Associate Director Investigation Support

Profile

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.

Summary:

Accountable to direct and lead the investigation team that manages the Root Cause analysis execution for Operations, Manufacturing Technology, and any other complex site Investigation for all growth products manufactured at the Manati site. Directs a team of investigators who lead the execution of investigations. In addition, provides a technical oversight of investigation documents and develop strategies to improve the investigation program alongside the Compliance area.

Responsibilities:


Oversees the execution of the investigation processes across BMS Manati. Assesses site performance and develops improvement plans to advance investigation program maturity in conjunction with site Compliance and Investigations-Global Process Owner.
Supports site Investigation Review Board meetings.
Lead complex investigations and corrective actions identification where root cause is in Manufacturing, MT, or other complex processes.
Review and approve site investigations.
Active participation during Notification to Management events.
Analyze, recommend and implement corrective actions in response to investigation Quality System performance metrics.
Provide technical oversight, review and approval of investigations, SOPs and CAPAs for Manufacturing Site Quality activities.
Oversees and provides leadership and direction for a highly effective, interactive technical Team of lead investigators who lead investigations.


Knowledge/Skill Required


PhD or Master in Sciences or Bachelors Degree in Chemistry, Biochemistry, Chemical or Mechanical Engineering
Eight (8) years of progressive managerial experience in Pharmaceutical industry and at least five (5) years experience within a parenteral or biotechnology manufacturing industry.
Experience in both written and verbal communication with FDA and EMA regulatory authority interactions, including PAI & GMP inspections.
Demonstrated technical expertise In Biologics DP, API and pharmaceutical drug product.
Ability to build productive relationships, lead and influence across multiple departments that perform similar activities to drive alignment and change where the resources and decisions are outside of the leaders direct reporting line.
Excellent communication and interpersonal skills, with the ability to interface with a broad range of internal and external stakeholders at all levels of the organization.
Strong project management and execution skills, and is able to manage multiple projects and prioritize as needed. Ability to plan and conduct projects within a multi-disciplinary environment.
Understanding of protein therapeutics, their potential degradation pathways, and their behavior in industrial scale parenteral manufacturing operations, including large scale formulation, filtration, and filling.
Excellent Technical Writing/Oral communication skills (English/Spanish)
Proficient in Statistical Process Control and Process Capability
Proven assessment, analytical and problem-solving skills


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.

Company: Bristol-Myers Squibb

Req Number: R1528147_EN

Updated: 2020-07-29 00:00:00.000 UTC

Location: Manati, PR

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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