Principal Scientist TSMS

Eli Lilly and Company • Carolina, PR

21h • Onsite

About The Position

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Patients are at the center of everything we do at Lilly. We are currently hiring a Scientist TSMS. This role supports critical work that helps bring medicines and solutions to patients responsibly and efficiently. #WeAreLilly Organization Overview: The TSMS function provides technical expertise and support to Dry Product Operations (DPO) ensuring compliance with cGMP, regulations, company standards and business practices. The primary areas of support include technical expertise for process manufacturing and business process improvements, compliance with business systems, new product introduction, site technical agenda for continuous improvement, process and cleaning validation programs.

Requirements

• Bachelor / Master degree or PhD in Chemical Engineering, Chemistry or scientific related field.
• Minimum of five (5) years’ experience in pharmaceutical manufacturing industry.
• Demonstrated strong technical knowledge in Process and Equipment requirements, specifically those related to Active Pharmaceutical Ingredient and or Spray Dried Dispersion (SDD) and/or Dry Product operations.
• Knowledge of process safety management.
• Bilingual (English/Spanish) with strong written and oral communication skills.
• Excellent communication skills at all levels (with both internal and external resources).
• Strong leadership and organizational skills
• Knowledge in managing multiple project objectives or assignments.
• Technical Writing
• Strong customer service focus
• Computer literate, self-driven, teamwork oriented, problem-solving skills, critical thinking.
• Knowledgeable of cGMP and process safety requirements and experience in conducting activities in a regulated environment.
• Ability to accomplish multiple tasks.
• Influence skill.
• Demonstrated technical leadership skills.
• Available to work or provide support to a 24/7 operation, if necessary.
• Availability to travel within and outside Puerto Rico and U.S.
• Work as a resource in other strategic areas of the business, based on business needs.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Responsibilities

• Provide DPO expertise for site capital projects to make sure that established process/equipment design requirements are fulfilled.
• Establish and maintain technical information of the process and unit operations within the manufacturing process.
• Develop and monitor process indicators to identify and address performance issues and identify improvement opportunities.
• Perform troubleshooting and investigation on unexpected issues.
• Own process related deviations, CAPAs and changes.
• Lead or participate in investigations, problem-solving activities such as root cause analysis, FMEA, problem analysis and in development/implementation of countermeasure for quality events.
• Provide technical expertise for requirements, design, selection, installation, qualification, operation, of process and equipment.
• Perform and summarize improvement opportunities in technical reports, investigations, plant/lab trials, data analysis and process modeling.
• Ensure process complies with current industry regulatory expectations, new regulations, and corporate policies and programs.
• Develop and/or provide technical training to Operators, Process Team members and less experienced and/or new Scientists on DPO process requirements.
• Provide technical support to achieve the reliable and compliant manufacture of oral drug products following the applicable regulations and corporate standards.
• Evaluate preventive / corrective actions applying scientific expertise on process, equipment, facilities, computer systems and manufacturing operations.
• Responsible for regulatory submission and active participation in continuous improvement initiatives.
• Provide technical support for the technology transfer of solid dosage products to a commercial facility.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Number of Employees: 5,001-10,000 employees