Are you looking for a challenging new opportunity to test and growth your laboratory skills? We have an immediate need for a Sr Associate Scientist to join AML’s Drug Product Process Development Laboratory 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 Your primary technical areas of focus will be the laboratory using your expertise with analytical balance, microscope, caliper and filling aseptic techniques. In this role you will conceive, design, implement and execute specific scientific experiments, which contribute to the successful completion of goals and/or projects under general mentorship of supervisor. The position will be reporting to an administrative work schedule with the flexibility to support the non-standard shift organization, as per business needs. Who We Are AML Drug Product Process Development Laboratory team focus on the preparation of standard or challenge units for performing development/characterizations studies, manual inspection certifications and commercial equipment set up. Your main responsibilities: Preparation of syringes/vials with cosmetic, particle or solution defects used for developmental studies, equipment characterization, training activities or commercial equipment setup Designs, monitors or conducts, and interprets laboratory experiments with general oversight of supervisor Performs data analysis, provides interpretation and integrates results into the context of a project Introduces new or improved methods into the laboratory Develops and implements new protocols with minimal review May serve as a representative to cross-functional teams or as a lead on department teams, with guidance Recommends decisions regarding scientific-related issues Demonstrates skills in problem solving at the project level Demonstrates skills in the evaluation of primary container defective conditions Demonstrates skills to perform complex mathematical or statistical calculation Demonstrates expertise and is responsible for making improvements in one or more major laboratory instruments/techniques and process Acts as a resource in area of expertise Authors complex technical documents, reports, presentations, regulatory documents, invention disclosure submissions and/or patents clearly and concisely with minimal revision Assumes influential role in department-wide support efforts such as safety, recruiting and committees Under general direction, has overall responsibility for a program or project of limited scope Provides constructive criticism, suggestions and interpretation of results to co-workers . You will Need: Bachelor’s degree & 5 years of scientific experience in GMP regulated environment OR Master’s degree & 3 years of Scientific experience in GMP regulated environment OR Doctorate Degree Beyond that, you will also need: Education discipline/background in Life Sciences and/or Engineering Advanced scientific analysis and troubleshooting skills. Advanced work skills on laboratory equipment and instruments such as micrometer, caliper, microscope and analytical balance. Create cosmetic defects on vials and syringes Seed particle in solution on vials and syringes Knowledge in Electronic Laboratory Notebook Knowledge in Sample Management Knowledge in aseptic techniques Knowledge in 5S and Lean Manufacturing Concepts Knowledge in Visual Manual Inspection Techniques Ability to develop new defective conditions on primary containers Ability to motivate and/or supervise the activities of others. Organized, have multi-task project experience, and be able to communicate and work well with other departments. Be able to work in fast environment and prioritize multiple tasks Excellent interpersonal skills with ability to interact with internal and external customers. Proven skills and proficiencies in the following areas: Verbal communication Written communication including technical writing skills, negotiation and conflict resolution, analytical problem solving and project management Ability to be flexible and handle change. Computer literacy. Skills requiring the application of scientific theory. Creative skills in the design and performance of scientific experiments and interpretation of results. Strong knowledge of cGMP’s. Fully bilingual (English/Spanish).
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