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.
Shift: Wed-Sat PM (1330-0000)
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
Master’s degree in related field is preferred. Minimum of Bachelor’s degree and/or equivalent combination of education and experience is required.
7-10 years of relevant cGMP experience. Experience in FDA/EMA regulation in the biotechnology and/or cellular therapy field is preferred.
Demonstrated proficiency in selection of team and effectively managing personnel issues is highly desired. Proven ability to demonstrate attention to detail, personal and team accountability where it is critical to success.
Knowledge, Skills, and Abilities
Must exercise accurate judgment and be able to evaluate information critically and decide upon appropriate course of action. Must be able to correlate events and determine the action plan required to avoid incidents recurrence and apply them.
Proven commitment to quality and continuous improvement.
Possesses excellent compliance understanding. This includes both technical and regulatory requirements pertaining to equipment function and application. Understands biotechnology processing, the purpose of unit operations, clean room design and behavior, and microbial control concepts, including aseptic technique. Is able to couple a technical process understanding with a strong regulatory and compliance understanding to ensure that operations are conducted in an efficient, and above all, compliant manner to deliver safe and effective therapies to our patients.
DUTIES AND RESPONSIBILITIES:
Using the production schedule, develops and manages a daily plan for a work team of Quality Assurance Operations associates.
Leads/ supports deviation process, investigations and closure. Participates in cross functional project teams, provides QA support to technical transfers in conjunction with relevant teams/ individuals.
Ensures deviations, CAPA, change controls, process transfers, and other business drivers are supported in a compliant manner.
Ensures QA reviews and approves documents, including standard operating procedures, batch records, material specifications, and validation protocols and reports.
Interviews, hires, coaches, motivates, and develops exceptional staff. Sets performance objectives and development plans. Monitors performance progress conducts annual performance reviews for all direct reports and recommends advancements for Quality Assurance Operations Team when appropriate.
Champions a culture of exceptional teamwork, communication, and continuous improvement within the QA Operations team and across the organization.
Ensures a culture that embraces the safety of the work environment and the safety of the patients by compliance with company procedures and policies, and cGMP requirements.
Identifies and mitigates risks in production, quality and supporting operations that could negatively impact the safety, identity, strength purity or quality of the product.
Assists in the design, implementation and continuous improvement of Quality Assurance systems that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.
Provides leadership support during trouble shooting of equipment, operation and processes as it relates to ensuring the quality and compliance of the product.
Provides Quality input during the optimization of the use of raw materials, equipment and personnel in producing compliant products and leads/participates in continuous improvement initiatives as part of Juno’s commitment to operational excellence.
Assists in the development and communication of team policies, organizational structure, shift structure, and career ladders. Ensures adherence to all policies and regulations.
Actively pursues learning of required skills and new skills.
Ensures team goals are met.
WORKING CONDITIONS (US Only):
While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings.
Work in areas that may have strong magnets.
May work in areas with exposure to vapor phase liquid nitrogen
Must be able to obtain gowning qualification to enter a cleanroom environment
May be required to work nights, weekends and holidays in a 10-hour shift structure.
Will be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include, but not limited to: safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hairnets, gloves, and hearing protection.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
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 if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to firstname.lastname@example.org. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Bristol-Myers Squibb is a global BioPharma company firmly focused on its Mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
Around the world, our medicines help millions of people in their fight against such diseases as cancer, cardiovascular disease, diabetes, hepatitis B, HIV/AIDS, rheumatoid arthritis and psychiatric disorders.
At Bristol-Myers Squibb, our BioPharma strategy uniquely combines the reach and resources of a major pharma company with the entrepreneurial spirit and agility of a successful biotech company. With this strategy, we focus on our customers’ needs, giving maximum priority to accelerating pipeline development, delivering sales growth and continuing to manage costs.
The strategy is working. For the past three years, our total return for shareholders, including dividends, has been among the best in the industry. We outperformed most mega pharma companies, diversified companies and pure biotech companies. Reflecting our long-standing commitment to deliver shareholder value, our company has paid dividends to stockholders for more than 300 consecutive quarters.
In addition, we have delivered 13 new medicines to patients since 2002, and we have the possibility of two new approvals in 2012.
Our R&D organization is considered among the most productive in the industry. And the String of Pearls strategy of innovative alliances, partnerships and acquisitions further enhances our internal capabilities. Our full array of pearls encompasses many of our key disease areas, including cancer, cardiovascular disease, immunology, neuroscience and virology.
Pursuing our Mission also means we are working to provide patient access to health care. We are striving to that goal through public/private partnerships like SECURE THE FUTURE, our groundbreaking $150 million program to help confront HIV/AIDS in Africa. In addition, through our patient assistance programs, we provide free medications to qualifying patients with financial hardship in the U.S.
Innovation is critical for successfully executing our BioPharma strategy. That innovation is enhanced by a diverse workforce and an inclusive culture. Bristol-Myers Squibb has been recognized year after year as one of the best companies for female executives and working mothers. We’ve also been recognized by the Human Rights Campaign Foundation’s Corporate Equality Index for achieving a perfect score for four consecutive years.
Preservation of our natural resources also represents one of our key commitments. At many of our facilities worldwide, our company is integrating comprehensive energy management, pollution controls and other practices to reduce environmental impacts. Bristol-Myers Squibb is recognized among the leading sustainability-driven companies.
Bristol-Myers Squibb delivers on its commitments: to our patients and customers, to our employees, to our global communities, to our shareholders and to our environment.
Ultimately, our success as a BioPharma leader is measured by the difference we make in the lives of patients. I invite you to listen to some of those stories – which may also be those of our own employees – throughout our website and on www.prevail.bms.com.