Product Developer/Lab Manager (PDLM)
Summary of PDLM Responsibilities
The PDLM will perform various day to day activities in the Company’s research facilities related to developing multiple nutritional and therapeutic products towards the regulatory pipeline and GO TO market; develop grant proposals, patent applications, GRAS dossiers, claim substantiation dossiers, IND filings, NDA filings, complete and submit all necessary forms for the State and Federal authorities related to research compliance. You will work BTI’s senior leadership team.
Lab and Animal Facility Management
- Maintain housing and husbandry, genotyping, regulatory and safety, and keep thorough record for animals
- Develop breeding and genotyping protocols new strains of mice
- Direct and engage in day-to-day operations for pre-clinical efficacy and safety development of novel drugs and medical foods for chronic, infectious and immune-mediated diseases
- Keep detailed and accurate computer records and maintain/update data in computer-based applications/databases
- Maintain and stock materials/reagents/products used in laboratory procedures
- Supervise, optimize and develop the design of standard operating procedures for animal facilities and laboratories
- Develop and upkeep systems for maintaining laboratory operations
- Assume the role of project manager and generate supportive data for preclinical experiments.
- Use internal data to define follow-up studies that are strategically focused and therapeutically aligned.
- Assay optimization to characterize immunity at the molecular, cellular and tissue levels.
- Provides knowledge for development and maintenance of regulatory compliance and animal care and use guidelines; Food and Drug Administration (FDA), United States Department of Agriculture (USDA), Institutional Animal Care and Use Committee (IACUC), Association for the Assessment and Accreditation of Laboratory Animal Care, International (AAALAC), Occupational Safety & Health Administration (OSHA)
- Submit protocols and amendments to the IACUC, IRB, and IBC
- Facilitate the development of IACUC, IBC, and IRB
- Train, mentor and supervise experimental laboratory staff with techniques and experimental procedures
- Manage the BTI Intern program
- Work independently and collaboratively in a matrixed environment
Reports, Papers, Grants
- Contribute to IP conscious publications of original research results in peer-reviewed journals
- Contribute to writing, generating figures, and compiling reports for grants and product development reports
- Create reports for experimental results and communicate them to a transdisciplinary team
- Develop products, nutritional formulations, APIs, product pipelines for the pharmaceutical, nutritional and informatics divisions of BTI
- Develop infrastructure for scientific support behind BTI products
- Understand and develop partnership and other types of agreements
- Protect BTI intellectual properties, brands and products by help write patent applications, trade secrets, and trademarks.
- Contribute to the submission of research proposals to funding agencies, if necessary as PI as instructed by the CEO
- Identify/Propose funding opportunities for R&D programs that are programmatically aligned with BTI
- Manage acquisition of IND-enabling efficacy, safety, toxicity, PK/PD data under GLP by interfacing with subcontractors and consultants in CMC/API, IND-enabling GLP Tox and clinical.
- Knowledge or experience in therapeutic development for chronic inflammation and autoimmune disorders.
- Expertise in basic, translational and clinical research.
- Expertise in marketing
- SBIR/STTR and R01 Grant and IDIQ contract writing experience.
- Experience in pre- and post-award contract and grant management.
- Previous expertise in mouse models of inflammatory bowel disease and diabetes.
- Expertise in patent development.
- Computational/bioinformatics skills and expertise.
- Demonstrated experience in creating and maintaining a professional website using expression engine or other content management systems.
- Knowledge of genomics in multiple disease areas (oncology, microbiome, and immunology preferred)
- Proven track record of leading the development and deployment of bioinformatics systems and applications that are an integral part of drug development and translational medicine.
- Demonstrated ability to establishing effective collaborative relationships with cross functional scientific and clinical teams.
- Strong communication and organizational skills.
- Experience with statistical and pharmacometric methods for data mining.