Senior Scientist - Validations

Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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. Read more:careers.bms.com/working-with-us .

Position:Senior Scientist - Validations

Location: Manatí PR

Key Responsibilities

1. Prepares well-documented protocols for all processes to be qualified/validated based on corporate guidelines, procedures, FDA Regulations, and Industry current practices.
2. Coordinates the validation activities with related departments (Engineering, Manufacturing, QC/QA, Technical groups)
3. Develops and controls detailed time and event schedules for all studies/projects assigned.
4. Performs qualification/validation studies as per established protocol.
5. Reports in an accurate and timely manner all the studies/project assigned in accordance with the designed protocol.
6. Evaluates process/equipment performance during the studies to determine acceptability, reproducibility, and control.
7. Provides timely and efficient technical support to user on qualified/validated systems/processes.
8. Maintains all documentation records in accordance with cGMP's, company policies and FDA regulations.
9. Maintains an understanding of the current technical and regulatory trends in the pharmaceutical industry.
10. Proposes and formalize alternatives for continuous improvement to qualification and validation processes.
11. Maintains validation programs in conformance with department standards and government/corporate regulation/specification.
12. Utilizes statistical tools and other techniques to assess performance of validation studies.
13. Assists management during FDA inspections by interacting with FDA/auditors during inspection or audits.
14. Provides annual revision of the validation programs covered in the validation Master Plan.
15. Update Operational procedure of equipment/system validated according to actual results.
16. Train impacted personnel by updated operational procedure.
17. Collaborates with internal /external clients as requested and or permitted by immediate supervisor.
18. Provides backup support to the Validation Principal Scientist or Senior Principal Scientist during his/her absence and makes section decision as needed.
19. Serve as technical expert, finding the best solutions, and propose initiatives during projects, line interventions, troubleshooting and day to day process.
at the operations related areas. Actively participate in triages, investigations resolution, etc., to support in the decision making to keep process continuity.
20. Able to establish effective mentoring and coaching to other potential colleagues, seeking to maximize their professional growing potential and development that also renders benefit to company objectives and goals.

Qualifications & Experience

Bachelor's degree in pharmacy, Chemistry or Chemical / Mechanical Engineering or any other related Science field.
Five (5) years of experience in pharmaceutical manufacturing processes, technologies, and aseptic processing equipment for Parenteral and biological dosage forms.
Three (3) years of experience in pharmaceutical technology transfer, process improvements and troubleshooting.
Proficient knowledge of biopharmaceutical formulation processes, Parenteral filling, and syringe filling processes.
Proficient knowledge of product and process development, manufacturing scale up, continuous process improvement and troubleshooting processes in conformance with departmental standards and in compliance with regulations.
Detailed understanding of how Parenteral manufacturing processes are controlled and validated.
Ability to effectively manage multiple projects at the same time with minimum supervision and to incorporate a wide array of technical principles, concepts, and theories in innovative ways to technology transfer and scale-up activities.
Strong project management skills.
Proficient time management skills, planning and organization capabilities.
Proven ability to influence and work with people at different levels and departments.
Proven leadership & teamwork skills, self-starter, results oriented and build and maintain strong relationships with multiple groups.
Proficient in Statistical Process Control, Process Capability and Risk Assessment/Management
Proven assessment, analytical and problem-solving skills.
Proficient presentation skills and Technical Writing/Oral communication skills (English/Spanish)
Proficient in cGMP's, OSHA and FDA Regulations as it applies to pharmaceutical industry.

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
#LI-Onsite
BMSBL

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as "Transforming patients' lives through science™ ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application, or in any part of the recruitment process, direct your inquiries ******. Visitcareers.bms.com/eeo-accessibilityto access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:https://careers.bms.com/california-residents/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.