Associate Director, MSAT

Asklepios BioPharmaceutical, Inc. (AskBio)•Durham, NC

1d•Onsite

About The Position

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 partnering to develop a life cycle management process for commercial drug substance and drug product manufacturing. This position will work closely with Process and Analytical Development, Quality Control, Quality Assurance, Manufacturing Operations, 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 position will be office-based in RTP, NC and will report to the Vice President, Preclinical Manufacturing & Manufacturing Science and Technology.

Requirements

Bachelor’s degree in a scientific or engineering discipline and 10+ years of relevant experience OR Master’s Degree in a relevant scientific or Engineering field and 8+ years of experience
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 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.
Proven track record of leading cross-functional collaborations to improve business processes.
Able to travel, domestic and international, up to ~10%.

Nice To Haves

Prior experience in manufacturing technology of gene therapy products is strongly preferred.
Prior CMC experience with pre-approval and post-approval activities for a biologic or gene therapy product
Experience developing or leading a Continuous Process Verification Campaign including trending, and annual product life cycle monitoring and reporting with biologic or 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

Responsibilities

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 the value of study results 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 plan 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 and persuasive 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 and working order.
Ensure supplies and materials for experiments are properly planned and support proper scheduling of laboratory work.