Senior Scientist, Parenteral Drug Product Development (Biotech)

Location: Cambridge, Massachusetts, United States

Base salary: $138,000–$184,500 per year

Company

hirify.global is a mid-sized biotechnology company developing life-changing medicines with a focus on scientific innovation and collaborative product development.

What you will do

• Design and execute formulation and process development studies for preclinical, clinical, and commercial parenteral drug products.
• Lead sterile drug product formulation optimization, manufacturing process development, technology transfer, and lifecycle management.
• Provide technical support for GMP manufacturing campaigns, engineering runs, process validation, PPQ, and commercial manufacturing.
• Develop strategies for vials, prefilled syringes, advanced delivery systems, filters, single-use systems, and other container closure components.
• Coordinate drug product supply for nonclinical and clinical studies and collaborate with drug substance, analytical, device, manufacturing, quality, regulatory, and external manufacturing groups.
• Author technical reports, development and validation protocols, regulatory submission documents, and responses to health authority questions.

Requirements

• Ph.D. in Chemical Engineering, Materials Science, Pharmaceutical Sciences, Pharmaceutics, Analytical Chemistry, or a related field with 4+ years of pharmaceutical or biotech experience; alternatively, an M.S. with 8+ years or a B.S. with 10+ years of relevant experience.
• Demonstrated experience in sterile drug product development and parenteral formulations.
• Strong understanding of mixing, sterile filtration, aseptic filling, lyophilization, and container closure systems.
• Experience with biopharmaceutical product development or CDMOs, GMP guidelines, quality-by-design risk assessments, process validation, PPQ, engineering batches, and technology transfer.
• Experience with analytical and characterization techniques for sterile drug products and with regulatory submissions including IND, IMPD, and NDA documents.
• Ability to independently lead technical initiatives, solve complex scientific problems, and collaborate across multidisciplinary teams.

Nice to have

• Experience developing formulations for proteins, antibodies, antibody-drug conjugates, oligonucleotides, peptides, or other complex biologics.
• Experience developing and analyzing drug delivery systems and targeted conjugate molecules.
• Knowledge of statistical software, design of experiments programming, and visualization of complex datasets.

Culture & Benefits

• Collaborative, matrixed environment within a growing biotechnology development organization.
• 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.
• Short- and long-term incentives, cash bonuses, equity opportunities, employee stock purchase plan, and 401(k) matching.
• Fitness and wellness programs, tuition reimbursement of up to $10,000 per year, and Employee Resource Group participation.