Integrated BioTherapeutics, Inc (Rockville, MD) is seeking a highly motivated and highly qualified candidate in a lab‐based position as a Research Assistant/Associate (level based on experience) within a dynamic, research-focused group developing viral vaccines and therapeutics against filovirus, Nipah and coronavirus. The successful candidate will have the opportunity to perform platform technology development activities, which advances IBT’s biotherapeutics pipeline toward clinical and commercial development. The candidate will be involved in the development of vaccine platforms, including mammalian recombinant protein expression and viral vectors. This role will focus on the molecular biology component of cell line development with an emphasis on vector design and protein expression. Additional skillsets in mammalian cell biology, including cell culture maintenance, clone screening, flow cytometry, and cell line characterization are also desired but not required. The successful candidate will help to design and drive innovative improvements to current platform, practices and infrastructure to ensure successful delivery of the project portfolio under supervision of Principal Scientist.
- Be a key member of the Virology team that will support the execution of both technology development and pipeline projects.
- Demonstrate outstanding communication and presentation skills, a documented ability to troubleshoot technical issues, an ability to plan and carry out experiments independently, and to work with complex instrumentation and software.
- Effectively document all lab activities in notebooks/elsewhere as required and appropriate, in a timely fashion; author technical reports as needed.
- Read and understand current literature as needed to support setup, troubleshooting and optimization of experiments.
- Evaluate data and provide clear reports that can be shared and transferred to and from cross‐functional teams; responsible for clear communication in both written and oral forms.
- Adherence to safety protocols and knowledge of basic laboratory procedures to advance projects under rapidly shifting priorities and timelines.
- Support laboratory activities by monitoring lab equipment and maintaining a clean and safe working environment.
- Required to be onsite; 40H/week; Timing is flexible
- Requires BS in cell/molecular biology or related field with 3+ years’ experience in tissue culture activities or a Master’s Degree with 2+ years’ experience in the area of mammalian cell line development and/or molecular biology.
- Self-motivated and highly productive technical scientist who applies extensive technical and scientific knowledge as well as practical experience to deliver high quality results
- Molecular biology experience required for this position:
- Plasmid construction, DNA preparation and analysis
- DNA transfection
- DNA electrophoresis
- Strong analytical skills and oral and written communications skills are required
Associate Director/ Director of Quality Assurance
Integrated Biotherapeutics (IBT) is a clinical stage biotechnology company with an exciting pipeline of vaccines and antibody therapeutics. Located in Rockville, MD, the company has both a significant product development focus, and offers reagents and analytical testing services to the biotechnology industry through its IBT Bioservices division. The company offers a highly stimulating scientific work environment and believes in teamwork and integration of talent from many disciplines. Here, you will interact with internationally renowned scientists and become involved in collaborations with leading research laboratories in pursuit of your goals.
IBT has an immediate need for an Associate Director / Director of Quality Assurance. The title offered to the prospective candidate will be commensurate with his or her level of experience in the biotechnology industry. The principal responsibilities of the candidate will be to establish and maintain a Quality Management System (QMS) to support regulated testing, including testing following Good Laboratory Practice as defined in 21CFR part 58. The position reports to the VP, Programs and Operations.
Responsibilities and Job Function
- Provide Quality oversight of GMP-compliant manufacturing performed at contractor sites
- Work with vendors performing contracted studies to establish Quality Agreements
- Qualify vendors for contracted manufacturing and other regulated work
- Serve as IBT’s Quality authority in the investigation of deviations, corrective and preventative actions (CAPA) and in change control
- Review manufacturing batch records and other records related to regulated testing as part of the approval process for release of investigational products
- Provide oversight over the design and execution of stability studies performed on GMP products
- Work with the IBT Senior Management Team to establish an appropriate Document Control System
- Expand IBT’s QMS through the generation of SOPs and policies that support release of investigational product for clinical use
- Build upon IBT’s current Quality infrastructure to establish and in-house GLP-compliant testing capability
- Provide oversight for IBT’s internal regulated testing program to ensure that all Quality aspects of testing, including design and execution of assay qualification and validation protocols, control of critical reagents, and physical infrastructure are in compliance
- Ensure that employees are trained as appropriate on policies and procedures pertaining to the QMS
- Establish strong relationships at IBT and with IBT’s business partners to enhance and ensure quality awareness
- Develop and monitor appropriate metrics to track quality and process improvement
Required Education and Experience
- Bachelor’s degree in biological sciences or related field; advanced degree(s) preferred
- Minimum of 5 years (for Associate Director) to 10 years (for Director) in GxP environment, with at least 5 years of GLP/GMP Quality Assurance experience
- Experience as a successful contributor in the Quality department in the pharmaceutical, biotechnology field
- Expert knowledge of USP, GxP, FDA, and EMA regulatory requirements and guidance applicable to biopharmaceuticals
- Broad understanding of contemporary quality practices as they apply to product development, product testing and GMP manufacturing
- Experience in establishing and maintaining Quality infrastructure at a small to mid-sized company
- Demonstrated ability to accomplish goals with fellow employees who are not direct reports
- Strong sense of ethics and honesty
- Strong written and verbal communication skills
A competitive salary and benefit package commensurate with experience will be offered.