Asklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicines that can potentially cure genetic diseases has never wavered. At AskBio, we’ve built a foundation of therapeutic programs, AAV manufacturing and a rich portfolio of patented technology. Our therapeutic focus includes neuromuscular, central nervous system, cardiovascular and metabolic diseases with clinical trials underway for Pompe disease, Parkinson’s disease, and congestive heart failure. Our gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library. We became a wholly-owned, independently operated, subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy (CGT) platform. Our global headquarters is in Research Triangle Park, NC. Additionally, we have significant operations in Philadelphia, PA, Columbus, OH, Scotland, France, and Spain. 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. AskBio 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 AskBio’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 AskBio’s contract manufacturing facility. Additionally, this position will be responsible for performing Phase III clinical 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. Responsibilities Facilitate the transfer of several unit operations of small-scale processes from Process Development into the MSAT laboratory and cGMP production to demonstrate successful knowledge transfer. Follow Design of experiment (DOE) methodology using JMP Statistical Software to execute and analyze experiments to optimize one or more process steps. Perform and analyze risk-based process characterization experiments to define the process control strategy for PPQ. Execute studies to qualify small-scale models that are predictive of clinical manufacturing. Author technical protocols and reports to support experimental work while maintaining organized electronic laboratory notebooks. Provide effective communication of experimental results in technical presentations with internal stakeholders. Execute manufacturing and MSAT investigations by contributing technical expertise to the root-cause analysis and driving factor inclusion/exclusion based on data evidence to drive issue resolution. Support the maintenance of the laboratory in a clean, organized, and efficient working order. Responsible for routine preventative maintenance/calibration of instruments/equipment. Responsible for materials supply and management for experiments. Requirements Master’s Degree in Biology, Chemistry, Biochemistry, Chemical Engineering or related field and 1 years of Biopharmaceutical Experience, or Bachelor’s Degree in Biology, Chemistry, Biochemistry, Chemical Engineering or related field and 2 years of Biopharmaceutical Experience Upstream and/or downstream biomanufacturing experience with a foundational understanding of cGMP manufacturing operations. Excellent written and verbal communication skills, with experience interacting with a range of internal stakeholders. Proficiency in using Microsoft Office Suite (Word, Excel, PowerPoint). Able to travel, domestic and international, up to ~10%. Preferred Experience Familiarity with JMP Statistical Software and Design of Experiments (DOE). Familiarity with PPQ and/or Process Validation principles and practices. Design Process Characterization studies with limited oversight. Working knowledge of cGMP Biomanufacturing. Demonstrated problem-solving and analytical skills, with the ability to troubleshoot technical issues. The ideal candidate will be: A motivated, organized, and disciplined individual who strives to be part of a best in-class, collaborative tech transfer team. Enjoys learning and working in a fast-paced, highly interactive environment. Interested in becoming proficient in upstream and downstream biomanufacturing operations including process scale-up, tech transfer, process characterization, and developing process control strategies. An individual with a continuous improvement mindset, and who aims to optimize process operations and performance via ability to seek out solutions. Willing to travel, domestic and international, up to ~10%. Asklepios BioPharmaceutical, Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job‐related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at (919) 561-6210 or sending us an email at careers@askbio.com. Agencies: Please do not contact any employee at AskBio about this requisition. Any resume submitted by a recruitment agency to any employee at AskBio, through any medium, will be deemed the sole property of AskBio unless the agency was engaged by AskBio Talent Acquisition team to recruit for that position. All agencies must have a prior executed service agreement with AskBio prior to any search engagement. If a candidate who was submitted outside of the AskBio agency process is hired by AskBio, no fee or payment of any kind will be paid to the agency. Asklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicines that can potentially cure genetic diseases has never wavered. At AskBio, we’ve built a foundation of therapeutic programs, AAV manufacturing and a rich portfolio of patented technology. Our therapeutic focus includes neuromuscular, central nervous system, cardiovascular and metabolic diseases with clinical trials underway for Pompe disease, Parkinson’s disease, and congestive heart failure. Our gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library. We became a wholly-owned, independently operated, subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy (CGT) platform. Our global headquarters is in Research Triangle Park, NC. Additionally, we have significant operations in Philadelphia, PA, Columbus, OH, Scotland, France, and Spain.