Supervisor of Upstream Process development

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POST DATE 9/14/2016
END DATE 10/13/2016

MilliporeSigma Rockville, MD

Company
MilliporeSigma
Job Classification
Full Time
Company Ref #
151641
AJE Ref #
576167296
Location
Rockville, MD
Experience
Entry Level (0 - 2 years)
Job Type
Regular
Education
Masters Degree

JOB DESCRIPTION

APPLY
Within the Biodevelopment Process Development group, manages the upstream team for process development or process validation projects (monoclonal antibodies or fusion-proteins) production using mammalian cells, support the implementation, coordination, development, and troubleshooting for the mammalian cell processes. Transfer & troubleshooting for mammalian production processes (media buffer preparation, cell culture & purification) until complete issues solving.



KEY RESPONSIBILITIES



* Drive client project execution according to budget and timelines given to the project team

* Design fit-for-purpose cell culture 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 upstream 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 upstream process development activities * Represent & promote E2E and Biodevelopment activities (presentations, congresses, events) * Technical lead on the overall projects (supervises upstream processes development and implementation of new methods and services)



EDUCATION AND EXPERIENCE



Engineering/Master degree (PhD preferred) in biotechnology with 5+years in the biopharmaceutical industry

Successful managerial experience

Hands-on experience in process development and manufacturing of monoclonal antibodies.

Knowledge of quality attributes of glyco-proteins a must.

Hands-on experience in process validation

Quality mindset and good understanding of Good Manufacturing Practices

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.