Associate Scientists Purification Process Development
Merck KGaA
 Billerica, MA

Job Title: Associate Scientists Purification Process Development

Job Location: EMD Serono Research & Development Institute (SRDI), Inc., 45A Middlesex Turnpike, Billerica, MA 01821

Responsibilities:

The Associate Scientist Purification Process Development duties will encompass the following:

  • Responsible for good laboratory practice (GLP) Toxicology drug substance production, which includes, protein purification, depth filtration, viral inactivation, nano-filtration, Ultrafiltration and Diafiltration (UF/DF), and biochemical and biophysical characterization of proteins;
  • Execute protein purification with affinity, size exclusion, ion exchange, and hydrophobic interaction chromatography using AKTA AVANT and MOBIUS Flexready purification skid;
  • Perform analyses including Sodium Dodecyl Sulfate-PolyAcrylamide Gel Electrophoresis (SDS-PAGE), Size Exclusion High Pressure Liquid Chromatography (SE-HPLC), Limulus Amoebocyte Lysate (LAL), host cell-DNA, host cell protein, as necessary;
  • Write and execute batch records and Standard Operating Procedures (SOPs) related to GLP protein production, and Research Operating Procedures (ROPs) for novel purifications;
  • 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 milligram 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;
  • Engage in small-scale studies and pilot scale purification studies; and
  • Apply design of experiments (DOE) methods to purification activities and analyze data for process characterization with JMP software.

Requirements & Qualifications:

  • Masters in biotechnology, biochemistry, medicinal chemistry, chemical engineering, or closely related, plus one (1) year of work experience in protein production in a setting that adheres to Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) regulations.

ALSO REQUIRED

  • Demonstrated ability with purification unit operations including nano-filtration, depth filtration, viral inactivation, chromatography, TFF UF/DF, AKTA, UNICORN, and HPLC systems gained through one (1) year of work experience;
  • Demonstrated ability with troubleshooting and maintenance of AKTA AVANT and Mobius FlexReady gained through (1) one year of work experience;
  • Demonstrated ability in protein purification via affinity, hydrophobic interaction (HIC), ion exchange (IEX), size exclusion (SEC), and mixed-mode chromatography gained through one (1) year of work experience;
  • Demonstrated knowledge and ability in biochemical characterization of proteins including analytical and biophysical techniques gained through one (1) year of work experience;
  • Demonstrated ability in chromatographic resin screening and process optimization gained through one (1) year of work experience; and
  • Demonstrated knowledge of design of experiments (DOE), compiling technical reports, and data analysis using statistical tool (JMP Software) gained through one (1) year of work experience.

All years of experience may be gained concurrently.

This position is eligible for the EMD SRDI, Inc. Employee Referral Program.

Qualified candidates should send resumes to:

EMD SRDI, Inc.

ATTN: Req #199733

400 Summit Drive

Burlington, MA 01803

Job Requisition ID: 199733

Location: Billerica

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.