Thrive in the dynamic and challenging environment of a contract development and manufacturing organization. Driven to excel through self-leadership and thriving team engagement. If this describes you, then look no further than LSNE. We have the experience, expertise and a successful track record in completing development of life-changing pharmaceuticals and medical devices. Together with our clients, we work to bring about treatment of many forms of cancers, Diabetes, communicable diseases, and many other illnesses. Come make a difference. Your work will matter and your contributions will be significant in these endeavors.
We offer a competitive compensation and benefits package and a very generous paid time off benefit. Join our team!
The Formulation Technician IV leads others in a variety of complex tasks under general guidance and in accordance with the manufacturing instruction set inclusive of current GMP/ISO requirements and standards and following all safety. Guidelines of LSNE. With general supervision, the technician leads and performs all manufacturing operations including but not limited to work functions in equipment prep, dispensing, dissolution, formulation, purification, and aseptic compounding activities for biopharma and medical device products. Addresses non routine matters. Utilizes technical knowledge and experience to resolve complex manufacturing problems. Monitors personnel interaction to ensure proper behaviors. Escalates matters requiring resolution by management. Works with, reviews and revises master production records and standard operating procedures. Trains and guides less experienced personnel. Is a model of the Guardian values and behaviors.
Maintains and adheres to safe work habits and all applicable LSNE safety procedures and guidelines. Is proactive in identifying safety risks and alerts management to take corrective action
Maintains weekly/daily schedule up to date and provides direction to team
Works with management to provide a positive culture within operations
Has ownership for the daily formulation activities to ensure scheduled all scheduled tasks/events are completed
Is responsible for critical steps in the formulation process including but not limited to, lab setup and process flows, in-process testing, API dissolution and final QS while ensuring safety, batch integrity and prevention or errors that could lead to product and or finical loss
Initiate the production of batch documentation used for engineering and cGMP production
Prepare and update Master Production Batch records and SOPs accurately for communicating and initiate the documentation change process for needed documentation changes
Complete executed Batch Records accurately and completely prior to submission to supervision for review
Comply with all area SOPs and ensure logbooks are completed, and adhere to cGMP requirements
Author process deviations when these occur within the department, participate in investigations, and contribute to identifying corrective and preventative actions
Cross train to increase technical skills across the department
Trains others on the team, and ensures proper training completion within the team prior to assigning tasks
Accountable for timely communication to management and clients of issues, challenges as well as opportunities for process improvements.
As a member of the manufacturing team, you will perform other manufacturing tasks for example filling, capping etc., as needed.
Work with enabling groups to improve/implement processes.
Other duties as assigned
Experience and knowledge of formulation/compounding tools and equipment
Minimum 3 year's work experience in formulation within a GMP environment preferably in fill finish pharmaceutical operations
Leadership experience in a lead or supervisor type role preferred
Demonstrated ability to prioritize multiple projects and activities
Strong interpersonal skills
Strong working knowledge of MS Office suite is preferable
Attention to detail and positive attitude are key attributes
Able to follow rules and regulations perfectly
Able to stand for long periods of time, the majority of the work shift
Able to lift 30lbs repeatedly
Able to wear PPE (mask, gloves, respiratory)
COMMUNICATIONS & CONTACTS
TRAVEL - < 10%
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the above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. they are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.>
Lsne Contract Manufacturing