Oral Solid Dosage Formulation Scientist

Client Overview:
Our client is a pharmaceutical development organization that partners with innovators and generic manufacturers to take drug products from concept through commercial launch. Their teams support NCEs, 505(b)(2), and generic programs, with expertise in formulation development, clinical supply manufacturing, technology transfer, and commercial support. They offer a collaborative, science-driven environment where Oral Solid Dosage Formulation Scientists can do impactful work that helps bring new therapies to patients.

Salary/Hourly Rate:
$70k - $105k

Position Overview:
Our client is seeking an Oral Solid Dosage Formulation Scientist to join a growing product development team. In this role, the Oral Solid Dosage Formulation Scientist will use scientific and technical expertise to independently develop and optimize pharmaceutical formulations, primarily tablets and capsules, as well as oral liquids and powders for suspension. The Oral Solid Dosage Formulation Scientist works with minimal supervision on hands-on formulation and process development, including formulation design, excipient selection, experimental trials, optimization, scale-up, and technology transfer. Projects span NCEs, 505(b)(2), and generic products, and the work includes clinical supply manufacture, process validation, and support for commercial manufacturing.

Responsibilities of the Oral Solid Dosage Formulation Scientist:

• Independently design, develop, and optimize oral solid dosage formulations (tablets and capsules), including immediate- and modified-release products. This includes literature search, pre-formulation, excipient selection, formulation design, hands-on laboratory development, troubleshooting, process scale-up and optimization, exhibit and clinical batch manufacture, technology transfer, process validation, and commercial launch.
• Develop and execute product development and technology transfer work plans and schedules on time.
• Draft technical documents such as SOPs, proposals, presentations, batch records, protocols, reports, deviations, investigations, and regulatory submission documents, and maintain high-quality laboratory documentation in line with regulatory guidance and site SOPs.
• Perform secondary review of colleagues' work for scientific accuracy and compliance.
• Apply sound experimental design and QbD principles to development projects.
• Help customers with technical needs, gap assessments, troubleshooting, and equipment selection.
• Participate in continuous improvement projects and departmental initiatives, and evaluate new technologies to expand service offerings.
• Train and mentor junior scientists and technical staff in product development principles and practices.
• Work in cross-functional teams including Project Management, Manufacturing, Packaging, Analytical R&D, Quality Control, Purchasing, Engineering, Quality Assurance, and external customers.
• Communicate internally and externally through verbal and written updates, presentations, and formal reports.
• Follow all regulatory guidance and internal SOPs to maintain a safe, clean cGMP environment.
• Represent the company through participation in conferences and seminars.

Required Experience/Skills for the Oral Solid Dosage Formulation Scientist:

• Direct pharmaceutical formulation development experience as an Oral Solid Dosage Formulation Scientist or similar role. Analytical chemistry experience alone does not meet this requirement.
• At least 3 years (Ph.D.) to 6 years (BS/MS) of experience in pharmaceutical product development and/or tech transfer for oral solid products.
• Demonstrated hands-on experience with formulation development and manufacturing of oral solid dosage products.
• Familiarity with technologies such as fluid beds, high shear granulators, roller compactors, dryers, tablet presses, coating machines, blenders, and mills.
• Good knowledge of cGMPs and safety practices.
• Self-motivated, with strong problem-solving and project management skills, and the ability to handle time constraints and customer demands.
• Excellent verbal, written, and interpersonal communication skills.

Preferred Experience/Skills for the Oral Solid Dosage Formulation Scientist:

• Knowledge of controlled substance handling.
• Experience mentoring junior scientists.
• Experience with modified-release formulations and regulatory submission documentation.

Education Requirements:

• BS, MS, or Ph.D. in Pharmaceutical Sciences, Pharmaceutics, Chemical Engineering, Chemistry, or a related field.

Benefits:

• Medical.
• Dental.
• Vision.

Job Wrapping ID: #LI-AJ3

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EOE/M/F/D/V/SO

Position ID: 411349