A challenging and varied job in our Analytical Developments Characterization team in Copenhagen as a technical expert and Team leader is open for an innovative  new colleague with structural protein chemistry experience and a strong ability to drive expansion of our analytical characterization offering.

The Job
AGC Biologics continues to enjoy great success, with a steadily increasing number of customers and projects – many of which are late stage development projects preparing for commercial launch. At the same time, we are handling many new and exciting customer projects and give support to processes already running in our facility for clinical and commercial supply. With AGC Biologics increasing activities, we are looking for a new colleague with analytical protein characterization experience and preferably leadership experience.

The team leader is responsible for the Analytical Development characterization team consisting of two technicians and three scientists involved in characterization method development, sample testing and reporting as well as expanding the characterization group into new characterization offerings or our customers. More specifically, the team implements characterization methods as Intact Mass, Subunits, Pepmap/LCMS, Glycans, sialic acid, polysorbate analysis etc. The candidate will also implement/develop characterization methods and secure execution and delivery of characterization results and reports both individually and through others. The characterization area is a development area for AGC and techniques enabling FcRn binding and other characterization methods are currently being implemented. The candidate will also be assigned to projects as an AD representative and support the other scientist in that role.

Moreover, the Team Leader will direct the day-to-day line and project related activities focused on characterization of Products in all phases of the drug delivery lifecycle, through interaction with scientific and technical staff in both Analytical Development, Upstream Development, Downstream Development and the production. Progress, goals and milestones shall be communicated through verbal or written reports and presentations internally and to the rest of the AGC organization. This role requires proven scientific and technical skills as a professional in the field of analytical characterization sciences, including leadership working with an engaged and committed team. The Team leader will work closely with and oversee day-to-day activities of scientific staff and report directly to the department Sr. Director of Analytical Development. The team leader must create a positive, motivating and productive working climate in accordance with AGC Biologics values. Additionally she/he must conduct employee performance appraisals and set goals. Additionally, the candidate is responsible for cross-organizational activities associated with the Manufacturing, Quality, and Development organization through the role as team leader, by conveying and reporting result of relevance from the department to stakeholders.

Key responsibilities:

  • Team Leader - Functions in a team setting efficiently with other team members and team lead peers within Analytical Development
  • ​Implement/Develop characterization methods
  • Deliver analytical characterization results/reports
  • Develop the Analytical characterization area offering in accordance with our clients needs
  • Monitor team member’s participation, engagement, and performance to ensure individual performance in the team setting
  • Communicate clear instructions and feedback to team members and listen to team members' feedback
  • Facilitate and or provide training for team members on a as needed basis
  • Develop team strategy to reach team and department goals
  • Comply with all company policies, procedures, internal and external quality standards, and relevant regulatory standards
  • Manage the flow of day-to-day operations in the team – ability to balance workload over several projects simultaneously
  • Provides innovative solutions to complex problems surrounding the Development and Manufacturing processes - Provide scientific support to Manufacturing on e.g. investigations and provide required documentation for operations in the manufacturing area 
  • Supports requests for technical assistance from the rest of the AGC biologics organization – ensuring seamless cross-organizational interactions Interfaces with internal and external stakeholders and represents the department and team effectively and professionally
  • Engages in preparation of proposals for planning of new projects including the acquirement of novel technology platforms
  • Reports and updates to department manager on the team's progress
  • Designs test methods, plans, and or protocols, creates technical reports and presentations and completes tasks delegated by head of department - Assists Head of department in department and scientific efforts as needed.
  • Contribute to IND and BLA writing

The position offer interaction with a large number of stakeholders, and is unique in having contact with both our customers and all internal departments involved in process development and manufacturing. You will be introduced to biopharmaceutical companies globally and be an active player in their projects.  The daily challenges will vary a lot, and two days will never be the same

The Department
The Analytical Development (AD) department currently consists of 37 highly skilled colleagues divided in 4 teams; AD PD support, AD Bioassay, AD Chromatographic assays and AD Characterization. AD is responsible for implementation of methods by transfer from the customers or adjusting platform methods or by development from start. AD delivers analytical result to support Upstream- and downstream development during transfer or implementation of the processes as well as production with test of the ENG batches. AD is responsible for method transfer to QC, establishment of interim reference material, in use studies, cleaning verification and forced degradation studies. You will be a part of the analytical development management team headed by the department Sr. Director. We have an open communication and strong support and flexibility within the department.

The department is recognized as a group of analytical and protein chemistry experts and provides input in meetings with potential new customers, audits and inspections with both global and national authorities.

We are looking for a Teamlead for our AD characterization team, who can grow the current support of our customer projects by high standard characterization analytics already in place and expand the business area offering new characterization possibilities to our customers. The right candidate should be able to motivate a team and enforce a high degree of independence and team spirit.

Your profile
In our new colleague, we are looking for a person with:
  • Degree in science, engineering, or a related field (MSc. or PhD)
  • Experience with analytical characterization of biologics
    • 5+ years experience with analytical Characteization development, implemnetaion and reporting.
    • 2+ years experience with Phase III or Commercial products
    • Preferably 1+ year as 1st line manager
  • Good English communication and ability to effectively communicate with others engaging with customers and colleges of various cultural background, with an ability to obtain buy-in from all key stakeholders
  • Preferable familiar with EMA, FDA, and ICH regulations for biologics
  • Strong driver of interdepartmental tasks with the ability to keep the end goal in mind and prioritize between many different tasks.

Submit your application as soon as possible. We treat the applications as we receive them, and conduct interviews with qualified candidates. When the right candidate is found, the add will close.

For further information regarding the position, please contact Helle G. Wendelboe, Sr. Director, Analytical Development, at +45 22943090.

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AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.


Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.

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