Scientist I/II, PD Downstream jobs in United States
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PackGene Biotech, Inc. · 2 days ago

Scientist I/II, PD Downstream

PackGene Biotech, Inc. is a leader in gene therapy product development, striving to make gene therapy accessible to more patients. The Scientist I/II, PD Downstream role involves planning and executing lab operations, performing downstream unit operations, and serving as a subject matter expert in viral vector processes.

BiotechnologyHealth Care
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H1B Sponsor Likelynote

Responsibilities

Participate in planning and hands-on execution of lab operation activities, including new equipment acquisition, training and maintenance
Hands-on execution of downstream unit operations such as clarification and filtration, tangential flow filtration (TFF), chromatography purification with AKTA system and ultracentrifugation unit operations
Downstream process development and operation experience of viral vectors or protein/antibody therapeutics is strongly preferred
Maintain a high level of technical acumen in the field of viral vector downstream process
Participate in client meetings and serve as a downstream process subject matter expert (SME)
Work with a cross-functional team to perform technology transfer of downstream procedures into GMP
Ability to pass gowning training and support GMP operations in cleanrooms
Design and execute downstream development studies, involving suspension and adherence platform process. Occasional weekend work may be required
Perform timely data acquisition, analysis and troubleshooting; report project progress in cross-functional team meetings
Ability to troubleshoot process and equipment, and support deviation investigations and make scientifically sound decisions
Draft and review technical documents such as protocols, technical reports, and risk assessments
Ability to perform scientific review of master batch records and SOPs
Ability to create and review Unicorn methods for accuracy
Ensure timeline adherence
Coach of junior associates on experimental rationale, design, execution and troubleshooting
High level of accountability, integrity and communication; foster a culture of collaboration, trust, and teamwork
Build strong and cohesive working relationships with colleagues from other teams to accomplish company goals

Qualification

Downstream process developmentViral vector experienceGMP knowledgeDesign of Experiments (DOE)Biologics developmentMS Office proficiencyMultitaskingCross-functional teamworkProblem-solvingCommunication

Required

Ph.D. or M.S. in Biology, Biotechnology, Engineering, or other gene therapy-related field
1-4+ years for Ph.D. or 4-8 years for M.S. of industrial experience in Biologics development, including protein, antibody, and viral vectors (AAV, or lentiviral vector)
Proficient in QbD based approach utilizing Design of Experiments (DOE)
Working knowledge of GMP, FDA-regulated industry
Demonstrated ability to work cross functionally in multi-disciplinary teamwork
Proficient in MS Office suites of products
Ability to multitask, prioritize work independently
Capable of analyzing problems and finding solutions
Ability to work under pressure while maintaining a professional manner
Ability to pass gowning training and support GMP operations in cleanrooms
High level of accountability, integrity and communication; foster a culture of collaboration, trust, and teamwork

Preferred

Downstream process development and operation experience of viral vectors or protein/antibody therapeutics is strongly preferred

Company

PackGene Biotech, Inc.

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PackGene is a world-leading AAV vector packaging CRO and CDMO. Founded in Massachusetts, USA, PackGene now has offices in Boston, Houston and Zurich.

H1B Sponsorship

PackGene Biotech, Inc. 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 (1)
2023 (1)
2021 (1)

Funding

Current Stage
Growth Stage
Total Funding
$14.14M
Key Investors
CMG-SDIC Capital ManagementCMB International Capital CorporationHSG
2023-12-01Series C· $14.14M
2023-04-18Series C
2021-04-07Series C

Leadership Team

H
Huapeng Li
Founder, Chairman and General Manager
Company data provided by crunchbase