*Manager for Analytical Development, Process Development (PD) support

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A challenging and varied job in our Analytical Development Department in Copenhagen as a planning coordinator and manager is open for a new colleague with analytical protein knowledge and planning experience and a strong ability to drive interdepartmental collaboration.

The Job
[xxxxx] continues to enjoy great success, with a steadily increasing number of customers and projects – both early and 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. In all aspects, fast analytical results are needed to support delivery of new needed pharmaceuticals to patient’s worldwide. With [xxxxx] increasing activities, we are looking for a new colleague with biopharmaceuticals analytical sciences and planning experience and preferably leadership experience.

The manager is responsible for the analytical development PD support bioassay team consisting of five technicians and one scientist as well as planning for additional 2-3 technicians from another team in the department. More specifically, the team execute the sample analysis in analytical development coming from Upstream Process Development, Downstream Process Development, Production Engineering runs, and AD studies e.g. non-GMP Stability, in use studies, forced degradation studies, cleaning verification etc.. The candidate will participate in analytical troubleshooting arising from the sample analysis in collaboration with other managers in the department.

Moreover, the manager will direct the day-to-day planning of which analytical bioassays are to be executed and results delivered, through visual planning with the team and rotating personnel from another team in the department. This takes place based on close collaboration with internal customers and an overall priority of projects. On a daily basis, the tasks also include improvement of laboratory workflow to reduce the turn-around-time for analytical samples results requested. Analytical Development is looking for an engaged and ambitious person with excellent planning skills, which are good at operating in a very changeable setting, where priorities can shift fast based on customer needs. The manager is responsible for scientific sparring in relation to the execution of analytical assays as well as planning of instrument usages, reagent availability and preparation, which include collaboration with 5 -6 student helpers in the department.

Key responsibilities:

  • Manager- Functions in a team setting efficiently with other team members and manager peers within Analytical Development.
  • Planning of execution of analytical samples according to requests and timelines
  • Plan utilization of department instruments.
  • Deliver analytical results to the requesters
  • 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.
  • Manage the flow of day-to-day operations in the team – ability to balance workload over several projects simultaneously.
  • 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.
  • Provides innovative solutions to logistic challenges surrounding the analytical support - Provide scientific support to analytical trouble shooting.
  • Reports and updates to department manager on the team's progress.
  • Secure input to updates of analytical procedures and worksheets to improve execution excellence.

The position offer interaction with a large number of stakeholders, and is unique in having contact with all internal departments involved in process development, analytics and manufacturing for engineering runs. You will be introduced to a large diversity of biopharmaceutical analytical methods and be an active player in their executions. The daily challenges will vary a lot, and two days will never be the same.

The Department
The AD department at [xxxxx] consists of five teams: AD PD bioassay support (7), AD PD HPLC support HPLC (8),AD HPLC (10) AD Bioassay (8) and AD Characterization (7). The AD groups are responsible for implementing of analytical method, supporting the Upstream and Downstream Process Development and Production Engineering with analytical results and AD studies e.g. non-GMP stability, in use stability, forced degradation, cleaning verification, interim reference material, characterization analysis, peak characterization etc..
Within this broad working area, many different customers’ projects and with various biopharmaceuticals the AD department differs from traditional AD lab. The position requires an engaged excellent planner, ambitious employee and in depth knowledge within analytical. AD have a close collaboration with customers, and departments across the organization to gain control of all steps in the manufacturing processes.

Your profile
In our new colleague, we’re looking for a person with:

  • Degree in science, engineering, or a related field (MSc. or PhD)
  • Knowledge of protein structure and biochemistry
  • Experience with analytical sciences and planning of analytical execution for biologics
  • 5+ years experience in an analytical setting preferable with both experience within HPLC, CE and bioassay methods for biologics.
  • 2+ years experience with planning in a complex settings
  • Preferably 1+ year as 1st line manager
  • Good English communication and ability to effectively communicate with others engaging with team members and colleagues of various cultural background, with an ability to obtain buy-in from all key stakeholders
  • Ability to apply organizational skills to systems and efficiency improvement.
  • Strong driver of interdepartmental tasks with the ability to keep the end goal in mind and prioritize between many different tasks
  • Lean skills will be an advantage

[xxxxx] Copenhagen
[xxxxx] offers a dynamic working place and an excellent opportunity for working and growing with a varied array of tasks and challenges. You will get insight into and experience with the way the various departments throughout a biologics contract development and manufacturing organization interact in order to achieve success. Exciting and challenging assignments will keep coming your way, but you will to a large extent be able to plan your daily work on your own. [xxxxx] offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. AGC employees have a flexible attitude and we help each other to reach deadlines together as one team, in accordance with our slogan - Right. On Time.

About [xxxxx]
[xxxxx] (AGC) is a global Contract Manufacturing Organization (CMO) with biomanufacturing facilities in Europe, Japan 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.

[xxxxx] also offers non-exclusive license to CHEF1™, a proprietary CHO cell line development platform. CHEF1 delivers stable, high-titer, production-quality cell lines in optimized time frames. It is the foundation of [xxxxx]’ innovative approach to cell line and process development.

Visit [xxxxx] learn why [xxxxx] is a World Leader in process development and contract manufacturing.


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Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

Arbejdsstedet er beliggende i København

Jobbet er oprettet på vores service den 24.2.2024, men kan have været deaktiveret og genaktiveret igen.

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Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
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