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

• Lead the execution of 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

• Bachelors Degree or higher in Chemical Engineering Chemistry Biology or comparable discipline.

• 2 years of 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.

• Mechanistic understanding of downstream processing separation sciences.

• 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

• 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. #VetJobs #EBRGs

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The salary range for this role is

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 employees 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 vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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