The Line Lead provides leadership and production support to their Pilot Plant manufacturing team to ensure the Pilot Plant schedule is met in accordance with all Standard Operating Procedures (SOPs) and batch records. Collaborates on and monitors daily work activities to ensure a safe work environment for all employees. The Line Lead demonstrates a comprehensive understanding of GMP manufacturing and packaging operations processes and procedures as well as flexibility when working on development projects.
Description of Essential Duties
Executes manufacturing operations, processes and procedures (including Press operation).
Supports both development and commercial activities by working alongside team.
Sets up, adjusts and troubleshoots pharmaceutical manufacturing machinery and ensures manufacturing/press/packaging operations are completed per standard operating procedure.
Accountable for team job performance (e.g. accuracy in documentation; ensures SOPs are followed).
Coordinates material availability with material handling and supervisory team and provides oversight and leadership of work activities within their team. Troubleshoots mechanical issues, as needed.
Collaborates with R&D and Technical Services teams on development, feasibility and registration batch manufacturing.
Reviews batch records in real-time to ensure they are accurate and complete prior to submitting to Quality assurance review.
Works with R&D, Tech Services, Quality and Operations training on manufacturing/packaging-related SOPs and batch records. Responsible to train or assist in the training of new team members. Monitors employee training to ensure compliance and qualifications for their team.
Identifies and supports continuous improvement initiatives.
Keeps team focused on production tasks to drive for better efficiencies and meet defined team metrics.
Provides feedback to the supervisor so that he/she can better assess employee’s overall performance.
Education& Experience
High School diploma or equivalent. Minimum of 3 years’ manufacturing, packaging or automation, mechanical or automotive experience required. Minimum 1-year USL experience strongly preferred. Demonstrated leadership and teamwork behavior required. Pharmaceutical or food industry preferred. Prior knowledge of cGMP's and SOP's. Flexibility and the willingness to learn and adapt to changing priorities required.
Education& Experience
High School diploma or equivalent. Minimum of 3 years’ manufacturing, packaging or automation, mechanical or automotive experience required. Minimum 1-year USL experience strongly preferred. Demonstrated leadership and teamwork behavior required. Pharmaceutical or food industry preferred. Prior knowledge of cGMP's and SOP's. Flexibility and the willingness to learn and adapt to changing priorities required.
Upsher-Smith Laboratories, LLC is a trusted U.S. pharmaceutical company that has strived to deliver quality, affordable generic medications for nearly a century. In June 2017, Upsher-Smith was acquired by Sawai Pharmaceutical Co., Ltd., a large publicly traded generics company in Japan that had been seeking entry into the U.S. market. Upsher-Smith and Sawai share a strikingly similar family history and hold many of the same cherished goals and values—most importantly, the philosophy of always putting patients first.
Upsher-Smith will continue to do those things we feel we do best—provide a consistent supply of quality, affordable medications, and invest in our historically strong industry relationships. And as we further organize into one global company with Sawai, we will begin to benefit from Sawai’s extensive resources and management focus. Ultimately, we believe our acquisition by Sawai represents a tremendous opportunity to leverage each other for growth worldwide as we embark together on an exciting new chapter in generics.