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5 дней назад

Senior Scientist, Sterile Product Development (Onsite)

117 000 - 184 200$
Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Senior Scientist, Sterile Product Development (Long-Acting Injectables/Peptide Drug Conjugates): Developing parenteral formulations and scalable manufacturing processes from preclinical development through commercialization with an accent on formulation science, drug–excipient interactions, stability, and delivery-system performance. Focus on designing complex studies, defining critical quality attributes and process parameters, supporting scale-up and technology transfer, and providing scientific leadership across multidisciplinary development workstreams.

Location: Onsite in Rahway, New Jersey, United States. Relocation is listed as domestic/international. Flexible work arrangements are not applicable.

Base salary: $117,000–$184,200 per year, plus eligibility for annual bonus and long-term incentive where applicable.

Company

hirify.global develops pharmaceutical products and technologies across small molecules, peptides, biologics, and sterile drug delivery.

What you will do

  • Design, execute, and interpret formulation and process development studies for long-acting injectables, peptide drug conjugates, and conventional parenteral formulations.
  • Evaluate controlled-release systems, crystalline suspensions, drug–excipient and drug–polymer interactions, stability, aggregation, particle size, injectability, syringeability, and device compatibility.
  • Support scalable manufacturing process development, design-space definition, clinical and commercial scale-up, validation, and technology transfer to GMP facilities.
  • Identify critical quality attributes and critical process parameters, contribute to clinical strategy and risk mitigation, and support CMC submissions and health authority interactions.
  • Lead defined technical workstreams by planning experiments, troubleshooting challenges, interpreting data, communicating risks, and recommending next steps without formal people-management responsibility.
  • Contribute to capability development, external collaborations, patents, publications, presentations, and scientific activities related to sterile product development.

Requirements

  • Ph.D. with 0 years of industry experience, or M.S. with 4+ years of industry experience in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, Biochemical Engineering, Chemistry, Materials Science, or a related discipline.
  • Strong scientific foundation and hands-on or academic experience in parenteral formulation or process development, including relevant experience with long-acting injectables, sustained-release formulations, peptides, or drug conjugates.
  • Experience applying Quality by Design principles and Design of Experiments approaches to formulation and process development.
  • Experience providing experimental or technical support for process scale-up, validation, or technology transfer involving sterile injectable products.
  • Ability to independently plan and execute studies, interpret complex data, communicate clear scientific recommendations, collaborate across functions, and provide technical leadership within a defined workstream.

Nice to have

  • Experience with polymer depots, microspheres, nanosuspensions, or in situ forming long-acting injectable systems, particularly across both LAI and peptide or drug-conjugate development.
  • Working knowledge of CMC regulatory expectations and scientific documentation for sterile parenteral development and commercial submissions.
  • Experience with controlled-release mechanisms, formulation-performance relationships, drug–polymer and drug–excipient interactions, and peptide or conjugate integrity.
  • Experience with device–drug product integration, including prefilled syringes and relevant delivery systems.
  • Understanding of clinical and patient-centric considerations such as dosing interval, injection volume, and administration route.
  • Experience supporting global regulatory filings and health authority interactions, plus contributions to publications, patents, or external scientific collaborations.

Culture & Benefits

  • Regular employee status with medical, dental, vision, insurance, retirement, 401(k), paid holidays, vacation, compassionate leave, and sick days.
  • Cross-functional collaboration with Clinical, Non-Clinical, Quality, Regulatory, Manufacturing, and Engineering colleagues.
  • Inclusive environment focused on diverse perspectives, respectful challenge, and collective problem-solving.
  • Travel requirements are 10%; no valid driving license is required.
  • Visa sponsorship is available.

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