Director, Manufacturing

About AskBio

Asklepios BioPharmaceutical, Inc. (AskBio), a wholly owned and independently operated subsidiary of Bayer AG acquired in 2020, is a fully integrated AAV gene therapy company dedicated to developing life-saving medicines that have the potential to cure genetic diseases. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular and metabolic disease indications with a clinical-stage pipeline that includes therapeutics for Pompe disease, Parkinson’s disease, and congestive heart failure, as well as out-licensed clinical indications for hemophilia and Duchenne muscular dystrophy. AskBio’s gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, UK, the company has generated hundreds of proprietary third generation AAV capsids and promoters, several of which have entered clinical testing. Founded in 2001 and an early innovator in the gene therapy field, the company holds more than 850 patents in areas such as AAV production and chimeric and self-complementary capsids. Learn more at www.askbio.com.

We have an opportunity for a Director, Manufacturing to join the AskBio team and be part of our continued success!

Position Overview

The Director, Manufacturing is a critical member of the Process Development & Manufacturing team in AskBio CMC and will oversee routine upstream cell culture and rAAV viral vector production and downstream purification operations to support the AskBio’s early research and development programs as well as provide CMC support for GLP and GMP manufacturing at Viralgen Vector Core. This individual will lead a team of scientists and associates to manufacture and characterize high quality recombinant AAV vectors in a highly interdisciplinary environment and be expected to communicate effectively and productively with the research & development organization, early stage upstream and downstream PD group, regulatory CMC group and other cross-functional organizations such as preclinical, clinical, and translational sciences groups as needed to ensure the product quality expectations are achieved.

Job Responsibilities 

  • Lead a team of scientists & associates to produce and analytically characterize the high-quality vectors to support various early research programs.
  • Develop procedures and documentation system to successfully perform specific unit operations in the production and characterization of rAAV vectors.
  • Oversee routine upstream vector production, and downstream purification operations to produce rAAV vector and analytical testing of manufactured rAAV vectors.
  • Assist in troubleshooting of experiments and implement proper risk mitigation plans.
  • Establish and maintain scheduling of vector core laboratory and its employees.
  • Approve and maintain the complete batch records of vector productions; manage samples throughout the batch production and collaborate with the analytical support team to support timely testing, data generation and release of AAV viral vectors.
  • Oversee the inventory, and equipment maintenance, and perform other duties as required and in collaboration with facilities and engineering teams.
  • Evaluate, procure, and implement new equipment needed to support AAV viral vector production.
  • Manage and mentor employees through short-term and long-term goals to meet organizational and corporate objectives.
  • Work closely with project management teams to establish project timeline and ensuring works are completed according to the program timeline.
  • Prepare and report manufacturing metrics as required by CMC management.
  • Participate in program team meetings and provide updates.
  • Work seamlessly with cross functional stakeholders to help advance the rAAV vector production portfolios.
  • Ensure that the scope of all pre-clinical manufacturing activities is aligned with non-clinical, clinical, CMC (cGMP manufacturing, Quality Control, Quality Assurance), and corporate timeline and budget requirements.

Required Education & Experience 

  • BS in Chemical Engineering, Biochemistry, Biology or a relevant scientific or engineering discipline.
  • 9+ years of hands-on industrial experience including, but not limited to, managing teams of at least 3-5 scientists and associates, the manufacturing of the biologics (mAb, recombinant protein, vaccine, or viral vector) and mammalian cell culture, depth flow filtration (DFF), chromatography, tangential flow filtration (TFF), and other relevant unit operations to produce the vectors.
  • Technical writing skills with experience authoring/reviewing protocols, reports, SOPs, and batch records.

Preferred Experience & Skills

  • Master’s of Science Degree.
  • Excellent written and verbal communication skills.
  • Experience with GLP grade and/or GMP grade biologics manufacturing, GMP quality and producing rAAV viral vectors.
  • Proven record of successfully planning experiments and executing projects in collaboration with internal or external stakeholders.
  • Strong team player who works closely and effectively within cross-functional organizations.
  • Hands-on knowledge of DOE, JMP, FlowJo and GraphPad statistical software for use in design of technology development studies.
  • Experience in regulatory IND filing and working knowledge of US/EU CLD requirements.
  • Proven ability to hire & integrate new talent into organization, manage employee performance and development and model the company’s core values and culture.