Work Schedule
First Shift (Days)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, No contact lens allowed; prescriptive glasses will be provided, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Position is based Manati, Puerto Rico. Position will support our Drug Product Division (DPD) at Thermo Fisher Scientific.
Lead a Quality Control team responsible for ensuring product excellence and regulatory compliance at Thermo Fisher Scientific. Implement analytical testing, method validation, and quality systems while supporting a culture of continuous improvement. Collaborate with cross-functional teams to deliver high-quality products that help make the world healthier, cleaner, and safer.
Oversee testing operations including raw materials, in-process controls, environmental monitoring, and finished product release.
Support data integrity and Good Manufacturing Practices (GMP) while developing team members through mentoring and training.
Ensure laboratory readiness for regulatory inspections and customer audits while improving operational efficiency through quality metrics and process improvements.
Keys to Success:
BS Degree required. Preferred Fields of Study: Chemistry, Biology, Biochemistry, Pharmaceutical Sciences, or related scientific field.
Advanced degree preferred.
Advanced degree plus 6 years of experience, or Bachelor's degree plus 8 years of experience in regulated pharmaceutical, or biotech industry quality control.
5 years of people management experience leading QC laboratory teams.
Experience managing laboratory investigations, deviations, and CAPA processes.
Experience with laboratory information management systems (LIMS) and data integrity requirements.
Experience supporting regulatory inspections and customer audits.
Knowledge, Skills, Abilitie s
Extensive knowledge of cGMP regulations, quality systems, and regulatory requirements (FDA, EMA, ICH)
Strong understanding of analytical testing methods and laboratory operations
Demonstrated success implementing and improving quality systems and processes
Leadership experience developing and mentoring staff
Project management and organizational skills
Clear written and verbal communication skills
Proficiency with standard business software (MS Office) and quality systems
Ability to adapt to changing priorities
Problem-solving skills and scientific decision-making abilities
Commitment to workplace safety and compliance
Client Communications ability
Benefits
We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.
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