9 дней назад
Scientist I, Parenteral Drug Product Development (Biotech)
103 000 - 133 750$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Scientist I, Parenteral Drug Product Development (Biotech): Developing sterile parenteral drug products and manufacturing processes for preclinical, clinical, and commercial programs with an accent on formulation optimization, process characterization, and technology transfer. Focus on supporting GMP manufacturing, process validation and PPQ activities, container closure evaluation, and CMC documentation for regulatory submissions.
Location: Cambridge, Massachusetts, United States
Salary: $103,000–$133,750 base compensation per year
Company
is a mid-sized biotechnology company developing life-changing medicines through research, manufacturing, and cross-functional technical development.
What you will do
- Design and execute formulation and process development studies for preclinical, clinical, and commercial drug product programs.
- Develop sterile parenteral 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, equipment, single-use systems, filters, and container closure systems.
- Prepare drug product supplies for nonclinical studies and collaborate with drug substance, analytical, device engineering, manufacturing, quality, regulatory, and external manufacturing teams.
- Author development protocols, technical reports, validation documents, 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 biotechnology experience; or an M.S. with 2–4+ years; or a B.S. with 4–6+ years of relevant experience.
- Experience with pharmaceutical drug product development, preferably sterile drug products and parenteral formulations.
- Knowledge of mixing, sterile filtration, aseptic filling, lyophilization, and container closure systems.
- Experience planning laboratory experiments, analyzing data, drawing scientific conclusions, and applying analytical and characterization techniques.
- Experience with process validation, PPQ, engineering batches, technology transfer, and technical or regulatory documentation.
- Ability to work independently, solve scientific problems, and collaborate across multidisciplinary teams.
Nice to have
- Experience with oligonucleotides, peptides, antibodies, conjugated therapeutics, biologics, or high-concentration protein formulations.
- Experience developing drug delivery systems and targeted conjugate molecules.
- Knowledge of statistical software, design of experiments, programming, and visualization of complex datasets.
Culture & Benefits
- Collaborative, fast-paced matrix environment with opportunities for learning and professional growth.
- Medical, dental, vision, life, disability, fitness, and wellness benefits.
- Paid vacation, company holidays, end-of-year shutdown, sick time, and parental leave.
- 401(k) plan with company matching, employee stock purchase plan, cash bonuses, and equity incentives.
- Tuition reimbursement of up to $10,000 per calendar year and employee resource group participation.
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