Associate Scientist, Downstream - Biologics Drug Substance Commercialization

** Job Description*
* We aspire to be the premier research-intensive biopharmaceutical company. Our manufacturing division is at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases. We are seeking a motivated scientist/engineer to join our Bioprocess Drug Substance Commercialization (BDSC) group.

This role offers an exciting opportunity to work on late-stage process development, technology transfer, and in-line support of biologics.

** Responsibilities*
* + Execute hands-on experiments in biologics downstream processing, including lab-scale process characterization, pilot-scale process development, and process scale-up/scale-down model development.

+ Collaborate with commercial manufacturing teams as a process sciences representative to support facility start-up and in-line support activities, including on-the-floor support for drug substance manufacturing as needed.

+ Author and/or review technical documents to support Process Performance Qualification (PPQ) and licensure.

** Qualifications*
* _Required_

+ Bachelor's Degree or higher in Chemical Engineering, Chemistry, Biology or comparable discipline.

+ Experience executing lab activities, including authoring study protocols, planning and performing experiments, performing data analysis, and writing technical reports.

+ Ability to execute experiments independently in a manner that meets quality and timeline expectations.

+ Well-developed communication, organizational, and problem-solving skills, with an attention to detail.

_Preferred_

+

Experience with downstream processing of monoclonal antibody (mAb) products or similar products in a laboratory or manufacturing setting, including unit operations such as membrane filtration, preparative chromatography, ultrafiltration or tangential flow filtration, and viral clearance.

+ Large molecule drug substance technology transfer experience.

+ Collaboration with analytical teams, pilot-scale, and/or manufacturing environments.

+ Experience authoring technical documentation in support of the following: process description, process characterization, process performance qualification, risk assessment, control strategy, process comparability reports, and/or regulatory submissions.

+ Current Good Manufacturing Practice (cGMP) awareness or experience. #EBRG's #Vet Jobs

*
* Required Skills:

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* Analytical Chemistry, Analytical Chemistry, Biologics, Biology, Biomolecular Chemistry, Bioprocesses, Bioreactors, Biotechnology, Business Process Documentation, Centrifugation, Chemistry, Chromatographic Techniques, Clinical Manufacturing, Cross-Functional Teamwork, Data Analysis, Design of Experiments (DOE), Downstream Process Development, Downstream Processing, Evaluating New Technologies, Experimentation, Good Manufacturing Practices (GMP), High-Throughput Screening, Innovation, Laboratory Management, Laboratory Research {+ 9 more}

** Preferred

Skills:

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* Current Employees apply HERE ($6687.htmld)

Current Contingent Workers apply HERE ($4020.htmld)

** US and Puerto Rico Residents Only:*
* Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please  ()  if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

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