Scientist Pipeline AGC Biologics

Job title:

Scientist Pipeline AGC Biologics

Company:

AGC Biologics

Job description

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.Scientist for QA or Manufacturing at AGC Biologics, CopenhagenAre you passionate about ensuring quality in manufacturing processes? Do you have a scientific background and experience in Quality Assurance or Manufacturing? If so, we have an exciting opportunity for you!About AGC BiologicsAGC Biologics is a leading global organization specializing in the development and manufacturing of biopharmaceutical products. We focus on delivering high-quality solutions for clinical and commercial markets. Our commitment to innovation and excellence drives our mission to improve patient outcomes around the world.Job DescriptionJoin our dynamic QA or Manufacturing department to ensure the highest standards of quality in our production processes. As a Scientist, you will work closely with cross-functional teams, including QA, QC, and Development, to support the manufacturing of biopharmaceutical products.Key Responsibilities:

• Master Production Record Management: Accountable for creating, reviewing, and maintaining the Master Production Record.
• Production Support: Provide on-call/shopfloor support during critical process steps and facilitate solutions during breakdowns in batch execution.
• Deviation Management: Accountable for timely deviation closure, including systematic problem-solving during root cause investigations and handling other quality documents.
• Compliance: Establish and maintain procedures to ensure compliance with cGMP regulations.
• Customer Interaction: Act as a representative in customer meetings and support audits and inspections.
• Continuous Improvement: Capture learnings and implement continuous improvements to processes.
• Training: Responsible for project-specific training of technicians.

Areas of FocusWe are looking for scientists to support the following main areas:

• Microbial Production
• Mammalian Production
• Solution Preparation
• Manufacturing Support
• Facility & Equipment
• Material Management

Within these areas in Manufacturing, you will be involved in:

• Upstream Processing: Cultivation of cells, media preparation, and bioreactor operation.
• Downstream Processing: Protein purification, filtration, and chromatography.
• Solution Preparation: Buffer preparation, media and solution mixing, and sterilization.

About YouWe imagine that you:

• Hold a relevant degree in a scientific or technical field.
• Have 1+ years of experience in the biopharmaceutical or related industry, preferably in a cGMP environment.
• Have experience with protein purification and chromatography.
• Are interested in equipment maintenance and instrumentation.
• Possess strong collaboration and communication skills.
• Are proficient in English (reading, writing, and speaking).
• Are positive, flexible, and thrive on new assignments and responsibilities.
• Can handle unpredictability and work effectively in a dynamic environment.

Preferred Competencies and Experiences:

• Masters or Bachelor’s Degree in natural or life science-related fields.
• Knowledge of upstream or/and downstream processes.
• Experience writing, reviewing, and approving GMP documentation.
• Experience with operations of single-use technologies and aseptic processing.
• Experience in clinical/commercial GMP manufacturing.
• Self-motivated, organized, and proactive.
• Ability to coordinate multi-departmental tasks and deliverables.
• Experience working with multiple projects simultaneously.
• Demonstrated experience leading troubleshooting efforts.
• Strong communication and presentation skills necessary to interact with internal and external stakeholders.

Work ConditionsWithin manufacturing our team could operate on rotating shifts, including days, evenings, nights, weekends, and overtime during peak periods. Flexibility in work hours is essential.We review applications on an ongoing basis, so send in your application today.Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com. Want to keep posted about our growth and learn more about our company? Follow us on and give us a quick Like on !AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.

Expected salary

Location

København

Job date

Thu, 08 Aug 2024 03:32:17 GMT

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