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.

Position: Principal Process Scientist

Location: Manati, Puerto Rico

1) Leads process development and implementation activities for sterile drug product manufacturing processes.

2) Ensures the optimization of existing processes, and establishment of new processes/methods to support new products.

3) Partners with Quality Department to execute statistical analyses and implement design of experiments (DOE) methodology to support critical investigations.

4) Forms and leads cross functional teams as needed to support process improvement initiatives and process investigations.

5) Provides technical process support and leadership in ensuring timely and sound resolution of incidents and deviations and enhancing the quality and effectiveness of manufacturing systems.

6) Partners with Quality to conduct thorough evaluations of equipment and material issues as it pertains to existing and new products.

7) Partners with Manufacturing, Engineering, Information Technology, Process Engineering and other functional teams to ensure equipment and automation are capable to deliver the intended manufacturing process performance in terms of yield and operational efficiencies.

8) Provides technical input early in the process and ensures sound knowledge-based consultation with required functions to ensure an efficient manufacturing process.

9) Participates with engineering, equipment vendors, and operations to enable best-in-class manufacturing and inspection processes.

10) Knowledgeable of industry trends and data to influence and support definition of quality standards for inspection of sterile parenteral products.

11) Partners with Manufacturing and understands equipment/process contribution to product rejects. Develops and maintain effective working relationships with other division groups in support of technology transfer, validation, productivity and process support activities.

12) Acts as core team member in the support of site investigations, as well as in new product introduction teams for internal or external manufacturing organization.

13) Assists the Technical Services Director to assure best utilization of state-of-the-art technology and best pharmaceutical manufacturing practices

• Knowledge/Skill:
• Bachelor degree in Pharmacy, Engineering, Chemistry or Sciences
• Seven (7) years of Technical Services experience within the Pharmaceutical/medical device industry
• Note: Candidates with Masters/PhD degree in Pharmacy, Engineering, Chemistry or Science will require four (4) years experience within the pharmaceutical or medical device industry.
• Thorough knowledge in the application of process statistics and Design of Experiments to achieve robust manufacturing processes.
• Experience in the implementation of both manual and automated visual inspection processes for parenteral products and/or medical devices.
• Excellent organizational skills and ability to successfully manage multiple technical projects and priorities.
• Proven ability to drive complex process investigations to root cause, and implement corrective actions.
• Knowledge in Engineering and statistical quality control principles.
• Knowledge of QbD (Quality by Design) principles, and their application to manufacturing processes.
• Ability to work in a fast paced, complex and changing environment.
• Strong project management skills and experiences.
• Excellent analytical and strategic thinking skills and experiences.
• · Outstanding communication skills, both in English and Spanish (oral, written). Outstanding decision making skills. .

BMSBL

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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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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