Executive Director, Analytical Strategy and

4 weeks ago

Summit, United States Bristol-Myers Squibb Full time

**Working with Us**
Challenging. 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.

**Position Summary**

The 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-HYBRID

**Uniquely Interesting Work, Life-changing Careers**

**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

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