Associate Director / Senior Principal Scientist - Bioanalysis (R1547930-en-us)
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Nonclinical Research and Development (NCRD) is an integrated function with responsibility for characterizing nonclinical safety and disposition characteristics of the entire BMS Research and Development pipeline programs, with critical role from early discovery to submission of marketing authorization applications. We utilize our deep expertise in toxicology/pathology, ADME, PK/PD and Bioanalytics in all modalities (small and large molecules, cellular therapies and other novel modalities) to collaborate with peer R&D functions to identify and solve issues, discover high quality drug candidates, enable their clinical development and successful marketing authorizations across the globe.
Developing bioanalytical strategies for various biologics development programs following internal SOPs and Health Authority guidances
Background in DMPK concepts and nonclinical PK and TK related data interpretation
Responsible to ensure development of high quality ligand binding assays used to support PK/PD/Immunogenicity assessments and subsequent validation and support of sample analysis.
Oversee reagent development to support the bioanalytical strategy
Evaluate new technologies for analysis of large molecules and implement as needed.
Compile and interpret bioanalytical data, author and/or review of protocols and reports.
Lead the preparation of regulatory documents including INDs, NDAs, and BLA submission documents and being responsible for responding to Health Authority queries related to bioanalysis
Acting as the bioanalytical liaison with clinical, and non-clinical internal cross-functional project teams and external collaborators
Managing technology transfers of immunogenicity and PK methods and related bioanalytical activities (e.g., development data, validation and study reports) to contract research laboratories and ensuring the scientific quality of data in order to meet US and OUS regulatory expectations.
Performing technical audits of existing contract research laboratories supporting bioanalytical work
Reporting study sample results to stakeholders following the departmental policies and procedures and participate in tech transfers of assays to business partners and troubleshooting assays when problems arise.
Contributing to the preparation of technical reports and departmental SOPs and the preparation and presentation of scientific material at internal and external meetings and will be encouraged to publish as part of project publication plans.
Ensuring compliance and maintain required training in BMS and departmental SOPs, safety guidelines and other applicable regulations.
Achieving objectives in a manner consistent with the BMS Biopharm Behaviors.
The successful candidate will be self-motivated, have good interpersonal and communication skills, be able to multi-task, be highly organized, have a strong desire to succeed in a multifunctional team setting, proven ability to meet goals working in a group of peers, and proven innovative thinking.
Ph.D. in biological sciences or related discipline with >10 years of relevant experience. Or MS in relevant scientific discipline with >12 years of relevant experience
Excellent interpersonal, written and oral communication skills
Experience managing the bioanalytical portion of non-clinical and clinical studies for biologics conducted at CROs
Experience preparing regulatory documents related to the bioanalysis
Proven technical expertise in developing and validating ligand binding assays in technologies such as ELISA, ECL (MSD) or Gyrolab; including PK/ADA/Nab assay problem solving and analytical skills
Understanding of the drug development process for biologics, especially as it applies to bioanalysis
Experience with sample management systems and Watson LIMS is a plus.
Strong understanding of the scientific/regulatory standards for bioanalysis of biologics, including knowledge of GLPs, 21 CFR Part 11, FDA, EMA and other relevant Bioanalytical Guidances is important.
Proven track-record of performing large molecule bioanalytical sample analysis and knowledge and interpretation of PK data and potential impact of ADA on PK is a most.
Prior experience in representing functional area in cross-functional product teams
Proven record of peer-reviewed publications in the relevant technical areas
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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