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

Knowledge

  • 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.

Problem Solving

  • 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.

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.

Interpersonal Communication

  • 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

  • Situational Leadership

  • Decision making skills

Requirements

  • 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.

Preferred Requirements

  • MBA preferred.

  • 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.