Manufacturing Shift Manager
Job
AstraZeneca Pharmaceuticals LP
Gaithersburg, MD (In Person)
$118,529 Salary, Full-Time
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Job Description
Manufacturing Shift Manager
Manufacturing Shift Manager (Wednesday
- Saturday, 7:00AM
- 5:30PM)
Rockville, MD Summary:
The Manufacturing Shift Manager is accountable for execution on the direct manufacturing floor. Expectations of proficient use of cGxPs is required, as well as resource and workload management. Must be able and willing to work onsite shift days/hours of Wednesday-Saturday 0700-1730Responsibilities:
- Managing the operations pertaining to the production of cell therapy products
- Coaching, 1:1 meetings and support, leadership of staff
- Oversight of staff, including On the floor support expected 50%+ of time.
- Oversee and assist as required of successful execution of manufacturing batch records, work instructions and SOPs, with a focus 'right the first time'
- Provides technical instruction to the team and allocates administrative work w possible
- assigning tasks to other manufacturing staff, leading activities on manufacturing floor, communicating to staff about product status at shift change, troubleshooting processing and equipment issues.
- Ownership and oversight of the Tier 2 cross-functional board and metrics, as well as participation and escalation to Tier 3 and cross-functional leaders to resolve issues seen within the manufacturing site.
- Execute procedural review and approval of documentation. Documentation of all activities to meet cGMP requirements. Review (batch records, SOPs, Logbooks) for completeness, clarity, accuracy and submit edits to documents for revision as needed.
- Create, Own, and Assist with deviations/non-conformances/OOS investigations in a timely manner.
- Routinely monitor, clean, prepare and operate sophisticated automated cell processing, cell expansion and filling equipment in cleanroom environments.
- Assist and Oversee training of personnel on aseptic processing, equipment operation, cGMPs, documentation, technical theory, or other tasks.
- Lead and oversee problem solving activities, tech transfer activities. Support process development of platform processes, contributing to the plans and designs of studies/experiments. Provide guidance and strategy for Manufacturing Execution systems (MES) and other digital systems used within manufacturing.
- Oversee non-routine activities on production floor.
- Ensures a safe work environment in accordance with AstraZeneca standards.
- Participate as Manufacturing representative on multiple cross-functional "working groups" collaborating as part of a process execution team at site.
- Timely and appropriate escalation to upper management, as well as cascade to all manufacturing staff members.
Minimum Qualifications:
Education:
Bachelor's degree in life sciences, engineering, or a related fieldExperience:
3+ years of general cGMP manufacturing experience.- 1+ years of experience of prior supervisory or management experience.
- Significant knowledge in biologics manufacturing process, cell culture and/or vector products.
- Demonstrated leadership, organization and time management skills.
- Proven logic and decision-making abilities, critical thinking and troubleshooting skills.
- Must be able and willing to work onsite shift days/hours of Wednesday-Saturday 0700-1730
Desirable Qualifications:
Experience:
5+ years of general cGMP manufacturing experience, including 1+ years of Cell Therapy experience.- 3+ years of experience of prior supervisory or management experience.
Skills:
Previous manufacturing or process development experience with cell therapy or vector products.- Dynamic individual with the ability to communicate and engage others.
- Independent and self-starting. Ability to work with minimal supervision.
- Demonstrate flexibility and willingness to change ways of working/identify opportunities to improve processes within cGMP clinical manufacturing environment. The annual base salary (or hourly rate of compensation) for this position ranges from $94,692
- $142,366.
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