If you’re inspired by the possibilities of science to change lives and you thrive when making brave decisions – join us.
MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you’ll have the opportunity to make a difference in people’s lives every day. As one of the world’s premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. As a Production Supervisor/Senior Production Supervisor in Frederick, MD, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.
We’re constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We’re pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we’re industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.
MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.
Main Duties and Responsibilities
This position will be responsible for the central services manufacturing process, managing and leading a team on the night shift. Supervisory duties will be both on and off the floor.
Daily supervising and performing on-the-floor operations pertaining to biologics manufacture in a cGMP environment (70-80% time on shop floor):
- Coaching, counselling, training/development, discipline and recognition of direct staff, including performing annual performance reviews
- Ensuring performance of all process steps specific to the phase or stage of operation (e.g. upstream, downstream, support)
- Coach staff and intervene during operations when required to achieve on-floor performance expectations
- Ownership of Tier 1, shift change meetings to coordinate cross-functional resource allocation needs for issues identified and maintain production targets
- Executing production and resource schedule against operational plan
Daily off-floor support provided (20-30% off floor coordination):
- Generating SOPs, MPRs, and SPRs for equipment and procedures used in routine biologics manufacture.
- Monitoring and creating documents and/or spreadsheets to support business reporting requirements
- Final review of completed manufacturing documentation per compliance standards and established timelines
- Collaborating with Manufacturing Process Lead to resolve problems, identifying root cause, and proposing process improvements through clear communication to senior management
- Participating and/or leading multi-functional project teams, as necessary
- Participate in helping to evaluate and establish potential new interdepartmental procedures and practices. Identify and implement opportunities for changes/improvements for the overall department/manufacturing as well as their particular shift impacting process/operational/business
- Other duties as assigned or identified
- BS/BA degree preferred Associates degree and High School Diploma acceptable with experience
- 7-10 years work experience in pilot or commercial biologics manufacturing under cGMP with Bachelors. 5-7 years experience with Masters degree. 10-15 years experience with Associates Degree and 15+ years experience with High School education.
- Knowledgeable of the current Code of the Federal Regulations (CFR’s) and Current Good Manufacturing Practices (cGMP’s)
- Sufficient understanding of process, systems and equipment to troubleshoot problems and provide solutions to senior management
- Expert knowledge of electronic quality systems
- Possesses strong verbal and written communication skills
- Monitors daily operations of a unit and actively assists, or provides direction to, subordinates as required
- May perform, especially in staff or professional groups, ongoing operational tasks of organizational unit
- Situational Leadership
- Good organizational skills
- Ability to thoroughly investigate/ perform root cause analysis, identify potential issues and propose solutions through verbal and written communication
- Ability to apply principles of logical or scientific thinking to a wide range of practical problems
- Ability to apply common sense understanding and knowledge of when to stop and seek input and approval from management
Freedom to Act
- Assignments are received in task-orientated terms.
- Provides direction to subordinates using established policies and precedents
- Work is reviewed for soundness of judgment and overall quality and efficiency
- Administers and executes policies and procedures that typically affect individual subordinate employees
- Ability to make and act on routine decisions
- Assess and provide options to management for process decisions that have a significant impact to the department
- Plans and supervises execution of group’s day-to-day and week-to-week activities
- Ensures that projects are completed on schedule following established procedures and schedules
- Erroneous decisions or recommendations or failure to achieve results might cause delays in program schedules and result in the allocation of more resources
- Majority of liaison is on internal basis with subordinates and supervisors at equivalent level or one level higher
- Liaison normally involves specific phases of a project or operation
- Contacts with outside vendors and senior management are infrequent and involve routine matters
Next Steps – Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.