BIOINFORMATICS SCIENTIST: Job Code R-01
MISSION STATEMENT: To contribute computational biology expertise to the success of oncology research projects.
RESPONSIBILITIES: This person will be the primary point of contact for all informatics needs within the Oncology focus. Working hand-in-hand with experimental scientists, the successful candidate will identify opportunities to apply innovative computational approaches to facilitate target identification and validation, biomarker analysis, and mechanism-of-action studies. In collaboration with other members of Research Informatics the successful candidate will be responsible for providing projects teams with solutions for sequence analysis, transcript profiling, proteomics, and pathway analysis. Activity areas include data analysis, information management, and experimental design.
QUALIFICATIONS: The successful candidate will have demonstrated expertise and hands-on experience in computational biology/bioinformatics. Strong communication skills and a team-oriented mindset are critical for success. In-depth knowledge of algorithms, tools, and databases for sequence analysis and expression profiling are required. Experience in proteomics data analysis and/or pathway analysis would be considered a strong plus. Programming skills are highly desirable.
MOLECULAR BIOLOGIST: Job Code R-02
MISSION STATEMENT: An opportunity exists for an Industry experienced PhD Molecular Biologist working in Oncology.
RESPONSIBILITIES: 1) The selected individual will be responsible for mode of action (MOA) studies to further the developmental pipeline; 2) Target identification and validation; 3) Determination of mode of action of small molecule compounds; 4) RNAi. The candidate will be an active contributor to both exploratory and drug discovery project teams.
QUALIFICATIONS: Doctoral level degree (Ph.D.) with a minimum of 2 -3 years industry experience in cancer biology. Candidate should have strong experience in cell biology/molecular biology techniques.
FORMULATION SCIENTIST (CA): Job Code R-03
MISSION STATEMENT: Conduct biopharmaceutical drug formulation development for preclinical, clinical and commercial uses.
RESPONSIBILITIES: 1) Independently develop protein / antibody drug formulation in both solution and solid form; 2) Act as an intellectual resource for physical and chemical analysis of biopharmaceutical products in the area of expertise, such as particle analysis, HPLC, DSC, CD, FTIR, light scattering, analytical ultra-centrifugation, etc.; 3) Design experiments for excipients screening and maintain drug stability programs; 4) Be a CMC team member, achieving corporate objectives through active participation in project teams and initiation and maintenance of effective interactions with others; 5) Communicate scientific data and concepts effectively; 6) Prepare publications for scientific journals and/or regulatory submissions as appropriate; 7) Select, train and supervise junior level staff; 8) Maintain a working knowledge of regulatory guidelines including but not limited to analytical method validation, product stability, and product comparability.
QUALIFICATIONS: 1) Scientific Ph.D. or equivalent combination of education and working experience with 4+ years of working in the protein formulation development or related fields. 2) Must have strong analytical skill with relevant physical and chemical analytical instrumentation for protein characterization. 3) Experiences with liquid and solid protein drug formulation, process and maintaining product stability program are essential. 4) Broad knowledge about drug development, immunology and protein biochemistry 5) Extensive laboratory experience in the hands-on use and application of physical-chemical and functional characterization instruments, such as HPLC, SDS-PAGE, CE, DSC, FT/IR, light scattering, and analytical centrifugation, etc.; 6) Knowledge about protein unfolding, degradation pathways, antibody structure and basic immunology as well as experience with solid protein formulation.
NOTE: A position also exists for a Director of Protein Formulation and for Associate Scientists in Protein Formulation (BS/MS).
SENIOR SCIENTIST PHARMACEUTICAL DEVELOPMENT: Job Code R-04
KEY TO THE POSITION: Experience in solid dosage formulation development.
RESPONSIBILITIES: 1) Develop and transfer to contract sites drug product manufacturing processes; 2) Develop formulations for typical oral and parenteral dosage forms including aseptic solutions and freeze-dried parenterals, capsules, tablets, oral solutions and suspensions; 3) Develop dosage forms and processes consistent with all requirements of corporate partner(s) and US or EU regulations; 4) Train contract manufacturer's personnel in pertinent processes and procedures 5) Work with package engineers to explore new drug delivery devices and source critical packaging components; 6) Troubleshoot problematic formulations and processes and identify solutions to these problems; 7) Supervise the preparation and execution of process validation protocols; 8) Support contract manufacturer's personnel in preparing and validating cleaning and sanitization procedures; 9) Additional responsibilities as required.
REQUIREMENTS: PhD preferred plus a minimum of 5 years pharmaceutical development experience. Additionally the qualified candidate should have experience supervising contract manufacturing sites and experience in parenteral and oral dosage form development.
|
