Manager - Downstream Process Development

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 scaleup 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 handson 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 tightknit 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.

Remote Work :

No