R&D Analytical Development Scientist

PCI Pharma Services

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

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.

We are looking for a person to join the Analytical Development area, actively participating in the development, optimization, validation and transfer of analytical methods, providing support to the studies necessary for the development, registration and manufacturing of pharmaceutical products.

Main Responsibilities

• Development and/or optimization of new or existing analytical methods (small molecules)
• Development of bioanalytical methods such as CE (CE-SDS, CIEF), H/UPLC (SEC, RP, HILIC, IEX), ELISA and Western blot for the analysis of biological products.
• Elaboration of transfer and validation protocols of analytical methods as well as the corresponding reports
• Elaboration of protocols, reports and pertinent research framed in the studies necessary for the development and registration phase of pharmaceutical products
• Management, organization and supervision of the Analytical Development Analysts assigned to the execution of experimental activities as well as technical support to them and to the training staff
• Review of the documentation generated by the Analytical Development Analysts and evaluation of data, study of trends
• Communication with the client
• Verification of new USP, EP monographs
• Participation and support in quality events, as well as elaboration and/or review of Specifications, Analysis Procedure, special requirements and other Laboratory procedures or related
• Analytical support for the preparation of technical product documentation
• Collaboration with the Galenic Development and/or Production department for the analysis of samples from different points of the manufacturing process of pharmaceutical products
• Collaboration with the Quality Control department in the management, organization and cleaning of the laboratory
• Participation in internal and external audits (from clients or competent health authorities)

• University degree in Chemistry, Pharmacy, Biotechnology or similar
• Familiarity with GMP regulations
• Advanced knowledge in development, optimization, validation and transfer of analytical methods (U/HPLC, ELISA, CE)
• Previous experience in Analytical Development within the pharmaceutical industry or regulated environments (preferable)
• Good organizational, communication skills, technical rigor and quality orientation
• Fluency in spoken and written Spanish and English

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.