Manager - Downstream Process Development - Plainville, United States - Lifelancer

Lifelancer Plainville, United States

6 days ago

Description

Job Description

Job Title: Manager - Downstream Process Development

Location/Division Specific Information: US - Massachusetts Plainville

How will you make an impact?

In Viral Vector Service BioProcess Sciences, we develop, characterize and scale-up bioprocesses for robust manufacture of viral vectors to help our clients deliver lifesaving therapies to patients.

As Downstream Process Lead, You will plan, design, implement, and document laboratory and tech transfer activities. You will also serve as domain expert in downstream processing for viral vector while supporting detailed transfer of processes from clients into Bioprocess Sciences lab. You will also be supporting tech transfer out to the cGMP manufacturing space.

This is a hands-on position. The ideal candidate shall have excellent lab skills, strong documentation skills, ability to analyze and interpret data to draw conclusions and make recommendations, and tight-knit partnership skills.

What will you do?

· Lead planning and execution of tech transfer, process development and scale up activities (both bench and pilot scale) and preparing summary reports/presentations.

· Review and author documents (development plans, batch records, SOPs, protocols, summary reports), including deviation and/or investigational reports.

· Lead multiple projects; handle project tasks and timelines

· Independently design experimental plans, perform studies, and analyze and report study results and recommendations both verbally and in written formats.

· Lead all aspects of downstream execution with members of the larger team while acting as a SME for downstream viral vector processing. Train junior team members.

· Interact with clients, ensures accurate data and presentations to presented to clients. Assist in preparing detailed process development reports for products at different phase.

· Support sourcing, purchase, installation, startup and calibration and maintenance of Process Development equipment.

· Collaborate with global BPS team, Quality, and Project Management teams to facilitate technology transfer and project success

· Lead Practical Process Improvement (PPI) initiatives

How will you get here?

Education

· B.S. in (bio)Chemical Engineering., Biochemistry, or related field with 8 yrs., Masters with 5 yrs., or Ph.D. with 3 yrs. of industrial experience including leadership experience.

Experience

· Design and execution of chromatography, tangential flow filtration, depth filtration, viral clearance, and ultracentrifugation studies to support scale up, development and characterization of gene therapy processes.

· Collaborate with Upstream and Analytical Testing/Development teams to build process understanding and design space

Knowledge, Skills, Abilities

· Strong practical knowledge of downstream purification of mammalian and insect cell culture processes

· Prior viral vector purification experience is desired

· Experience in scale up and scale down of purification processes.

· Understanding of cGMP and regulatory requirements of biopharmaceutical manufacturing.

· Strong interpersonal and communications skills; written and oral

· Experience with technology transfer, facility fit assessment, statistical analysis methodology and software (JMP or similar tools) is desired

· Ability to function in a fluid environment balance priorities.

· A flexible work schedule might be required (Weekends and nights as needed to support lab activities).

Please use the below link for job application and quicker response.

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