Formulation Scientist

Novel Laboratories, Inc.

Somerset, NJFull-time$94–112K/yrSeen 2 days agoSeen in employer's feed 2 days ago

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At a glance

Compensation

$94–112K/yr

Location

Somerset, NJ

Schedule

Full-time

Work Authorization

Not specified

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Requirements

Credentials this posting asks for.

Master's degree

Job overview

Novel Laboratories, Inc. seeks a Formulation Scientist to design and conduct pharmaceutical characterization studies and support formulation and product development across nasal spray, oral liquid, inhaled, and other dosage forms. The role includes aerosol characterization, scale-up and submission batches, raw-material evaluation, regulatory submission writing, and compliance with cGMP, USP methodologies, and ICH guidelines.

Skills & qualifications

RequiredNice to have

Skills

Pharmaceutical CharacterizationpMDI and DPI CharacterizationAerosol CharacterizationScale-Up BatchesRegulatory Submission BatchesFormulation DevelopmentProduct DevelopmentRaw Material EvaluationRegulatory Submission Writing

Qualifications

Master's DegreeChemistry or Related Field2 Years Pharmaceutical Characterization Experience2 Years pMDI and DPI Characterization Experience2 Years Aerosol Characterization Experience2 Years Scale-Up and Submission Batch Experience2 Years Formulation and Product Development Experience2 Years Raw Material Evaluation Experience2 Years Regulatory Submission Writing Experience

Full job description

Experience Required

2 years

Minimum Education Required

Master's Degree

Compensation

$93,633.28 - $112,360.00 / Yearly

Hours Per Week

Number Of Positions

Job Description

Novel Laboratories, Inc. seeks a Formulation Scientist in Somerset, New Jersey to design and conduct pharmaceutical characterization studies. Support formulation and product development efforts for unit dose nasal spray and oral liquid technology. Design and conduct characterization studies for pressurized Metered Dose Inhalers (pMDIs) and Dry Powder Inhaler (DPI) products. Perform aerosol characterization methodologies for orally inhaled and nasal products (OINDPs). Execute scale-up batches and submission batches required for pharmaceutical regulatory submissions, including ANDA and NDA (505(b)(2)) submissions. Ensure compliance with cGMP requirements. Analyze data, identify trends, and perform statistical analysis on pharmaceutical data to ensure reproducible results. Evaluate and select raw materials for pharmaceutical development and manufacturing, including APIs, excipients, primary and secondary packaging materials, and device component materials. Ensure drug product and drug device combination quality and safety through Chemistry, Manufacturing, and Controls (CMC) activities. Perform formulation and product development activities across multiple dosage forms, including tablet, oral suspension, and inhaled product. Write regulatory submission modules to support pharmaceutical regulatory submissions and product approvals. Ensure compliance with United States Pharmacopeia (USP) methodologies, International Council for Harmonization (ICH) guidelines, and drug device combinations guidelines for pharmaceutical manufacturing activities. Annual salary: $93,633.28 - $112,360.

Requirements: Master’s degree in Chemistry, Pharmaceutical Manufacturing, Pharmaceutical Sciences, or a related field plus two years of pharmaceutical characterization studies experience. Must have at least two years of experience in each of the following: 1. Designing and conducting characterization studies for pressurized Metered Dose Inhalers (pMDIs) and Dry Powder Inhaler (DPI) products; 2. Performing aerosol characterization methodologies for orally inhaled and nasal products (OINDPs); 3. Executing scale-up batches and submission batches required for pharmaceutical regulatory submissions, including ANDA and NDA (505(b)(2)) submissions; 4. Perform formulation and product development activities across multiple dosage forms, including tablet, oral suspension, and inhaled product; 5. Evaluating and selecting raw materials for pharmaceutical manufacturing including APIs, excipients, primary and secondary packaging materials, and device component materials; and 6. Writing regulatory submission modules to support pharmaceutical regulatory submissions and product approvals. To apply, please send resume to [email protected] and cite requisition number 00187 or apply at www.lupin.com/US/.