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 0700-1730  

Responsibilities: 

• 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 where 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 field 

• Experience: 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. 

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The annual base salary (or hourly rate of compensation) for this position ranges from $94,692 -$142,366. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.