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Position: Principal Scientist - Validations

Location: Manati... PR

Key Responsibilities

1.Assists in technology transfer activities, effectively integrating site time and event schedules to priorities established through corporate structures.

2.Leads the validations program and technical departmental documentation system to assure a high level of compliance to regulatory and compliance requirements and the efficacy, repeatability and robustness of manufacturing processes and associated equipment.

3.Assists the pharmaceutical process support activities, leading to successful on time resolution of incidents and deviations and enhanced quality and effectiveness of manufacturing systems.This includes site activities for optimization of new and existing manufacturing processes to assure effectiveness and robustness.

4.Partners with the Site management team:

•In the identification and implementation of quality and productivity initiatives based on business needs and priorities.

•For identification of best practices in industry related to validation, technology transfers, manufacturing technology and process support to manufacturing; effective introduction to the site operational environment to create a competitive advantage.

•For the definition of needs and implementation of plans for enhancement of manufacturing capabilities for the site based on product pipeline and strategic needs: equipment, facilities, introduction of state of the art technologies and systems

5.Identifies optimal regulatory strategies to assist in support site transfers, site process changes and optimization projects.Assures an effective interface to regulatory management.

6.Assists in assuring an effective integration of plans and resources to achieve effectiveness and timeliness of process support, productivity, technology transfer and validation activities across the site and ensure effective use of proper project management tools..

7.Develops and maintain effective working relationships with other division groups in support of technology transfer, validation, productivity and process support activities.

8.Implements a sound leadership development program to transform Validations Organization into a high performing team ensuring a sound Succession Plan.

9.Assists in assuring that effective systems are in place at the site to assure compliance to corporate guidelines for Technology Transfer, Validations, Raw Material Qualification and other areas related to Manufacturing Technology accountability.

10.Assists in the development and control of the Site’s Start Up and the Manufacturing Technology department’s Overhead Budgets.

11.Assists as needed in the transfer and support of products from / to other sites.

12.Creates, revises, and/or approves Master Documentation as required by the Director, Manufacturing Technology.

13.Serves as a liaison between the site and other BMS divisions related to qualification / validation efforts.

14. Performs as the backup of the MS&T Validation Associate Director or any other MT Leads, as needed.

15. Partners with peers to ensure effective technical transfers, new product launches or routine process support as required.

Qualifications & Experience

• Bachelors degree in Pharmacy, Engineering or Sciences

• Five (5) years of managerial experience

• Seven (7) years experience in the Manufacturing Technology and/or Validations fields within the pharmaceutical Industry. Note: Candidates with Masters or PhD degree in Pharmacy, Engineering or Science will require three (3) years experience in the Manufacturing Technology or Validations fields within the Pharmaceutical Industry.

• Minimum three (3) years experience in parenteral manufacturing of protein therapeutics (biologics) strongly preferred, along with demonstrated knowledge of how these products behave in parenteral processes.

• Strong knowledge and practical experience in manufacturing processes, technologies and processing equipment, CGMP’s and FDA regulations and trends.

• Excellent organizational skills and the ability to manage multitude of technical / validation projects.

• Strong project management skills.

• Excellent analytical and strategic thinking skills.

• Management leadership, interpersonal and teamwork skills.

• Strong mentoring skills with excellent people development skills.

• Outstanding communication skills, both in English and Spanish (oral, written).

• Ability to escalate issues appropriately.

• Ability to work in a fast paced, complex and changing environment.

• Ability to lead Validation Area and influence the site management team towards sustained excellence standards.

BMSBL

#LI-Onsite

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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to 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.

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

Salary Criteria