R&D Process Development Scientist II

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.

The role

The Galenical Development Technician (Scientist II) is responsible, under the direction of the department manager and supervisor, for product formulation development, implementation and optimization of manufacturing processes. The successful person performs their function in accordance with the GMP and FDA standards applicable to the target market, as well as with the company's quality criteria and internal procedures.

Main responsibilities

• Performance new product development and product transfer activities at manufacturing level, including : Formulation development, technical evaluation of documentation in transfer processes and process development and adaptation of the processes to the plant according to GMP, FDA and ICH regulations.
• Evaluation of starting materials according to the pharmacopoeias of the markets for which the product is intended.
• Technical communications with customers.
• Writing of manufacturing guidelines and review of guidelines executed during the development phase until the commercial proposal once the process has been validated, and follow-up of these manufacturing processes.
• Transfer of validated processes to the Production department and support if necessary.
• Drafting of support studies and documentation associated with registration batches (e.g. material compatibility studies, stability studies, characterization studies, holding time studies, risk analysis).
• Participation in new product registration activities.
• Drafting of documentation associated with process validation batches (e.g. process validation protocols and reports).
• Training of manufacturing personnel in the developed processes.
• Drafting, updating and review of application procedures for galenic development.
• Participation in the drafting, updating and review of plant procedures related to their area of competence.
• Initiation, investigation and participation in the actions of quality events detected in assigned projects : deviations, change controls, corrective and preventive actions, complaints, rejections and other quality events that apply.
• Participation in internal and external audits (from customers or competent health authorities).
• Management, organization and supervision of the activities of the galenic development laboratory staff.
• Perform their duties following the quality criteria, safety and hygiene standards established by the company.
• Carrying out duties in accordance with the quality standards, safety, and hygiene regulations established by the company.

Requirements

BENEFITS

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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.

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