Lead, Manufacturing
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Job Location:
Durham County, NC - USA
Monthly Salary:
$ 32 - 42
Posted on:
16 hours ago
Vacancies:
1 Vacancy
Job Summary
This position follows a traditional 2-2-3 format from 6a-6P (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 Parenteral Filling teamis looking for an agile self-starter who takes accountability is willing to learn quickly in a dynamic environment and prioritizes accurate and ethicaldata 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 skillsin addition totechnical experience with the opportunity for continued career developmentand on the job training. Key soft skills to look for are teamwork interpersonal skills for conflict resolution teachability patience andwillingness 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 4.5years of direct biomanufacturing experience
Certificate or HS diploma in an engineering or scientific discipline preferred 5years of direct biomanufacturing experience
Preferred Skills
Prior Parenteral Filling experience in a leadership capacity
Lean Six Sigma and 5S certifications
Experience with Trackwise Delta V and LIMS in addition to cGMP experience.
Additional Information
Base salary offered is determined through an analytical approach utilizing a combination of factors including but not limited to relevant skills & experience job location and internal equity.
Regular employees are eligible to receive both short term and long-term incentives including cash bonus and equity incentive opportunities designed to reward recent achievements and recognize your future potential based on individual business unit and company performance.
In addition to compensation Biogen offers a full and highly competitive range of benefits designed to support our employees and their families physical financial emotional and social well-being; including but not limited to:
- Medical Dental Vision & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10000 per calendar year
- Employee Resource Groups participation
Why Biogen
We are a global team with a commitment to excellence and a pioneering spirit. As a mid-sized biotechnology company we provide the stability and resources of a well-established 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 life-changing 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 onto 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 E-Verify Employer in the United States.
Key Skills
- Lean Manufacturing
- Six Sigma
- Continuous Improvement
- ISO 9001
- Lean Six Sigma
- Management Experience
- Manufacturing & Controls
- 5S
- Manufacturing Management
- Kaizen
- Chemistry
- Manufacturing
About Company
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities, ... View more
