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A career at the company offers opportunity, ownership and impact.
All over the world, the company colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. the company, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
The qualified candidate will lead a team of highly skilled large-molecule bioanalytical (BA) scientists in a regulated laboratory environment within the Pharmacokinetics, Dynamics and Metabolism New Biologic Entities (PDM-NBE) group in the BioMedicines Design Department (BMD) of the company World Wide Research and Development (WRD). The role will provide expert leadership in the development and execution of large-molecule BA methods for PK, ADA, and nAb assays (cell-based methods an area of focus) supporting projects from IND enabling toxicology through clinical development of novel protein therapeutics. These methods will be used to deliver a diverse clinical portfolio, including mAb, Fc-Fusion and Bi-specific protein therapeutics, as well as emerging modalities such as immuno-oncology, nanoparticle and gene therapies. The successful candidate will also ensure development and integration of future strategies for the Regulated BA discipline, including current and emerging modality specific BA strategies, analytical platform / technology development, process improvements and operational compliance within a global regulatory framework.
Key accountabilities include:
• Leading a team of colleagues in the generation and interpretation of BA data to enable project milestone delivery and advancement of key platform technologies across multiple projects
• Direct responsibility and oversight of the design and implementation of project-specific BA strategies in compliance with GLP and GCP regulated laboratory environments
• Design, completion and communication of required BA investigations of PK, ADA, and nAb methods ensuring scientific integrity of BA methods and data within PDM-NBE and in partnership with CROs
• Interfacing with key stakeholders within PDM-NBE, BMD, and WRD to understand, deliver, and communicate key BA results and conclusions
• Ensure influence of and alignment with key regulatory guidances
• Influence the strategic direction of the PDM-NBE BA Discipline
• Direct management, supervision, and coaching of team members
• Direct responsibility and leadership in leading and training the next generation of bioanalytical scientists and Bioanalytical Principal Investigators
• Direct project Bioanalytical Principle Investigator (BA PI) role and / or supervision of other BA PIs reporting to this position
• Design and leadership in implementation of Bioanalytical strategy for the company portfolio of Biotherapeutic modalities
• Serve as a leader, manager and mentor for a range of Scientists, both directly reporting or within a matrix organization; build and maintains a change-agile, high performing culture of innovation, impact, trust, accountability, and mutual respect
• Bioanalytical support of the company NBE portfolio including development of robust and reliable ligand binding and cell based assays suitable for detection of drug concentration, detection and characterization of anti-drug antibodies in various matrixes using a range of potential bioanalytical platforms; on-time data delivery or assay transfer
• Cell-based neutralizing antibody assay development and implementation
• Assay development, validation, troubleshooting, implementation for GLP (non-clinical) and GCP (clinical) support. Implementation may include oversight of external CRO based activities; When required, responsible for providing leadership and oversight for externally supported CRO based analytical methods
• Represents BA at various projects teams during non-clinical and clinical development phase
• Plays critical role representing BA to provide responses to regulatory requests and inquiries
• Develops innovative experimental designs, novel techniques or technologies to advance, improve or optimize scientific practices and procedures; Actively pursues bioanalytical innovation to improve assay quality, efficiency, cost effectiveness and appropriateness of assay for regulated support
• Integrates internal and/or external information to form novel hypotheses. Evaluates data in the context of all the different endpoints.
• Evaluates multiple new technologies and scientific approaches for solving a problem. Demonstrates the application/value of complex/cutting-edge/costly investments in science and technology.
• Responsible for GLP and GCP compliance of the group. Direct or supervisory responsibility to oversee SOP status and implementation
• Achievements exemplified through consistent publications, posters and / or invited presentations at scientific meetings.
• PhD with at least 10+ year relevant experience
• Industry experience with a focus in biotherapeutics development
• Proven track record of scientific achievement; excellent interpersonal and oral / written communication skills
• Proven track record in the area of biotherapeutics bioanalysis with understanding of a broad range of bioanalytical platforms including LBA and Cell based assays
• Direct experience in GLP/GCP compliant assay validation and sample analysis
• Direct experience in formulating strategy and monitoring group compliance strategy, identifying gaps and required solutions
Technical Skill Requirements
• Advanced knowledge of principles, concepts and practices in Regulated BA discipline
• Demonstrated extensive direct experience in assay design, troubleshooting, development, validation and study support
• Demonstrated extensive direct experience in mentorship/supervision of junior level scientists and other Bioanalytical Principal Investigators
• Demonstrated experience in GLP / GCP aspects, including internal and external regulatory documents
• Demonstrated achievements in advancing of bioanalytical science internally and externally
• Lead author or a co-author on internal/external publications and posters
• Displays significant knowledge of other scientifically relevant disciplines and functions
• Direct experience in participating in strategic scientific consultation within projects, and across function and portfolio
• Uses expertise in areas outside of primary training/discipline to influence Regulated BA discipline
• Direct experience in interacting with external organizations, including CROs
• Experience in communicating across disciplines to enable maximum impact of bioanalytical science
• Broad understanding of the drug discovery process.
• Solid familiarity with biotherapeutic structure, pharmacology, disposition and immunogenicity and the impact on assay selection
• Ability to author technical documents, e.g. SOPs, data Summary Reports and Bioanalytical procedures
• Strong adaptability to changing work assignments and priorities
• Strong leadership in building and maintaining teams characterized by a high performing culture of innovation, impact, trust, change agility, accountability, and mutual respect
• Seizes accountability, acts decisively, and holds people accountable
• High degree of self-awareness; uses business acumen to get things done
• Grows others; acknowledges contributions across the team
• Effective collaboration and partnering skills in a highly matrixed , multi-discipline organizational environment
• Able to identify opportunities for continuous improvements and lead implementation
• Can communicate and lead change
Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.
EEO & Employment Eligibility
the company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. the company also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. the company is an E-Verify employer.
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