Associate Director, MSAT - Durham, United States - Asklepios Biopharmaceutical

Description

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 Pro10TM, 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.

The Associate Director, Manufacturing Science and Technology (MSAT) will be responsible for 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, small scale model development, process characterization & validation, and commercial process life cycle management across drug substance and drug product manufacturing, 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. This role will sit onsite in our RTP Headquarters in NC.

Responsibilities & Accountabilities:

• Mentor and guide cross-functional team(s) on all aspects of Technology Transfer of gene therapy processes from Process Development into the MSAT laboratory and then into cGMP production.
• Use your knowledge of the Design of experiment (DOE) methodology to design optimization programs and guide teams as they manage process optimization campaigns.
• Develop a strategy for a risk-based small scale model development campaign that is predictive of manufacturing and enables process characterization.
• Mentor teams on the development of a risk-based process characterization campaign that maximizes value for studies results in data to support a PPQ-ready process control strategy.
• Lead the PPQ/Process Validation campaign for an AskBio gene therapy product including preparation of validation master plans, risk assessments, protocols and reports. Provide oversight of PPQ and Process Validation execution.
• Lead the development of a Continuous Process Verification Campaign for an AskBio gene therapy product including establishing trending, and annual reporting systems.
• Use your upstream and/or downstream biomanufacturing experience and technical understanding of cGMP manufacturing operations to design and guide continuous improvement projects, in partnership with process development and external manufacturing in order to improve manufacturability, reliability, yield and cost.
• Support equipment and reagent supplier technical evaluations, risk assessments, and raw material evaluation and qualification.
• Set standards for technical protocols and reports to support experimental work while ensuring your team maintains organized electronic laboratory notebooks. Review and approve documents and ensure suites of documents are suitably aligned.
• Provide effective communication of experimental results in technical presentations with internal and external stakeholders including communication to senior leadership, corporate functions, and external parties.
• Set standards for and give technical oversight of investigations into process deviations by employing robust quality risk management methodologies to guide resolution and implement corrective actions by leveraging a data-driven approach. Design and establish sustainable CAPAs as needed.
• Ensure the laboratory is clean, organized and maintained in an efficient working order. Ensure supplies and materials for experiments are properly planned and support proper scheduling of laboratory work.

Requirements:

• Master's Degree in a Life Sciences, Chemistry, Engineering or related discipline and 8+ years of manufacturing technology experience including 3+ years technical team leadership experience OR Bachelor's Degree in a Life Sciences, Chemistry, Engineering or related discipline.
• 10+ years of manufacturing technology experience including 3+ years technical team leadership experience.
• 2+ years of experience in one or more CMC functions.
• Significant experience in Upstream and/or Downstream biomanufacturing including aspects such as materials selection and qualification, cell bank management, bioreactors, harvest, recovery, filtration, process analytics. Experience should span platform development, technology transfer, Process Validation, and commercial process monitoring.
• Experience leading one or more PPQ/Process Validation campaigns including preparation and execution, validation master plans, risk assessments, protocols and reports.
• Proficiency with statistical analysis software such as JMP.
• Knowledge of US and international regulatory standards and ICH guidelines and substantial experience authoring and/or contributing to regulatory submissions.
• Significant regulatory inspection experience as an SME, or contributor.
• Excellent written and verbal communication skills with the ability to communicate effectively across several disciplines and experience levels.
• Strong attention to detail, highly organized and the ability to multitask in a fast-paced, highly interactive environment.
• Proven track record of leading cross-functional collaborations to improve business processes.
• Able to travel, domestic and international, up to ~10%.

Preferred Experience and Skills:

• Advanced degree in a Life Sciences, Chemistry, Engineering or related discipline is preferred (MS or PhD).
• Experience with viral vector manufacturing.
• Prior experience in manufacturing technology of gene therapy products.
• Prior experience and / or certification in a continuous improvement methodology (e.g. Six Sigma).
• Experience using data management systems, analysis, and reporting tools.
• Experience leading a Continuous Process Verification Campaign including trending, and annual product life cycle monitoring and reporting with biologic or gene therapy products.
• Prior CMC experience with pre-approval and post-approval activities for a biologic or gene therapy product.

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 or sending us an email at

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.