Principal Scientist, Investigations

Bristol Myers Squibb•Manatí, PR

1d•Onsite

About The Position

Working at Bristol Myers Squibb offers a challenging, meaningful, and life-changing experience with uniquely interesting work across all departments. The company fosters growth and development through extensive opportunities and high-achieving teams, ultimately transforming patients' lives and employees' careers. Bristol Myers Squibb values work-life balance and flexibility, providing a wide array of competitive benefits, services, and programs. This Principal Scientist role is responsible for providing technical expertise, compliance knowledge, and leadership to the lead investigators team within Parenteral Manufacturing (sterile & non-sterile) at the site. The incumbent must ensure that all investigations meet company standards for robustness, quality, and timeliness, while strictly adhering to Security guidelines, EHS regulations, and current Good Manufacturing Practices.

Requirements

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.

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.

Benefits

Competitive benefits, services and programs
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
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
Unlimited paid sick time (based on eligibility)
Up to 2 paid volunteer days per year (based on eligibility)
Summer hours flexibility (based on eligibility)
Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs
Annual Global Shutdown between Christmas and New Years Day