Sr. Manager, Bioanalytical Assay Research and Development - 1726
The Pharmacology and Toxicology department at AnaptysBio, Inc. is seeking an experienced senior level Manager to oversee Bioanalytical responsibilities for the organization. The Senior Manager will implement and execute on bioanalytical strategies to advance both preclinical and clinical assets and have a demonstrated success in biological drug development. The Senior Manager will play an essential and collaborative role in overseeing the development, transfer and validation across several platforms for PK, PD and immunogenicity assays. The successful candidate will have a strong working knowledge of GLP environment, current practice in the field of bioanalytics and will participate in authoring of regulatory documents.
• Provide scientific leadership and management to a new group within the company
• Supervise the development, validation, and implementation of appropriate bioanalytical assays (PK, PD, Immunogenicity, biomarker) to support preclinical and clinical development of biological products
• Supervise assay transfer to CROs and validation and sample analysis for GLP preclinical and clinical studies
• Establish and maintain effective bioanalytical outsourcing strategy and vendor relationships for bioanalytical sample analysis and assay development where required.
• Has overall responsibility for the technical bioanalytical conduct of studies/projects, as well as for interpretation, analysis, documentation, and reporting of results. Manages all study/project/lab activities, contributes to overall strategies and goals for the unit.
• Oversees BA program support; establishes target dates and priorities. Coordinates with minimal supervision study activities in intra- and interdisciplinary departmental groups.
• Interprets study results, evaluates data, and draws appropriate conclusions.
• Communicates knowledge obtained from external sources to the internal unit in timely manner.
• Presents scientific/technical work at internal/external meetings or recognized achievements in the development of new procedures.
• Maintains good understanding of relevant novel assay technologies/ principles/ protocols in own discipline and good understanding of closely related areas.
• Identifies complex problems (e.g. overall raw data quality, inconsistency of data/results, appropriateness of study design/approach/technology) and proposes creative and workable solutions.
• Writes SOPs, guidelines in his/her area where appropriate. Writes summary document contribution (IB, IND, etc.) with minimal guidance where appropriate.
• Establish close collaborations with other project team representatives in other disciplines.
Education & Experience:
• Ph.D. in biological sciences, analytical sciences, or related field, plus minimum of 5 years relevant experience; MS plus 10 years relevant experience; BS plus 15 years relevant experience
• Experience with diverse biotherapeutics portfolio, especially antibody therapeutics, highly desirable
• Advanced knowledge of scientific discipline and relevant laboratory tools and procedures.
• Proficient with full range of bioanalytical techniques used in job and core area.
• Working knowledge of tools and processes used in drug development.
• Understanding of management and training principles.
• Strong understanding of state of the art immunoassay and other bioanalytical techniques (and good knowledge/skills in PK/PD and Immunogenicity)
• General understanding of related bioanalytical techniques (e.g. LC-MS/MS, biacore), PK/PD modeling, drug metabolism, toxicology and clinical pharmacology.
• Thorough understanding of interactions and interpretation of PK, PD, and immunogenicity data.
• Sound understanding of the drug development process
• Knowledge and experience in working to appropriate regulatory and quality guidelines (e.g. GLP).
• Outstanding interpersonal and communication skills
• Effective interpersonal skills, with the ability to work effectively in as a team player in a complex, changing environment
• Self-motivated, independent, and results-oriented
• Capacity to organize assignments, work within deadlines
• Ability to function in a fast-paced entrepreneurial environment
• Strong analytical and organizational skills
• Highly attentive to details
• Position may require occasional evening and/or weekend commitment
• Position may require occasional travel