Scientist II, Drug Product Development (all genders)

Design and execute phase-appropriate formulation, drug product process development and stability studies. Implement pharmaceutical product development strategy and conduct formulation development and PD process experiments.

Requirements

• Master's degree in biotechnology, bioprocess engineering, pharmaceutical sciences, biochemistry or related field with min 5 years of relevant experience, or a PhD holder with 0-1 years of relevant experience
• Knowledgeable and experienced in Biosimilar/Biologics/Protein/peptide formulation and DP process development (mandatory)
• Able to prove practical hands-on experience of analytical techniques including HPLC/UPLC, Capillary Electrophoresis (CE), Isoelectric Focusing (IEF), Sub-visible particle analysis/characterization, DLS, DSC etc.
• Knowledgeable and experienced with design experiments (DoE) tools such as JMP, MODDE etc. and statistical analysis for biologic and/or biosimilar products
• Comfortable with deep understanding of protein-protein interactions, protein degradation and stabilization mechanisms
• Experienced in Drug product development and/or manufacturing of sterile injectable dosage forms including frozen, liquid, formulations in vials, pre-filled syringes and autoinjectors (will be preferred)
• Knowledgeable of regulatory guidance from the FDA and EMA for development of biologic drug products and biosimilars
• Knowledgeable of USP and Ph. Eur. as it relates to biologics development
• Fluent in English (mandatory). Having a comprehensive written and verbal French communication skills will be an added advantage
• Dynamic, with good interpersonal skills such as team player

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Visa Sponsorship
• Four Day Work Week
• Generous Parental Leave
• Tuition Reimbursement
• Relocation Assistance