Formulation Technician I/II/III (Sun-Wed 6:00 am - 4:30 pm)
LSNE Contract Manufacturing
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!
Formulation Technician I/II/III
This position will have the primary responsibility for daily formulation activities to ensure schedule activities are completed, formulation materials and equipment are maintained, as well as the responsibility for performing corrective and preventative actions.As a secondary function, provide troubleshooting expertise for manufacturing of products both internally and externally of the company.
- 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
- 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.
High School education or AS degree or BS degree in Chemical Engineering/ Bio Chemistry or other industry related discipline is preferred
- Experience and knowledge of formulation/compounding tools and equipment
- Minimum 2 year's formulation/compounding work experience in a GMP environment preferably in fill finish pharmaceutical operations
- 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
Works directly with aseptic and non-aseptic personnel. Works closely with Quality Assurance, MTS, Validation etc.
MANAGERIAL & SUPERVISORY RESPONSIBILITIES Not Applicable
TRAVEL - < 10%
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.