The Senior Scientist II will play a critical role as the subject matter expert (SME) and project lead of Pharmaceutical Development. The position will be responsible for preformulation studies, formulation and process development, optimization, scale-up and manufacturing in support of USL's growing pipeline of ANDAs and 505b2 products. The Senior Scientist II, must be able to collaborate effectively with a multidisciplinary team of scientists and engineers for formulation and process optimization and overall product development. Effective communication skills are essential for interactions with scientists and colleagues from numerous functions, serving on multi-disciplinary project teams.
Lead formulation development and optimization studies for solid oral dosage forms, liquids and suspensions by utilizing QbD principles.
Accountable for process optimization and scale-up activities, design space definition and technology transfer to commercial plant.
Serve as subject matter expert (SME) with internal team members and be able to clearly explain the purpose of experiments and experimental results to senior management and non-scientists within the company.
Prepare, review, and/or approve study protocols, study reports, manufacturing batch records, development campaign reports, CMC regulatory submission documents and SOPs.
Collaborate with cross functional teams including but not limited to Analytical Development, Technical Services, QA, Project Management and Regulatory to timely achieve project goals.
Proactively demonstrate leadership by advising and sharing knowledge and expert opinions with peers and senior management.
Ensures all development projects and deliverables are completed within established timelines, budgets, resources, and in accordance with regulatory, quality, and safety requirements.
Responsible to document all data generated in the laboratory notebooks.
Assist in maintaining high quality laboratory environment and comply with Health, Safety and Environmental responsibilities for the position.
Perform miscellaneous technical and administrative duties as required to meet company objectives.
Bachelors, Masters, or PhD in Pharmaceutical Sciences or related field with 9-13 (Bachelors), 7-11 (Masters), or 4-7 (PhD) years of industry experience. Candidates with PhD are strongly preferred.
Demonstrated extensive experience in formulation/process development and scale-up of solid oral dosage forms, liquids and suspensions.
Experience with development of semisolids and injectables is preferred.
Hands-on in oral drug product manufacturing unit operations including blending, wet- and dry-granulation, tableting, film-coating, milling, wurster coating.
A thorough understanding of cGMP, regulatory and safety requirements.
Proven ability to interpret experimental results to form appropriate recommendations and provide guidance on next experiments; prioritize tasks to align with company strategy.
Demonstrated leadership of technical teams and effective cross-functional communication.
Proven ability to solve critical business and scientific problems.
Strong interpersonal, communication, and project management skills with the ability to interact effectively with a cross-functional team.
Other Skills and abilities:
A history of achievement in pharmaceutical industry with an ability to multitask. Critical thinking, effective communication and organizational skills are essential for this role.
Upsher-Smith Laboratories, LLC is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Upsher-Smith Laboratories, LLC will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.
Upsher-Smith Laboratories, Inc.