mirus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the involved project management.Job Description:Design and execute formulation and process development studies for new or reformulated pharmaceutical products.Develop and optimize manufacturing processes at lab and pilot scales, and support technology transfer to commercial production.Prepare and review development reports, validation protocols, and tech transfer documentation.Conduct stability studies following ICH guidelines (accelerated and long-term).Collaborate with Regulatory Affairs to prepare technical dossiers (CTD format) for product registration submissions.Select appropriate excipients and evaluate suppliers for raw material qualification.Participate in scale-up activities and manufacturing trials.Ensure alignment with GMP, quality standards, and applicable pharmacopeial requirements.Requirements:Education & Experience:
Bachelor’s or Master’s degree in Pharmaceutical Sciences, Chemical Engineering, Industrial Pharmacy, or related field.
Experience in New Product Introduction
3+ years of experience in pharmaceutical product development, preferably in a regulated GMP environment.Technical Skills:Strong knowledge of formulation principles and unit operations (mixing, granulation, drying, compression, coating, etc.).Familiarity with regulatory requirements (FDA, EMA, WHO) and dossier preparation.Experience with stability studies, analytical techniques, and CMC documentation.Proficiency in tools like MS Office, and optionally DoE software (e.g., JMP, Minitab).Soft Skills:Strong analytical and problem-solving abilities.Excellent written and verbal communication skills.Ability to manage multiple projects and work cross-functionally.High attention to detail and commitment to quality.Preferred Qualifications:Experience in working with generic or branded pharmaceuticals.Knowledge of ICH Q8/Q9/Q10, QbD, or continuous manufacturing principles.Experience in tech transfer and commercial launch support.This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.
