Scientist Principal - Formulation (Pharm Tech)
Watson Pharmaceuticals 37 reviews - Fort Lauderdale, FL

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Under limited direction and supervision, oversees all technical aspects of the commercial process development for modified release solid dosage forms. Must be able to demonstrate strong understanding and working knowledge of commercial manufacturing equipment (eg., fluid bed coaters, pan coaters, blenders, tablet presses, high shear granulators, etc.). Assists R&D with the formulation development of modified release solid dosage forms for ANDA filing. Demonstrates technical expertise in the areas of modified release solid dosage form (both formulation and process development), polymer science, raw material properties and characterization, statistical analysis and Quality by Design to assist with the process development of new products and troubleshooting of major analytical non-conformances associated with existing products. Identifies and implements appropriate technologies to advance coating science capability within the site (ie., in-house characterization and measurement of extended release film coatings, spraying application technology/methodology, etc.), partner with industrial coating expertise in the areas of fluid bed Wurster coating and pan coating to leverage current coating knowledge, trends and technology.

· Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), OSHA, EPA, DEA and other regulatory requirements.
· Product formulations, product stability, FDA submission methods and practices and familiarity with regulatory guidance documents.
· Knowledge of controlled release dosage forms, including multiparticulate systems, matrix systems, diffusion controlled and osmotically engineered pharmaceutical dosage forms.
· Pharmaceutical solids manufacturing principles, practices and applications.
· Analytical test methodology (BU, Assay, CU, dissolution profile, etc.)
· Understanding of concepts of UV-VIS, HPLC, GC, TLC, DSC/TGA, X-ray etc.
· Pharmaceutical raw material tests and raw material characterization.
· Statistical computations (Cp, Cpk, Regression analysis, etc.) and use of statistical software (eg., Minitab, JMP, etc).
· Preparing responses to address deficiency letters and interfacing with regulatory agencies.
· Process improvement and OPEX.
· Process scale-up (fluid bed, blending, granulation, pan coating, etc).
· Technology transfer and project management principles.
· Process and cleaning validation.
· Annual product review (APR)
· Business, scientific and personal computer hardware and software applications.
· Business English usage, spelling, grammar and punctuation.
· Leadership and training practices and methods.
· Recruiting, interviewing, and selecting applicants in accordance with established employment practices and methods.
· Current Company policies, practices and procedures, including safety rules and regulations.
Skill in: · Ability to efficiently troubleshoot pharmaceutical unit operations, such as fluid bed coating, blending, compression, roller compaction, high shear granulation, particle and tablet coating, encapsulation and packaging.
· High level technical writing skills for complex reports and regulatory documents.
· Ability to prepare all types of pharmaceutical documentation (BR, BOM, CC, protocols, summary reports, evaluation reports, etc.).
· Ability to think “outside of the box” to come up with creative, effective solutions for problem solving activities and major product and process investigations.
· Leadership skills for providing guidance and training to assigned personnel.
· Ability to guide a team as well as work and contribute in a team environment, including leading the activities of technical personnel and making decisions.
· Communicating clearly and concisely, both orally and in writing; good presentation skills.
· Operating scientific and personal computers.
· Managing multiple projects, duties and assignments.
· Coordinating and reviewing the work of assigned department personnel.
· Establishing and maintaining cooperative working relationships with others.
· Managing, organizing, delegating assignments and reviewing work of assigned department staff
· Recruiting, interviewing, and selecting applicants in accordance with established employment practices and methods.
· Ensuring compliance with all Company policies and procedures, including safety rules and regulations.
· Ability to “think on your feet” and work under pressure with aggressive deadlines and due dates
· Effective time management and flexibility in work schedule
· Interface with external customers, Sr. and Executive Management and oversees the technical aspects of major product/project meetings
Ph.D from an accredited college or university with eleven (11) to thirteen (13) years related experience; or Master’s degree in a related field from accredited college or university with fourteen (14) to sixteen (16) years related experience; or Bachelor’s degree in a related field from an accredited university, and seventeen (17) to eighteen (18) years related pharmaceutical experience or an equivalent combination of education and experience .

About this company
37 reviews