R&D Formulation Scientist

Job Overview

The incumbent will utilize scientific and technical expertise to develop pharmaceutical products. These include oral solids, liquids and powders for suspension for NCEs, 505(b)2, and generic products. Major responsibilities include formulation and process development, technology transfer, manufacture of clinical supplies, process validation, support for commercial product manufacturing, The job involves working independently with minimal supervisory guidance on the bench development of new products, scale up and technology transfer of commercial products.

RESPONSIBILITIES:

·Perform activities for the development of oral solid dosage forms (immediate as well as modified release) including literature search, pre-formulation, formulation design, lab-scale formulation development, process scale-up and optimization, manufacture of exhibit batches and clinical supplies, technology transfer, process validation and commercial product launch.

·Develop and execute product development and technology transfer work plans and schedules in a timely manner.

·Draft technical documents such as SOPs, proposals, presentations, batch records, protocols, reports, deviations, investigations and regulatory submission documents. Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and site SOPs. Performs secondary review of other colleagues’ work and documentation for scientific accuracy and compliance.

· Use sound experimental design and QbD principles to execute development projects.

·Assist customers address technical needs, gap assessment, troubleshooting and equipment selection.

·Participate in continuous process improvement projects and support departmental initiatives, as well as evaluate new technologies to expand our service offering.

·Train/mentor junior scientists and technical staff in product development principles and practices.

·Work in cross-functional teams that include 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, discussions, presentations and formal reports as necessary.

·Observe all regulatory guidance’s and adhere to internal SOPs to maintain a safe, clean cGMP environment.

·Promote the company’s image through participation in conferences and seminars.

Qualifications

·BS / MS or Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering or related field.

·At least 3 years’ (for Ph.D.) to 6 years’ (for BS / MS) experience in a pharmaceutical product development and/or tech-transfer for oral solids products.

·Working knowledge of the formulation and manufacturing processes associated with the manufacture of solid and liquid oral dosage forms. Familiar with technologies such as fluid beds, high shear granulators, roller compactors dryers, tablet presses, coating machines, blenders, mills, etc.

·Good knowledge of cGMPs and safety practices. Knowledge of controlled substance handing is a plus.

·Must be self-motivated with good problem solving and project management skills. Ability to handle difficult situations produced by time constraints and customer demands is critical for this position.

·Excellent verbal and written communication and interpersonal skills.
Join us in shaping the future of pharmaceutical innovation! We are committed to fostering a vibrant environment where your expertise can thrive—driving impactful research that transforms lives through groundbreaking drug formulations.

Pay: $120,000.00 - $135,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Retirement plan
• Vision insurance

Work Location: In person