Supervisor of Downstream Process development
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POST DATE 9/14/2016
END DATE 10/13/2016
JOB DESCRIPTIONWithin the Biodevelopment Process Development group, will be primarily responsible 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. Drive client project execution according to budget and timelines given to the project team.
* Design fit-for-purpose purification experiments according to the stage of development
* Support staff for preparation of development and validation protocols to ensure proper execution of cell culture experiments within a defined quality framework
* Ensure scientific evaluation of impact of deviations to Downstream validation studies
* Compile and analyze experimental data to generate process knowledge and decide on next steps
* Write development and validation reports and ensure their timely delivery
* Prepare and present project updates to global project team and to upper management
* Ensure a continuous improvement within Downstream process development activities
* Represent & promote E2E and Biodevelopment activities (presentations, congresses, events)
* Technical lead on the overall projects (supervises Downstream processes development and implementation of new methods and services)
* Responsible for activities ranging from protein purification, filtration, biochemical and biophysical characterization of proteins:
* Execute routine protein purification with affinity, size exclusion, ion exchange, and hydrophobic interaction chromatography using AKTA systems (Unicorn software)
* Perform analyses including but not limited to SDS-PAGE, SE-HPLC, LAL, host cell-DNA, host cell protein, as necessary
* To develop, validate and transfer robust analytical methods required for successful drug development and manufacturing.
* To support follow-up and troubleshooting on analytical methods.
* 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.
EDUCATION AND EXPERIENCE
* Engineering/Master degree (PhD preferred) in biotechnology with 5+ years in the biopharmaceutical industry
* Successful managerial experience
* 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
* Excellent presentation and communication skills
* Results-oriented with ability to work and deliver under pressure
* Excellent English (written, oral)
MilliporeSigma is the North American life science brand of Merck KGaA, Darmstadt, Germany a leading science and technology company. It offers a broad range of innovative products and services to biotech and pharmaceutical drug therapies businesses. Through dedicated collaboration with the scientific and engineering communities, and as one of the top three R&D investors in the life science tools industry, the brand serves as a strategic partner to customers and helps advance the promise of life science.
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.