Principal Scientist, Investigations

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. 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 Objective

Accountable for providing technical expertise, compliance knowledge and overall leadership for the support of lead investigators team for Parenteral Manufacturing (sterile & non-sterile) to the site. Accountable for ensuring that investigations meet company expectations for robustness, quality, and time. The incumbent must comply with all Security guidelines, EHS regulations and the current Good Manufacturing Practices required by the job function.

Duties and Responsibilities

• Provides technical and managerial leadership to one or more scientists supporting site deviations/investigations.
• Lead and conducts site deviations and ensure that root cause analysis, execution of resulting solutions (CA/PA) are completed in a timely, effective and compliance manner. Support global investigation program.
• Participates in multi-disciplinary teams for investigations and technology transfer in support of pharmaceutical processes.
• Manage the assigned resources toward the fulfilment of investigation function based on a Tier Management process with effective communication.
• Participate and foster collaboration within the global investigation community within MS&T Manati.
• Conducts Quality/Safety Risk management assessments to establish required control systems to minimize risk.
• Provide technical assistance to supports the establishment of corrective actions to prevent recurrence of Quality Events focused on root cause.
• Provides training to manufacturing operators, product scientists, and other functions as needed on topics related to the investigation process and procedures.
• Promotes and model the BMS Core Behaviors, facilitating teamwork.
• Oversee the certification program for new investigators
• Oversees the execution of the investigation processes for Manufacturing Operations at BMS Manati. Assesses Investigation performance and develops improvement plans to advance area maturity in conjunction with site QA, Compliance and Investigations-Global Process Owner.
• Provides coaching and developmental activities for seniors and juniors scientists investigators.
• Support BMS Corporate Audits and other regulatory agencies (DEA, FDA, MHRA, ANVISA, etc.) by providing expertise.

Knowledge and Skills Required

• BS in Engineering, Pharmaceutical or Science with nine (9) years of experience in pharmaceutical operations, specifically in parenteral products or master’s degree in engineering, Pharmaceutical Sciences, Science or Management with six (6) years of experience in pharmaceutical operations, with broad knowledge in specifically in parenteral products.
• Proficient knowledge of FDA regulatory requirements
• Broad knowledge of relevant governmental regulations, cGMPs and guidelines pertaining to a biopharmaceutical manufacturing plant
• Ability to write detailed technical reports
• Ability to effectively present detailed technical information and respond to technical questions.
• Knowledge of pharmaceutical business processes
• Ability to review SOPs and work instructions
• Ability and aptitude to analyze data detecting inconsistencies, determining relative importance and to solve complex technical situations based on data
• Excellent technical writing/oral communication skills (English/Spanish)
• Excellent Time Management, planning and organization capabilities, Project management skills, leadership and teamwork skills
• 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
• Willing to work irregular hours, rotating shifts, weekends and holidays, when necessary
• Ability to make decisions while balancing speed, quality and risk
• Experience in identifying and taking informed business risks and escalating issues if needed
• Capability to challenge the status quo to simplify work and improve results
• Strategic and proactive mindset.

Working Conditions

• The incumbent may be expose to the chemical, biological, and pharmaceutical substances, and the mechanical and electronic equipment used to process, test and document manufacturing operations.
• Regular BMS sites meeting/training are expected within all BMS PR facilities or outside BMS facilities. Outside seminars are expected; frequency depends on project needs.
• Some travels required to perform evaluations, participate in multi-site initiatives or administrative meetings.
• Travel will depend on actual management needs but will be of approximately 15% of the incumbent's time.

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.

Manati - PR - US: $106,520 - $129,080

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. 

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
 

Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• Health Coverage: Medical, pharmacy, dental, and vision care.

• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).

• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.

​Work-life benefits include:

Paid Time Off

• US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)

• Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays

Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

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 a supportive culture, promoting global participation 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 an 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.

Supporting People with Disabilities

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

Candidate Rights

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/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

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

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1601400 : Principal Scientist, Investigations