Associate Director CAR T Process amp Technology

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.

PURPOSE AND SCOPE OF POSITION:

The Associate Director, CAR T Process and Technology is responsible for leading activities and personnel associated with change control, design, development, delivery, validation, maintenance, documentation, training and support of S12's ERP and MES along with associated manufacturing boundary systems across multiple clinical and commercial CAR T Operational Sites. The position has direct supervision over a staff of 12 FTEs and additional contractors with indirect management of projects and processes in a cross functional and collaborative environment.

The CAR T Process & Technology Department is within the CTDO S12 Supply Chain Organization which additionally supports materials management functions and warehouse operations within the S12 CAR T facility.

DUTIES AND RESPONSIBILITIES:

Provide leadership for Site CAR T Supply Chain Operations Process and Technology Department.

Lead the Summit S12 and Warren ERP platform to ensure compliance with site, global and industry standards.

Lead the Summit S12 MES platform to ensure compliance with site, global and industry standards.

Promotes and enforces standard systems, policies, and procedures for the Oracle platform across both sites.

Promotes an environment of continuous quality and improvement of processes, standards, and procedures.

Provides coaching, counseling, mentoring, and disciplining to maximize staff effectiveness and cohesion.

Major responsibilities include maintaining and implementing the site and global policies for Process and Technology, aligning with BMS Corporate processes and delivering and maintaining validated technologies suitable for commercial pharmaceutical manufacturing.

Works closely with business owners to establish and maintain service level expectations across all functions and site systems.

Understands emerging technology and proposes new system solutions/upgrades to improve existing technologies and evaluate potential business and compliance risk.

Continuously integrates with the business to understand current business processes and to provide technology guidance that enables and supports future plans and strategies.

Coordinates with Global Supply Chain Strategy, Global IT and other manufacturing sites on standardization of system lifecycle management in terms of implementation, support, validation, change management, and system data requirements from a local and global perspective.

Utilizes a high-level of understanding of pharmaceutical manufacturing processes, procedures, controls, and cGxP requirements.

Utilizes a good overall understanding of process automation, information management systems, SDLC, vendor quality management, infrastructure management, maintenance, and metrology used in manufacturing and laboratory environments.

Leads the effort to create and maintain local and global systems and data management strategies related to the cGxP environment and to ensure that those strategies consistently support company initiatives.

This position supports business and compliance objectives by ensuring projects and systems and technology service activities deliver high levels of quality, service and cost effectiveness. Performs other tasks as assigned.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

Strategic thinker with excellent problem solving and conflict resolution skills

Ability to foster a strong team-first environment with the ability to lead and organize multiple projects and initiative

Ability to develop others, delegate and motivate

Advanced knowledge of cGMP, GxP regulations and industry best practices

Advanced knowledge of ERP and MES Applications (Oracle / Emerson Syncade preferred)

Advanced knowledge in change control documentation and release implementation

Advanced written and verbal communication skills

Advanced critical reasoning and decision making skills

Advanced ability to interpret / write general business and complex technical documents

Requires ability to solve complex problems and prioritize across competing projects

Ability to travel 10% - 20% of time

Education and Experience:

Bachelor's degree required. Advanced degree preferred.

12 years of relevant work experience within a pharmaceutical or regulated industry

8 years direct experience in business system implementation including project planning, change control and testing

6 years of direct supervision experience

Understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique preferred

Advanced knowledge of relevant regulations and guidance; available to act as a resource for colleagues

Independent decision-making capability and ability to think conceptually and understand impact of decisions

Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a senior management team member and to engage and influence team members in a matrixed environment

WORKING CONDITIONS (US Only):

The incumbent will be required to work in an office environment potentially requiring ergonomic considerations

Occasional excursions to labs, production area or warehouse requiring some level of gowning.

Occasional domestic and international travel.

Exposure to typical manufacturing, laboratory, mechanical and warehouse environments.

Flexible to work across both Summit and Warren NJ sites.

Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals, and exposure to sanitization agents are expected.

Flexibility to don clean room garments and personal protective equipment (PPE),

Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas.

Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet.

Routine exposure to human blood components and must be able to work in an environment with blood derived components.

Must have the ability to work around laboratories and controlled, enclosed, restricted areas.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

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: R1526862_EN

Updated: 2020-06-25 00:00:00.000 UTC

Location: Summit,New Jersey

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.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com