Vice President, Analytical Strategy and Operations - New Brunswick, NJ, United States - Bristol-Myers Squibb

Description

Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department.

From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.

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SummaryThe Vice President, Analytical Strategy and Operations reports to SVP, Product Development and is the analytical strategic leader on the Product Development Leadership Team. This leader is responsible for the integration and alignment of analytical strategies among Product Development functions, and across the enterprise, including with Global Quality, Global Regulatory Sciences and the GPS Operating Units. The Vice President oversees essential analytical operations for Product Development, including analytical methods qualification, validation, and release & stability testing to ensure product quality and safety of small molecule and biologics drug substance and drug products, and is responsible for managing extensive internal and external analytical network. As an enterprise leader, the Vice President is responsible for stability testing and technical writing that directly contribute to all registrational filings. This leader is an expert talent developer, building and advancing the community of analytical professionals in Product Development, and developing the next generation of analytical leaders.

Key ResponsibilitiesLeads the development and implementation of an analytical strategy across global Product Development, including technology, digitalization, talent development, skills, and network implicationsOversees a global internal and external network to execute methods qualification, validation, and GxP regulated testing for drug substance and drug product batch release, clinical product stability, specifications, Long Term Stability studies to ensure continued product quality and patient safety.

Partner with Product Development functions in advancing analytical technologies for small molecules, biologics, nucleic acid and other modalities in the pipelineEnsures effective analytical method transfers and analytical commercial readinessLeads enterprise analytical centers of excellence for microbiology testing and industrial hygiene analysisLeads technical writing, stability, specifications, sample management, which includes authoring and review of CMC sections for INDs/IMPDs, BLAs/MAAs and the timely response to Health Authority information requests and communications and ensure robust control strategy and data package for supporting regulatory filings.

Responsible for safety, compliance, strategic planning, capacity and resource analysis, equipment utilization, continuous improvement, and ensuring consistent and harmonized day-to-day operations of analytical laboratories.

As a member of the Pharmaceutical Development Leadership Team, share the accountability for the advancement of BMS's development portfolio and the PD strategy beyond leadership of the Analytical Strategy & Operations GroupAs an expert talent developer, exemplifies the BMS Behaviors and leadership capabilities at all levels in the organization and amongst his/her peers.

Coaches, leads and mentors direct reports and builds a highly capable team through the attraction, training and development of the necessary skilled professionals to meet business needs.

Qualifications & ExperienceAdvanced degree in science of pharmaceutical related fields (Chem, Pham, Bio, Chem Eng) required.15+ years of CMC experience, with a focus in in analytical development, in a complex global environment with a track record of managing development programsExperience in small molecules and biologics/gene therapy preferred but not required.

A thorough understanding of GMP and GLP regulations, company policies and regulatory requirements, and their relation to the management and documentation of product quality investigations.

In-depth knowledge and understanding of the drug development process, including key components of non-clinical, clinical, commercial, and regulatory requirements that impact Product Development deliverables.

Able to anticipate industry trends and emerging issues using external insights.

Demonstrated managerial and leadership skills in leading within a matrix environment, and the ability to work across various functional organizational interfaces.

Strategic thinker who sees the bigger picture and possesses high business acumen; understands how the parts impact the overall business and makes the best decisions for the Organization.

Enterprise advocate who sees the bigger picture beyond own functional area, seeks to have an impact on organization wide performance; embrace complexity but strive for simplicityAuthentic Leadership who demonstrates an honest and unbiased understanding of their own strengths, limitations, and values; lives up to their principles and conviction without being rigid or dogmatic; generates trust by maintaining the highest level of consistency between their words and their actions.

Talent Developer who proactively develops talent for the long and short-term, both within and outside their team.

#LI-HYBRIDIf you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway.

You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary.

Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site ProtocolPhysical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles.

Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer.

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BMS cares about your well-being and the well-being of our staff, customers, patients, and communities.

As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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