Associate Director, Manufacturing Science and Technology (MSAT) -Upstream

Company: AskBio Asklepios BioPharmaceutical, Inc.
Location: Durham
Posted on: May 28, 2023

Job Description:

Associate Director, Manufacturing Science and Technology (MSAT) -Upstream page is loaded Associate Director, Manufacturing Science and Technology (MSAT) -Upstream Apply locations Durham, NC time type Full time posted on Posted Yesterday job requisition id R23-157 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.About the Role:The -Associate Director, Manufacturing Science and Technology (MSAT) - Upstream will be responsible for Upstream aspects of tech transfer, readiness, and implementation of AskBio's portfolio of gene therapy products into cGMP manufacturing from clinical production through commercial launch. The scope of the role includes manufacturing technology implementation and technical stewardship, technology transfer at GMP manufacturing scale, process optimization, process characterization & validation, and commercial process life cycle management across drug substance and drug product manufacturing technology, including packaging and device technology support. This position will work closely with Process and Analytical Development, Quality Control, Quality Assurance, Manufacturing & Supply Chain, and Regulatory teams, both within AskBio and with AskBio's manufacturing partners to define global process technology and manufacturing strategies, ensuring continuity of supply and adherence with global regulations and standards. Responsibilities & Accountabilities:
    • Responsible for Upstream process definition, qualification, technical support for AskBio's late stage clinical and commercial gene therapy product portfolio.
    • Support all aspects of process validation including: process risk assessments, process characterization, process performance qualification (PPQ) preparation and execution, validation master plans, risk assessments, protocols and reports, and establishment of continued process verification.
    • Partner with process development and manufacturing on platform development, technology selection and innovation, scale-up, and manufacturability.
    • Collaborate to refine the technical transfer process to support at-scale transfer of manufacturing processes between manufacturing partners and locations. Author and review Upstream CMC sections of regulatory filings and support the CMC review of regulatory submissions, manufacturing site inspections and health authority inquiries.
    • Collaborate to develop systems and procedures to enable proactive process monitoring, develop and implement platform analysis, interpret and report manufacturing process data and make recommendations for improvement.
    • Initiate and execute continuous improvement projects, in partnership with external manufacturing partners where applicable, to improve manufacturability, reliability, yield and cost.
    • Support equipment and reagent supplier technical evaluations, risk assessments, and raw material evaluation and qualification.
    • Provide MSAT team support for critical manufacturing investigations and technical oversight of deviations, change controls and CAPA's.
    • Assess, communicate, and mitigate key manufacturing and manufacturing technology risks.About you: Required Education and Experience
      • BS in a Life Sciences, Chemistry, or Engineering discipline; MS or PhD, preferred.
      • 7+ years manufacturing technology experience and 5+ years technical team leadership; experience with viral vector manufacturing is strongly preferred.
      • 2+ years of experience in one or more CMC functions.
      • Significant experience in Upstream biomanufacturing aspects including materials selection and qualification, cell bank management, bioreactors, harvest, recovery, filtration and process analytics.
      • Prior CMC experience with pre-approval and post-approval activities for a biologic or gene therapy product is preferred.
      • Experience contributing to platform development and technology transfer programs with internal or external partners is preferred.
      • Product life cycle monitoring and management experience with biologic or gene therapy products is preferred.
      • Knowledge of US and international regulatory standards and ICH guidelines.
      • Excellent written and verbal communication skills with the ability to communicate effectively across a number of disciplines and experience levels.
      • Strong attention to detail, highly organized and the ability to multitask in a fast-paced, highly interactive environment.
      • Demonstrated ability to forge strong partnerships with internal and external partners.
      • Able to travel, domestic and international, up to -10%. Preferred Experience and Skills
        • Advanced degree preferred (MS or PhD)
        • Prior experience in manufacturing technology of gene therapy products is strongly preferred.
        • Prior experience and / or certification in a continuous improvement methodology (e.g. Six Sigma) is preferred
        • Experience using data management systems, analysis, and reporting tools is preferred.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. Similar Jobs (1) Associate Director, Manufacturing Science and Technology (MSAT) - Downstream locations Durham, NC time type Full time posted on Posted Yesterday About Us 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.

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