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ProBio · 2 days ago

(Sr). Scientist, Downstream Process Development

Pennington, NJ

Full-time

Onsite

Mid, Senior Level

$80K/yr - $110K/yr

3+ years exp

ProBio is a company that provides end-to-end CDMO services in the biotechnology sector. The Senior Scientist in Downstream Process Development will support and lead the translation of research processes to GMP-compliant manufacturing, focusing on the development and optimization of viral vector manufacturing processes.

BiopharmaBiotechnologyLife ScienceMedicalPharmaceutical

H1B Sponsor Likely

Responsibilities

Hands-on experimental work in the development and optimization of downstream unit operations (TFF, Affinity/Ion Exchange/multimodal Chromatography, Viral clearance, Sterile filtration, etc.) for viral vector manufacturing process

Contribute to the planning, design, and execution of AAV/LVV purification-related experiments to analyze, interpret, and report data summary packages

Interact and collaborate with internal/external partnerships to evaluate and implement new bioprocessing technologies and strategies

Interact with cross functional teams (Analytic team, MFG, Supply chain, Facility, QA, QC) to support process technology transfer, cGMP risk evaluation, and deviation management

Maintain and follow detailed and comprehensive project timelines

Support in the preparation of CMC sections for regulatory submissions (IND, Annual Reports, and BLA), invention disclosures, progress reports, and publications

Present updates to project or upper management teams on process development and manufacturing support activities

Read and understand scientific literature in gene and cell therapy. Use the knowledge to generate ideas and contribute to process design and development

Perform other duties as assigned based on business needs

Qualification

Viral vector process developmentDownstream unit operationsProcess scale-up modelingDesign of Experiment (DOE)CMC regulatory affairsVerbalOrganizational skillsInterpersonal skillsCollaborationTeamworkWritten communication

Required

Bachelor's degree with 3-7 years, or Master's or Ph.D. degree with 1-3 years' relevant industry experience in Chemical/Biochemical Engineering, Biological Sciences, or a related scientific discipline in biotech development with particular experience in gene and cell therapy product design

Strong understanding of process scale-up and scale-down modeling

Good understanding of Design of Experiment (DOE) and statistical analysis

Strong organizational skills and detailed documentation abilities are required

Work independently in hands-on laboratory setting, self-motivated to learn and develop new techniques

Strong interpersonal, verbal, and written communication skills

Results oriented, be able to effectively prioritize and complete tasks on time

Collaboration and teamwork

Must be comfortable in a fast-paced, multi-tasking biotech environment

Preferred

Experience with LVV and AAV process development is a plus

Previous experience in viral vector process development and manufacturing is highly preferred

Experience in CMC regulatory affairs for FDA, and EMA is a plus

Company

ProBio

ProBio is a global contract development and manufacturing (CDMO) organization, which aims to accelerate the manufacturing of life-changing drugs, discover novel therapeutic targets, and develop innovative therapeutic approaches to manufacture best-in-class DNA, RNA, and protein-based therapeutics.

Founded in 2002

Pennington, New Jersey, USA

201-500 employees

https://probiocdmo.com/

H1B Sponsorship

ProBio has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (3)

2024 (8)