Within the Biodevelopment Process Development group, you will execute projects including developing, qualifying and transferring analytical and chromatographic methods for biotech molecules. You will execute client projects according to budget and timelines given to the project team. You will develop, qualify and transfer robust analytical methods required for successful drug development and manufacturing. You will lead experiment follow-up and troubleshooting on analytical methods. You will support process, pharmaceutical development and pre-formulation studies with chromatographic methods, technical expertise and solutions. You will compile and analyze experimental data to generate process knowledge and decide on next steps. You will write development and qualification reports and ensure their timely delivery. You will prepare and present project updates to global project team and to upper management.
· Apply consolidated knowledge on protein chemistry and direct experience on protein analysis by chromatographic, electrophoretic, spectroscopic and capillary techniques.
· Excellent knowledge of analytical development of analytical methods, qualification, tech transfer and applied statistics.
· Lead the biophysical characterization of proteins.
· Perform analyses including but not limited to CE-SDS, SE-HPLC, cIEF, LAL, host cell-DNA (qPCR), HCP, rPA, immunoassay and other biophysical/biochemical methods.
· Develop, qualify and tech transfer robust analytical methods required for successful drug development within process development to GMP manufacturing.
· To support follow-up and troubleshooting on analytical methods.
Who You Are:
· MS/PhD in chemistry, biochemistry or related biotechnology field with 3+ years in the biopharmaceutical industry.
· Solid and proven theoretical basis and hands-on experience in protein analytical method development and characterization.
· Proven track record in biochemical characterization of proteins including analytical and biophysical techniques.
· Ability to critically analyze data using statistical tools and to compile technical reports.
· Hands on experience in chromatographic and spectroscopic techniques applied to Biomolecules.
· Excellent presentation and communication skills
· Good knowledge on biotech processes development, and protein purification are nice to have.
· Experience with protein formulation strategies is highly desirable, including DOE.
· Results-oriented with ability to work and deliver under pressure in collaborative team environments.
Job Requisition ID: 207977
Career Level: C - Professional (1-3 years)
Working time model: full-time
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.
Nearest Major Market: Boston
Job Segment: Chemistry, Analytics, Biochemistry, Biotech, Scientist, Science, Management