tasks & Responsibilities

  • Responsible for GLP Tox drug substance production, which includes, protein purification, nano-filtration, UF/DF, and biochemical and biophysical characterization of proteins:-
  • Execute protein purification with affinity, size exclusion, ion exchange, and hydrophobic interaction chromatography using a purification skid.
  • Perform analyses including SDS-PAGE, SE-HPLC, LAL, host cell-DNA, host cell protein, as necessary
  • Write and execute batch records and SOPs relate to GLP protein production
  • Provide expertise and insight to guide development of appropriate purification methods
  • Develop novel purification processes as well as using standard methods to purify proteins from the mg to gram scale. Processes will be multiple steps and must provide necessary clearance of viruses, endotoxin, and host cell proteins and DNA.
  • Perform, develop and optimize robust, efficient, scalable strategies for improving process performance. Activities will include small-scale studies and pilot scale purification studies.
  • Apply DOE methods to purification activities
  • Demonstrate ability to work effectively in teams, both within the group and cross-functionally
  • Scientists analyze and interpret data, and present/document the results at meetings
  • Provide reports and prepare scientific presentations as needed. Write/revise ROPs and technical reports.

Who you are:

  • MS/BS in biotechnology, biochemistry or engineering field. 
  • BS with minimum of 3 years, or MS with mininum of 1 year of industrial experience is required for the position.
  • Fluent in written and spoken English
  • Experience with protein production in a GLP setting or in GMP environment.
  • Solid and proven theoretical basis and hands-on experience in protein purification and analytical characterization.
  • Hands-on experience with purification unit operations including filtration, chromatography, TFF, UF/DF, AKTA, UNICORN and HPLC systems. Strong hands-on experience in troubleshooting and routine instrument maintenance.
  • Experienced in protein purification via affinity, hydrophobic interaction (HIC), ion exchange (IEX), size exclusion (SEC) and mixed-mode chromatography
  • Knowledge and skills in biochemical characterization of proteins including analytical and biophysical techniques. Experience with protein formulation strategies is highly desirable.
  • Proven track record in Purification Process Development is necessary with emphasis on chromatographic separations and excellent understanding of and experience with chromatographic resin screening and process optimization. Experience with scale-up and GMP manufacturing is desirable. 
  • Solid and proven working knowledge of DOE. Ability to critically analyze data using statistical tools and to compile technical reports
  • Strong interest in evaluating and developing new protein purification technologies is desirable.
  • Familiarity with mammalian, microbial and yeast protein expression is a plus.

PERSONAL SKILLS & COMPETENCIES

  • The ideal candidates will be self-motivated, have excellent organization and communication skills, and be able to function in a fast-paced environment, multi-task and handle multiple responsibilities.
  • He/ She must also have aseptic techniques, comply with safety rules, and have awareness of company’s quality standards. Candidates must be able to generate detailed written records of the work accomplished in a timely manner.
  • He/she must possess computer skills and knowledge of common software and database management. S/he must have strong interpersonal skills with the ability to work well within a fast-paced and team-oriented environment.

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.

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