Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. **Responsibilities:** The Senior Analytical Development Analyst is responsible for executing the experimental portion of analytical validation and transfer protocols defined by the Supervisor and Senior and Junior Analytical Development Technicians, as well as the experimental portion of analytical method development in coordination with the Supervisor and Senior and Junior Analytical Development Technicians, while supporting them in project management, in accordance with applicable current regulations (GMP, FDA, etc.) and the company’s internal procedures. * Perform minor tests (pH, osmolality, viscosity, Karl Fischer titration, spectrophotometry, particle size, etc.) and major tests (dissolution testing, HPLC/UHPLC, GC) according to LSNE\-León’s standard operating procedures. * Execute the experimental portion of analytical method validations and transfers, following established protocols. * Document experimental work in all required formats per LSNE\-León’s described procedures, and review completeness and correctness prior to submission to the supervisor. * Participate in the development and optimization of analytical methods both experimentally and documentally, as well as support project management tasks (e.g., material requisitions, shipment coordination). * Prepare simple reports summarizing conclusions from executed experiments. * Review analytical packages and draft analytical methods. * Resolve routine instrument-related issues in the laboratory. * In collaboration with Quality Control personnel: manage standards, reagents, chromatographic columns, and laboratory materials, as well as handle samples from the Analytical Development Department. * In collaboration with Quality Control personnel: perform maintenance, calibration, and verification of laboratory instrumentation. * In collaboration with Quality Control personnel: participate in general laboratory management, organization, and cleanliness. * Assist in training interns and trainees. * Report completed work to the Supervisor and Senior and Junior Analytical Development Technicians. * Required but not limiting condition: at least one year of relevant industry and role experience. Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future **Equal Employment Opportunity (EEO) Statement:** *PCI Pharma Services is an Equal* *Opportunity/Affirmative* *Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.* *At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life\-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.*
David Muñoz
Indeed · HR
David Muñoz
Indeed · HR
