Associate Director, Manufacturing Science and Technology (MSAT)
Company: AskBio Asklepios BioPharmaceutical, Inc.
Location: Durham
Posted on: September 21, 2023
Job Description:
Associate Director, Manufacturing Science and Technology (MSAT)
page is loaded Associate Director, Manufacturing Science and
Technology (MSAT) Apply locations Durham, NC time type Full time
posted on Posted 6 Days Ago 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.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, 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. This role will sit onsite in our RTP Headquarters in NC.
Responsibilities & Accountabilities:
- Responsible for 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 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. 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 or Downstream
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. 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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Keywords: AskBio Asklepios BioPharmaceutical, Inc., Durham , Associate Director, Manufacturing Science and Technology (MSAT), Executive , Durham, North Carolina
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