Manufacturing Associate, Lead – Parenteral Filling (Nights)
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Job Location:
Durham County, NC - USA
Monthly Salary:
$ 33 - 43
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
About This Role
Our factories run 24/7 operations. Our manufacturing teams work 12-hour shifts (either Days or Nights) on a 2-2-3 calendar rotation.
Shift Details:
- 12-hour shifts
- Nights: 6:00 PM 6:00 AM
- Rotating 2-2-3 schedule
The Manufacturing Associate Lead plays a critical hands-on leadership role within a cGMP manufacturing environment performing and documenting daily manufacturing operations while ensuring compliance quality and efficiency. This role works closely with the Manufacturing Supervisor to coordinate shift activities allocate resources and support production validation and continuous improvement initiatives.
What Youll Do
- Execute manufacturing processing steps and manufacturing support activities in accordance with batch records SLRs control systems and standard operating procedures.
- Monitor and control processes serving as a subject matter expert (SME) for assigned unit operations and process steps.
- Coordinate and as required lead process steps while ensuring adherence to cGMP requirements.
- Partner with the Supervisor to schedule daily shift activities plan resource allocation and support production validation and project-related work.
- Ensure effective shift handoffs through clear communication of issues priorities and status updates.
- Document review and ensure completeness of cGMP documentation including batch production records (BPRs) SLRs deviations and equipment logbooks with real-time review for accuracy and compliance.
- Develop revise and maintain cGMP documents as needed.
- Actively participate in training activities manage individual training plans and provide hands-on training and knowledge sharing to other associates.
- Observe employee performance provide timely coaching and deliver feedback to the Supervisor during mid-year and end-of-year evaluations.
- Initiate and investigate deviations support root cause analysis and develop corrective and preventive actions (CAPAs) under Supervisor guidance.
- Lead or participate in troubleshooting efforts and serve as a potential SME during audits.
- Support equipment and facility maintenance activities to ensure operational readiness and compliance.
Who You Are
You are an agile accountable self-starter who thrives in a dynamic manufacturing environment and values accurate ethical data recordkeeping. You learn quickly follow procedures diligently and take ownership of your work and team outcomes. As a technical expert across multiple unit operations you bring strong process and equipment knowledge paired with the ability to lead schedule work train others and collaborate effectively. You excel in teamwork communicate clearly resolve conflicts constructively and approach coaching with patience and teachability. You are motivated by continuous improvement professional growth and contributing to a high-performing Parenteral Filling team.
Required Skills
- The following combinations of education and direct experience will be considered:
- Bachelors degree in Science Technology Engineering or Mathematics (STEM) or a related field from an accredited college or university with a minimum of 4 years of direct experience
- Associates degree in Science Technology Engineering or Mathematics (STEM) or related field from an accredited institution with a minimum of 4.5 years of direct experience
- High school diploma or equivalent with a minimum of 5 years of direct experience
- Demonstrated experience working in a cGMP manufacturing environment
- Strong documentation compliance and process execution skills
- Ability to lead tasks support teams and collaborate effectively across shifts
Preferred Skills
- Prior Parenteral Filling experience
- Experience with TrackWise DeltaV and LIMS systems
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.
Required Experience:
IC
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
