Scientist, Engineering

** Job Description*
* ** Position

Description:

*
* The Bioprocess Drug Substance and Commercialization (BDSC) group within our Manufacturing Division focuses on late-stage process development, technology transfer, and in-line support of biologics. We seek a motivated scientist/engineer to work under technical direction of a group leader to support development and licensure. In this role, you will be responsible for:

** Primary Responsibilities*
* + Leading the hands-on execution of experiments in biologics downstream processing, including lab-scale process characterization, pilot-scale process development, and process scale-up/scale-down model development

+ Collaborating 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

+ Authoring and/or reviewing technical documents to support Process Performance Qualification (PPQ) and licensure

** Position Qualifications**  **:*
* ** Education Minimum Requirement:*
* + Bachelor's Degree or higher in Chemical Engineering, Chemistry, Biology or comparable discipline with 2+ years of experience.

** Required

Experience and Skills:

*
* + Significant 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 unit operations

+ Mechanistic understanding of downstream processing separation sciences

+ Ability to understand and 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 and Skills:

*
* + Large molecule drug substance technology transfer

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

+ 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 #Vet Jobs

*
* Required Skills:

*
* Clinical Manufacturing, Data Analysis, Detail-Oriented, Downstream Process Development, Experimentation, Good Manufacturing Practices (GMP), Interdisciplinary Collaboration, Technical Writing, Technology Transfer, Writing Technical Documents

** Preferred

Skills:

*
* 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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The salary range for this role is

$87,300.00 - $

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays,…