Associate Director, External Manufacturing

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:

• Bring transformative therapeutics to patients in need.
• Provide an environment for employees to reach their fullest potential.
• Advance innovative science by pushing boundaries.

Our values:

• 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.
• Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.
• Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.

The Associate Director, External Manufacturing reporting to the Sr. Director, Global Manufacturing, will be responsible for directly managing global clinical and commercial operations with AskBio’s contract manufacturing partners. This position will work closely with external teams and AskBio’s cross functional operations oversight team to ensure on-time delivery of gene therapy products that meet all quality and compliance requirements. The role will be part of a team of manufacturing subject matter experts and contribute to cross functional leadership of the joint operating teams supporting external manufacturing operations. The ideal candidate will have demonstrated subject matter expertise in manufacturing operations, contract manufacturing management, and GMP operations as well as the ability to lead teams and to curate strong working relationships both within and external to the company. The ideal candidate will have experience in upstream and downstream processing and a knowledge of DNA plasmid manufacturing is preferred. This position will sit in our AskBio headquarters located in Research Triangle Park, Durham, NC.
Responsibilities

• Monitor, assess and report GMP manufacturing performance; develop and implement continuous improvement projects to enhance manufacturing performance.
• Work with analytical and process development team members to assess the manufacturability of new products and platform technology and to implement technology innovation with manufacturing partners.
• Establish a right first time and continuous improvement culture ensuring team members collaborate closely with Quality unit, that well defined and documented processes exist for manufacturing operations, and opportunities for improvement are continually evaluated and implemented. Influence external partners towards continuous improvement.
• Develop internal procedures that outline and detail oversight operations at AskBio CDMO’s, including person in plant responsibilities and documentation of site visits.
• Contribute to manufacturing and operations training program for AskBio team members to ensure manufacturing staff develop and maintain subject matter expertise in their assigned areas of responsibility.
• Contribute to and lead operations with external manufacturing partners to ensure the on-time product fulfillment according to the company’s program and manufacturing plans.
• Partner with the Quality Assurance group to manage batch documentation review, deviations and investigations, change controls, and CAPA’s, and to ensure the timely review and release of product from external manufacturing partners. Primary internal owner of investigations and change controls at the external manufacturing sites.
• Support the preparation of Regulatory documentation. Author manufacturing sections as needed.
• Work with manufacturing partners and within AskBio to establish SOW’s for manufacturing operations and related projects. Manage internal reviews of SOW’s and approvals.
• Oversee on-site execution of manufacturing operations and related projects at the external manufacturing sites and provide an on-site presence (person in plant) for external manufacturing operations.
• Assess, communicate, and mitigate key manufacturing risks and risks to product delivery that may impact CMC program timelines.
• Participate in strategic projects to develop AskBio’s clinical and commerical manufacturing capability.
• Engage with operating teams consisting of Manufacturing, Supply Chain, Quality, CMC Regulatory, Quality Control, MSAT and other functions as needed.

Required Education And Experience

• Demonstrated project leadership skills with the ability to provide cross functional, and cross-company leadership of key initiatives.
• Bachelor’s degree in an engineering or life sciences discipline with a minimum of 7 years relevant biologics GMP manufacturing experience and 3+ years of team leadership experience.
• Prior experience with drug substance and drug product manufacturing, including aseptic operations and with managing external manufacturing operations.
• Excellent written and verbal communication skills with the ability to communicate effectively across a number of disciplines and experience levels, including to senior management.
• Able to travel, domestic and international, to support operations at external manufacturing sites, up to ~20%.
• Prior hands-on GMP operations experience, prior experience preparing for and executing manufacturing site regulatory inspections and regulatory filings.
• Strong business and technical acumen with an ability to anticipate operational issues and proactively recommend mitigations and solutions.
• A continuous improvement mindset, with prior experience managing performance objectives, monitoring and assessing results, identifying areas for improvement, and implementing solutions.
• Strong attention to detail, highly organized and the ability to multitask in a fast-paced, highly interactive environment.
• Upstream, downstream, fill finish and plasmid manufacturing experience preferred. A subset of this experience can be considered.

Preferred Experience And Skills

• Advanced degree preferred (MS or MBA)
• Managing external manufacturing partnerships.
• Prior experience managing manufacturing of gene therapy products is strongly 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 [email protected].
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.