Lead Manufacturing
Lead Manufacturing
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
This position follows a traditional 223 format from 6pm6am on Red Day Shift
About This Role:
The Manufacturing Lead performs and documents daily manufacturing operations in a cGMP environment including operation of process equipment execution of validation protocols revising cGMP documents ensuring compliance to cGMP as well as maintaining equipment and facilities. This position works closely with shift Supervisor to coordinate critical activities collaboratively and utilizes resources efficiently. This is a key preparatory role for the Manufacturing Supervisor position.
The Manufacturing Lead responsibilities include but are not limited to:
- Executes manufacturing processing steps and/or manufacturing support activities monitoring the process against the batch record SLR and control system. Coordinates and/or leads process steps as required serving as a process step(s) expert.
- In coordination with Supervisor schedules tasks for a given shift and plan resource allocation. This includes production validation or other project activities. Also responsible for proper information sharing at shift exchange and ensure all issues are communicated appropriately.
- Documents/records and reviews cGMP data and information (including documentation of deviations) for processing steps and/or equipment activities following standard operating procedures. Develops and/or revises documents as needed. Key documentation includes batch records SLRs and equipment logbooks. Ensure completeness of BPR/SLR real time review.
- Actively participates in training activities managing their own individual training plan. Provides training to other associates as required and shares knowledge with others. Observes performance of employees provides timely and targeted coaching for employees and provides feedback to Supervisor mid and end of year.
- Initiates / investigates deviations develops and implements corrective and preventative actions as required by supervisor. Leads and/or actively participates in troubleshooting. Serves as possible SME for audits.
Who You Are:
Our Large Scale Manufacturing Buffer Prep team is looking for an agile selfstarter who takes accountability is willing to learn quickly in a dynamic environment and prioritizes accurate and ethical data recordkeeping. The incumbent is expected to be an expert on multiple unit operations have excellent technical understanding of the processes and equipment and is skilled at leading scheduling tasks training and supporting other associates. We prioritize the possession of a few soft skills in addition to technical experience with the opportunity for continued career development and on the job training. Key soft skills to look for are teamwork interpersonal skills for conflict resolution teachability patience and willingness to follow procedures.
Qualifications :
Required Skills
- Bachelors Degree in an engineering or scientific discipline preferred 4 years of direct biomanufacturing experience
- Associate degree in an engineering or scientific discipline preferred 4.5 years of direct biomanufacturing experience
- Certificate or HS diploma in an engineering or scientific discipline preferred 5 years of direct biomanufacturing experience
Preferred Skills
- Prior Buffer Prep experience in a leadership capacity
- Lean Six Sigma and 5S certifications
- Experience with Trackwise Delta V and LIMS in addition to cGMP experience.
- Highly detailed oriented with excellent documentation skills and exceptional troubleshooting abilities
Additional Information :
Why Biogen
We are a global team with a commitment to excellence and a pioneering spirit. As a midsized biotechnology company we provide the stability and resources of a wellestablished business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning growth and expanding their skills. Above all we work together to deliver lifechanging medicines with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds cultures and perspectives make us a stronger and more innovative company and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex gender identity or expression sexual orientation marital status race color national origin ancestry ethnicity religion age veteran status disability genetic information or any other basis protected by federal state or local law. Biogen is an EVerify Employer in the United States.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
