Develop injectable dosage forms (liquid, lyophilized or frozen drug product) for clinical and commercial use, including formulation development, drug product process development and scale-up, product characterization, technology transfer, and GMP manufacture support. Design and conduct studies to assess physiochemical stability of biologic drug candidates and lyophilized drug product, including solid state characterizations. Design and execute formulation development and optimization studies for bio pharmaceutics. Develop plans for and assist in process development studies for routine manufacturing unit operations for injectable dosage forms (e.g., freeze-thaw, mixing, filtration, filling, lyophilization etc.). Work closely and independently with counterparts from other functional areas to deliver on CMC milestones while adhering to broad project timelines. Lead and participate in technical team discussions. Mentor junior staff and provide technical leadership to the team. Generate, analyze, and present study data and results for team and senior management discussions. Author development reports and documents for regulatory filings. Maintain electronic laboratory notebook.

The employer permits the employee in this role to work remotely from their residence 2-3 days a week so long as that is with normal commuting distance or within the same metropolitan statistical area.

The employer and its U.S. affiliates are Equal Opportunity and Affirmative Action employers.
**For screening purposes only**

Job requires:
• PhD in Biochemistry, Molecular Biology, Pharmaceutics, Pharmaceutical Chemistry, Bioengineering or related discipline plus 0 years’ experience or
• MS plus 4 year's (or Bachelor's plus 6) bioanalytical assay experience, solid state analytical experience, drug product formulation experience.
• 2 years' experience in R&D scale lyophilized product development. Knowledge of lyo cycle design and formulation screening.
• 2 years' experience in unit operation (Filling, Filtration. Mixing, Lyophilization) process development.
• 2 years' experience in pilot scale manufacturing for sterile injectable biologics drug product, including both lyophilized and liquid product format parts (vials and prefilled syringes (PFS)).
• 2 years' experience in both automatic and manual filling techniques with multiple products and format types of various sizes (Vial, PFS etc).
• 18 months' experience in solid state analysis including DSC, KF assays, knowledge to run assays, develop/modify assays, maintain equipment and contact vendors.
• 18 months' experience in scale up and technical transfer of a lyophilized product between manufacturing sites, including lyo characterization (Kv, mass flow. Lyo modeling).

Please send us your resume via email at candidates (at) placementservicesusa (dot) com with reference #585175. Do not copy and paste your resume in the body email. Please attach it as a Word document. Thank you.