Scientist, Process Transfer & Validation

AGC Biologics


Dato: for 18 timer siden
By: København, Region Hovedstaden
Kontrakttype: Fuld tid
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.

Essential Job Duties/Responsibilities

Perform the duties below, under general supervision and following standard procedures, according to project timelines:

Project Ownership And Leadership

  • Act as project/process owner for early or late-stage projects.
  • Lead activities to transfer processes to Manufacturing from internal AGC Process Development or directly from customers and/or to validate and monitor those processes (applicable to late stage only).

Process Mapping And Risk Assessments

  • Work with clients and internal AGC stakeholders on process mapping, facility fit, and scale-up of manufacturing processes.
  • Perform process and other process-related risk assessments.
  • Collaborate across functional areas, including tech transfer, risk assessments, validations, and process monitoring.

Manufacturing Support And Problem Solving

  • Support manufacturing operations prior, during, and after batch execution to ensure batch success.
  • Analyze data and apply company policies and procedures to resolve complicated issues and propose improvements.

Audits And Compliance

  • Participate in audits and inspections covering topics related to owned projects.
  • Ensure compliance with company policies and regulatory requirements.

Data Presentation And Communication

  • Prepare and present data associated with manufacturing processes to internal and external clients.
  • Participate in project team meetings, decisions, and creation of milestones representing Process Transfer and Validation (PT&V).

Training And Mentorship

  • Provide training and support to new Process Transfer and Validation scientists.

Leadership Skills

Technical Leadership and Strategic Advice:

  • Provide technical leadership and standard professional advice to Manufacturing and other departments associated with GMP operations, based on guidelines and standard procedures.
  • Proven experience in successfully managing multiple projects simultaneously.

Collaboration And Communication

  • Demonstrated ability to interface and communicate effectively with internal and external clients.
  • Ability to coordinate multi-departmental tasks and deliverables to ensure collaboration and project success.
  • Engage in and promote teamwork, fostering a collaborative and supportive work environment.

Training And Development

  • Provide technical training to others on GMP manufacturing operations or functional areas, including risk assessments, tech transfer, validation, and process monitoring.
  • Take responsibility for your own professional development while contributing to the growth of functional expertise within the team.

Results-Driven Approach

  • Strive to improve processes and deliverables, being aware of the impacts of tasks and outcomes.
  • Deliver results with quality and the customer in mind, adhering to project timelines and organizational goals.

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 LinkedIn and give us a quick Like on Facebook!

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.
Send et CV

Se flere job i København, Region Hovedstaden