Process Development Sr. Associate Scientist- 34718

Description: Responsibilities:

• To perform experiments, organize data and analyze results with minimal review.
• Plans, conducts or monitors experiments, records and organizes data, analyzes and interprets results.
• Provides input to new processes to generate robust and reliable data and/or ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations.
• 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 lab.
• 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 expertise and is responsible for making improvements in one or more major laboratory instruments/techniques.
• 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.

Education:

• Master’s degree and 2 years of directly related experience experience.
• Bachelor’s degree and 4 years of directly related experience experience.
• Bachelor’s degree in Engineering

Preferred Qualifications:

• Preparation of syringes/vials with cosmetic, particle, or solution defects for developmental studies, equipment characterization, training activities, and commercial equipment setup.
• Creative manual skills and mindset to develop and create defects in glass and polymer surfaces; innovative and out-of-the-box thinking for cosmetic defect creation on vials and syringes.
• Develop, introduce, or improve defect creation methods in the laboratory.
• Demonstrated skills in the evaluation of primary container defective conditions.
• Experience with laboratory equipment and instruments: micrometer, caliper, microscope, stereomicroscope, analytical balance, pipette techniques, and other lab tools.
• Knowledge in aseptic techniques.
• Knowledge in 5S and Lean Manufacturing concepts.
• Knowledge in Visual Manual Inspection Techniques and manual visual inspection experience.
• Knowledge in Microsoft Excel, Smartsheet, and GMP electronic documentation platforms.
• Knowledge in problem solving/root cause analysis tools (5 Whys, Cause and Effect Diagrams).
• Advanced scientific analysis and troubleshooting skills.
• Strong knowledge of cGMP’s.
• Ability to motivate and/or support the activities of others.
• Organized, multi-task project experience, and able to communicate and work well with other departments.
• Ability to work in a fast-paced environment and prioritize multiple tasks; flexible and able to handle change.
• Excellent interpersonal skills with ability to interact with internal and external customers.
• Service oriented, positive attitude, and self-motivated.
• Strong communication skills; fully bilingual (English/Spanish).

Teamwork oriented.

Skills:

• Advanced scientific analysis and troubleshooting skills.
• Advanced laboratory work skills.
• Ability to motivate and/or supervise the activities of others.
• Must be well organized, have multi-task project experience, and be able to communicate and work well with other departments.
• Must have demonstrated skills and competencies 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 manage 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 cGMPs.
• Fully bilingual (English/Spanish).

Work Methodology:

100% Onsite

• 6 months (1st Contract)
• Administrative Shift (9am-6pm and/or 8am-5pm ,Saturdays and Sundays (if necessary per business needs).

Professional Service Contract