Employment Type : Full-Time
POSITION SUMMARY:
Lead position responsible for supporting the Bulk Buffer, Reagents and Bead production laboratories by following good documentation practices (cGDP) and relevant standard operating procedures (SOPs). Complete assigned tasks and ensure all activities are compliant with the company’s quality, safety and departmental policies and standards. Has advanced and specialized expertise in an analytical/scientific method or operational process. Works autonomously within established procedures and practices. Has developed advanced specialized expertise within a analytical/scientific area to perform the most complex work. Completes assignments and facilitates the work activities of others; may coordinate work beyond own area
ESSENTIAL JOB RESPONSIBILITIES:
Work safely with hazardous chemicals and follow all safety policies fostering a safe work environment
Immediately report all safety concerns including injuries and safety suggestions
Exercises judgment, based on previous experience, practices and precedents, to identify and solve problems that arise with little or no precedent
Works within defined processes and procedures or methodologies and may help determine the appropriate approach for new assignments
Exchanges ideas and information effectively; uses tact and diplomacy when dealing with others
Responsible for: liquid bead formulation, bulk buffer formulation, bead dropping using a beadulator, loading and unloading beads from the lyophilizer, sieving of beads, aliquoting and labeling of dyes and grease
Performs pH, Moisture, Conductivity and Density testing
Perform accurate real time documentation to ensure right first time (RFT) operations
Perform verification and review of peer activities
Train others on lab responsibilities
Serves as team lead, may allocate work and provide subject matter guidance to more junior team members
Monitor equipment and inform management of any issues
Maintain laboratory housekeeping including reagent and equipment inventory levels
Recognize issues and defects and complete necessary documentation and escalate accordingly
Recommend and implement improvement ideas in the lab that will positively affect production efficiency, Quality and Safety
Assist other department in qualification of new methods and instruments
Trouble shoot equipment and assay failures
Suggest and assist in SOP revisions
Assists management with audit activities
Manages projects within the department
Has additional assigned responsibilities to assist management
TRAINING RESPONSIBILITIES:
Complete all assigned and required training satisfactorily and on time
MINIMUM REQUIREMENTS:Education and Experience:
Bachelor’s degree with 0-2 years of related work experience.
Knowledge and skills:
Must be able to follow cGMP and cGLPs, FDA and ISO standards
Must be able to follow direction, able to understand SOPs and demonstrate understanding through speech and/or written form
Proficiency in computer systems such as Word, Excel, SAP, MES and e-mail
Has a good understanding of how related teams coordinate their efforts and resources to achieve objectives
Physical requirements/abilities:
Must be able to lift 25 Lb Must be able to stand for several hours. Work may involve repetitive arm/wrist motions
Ability to transport heavy materials up to 400 Lb with the appropriate machine or equipment assist
Ability to work in controlled environment
PREFERRED REQUIREMENTS:
Bachelor’s Degree in Life Sciences
Prior experience working in a GMP environment and pharmaceutical industry
Experience using analytical scales, Lyophilizer, Molecular assays, working with hazardous chemicals
Flexibility with the work schedule including modified shift times, overtime and weekends
Equipment validation including IQ/OQ/PQ
Assay development and transfer