At Kelly® Science, Engineering, Technology & Telecom (SETT), we’re passionate about helping you find a job that works for you. How about this one?
We’re seeking an Principal Scientist to work with one of our top global biopharmaceutical clients in the Carolina, PR area. With us, it’s all about finding the job that’s just right
Principal  Scientist – TSMS

 
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.
 
Responsibilities:

• Technical leadership – 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. 

Basic Requirements:

• Bachelor or 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.

Additional Skills/Preferences:

• 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.

Additional Information:

• 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.

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