Process Engineer II

Process Engineer II page is loaded## Process Engineer IIremote type:
Onsite locations:
Durham, NCtime type:
Full time posted on:
Posted 5 Days Agojob requisition :
R26-64

Ask Bio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson’s disease, and Pompe disease.

Ask Bio’s gene therapy platform includes Pro
10(TM), an industry-leading proprietary cell line manufacturing process, and an extensive array of capsids and promoters. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, Scotland, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre-clinical and clinical testing.
** Our vision:
** Pioneering science to create transformative molecular medicines.
** Our mission:
** Lead innovative science and drive clinical outcomes to transform people's lives.
** Our principles:
*** Advance innovative science by pushing boundaries.
* Bring transformative therapeutics to patients in need.
* Provide an environment for employees to reach their fullest potential.
** Our values:
*** Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.
* Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.
* Embrace Responsibility. We are humbled by the enormity of our mission.  We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers.
* Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action.
* Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what’s right in every situation. Make clear commitments and follow through.
** Position Summary
** Ask Bio is seeking a
** Manufacturing Science and Technology (MSAT)*
* ** Process Engineer II
** to join our Process Engineering team and support current and future commercialization efforts.  This position supports scale-up, technology transfer of Ask Bio’s portfolio of gene therapy products into cGMP manufacturing for clinical production, process validation and commercial launch.  The incumbent will onboard clinical programs into the MSAT laboratory, perform scale-up runs, and transfer programs to Ask Bio’s contract manufacturing facility.

Additionally, this position will be responsible for performing Phase III clinical enabling activities including scale-down model development and qualification, process characterization, and process control strategy definition to enable process performance qualification (PPQ) readiness for both drug substance and drug product manufacturing campaigns.  This position is highly collaborative and will require internal and external team interactions to ensure successful process scale-up, technology transfers, and cGMP manufacturing operations to ensure continuity of supply while adhering to global regulations and standards.

This role is based on-site at our RTP (Research Triangle Park) Headquarters in NC and reports to an Associate Director, MSAT.
** Job Responsibilities
*** Collaborate with cross-functional teams to transfer small-scale gene therapy processes from Process Development into the MSAT laboratory and subsequently perform scale-up and transfer to the cGMP manufacturing scale
* Perform process characterization experiments to generate robustness data and define the process control strategy for PPQ manufacturing campaigns. Contribute to process characterization experimental design and data analysis
* Develop and qualify small-scale models that are predictive of the cGMP manufacturing scale
* Author…