Bristol Myers Squibb Associate Director, Manufacturing Support Operations, Cell Therapy Manufacturing in Devens, Massachusetts
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:
BMS Cell Therapy Manufacturing seeks an Associate Director of Manufacturing Support Operations who brings enthusiasm, intellectual curiosity, scientific rigor, and a desire to help drive novel programs to oversee the support operations for the Manufacturing Cell Therapy department.
The support operations within the Manufacturing department includes three distinct teams: training, compliance (consisting of two groups: compliance and documentation), and scheduling.
DUTIES AND RESPONSIBILITIES:
Hire, lead, and develop a compliance team that is responsible for: 1) the creation, lifecycle management, and partnership for Standard Operating Procedures and 2) facility inspection readiness, quality system alignment, and developing internal controls/policies to ensure all compliance needs are met.
Hire, lead and develop a team that executes training strategy, including working with stakeholders to determine learning needs and priorities and provides appropriate training to meet those learning needs.
Hire, lead, and develop a team that creates and maintains detailed site plans for operations, including: apheresis/PBMC receipt, material kitting, process intermediates, manufacturing, drug product shipments, maintenance, and support operations.
Accountable for ensuring full quality and regulatory compliance of Manufacturing GMP operations through standard operating procedures and training curriculum.
Create and maintain procedures that are aligned to site/network directives and regulatory expectations.
Create, implement, and maintain training content and curriculum for all Manufacturing Operations.
Develop and manage the program for on-boarding of new team members.
Work closely with department managers to review all departmental policies for compliance issues.
Accountable for ensuring department personnel (Manufacturing Operations and Manufacturing Support) are updated on relevant procedures to ensure adequate compliance
Work as a liaison between Manufacturing and Quality Operations and relevant Management systems.
Develops and executes the scheduling strategy, including working with key stakeholders to determine needs and priorities.
Collaborate cross functionally to ensure adequate inputs, sequences, durations, and inter-dependencies in order to create scenario plans to accommodate required manufacturing batches and support work.
Assist with Tech Transfer, Manufacturing Risk Assessment, and mitigation evaluation activities.
Must be familiar with many GMP-related aspects and systems like:
Quality Risk Management
Document and Data Governance
Monitoring and Quality Reports
Must have the ability to challenge and make recommendations.
Escalate compliance and scheduling concerns in a timely manner.
The ability to review and approve change controls as the manufacturing representative.
Establish and maintain key performance indicators in alignment with department and product supply goals. Maintain and report applicable area or organizational metrics.
Ensure high levels of communication with team, support resources, and management regarding issue identification and resolution.
Evaluate functional strengths and developmental areas a team with the ability to focused on continuous improvement as it relates to compliance, scheduling, and training.
Other duties as assigned.
Bachelor’s Degree in a relevant scientific discipline.
Advanced degree preferred.
10+ years hands on experience in biotechnology/pharmaceutical manufacturing practices, guidelines, management practices, cGMP knowledge, and production and planning operations.
5+ years in a Manufacturing/Operations in a cGMP environment is required.
Technical writing, training curriculum development, and knowledge of operations scheduling preferred.
Ability to work by influencing peers and their reports and gain their cooperation.
Lead teams focused on technical writing of SOPs, training curriculum creation and implementation, and scheduling while supporting the end user requirements.
A high sense of urgency and a commitment to delivering results is essential.
Cell Therapy manufacturing experience preferred.
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.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to firstname.lastname@example.org. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Company: Bristol Myers Squibb
Req Number: R1546738
Updated: 2021-09-18 02:45:29.033 UTC
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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