Associate Director, Bioassay Development - Raleigh, United States - AskBio Asklepios BioPharmaceutical, Inc.

Description

Associate Director, Bioassay Development page is loaded

Associate Director, Bioassay Development

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locations

Durham, NC

time type

Full time

posted on

Posted 6 Days Ago

job requisition id

R24-36

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.

Position Overview
The

Associate Director, Bioassay Development , reporting to the Director of Analytical Sciences, will be responsible for the management of the Bioassay Development group within the Analytical Development department.

The successful candidate will be responsible for

coordinating intra-team and inter-team efforts to develop robust cell-based potency assays for product Release and characterization testing. Other responsibilities include the assessment and implementation of new analytical technologies in collaboration with other functional groups .

This position will be located in RTP, NC.

Responsibilities:
Lead a team responsible for developing robust bioassay/potency assays to support early and late-stage clinical trials

Responsible for internal analytical testing, characterization studies, and method qualification

Monitor performance of methods in operation

Participate in technical discussion, troubleshooting, and investigations

Produce high-quality documentation, reports, etc., suitable for publication and regulatory requirements

Participate in the writing of Standard Operating Procedures (SOPs) to support internal operations

Understand GDP and GMP regulatory requirements

Understand regulatory guidance for cell and gene therapy, particularly with regards to potency assurance strategies

Perform lab tasks as needed, including but not limited to, equipment monitoring and calibration

Manage and develop junior scientists and research associates

Experience with mammalian cell culture with expertise in of assays such as RT-ddPCR, cell-based activity assays with ELISA or MSD detection

Possess proficient knowledge of ddPCR, plate-based assays, and biochemical techniques such as BLI and capillary gel electrophoresis

Required Education and Experience
Ph.
D. and 8+ years of relevant experience or M.S. and 12+ years of relevant experience

Degree in Virology, Cell Biology, Immunology, or another relevant scientific field.

Experience leading and managing a team

Preferred Experience and Skills
8+ years of experience in the biopharmaceutical industry with experience in

developing bioassays for AAV gene therapy

Relevant knowledge and industrial experience in characterization and release testing to manufacture AAV gene therapy vectors or other complex biologics.

Experience and understanding of qualification and validation of analytical methods.

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.

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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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