|at ( view profile)|
|Date Posted||August 1, 2019|
|Address||700 E Main St|
The Research Scientist in the SPL R&D Department will work independently and in conjunction with appropriate teams to define scientific strategy and to support R&D program/project needs throughout product development process. The candidate will also independently lead, design and perform development and characterization in support of large molecules of various nature (e.g. proteins, polysaccharides and nucleic acids, etc.). This role requires internal cross functional alignment as well as ability to manage and work with external partners including technology/product licensor, CROs and CMOs. This position will report directly to the VP of Corporate Development and Technology (a.k.a., R&D).
Major duties and responsibilities:
- Understanding of corporate vision and mission and help define product portfolio and development strategy per program/project/technology timelines
- Lead drug development process including process development and characterization studies relevant to the stage of development. Studies include, but are not limited to, biological and biophysical characterization and studies spanning entire development process including functional characterization, animal models, toxicology and PK/PD, formulation development, and management of CRO and CMO.
- Author and review documents for regulatory filings (IND, NDA and BLA, and their foreign equivalent) and internal company use.
- Lead, facilitate, and participate in technical discussions to successfully resolve problems with all stakeholders, methods, project issues and deviations
- Deliver an improved focus on the scientific rigor within the R&D Department, ensuring consistent scientific excellence and scientific quality standards are met.
- Assist with the review and evaluation of novel drug product and technology for investment and in-licensing by SPL
- PhD in Biology, Chemistry, Biomedical Science, Biochemical Engineering, Pharmacy or a related field with at least 10 years of experience is required
- Understanding and select experience of drug product development process that spans early through late phase including biologics CMC and manufacturing process is required
- Hands on industrial experience in biotech/pharma with experience in drug development, drug product formulation and drug delivery.
- Demonstrated competency and experience in biologic drug product development within the pharmaceutical industry with a high level of technical understanding is required
- Effective communication skills and demonstrated leadership in providing integration of activities and delivering information across multifunctional groups and sites is required
- The candidate should be able to use emerging developments in relevant scientific fields to generate new research ideas and initiatives
- Demonstrated experience in scale-up of manufacturing processes and technical transfer of projects into commercial manufacturing is preferred
- Experience with authoring and reviewing regulatory filings is preferred
- Knowledge in drug delivery technology, genomics and NGS, cell therapy including stem cell product development is helpful
- Some understanding and experience with biosimilar product development and regulatory process, e.g., 351 (k), will be helpful
- This position may require up to 5% domestic travel