Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
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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.
JOB SUMMARY
The Formulation Scientist under the direction of Process Development Director is responsible for the development and optimization of product formulations and the implementation of manufacturing processes. They perform this function in accordance with the GMP and FDA standards applicable to the target market and the quality criteria established by the company.
JOB DUTIES
Development of product formulations in solution, suspension, emulsion and lyophilized forms for small molecules and biological products (mAb: monoclonal antibodies; ADC: antibody drug conjugate; proteins, peptides, oligonucleotides and high potency products).
Define and update the QTPPs and CQAs of the formulation: efficacy, safety, stability, purity and potency, etc.
In partnership with the client aid in the selection of suitable form of API for final drug product through pre-formulation and formulation techniques e.g. polymorph, isomeric conformation, melting point, hygroscopicity, pH and logP, particle size.
Evaluation and selection of excipients according to QTTP. Selection and concentration of the formulation excipients and definition of the CMA of the selected excipients.
Design of tests to evaluate the behavior of excipients and APIs: characterization studies, compatibility, solubility, dissolution, physico-chemical stability, etc.
Application of DoE methodology to design, perform and analyze laboratory scale experiments for the optimization of formulations and their manufacturing processes.
Selection, design and execution of supporting studies and documentation for the development of the project: general studies such as characterization, compatibility, robustness, stability, etc. and specific biological products studies such as freeze-thaw, shear stress, protein content, silicone compatibility, etc.
Selection of appropriate equipment, manufacturers and technologies for technical and manufacturing transfer. Perform tasks related to pre-clinical batches, including toxicological studies.
Selection of primary packaging materials based on characterization and chemical compatibility studies.
Coordinate with the Analytical Development team to develop analytical methods for new products, both biological and non-biological.
Work with PM, EHS, development teams based on other PCI sites and equipment vendors.
Process Development and adaptation to PCI-Leon site in accordance with GMP, FDA and ICH regulations.
Holding technical discussions with clients
Partner with PD Director and site team for adding new technology and aid in building Capex.
Carry out their duties in accordance with the quality criteria and health and safety standards established by the company.
Work in accordance with applicable GMP and FDA regulations.
To take part in the drafting, updating and revision of PCI-Leon site SOP in relation to his or her area of responsibility.
Drafting, updating and revision of Process Development SOP.
Drafting of MBR and review executed MBR during the development phase. Following up these manufacturing processes.
Initiation, investigation and participation in actions on quality events detected in assigned projects: deviations (DS), change controls (CC), corrective and preventive actions (CAPA), complaints, rejections (RC).
Training of production operator in the developed processes.
REQUIREMENTS
Master’s degree in pharmaceutics or a related scientific discipline.
At least 5 years’ experience in formulation development of product formulations in solution, suspension, emulsion and lyophilized forms for small molecules and biological products, defining QTPPs and CQAs, selecting suitable form of API and designing characterization studies, compatibility, solubility, dissolution, physico-chemical stability, etc.
Good level of spoken English and Spanish.
Very good written communication skills.
BENEFITS
At PCI, we believe our employees are our most valuable asset. That’s why we are committed to offering a benefits package designed to support your well-being and enhance your overall quality of life.
Here’s what we offer:
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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.
