Associate Director/Director Method Development, LBA
- - LBA
- Indianapolis, IN, USA
- Full Time
Title: Associate Director/Director Method Development, Ligand Binding Assays
AIT Bioscience (AITB) is a leading bioanalytical services contract research organization (CRO), serving the pharmaceutical, biotech, and animal health industries. LC-MS/MS and multiple large molecule platforms combine to provide regulatory compliant bioanalytical support for the development of new medicines, ranging from early-Discovery to Pre-Clinical support through to Clinical and Commercialization services.
AITB is the first and only CRO to provide solutions for all molecule types (large, small, and peptides/biomarkers) in a purpose-built facility utilizing a fully electronic analytical lab notebook system. With our customized, real-time QC system, quality has literally been built into everything we do and everywhere we do it. Bioanalytical capabilities and expertise support both stand-alone projects and full IND/NDA enabling programs, allowing AITB to support its clients with a hands-on approach, scientific collaboration, high quality, and on-time delivery.
Fully qualified candidates may expect competitive compensation, commensurate with experience. AITB offers a generous benefits package including medical, dental, vision, life, and disability insurance, 401(k) retirement plan, and the opportunity to work with a talented, dedicated and energetic workforce.
Your health and the health of our employees and our families is important. Therefore, we will be utilizing phone and video interviewing in accordance with COVID precautions and/or Stay-at-Home Orders for non-essential staff.
The Associate Director/Director Method Development, Ligand Binding Assays, is a key company role. The director will provide scientific, technical and strategic leadership; oversee bioanalytical deliverables (data and methods); and play a pivotal role in enabling AITB's large molecule clients to progress their drugs from early-phase discovery to late stage clinical programs. The individual is expected to have a strong scientific career path and demonstrated expertise in the field of immunoassay design, development, troubleshooting, qualification and validation, and preferably experience in cell therapy and/or gene therapy.
The candidate must have a demonstrated track record in successfully leading day-to-day operations for a team of direct reports, including driving productivity and function. The candidate must have excellent interpersonal skills and will work closely with representatives from pharmaceutical, biotechnology, and other sponsoring organizations both in a scientific and business development capacity. The candidate must be familiar with FDA guidance documents and industry white papers.
The position requires adaptability; excellent planning, organization, and communication skills; as well as the ability to work in a multidisciplinary, fast-paced, team-oriented, environment. The director will drive key company performance goals, influence the direction of the company as industry needs shift, and take responsibility to provide a collaborative meaningful work environment to the AITB staff.
Provide scientific leadership in the development, qualification and validation of immunogenicity assays (anti-drug assays), pharmacokinetic (PK) immunoassays, and biomarker immunoassays for both preclinical and clinical studies for large molecule drug candidates and gene therapy programs.
- Provide guidance on analytical issues, technical requirements, design and logistics, and regulatory requirements for immunoassay/ligand binding portfolio.
- Provide in-lab mentoring for scientific staff as needed to progress immunoassay/LBA development and troubleshooting.
- Review methods, validation plans, reports, and SOP's.
- Evaluate and implement new bioanalytical methods/technologies to solve challenging issues, including growth of scientific services to support cell and gene therapy programs.
- Implement the overall service line strategy to realize overarching company goals and to drive future initiatives.
- Oversee operational direction of assigned programs, including evaluating technical resources and timelines/scheduling to optimize effective delivery.
- Oversee Sponsor relationships, including Sponsor management, mentorship of peers/colleagues, and reinforcement of policies to drive long term success.
- Contribute to company forecasts and revenue recognition.
- Provide expert scientific commentary within a Business Development setting that results in study authorizations.
- Interface with Business Development to assess new project opportunities and determine resources needed to provide services within timelines and budgets.
- Contribute to resolution of assay problems and lab investigations, corrective and preventative actions, and assure good scientific judgment is utilized and documented.
- Work with other laboratory management to design and improve processes and procedures to increase efficiency, productivity, and quality.
- Author papers, educational sessions and/or presentations, and represent AITB at scientific conferences.
- Mentor and support professional development of AITB staff.
- Remain current with changing FDA and EU regulatory requirements for bioanalysis and assure data is compliant with applicable SOPs and regulatory requirements.
- Travel as needed to visit Sponsors, support Business Development, and attend scientific meetings and/or workshops.
Minimum Required Education and Experience
- Ph.D., or M.S. in biological sciences such as Immunology, Cell Biology, Biochemistry, Molecular Biology or similar.
- Minimum of 7 years (Associate Director) or 10 years (Director) assay development experience in biotech, CRO or pharmaceutical industry.
- Strong immunoassay background with expertise in PK, ADA, and enzyme/cell-based neutralization assays conducted in a regulated setting.
- Experience in developing immunoassays using different technologies including ELISA, MSD, Gyros, Ella, Quanterix or similar.
- Demonstrated track record in leading day-to-day operations for a scientific in-lab team.
- 2-5 years of prior experience in a supervisory role strongly preferred
- Excellent writing and editing skills are essential.
- Ability to build and foster cross-functional collaborations both internally and externally.
- A publication record that is immunoassay related is desirable.
At AIT Bioscience, we value you as a person, support your personal growth and development, and want you to succeed. This is primarily a first-shift position, with flexibility needed to occasionally pivot to alternate hours as directed. Qualified candidates please apply and submit your resume and cover letter along with desired salary range.