Executive Director, Analytical Strategy and Operations

Company: Disability Solutions
Location: New Brunswick
Posted on: April 15, 2024

Job 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. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.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. Read more: careers.bms.com/working-with-us .Position SummaryThe Executive Director, Analytical Strategy and Operations (ASO) reports to the Vice President and is a key analytical strategic leader for Product Development and ASO. This leader is responsible for the integration and alignment of analytical strategies 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 Executive Director is responsible for stability testing and technical writing that directly contribute to all registrational filings. This leader will be key to developing the next generation of analytical leaders within ASO.Key Responsibilities

• Leads the development and implementation of an analytical strategy across Pharmaceutical Development through a network of Analytical Leaders.
• Oversees a global internal and external network to execute clinical product stability, specifications, and Registrational 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 pipeline.
• Ensures effective analytical method transfers and analytical commercial readiness.
• Leads technical writing, specifications, stability and 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.
• As a member of the ASO Leadership Team, shares the accountability for the advancement of BMS's development portfolio and the represents diverse interests central to the Analytical Strategy & Operations Group
• As 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.
• The Executive Director will sit on a department wide analytical steering committee that will oversee engagement and retention and analytical scientists, work force efficiency and productivity, and collaborate to continuously improve the analytical operating model within Pharmaceutical Development organization. Qualifications & Experience
  • Advanced 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 programs.
  • Experience in small molecules and biologics 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.
  • 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 Protocol BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. 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. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. 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.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Keywords: Disability Solutions, Plainfield , Executive Director, Analytical Strategy and Operations, Executive , New Brunswick, New Jersey