Scientist II, Parenteral Drug Product Development (Biotech)

Location: Cambridge, Massachusetts, United States

Base salary: $117,000–$156,750 per year

Company

hirify.global is a mid-sized biotechnology company developing life-changing medicines and supporting oligonucleotide drug development programs.

What you will do

• Design and execute formulation and process development studies for preclinical, clinical, and commercial drug product programs.
• Develop sterile parenteral drug products, including formulation optimization, manufacturing processes, and technology transfer.
• Provide technical support for GMP manufacturing campaigns, engineering runs, process validation, and PPQ activities.
• Characterize products and processes, evaluate manufacturing robustness, and assess equipment, single-use systems, filters, and container closure systems.
• Collaborate with drug substance, analytical development, device engineering, manufacturing, quality, regulatory, and external manufacturing groups.
• Prepare nonclinical drug product supplies and author technical reports, protocols, and CMC documentation for regulatory submissions.

Requirements

• Ph.D. in Chemical Engineering, Pharmaceutical Sciences, Pharmaceutics, Analytical Chemistry, or a related field with 0–4 years of pharmaceutical or biotech experience; or an M.S. with 4+ years; or a B.S. with 6+ years of relevant experience.
• Experience in pharmaceutical drug product development, preferably sterile drug products and parenteral formulations.
• Understanding of mixing, sterile filtration, aseptic filling, lyophilization, and container closure systems.
• Experience planning laboratory experiments, analyzing data, drawing scientific conclusions, and using analytical and characterization techniques for sterile drug products.
• Experience with process validation, PPQ, engineering batches, technology transfer, technical reports, validation documents, and CMC documentation.
• Ability to work independently and collaborate effectively across multidisciplinary teams.

Nice to have

• Experience with oligonucleotide, peptide, antibody, conjugated, or biologic therapeutics.
• Experience with high-concentration protein formulations, drug delivery systems, or targeted conjugate molecules.
• Knowledge of statistical software, design of experiments, programming, and advanced data visualization.
• Exposure to IND, IMPD, or NDA regulatory submissions.

Culture & Benefits

• Collaborative, fast-paced matrix environment with opportunities for learning, growth, and independent contribution.
• Medical, dental, vision, life, short-term disability, and long-term disability insurance.
• Paid vacation, company holidays, sick time, end-of-year shutdown, and paid maternity and parental leave.
• 401(k) with company match, employee stock purchase plan, short- and long-term incentives, and equity opportunities.
• Fitness reimbursement, wellness programs, tuition reimbursement of up to $10,000 annually, and Employee Resource Groups.