AstraZeneca Pharmaceuticals LP Manufacturing Specialist in Frederick, Maryland
Manufacturing Specialist Job Description
At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Manufacturing Specialist, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.
Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.
Global Operations is fundamental to our purpose of delivering life-changing medicines to patients, touching every aspect of our business and providing a platform for everything that we do. We harness the specialist talents of 13,000 people around the world – 20% of our global workforce. With 30 production facilities in 18 countries we’re focused on supplying our medicines with care, quality and efficiency, reducing the time from lab to patient. Keen to bridge the gap between science and patients? Turn research into reality? And forge a global career that’s full of possibilities, as part of a world-class team? Come and thrive in our vibrant, energizing, connected and supportive culture and make a real difference to patients. Hear from our Senior Leaders about why they know AstraZeneca is a great place to work. https://lnkd.in/g8APibK
Major areas of responsibility may include the following:
Authoring, reviewing and approving MPRs, and SPRs for equipment and procedures used in routine biologics manufacture.
Change Control creation, assessment and approvals
Validation protocol approvals
Leads deviation investigations and CAPA identification; drive adherence to standard work and deviation/CAPA closure
Implements innovative technological or efficiency programs/solutions to enable the manufacture of biopharmaceuticals in a high quality, faster and more cost-effective manner.
Partners with Quality Assurance to manage quality records and inspection readiness
Primary Manufacturing support for internal and external audits
Coordination with Training department to ensure appropriate training development and effective floor execution roll out
Primary Manufacturing Operations interface for New Product Introductions
Coordinating and ensuring successful completion of tech transfer projects/ activities for the Manufacturing Department
Expert knowledge of biopharmaceutical manufacturing processes, systems and equipment
Expert knowledge of electronic manufacturing and quality systems
Knowledgeable of manufacturing automation systems and their application
Knowledgeable of application and practices of current Good Manufacturing Practices (cGMP's), international regulatory requirements and guidelines (such as European directives, ICH guidelines and European and Japanese pharmacopea requirements
Knowledgeable of late stage clinical and commercial manufacturing regulatory requirements and best practices
Knowledgeable in supply chain operations and business processes
Knowledgeable of troubleshooting/ root cause analysis tools
Working knowledge of Lean Manufacturing, SixSigma or other continuous improvement tools preferred
Represents the organization as the prime technical contact on programs and projects.
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
Partner with MS and T, and Engineering and Manufacturing to solve process and equipment related problems
Freedom To Act
Limited oversight and minimal instructions needed on routine work.
Assignments are received in objective-oriented terms.
Ability to make and act on routine decisions
Provides guidance to site teams and management based on organizational goals.
Work is reviewed for soundness of judgment and overall quality and efficiency.
Work typically impacts all teams at the FMC site.
Assesses and provides options to management for process decisions that have a significant impact.
Ensures that projects are completed on schedule following established procedures and schedules
Poor communication or erroneous decisions/ recommendations would normally result in critical delays and modifications to projects or operations; cause substantial expenditure of time, human resources, and funds; and jeopardize future business activity.
Must demonstrate excellent communication skills, both verbal and written, and effective presentation skills.
Contacts are frequent with individuals at high levels representing other departments, and/or representing outside organizations
Possesses strong verbal and written communication skills
Supervisory / Management Skills
Projects influence to assure alignment of site business processes with partners within MedImmune/AstraZeneca.
Monitors daily operations of a unit and actively assists, or provides direction to, subordinates as required
Good organizational skills
Qualified in Lead Technician duties and on-floor coaching
First-line management skills for daily operation
Decision making skills
B.S./B.A. engineering, biological sciences, physical sciences, or equivalent field of study required.
Minimum 5-7 years of work experience in process development, pilot plant or commercial biologics manufacturing under cGMP with Bachelors.
Lean/Six Sigma certification preferred.
3-5 years’ experience with Master’s degree.
2-4 years’ experience with PhD
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, gender or gender 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.