Are you looking for a meaningful new opportunity to test and growth your scientific skills? We have an immediate need for a Process Development Scientist to join AML’s Drug Product Process Development Team. This is an outstanding opportunity to seek a variety of challenges and responsibilities in support to our manufacturing facility at Leading Pharmaceutical / Biotech Company Manufacturing Limited in Juncos, Puerto Rico. You will provide support to Leading Pharmaceutical / Biotech Company drug product network manufacturing operations. The Role This role will conceive, design, implement and execute specific scientific experiments, which contribute to the successful completion of goals and/or projects under general guidance of supervisor. Under general guidance of supervisor, Conceives and designs, executes or evaluates, and interprets experimental strategies Provides input to new processes to generate robust and reliable data Ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations Technical lead in the transfer of new products/process to the manufacturing area including the development of characterization/validation strategies, executions and reports SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO: Provide support to commercial operations on a day to day basis (Change control assessments, product impact assessments, document revisions, etc.) Develops and follows timelines for completing project team work. Designs, monitors or conducts experimental strategies or projects which significantly contribute to attaining high priority goals. Apply advanced technical principles, theories, and concepts in the development of new principles and concepts. Conceive plans and conduct scientific research/investigation in areas of considerable scope and complexity. Perform work that involves in-depth investigation of subject area, definition of scope, selection of areas of investigation, and development of novel concepts. Provides data analysis and interpretation, and assesses impact of the data on the project Establish leads and/or participate in technical forums for sharing of best practices and application of formulation (parenteral/oral solid dosage), filling, granulation, compression, coating process expertise Support technology transfer projects for the formulation(parenteral and solid dosage), filling, granulation, compression, coating operations. Prompt and regular attendance to workplace May introduce advanced scientific methods. Develops and implements new and novel protocols to address specific issues May support or lead efforts with research, introduction of new technologies, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility or process modifications. May represent the department on project teams under supervision of a senior scientific staff member. May initiate productive collaborations within and outside of the department or company. Advises or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies. Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents. May develop supervisory and mentoring skills. Interacts effectively with variety of communication and working styles Be flexible to support extended hour, non-standard shifts and manage changes. You will need Doctorate degree OR Master’s degree and 3 years of Process Development and/or Technical Services experience in GMP regulated industry OR Bachelor’s degree and 5 years of Process Development and/or Technical Services experience in GMP regulated industry PREFERRED QUALIFICATIONS Education discipline/background in Life Sciences and/or Engineering (Studies in Biochemistry or Protein Synthesis) Knowledgeable and experience in oral solid dosage manufacturing process (experience working with wet granulation, , direct compression, dry granulation, , tablet compression/capsule fillingand coating is preferred) Experienced in parenteral aseptic and oral dosage formulation processes. Working knowledge of pharmaceutical/biotech processes. Familiarity with documentation in a highly regulated environment. Ability to interpret and apply GLPs and GMPs. Ability to apply science to production. Able to develop solutions to routine technical problems of limited scope. Advanced laboratory work skills Experience in technology transfer and process validation lifecycle Knowledge of Validation processes and requirements as applied to new equipment installations Comprehensive understanding of validation protocol execution requirements Good understanding of process monitoring and statistical tools Be organized, have multi-task project experience and be able to communicate & work well with other departments Skills in the following areas: Verbal communication(English / Spanish) Problem solving Written communication including technical writing skills (English / Spanish) Statistical analysis Design of Experiments Project management Negotiation, persuasion and facilitation Collaboration Conflict Resolution Leadership and teambuilding Computer literacy (Windows environment: Word, Excel, Power Point, Minitab, MS Project). Fully bilingual (English/Spanish)
