Allergan API Specialist Principal Senior - (Drug Substance) in North Brunswick, New Jersey
API Specialist Principal Senior - (Drug Substance)
North Brunswick, New Jersey, United States at http://agn.referrals.selectminds.com/jobs/481/other-jobs-matching/location-only
Sep 09, 2016Post Date
Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology, anti-infective and cardiovascular therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.
Our success is powered by our world-class team’s commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right.
Join one of the world’s fastest growing pharmaceutical companies!
At Allergan you will have the opportunity to thrive in a fast-paced, strategic environment where bold, innovative thinking isn’t just welcomed, it’s encouraged. Across all functions, we relish the opportunity to help our people fulfill their potential. Our rapid growth strategy means plenty of opportunities to step into the spotlight.
Summary: Under administrative direction, oversees, plans and directs technical activities in support of Active Pharmaceutical Ingredient (API) technology transfer of new products, provides technical direction for scale-up of new and currently approved API projects, and in the areas of marketed product support, process optimization, process validation, qualification of manufacturing facilities, equipment and supporting systems.
Essential Job Functions: This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks.
Develops and executes process design and test plans to provide a technical basis for developing and evaluating new or improved API.
Oversees, reviews, and/or participates in process development/improvement activities, process validation protocols and reports, and product and process transfer plans, making recommendations for changes and/or improvements.
Directs the coordination of API process transfer activities; oversees and approves API rationalization process and projects in conjunction with Research and Development, Manufacturing, Quality Assurance, Regulatory Affairs.
Works cross-functionally with R&D, Product Development, and other departments, as well as internally with Process Technology colleagues, to solve process and analytical related issues.
Designs and assists in conducting optimization studies aimed at enhancing the quality and supply reliability of APIs used in Allergan products as well as reducing cost of goods.
Provides technical support for investigation and remediation of out of specification results and process deviations for APIs used in marketed products.
Serves as technical reviewer of API-related change controls.
Provides direction to external CMOs during the design, purchase and validation of new process equipment, both for new and existing APIs. Defines the Process Validation (PPQ/CPV) requirements resulting from such equipment changes.
Leads and executes projects for evaluation and qualification of new sources of raw materials, intermediates and final APIs for new and marketed products
Serves as primary point of contact for API-related technical advice and expertise to internal manufacturing sites and contract manufacturing partners.
Leads or participates in data analysis and interpretation using relevant statistical tools to evaluate experimental results generated as well as production data to improve process control and process robustness.
Authors or reviews relevant CMC documentation, including regulatory filings as required.
Provides information to support establishing overall budgets, schedules and performance standards as related to API processing operations. Provides direction to meet department objectives.
Reports progressof research work and significance of results. Recommends utilization of the results or changes inthe scope of work or termination of projects.
Helps determine organizational objectives,and interprets progress of projects. Completed work is reviewed, from a long-term perspective for results.
Carries out limited managerial responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.
Responsible for training, developing, and advisingstaff. Accomplishes someresults through lower management levels as required.
Supports preparation for briefings and technical meetings for top management and interacts with equivalent level staff concerning matters of significance to thecompany.
Ensures compliance with all Company policies and procedures, including safety rules and regulations.
Performs related duties as assigned.
Required Knowledge and Skills :
Knowledge of :
GMPs, Occupational Safety and Health Administration, Environmental Protection Agency, and FDA regulations, requirements and guidelines.
Extensive knowledge of development and bulk manufacturing of APIs.
Business, scientific and personal computer hardware and software applications.
Business English usage, spelling, grammar and punctuation.
Analytical instrumentation and testing principles and practices relating to API.
Broad knowledge of API manufacturing principles and unit operations, reaction chemistry and chemical synthesis techniques including as compounding/ mixing, crystallization, isolation, purification, vacuum/ filter drying, particle sizing, etc.
Current Company policies, practices and procedures, including safety rules and regulations
• Creating, planning and implementing goals, objectives and practices for effective, efficient and cost effective management of allocated resources.
• Researching,analyzing and evaluating new products and processes, procedures and equipment.
• Responding to complex inquiries from management, employees and regulatory agencies.
• Preparing, presenting and administering budgets and financial reports.
• Formulating and implementing SOPs.
• Communicating clearly and concisely, both orally and in writing.
• Managing multiple projects, duties and assignments.
• Interpreting and applying Federal, state and local policies, procedures and regulations.
• Establishing and maintaining cooperative working relationships with others.
Bachelor’s, Masters or PhD degree inChemistry, Chemical Engineering ora related field from an accreditedcollege or university, and a minimum of five (5) years API process support, development, and/or scale-up experience in the pharmaceutical industry. Graduate degree preferred.