Manager, Senior Product Scientist
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.
MAJOR DUTIES AND RESPONSIBILITIES:
- Coordinates and executes process, cleaning and/ or packaging validations, product transfer and/ or new product transfer activities. Prepares and issues protocols, master batch records, BOM, BOS, reports and any other documents related to desired activity.
- Provides scientific knowledge in transferring, implementing, supporting, optimizing and troubleshooting in support of conventional and continuous manufacturing and/ or packaging processes.
- Participates in multi-disciplinary teams for investigations, technology transfer, installation and qualification of manufacturing equipment in support of conventional and continuous manufacturing and/ or packaging processes.
- Plays a key role in data management, mining and process robustness monitoring related to manufacturing and/ or packaging processes, as applicable.
- Lead and/ or contributes to the manufacturing site for troubleshooting, product impact assessments during deviations and investigations.
- Provide technical assistance in analyzing manufacturing and/or packaging problems of a complex nature. Design and carries out experimentation to collect data to solve manufacturing and/or packaging problems and recommends a course of action to management.
- Applies process understanding to assist in process improvements and in process engineering activities to support existing and new products.
- Evaluate raw data and organizes results in a manner compatible with analysis, using computer and other methods. Presents numerical information through computer readouts, graphs, charts tables, written reports or other methods. Analyzes and interprets statistics to point out significant difference in relationship among sources of information, and prepares conclusions and forecasts based on data summaries.
- Analyzes stability and analytical history in a timely and effective manner, which will allow proper response to any problem that may develop and implement corrective actions.
- Carry out process optimization studies and implements new opportunities for HCO processes.
- Provides training to manufacturing operators, product scientists, and other functions as needed on manufacturing and/ or packaging technologies.
- Support BMS Corporate Audits and other regulatory agencies (DEA, FDA, MHRA, ANVISA, etc.) by providing expertise.
- Support activities of start-up during shutdowns or atmospheric events.
A. This position has the responsibility for taking action, making final decisions and developing recommendations:
- Objectives and tasks accomplishments shall be based in current GMPs, existing operational procedures and BMS policies and internal controls.
- Assume responsibility using initiative and good judgment.
- Applies scientific rigor to address implementation, update, modification and lifecycle of the existing products manufactured and/ or packaged in HCO site.
- Decisions are based on policies, procedures and investigation processes.
- Provides recommendations as required by the business.
B. The nature of the supervision for the role and goals are:
- Work with minimal supervision to accomplish agreed goals/objectives.
- Notifies immediate supervisor of any inconsistencies or violations to Company operation procedures and policies.
- Daily contact with site and external peers, management and staff to set and / or follow priorities driven by business needs.
- Working relationship with members from other disciplines (Manufacturing, Engineering / Maintenance, QA/QC, etc.).
KNOWLEDGE / SKILLS
- Bachelor o Master degree in Science, Pharmaceutical Technology or Engineering
- Six (6) years’ experience in a pharmaceutical manufacturing environment or manufacturing processes or equivalent experience inside the pharmaceutical industry
- Strong knowledge of FDA regulatory requirements
- Strong knowledge of relevant governmental regulations, cGMPs and guidelines pertaining to a biopharmaceutical manufacturing plant
- Able to write detailed technical protocols, reports or investigations
- Knowledge in statistical tools
- Able to effectively present detailed technical information and respond to technical questions
- Knowledge of pharmaceutical business processes and equipment
- Ability to review procedures and work instructions
- Significant abilities and aptitude to analyze data detecting inconsistencies, determining relative importance and to solve complex technical situations based on data
- Bilingual English/Spanish, both written and verbal are required
- Able to interact effectively with people to establish and maintain excellent working relationship with at all organizational levels
- Able to plan and prioritize multiple complex activities simultaneously
- Able to audit technical reports for compliance and accuracy
- Willing to work irregular hours, rotating shifts, weekends and holidays, when necessary.
WORKING CONDITIONS working conditions that are considered undesirable, potentially hazardous, require travel, or require absence from home overnight:
A. Describe exposure to any hazards / disagreeable conditions in the work environment:
- Occasional exposure to excessive noise.
- Frequent walking, and occasionally sitting and standing.
- Occasionally light material handling.
B. Travel required:
- Some travel required to perform manufacturing equipment evaluation and/or technical training.
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.
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