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 1^st 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.

Application
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.

Want to keep posted about our growth and to learn more about our company?

We also urge you to follow us on our LinkedIn Company Page and give us a quick Like on Facebook !

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.

Apply for this Job

* Required

First Name *

Last Name *

Email *

Phone *

Location (City) *

Resume/CV *

Dropbox Google Drive

(File types: pdf, doc, docx, txt, rtf)

Cover Letter

Dropbox Google Drive

(File types: pdf, doc, docx, txt, rtf)

When autocomplete results are available use up and down arrows to review

+ Add another education

LinkedIn Profile URL

How did you hear about this position? *

If you are being referred to AGC Biologics by a current employee, please enter their name below.

Current Mailing Address: *

Address, City and State

Are you willing to relocate? *

GDPR Consent *

Privacy information for sending job applications

Pursuant to art. 13 of Regulation (EU) 2016/679 (hereafter "GDPR"), laying down provisions for the protection of persons and other subjects regarding the processing of personal data, we wish to inform you that the personal data you provide will be processed in compliance with the aforementioned legislation.

AGC Biologics Inc., together with its parent company, its subsidiaries and affiliates (collectively, “AGC Biologics Group”, “we”, “us” or “our”), recognize the importance of protecting your privacy. This Policy is designed to assist you in understanding how we collect, use, safeguard and disclose your personal information when using the “join our team” service. We also describe how you can contact us about our privacy practices.

Data Controller

You are informed that your data is collected by the specific AGC Biologics Group company and processed in accordance with the applicable laws.

Type of data processed

By sending your curriculum vitae (CV), you are communicating your personal identification data concerning your training and work experience. Pursuant to articles 9 and 10 of the GDPR, you could give us data qualifying as "particular categories of personal data" (ie those data revealing "racial or ethnic origin, political opinions, religious or philosophical convictions, or union membership, data relating to the health or sexual life or sexual orientation of the person”). With reference to the processing of these particular categories of data, we inform you that, if not necessary for the purpose of completing the selection activity, it is preferable to avoid the inclusion in the CV of such sensitive data.

Purpose and legal basis

The personal data you provide are necessary to evaluate your potential suitability for the purpose of a possible inclusion within our staff.

The processing of data reported in your CV is based on your express consent in the act of sending the CV itself, accepting this Policy. We remind you that you may revoke your consent here expressed at any time, by means of a written communication to the Data Controller or using the “join our team” service. This does not prejudice the lawfulness of the treatment based on the consent given before the revocation. We invite you to promptly communicate any changes in the data furnished. We may contact you by email requesting your consent to conserve your CV for an additional period of time, basing said communication on our legitimated interest of maintaining a contact with you.

Optional supply of personal data

The provision of personal data indicated as required is necessary. Therefore, any refusal to provide such data would make it impossible to manage the relationship with you and would then cause the impossibility of your possible inclusion in our staff.

Method of treatment

The processing of personal data will be based on principles of correctness, lawfulness and transparency, protecting your privacy and your rights and will take place using suitable tools to guarantee their security.

Categories of recipients to whom personal data might be disclosed or communicated, scope of dissemination of personal data

With respect to the activities and purposes stated above, personal data will be processed exclusively by employees and / or collaborators of the Data Controller, also through third parties appointed as Data Processors (e.gg. business consultants or external companies in charge of maintenance of the “join our team” service and related activities), in compliance with the provisions of the law also with regard to security measures to protect and safeguard the data provided.

The list of Data Processors can be requested to the Data Controller.

The Data Controller may communicate and disseminate personal data for the sole purpose of executing legal obligations.

Data retention

The data collected will be kept for the time strictly necessary for their treatment and in any case no later than one year/six months, unless you authorize us to extend such period, following our written request.

International data transfer

Your personal data may be transferred to, and processed in, countries other than the country in which you are resident. These countries may have data protection laws that are different to the laws of your country (and, in some cases, may not be as protective).

Specifically, our servers are or will be located in the European Economic Area or EEA or any other country that is compliant with the principles of the GDPR, and third party service providers and partners operate around the world. This means that when we collect your personal data we may process it in any of these countries.

However, we have taken appropriate safeguards to require that your Personal Data will remain protected in accordance with this Policy. These include implementing an intra-group data transfer agreement based on the European Commission's Standard Contractual Clauses (the "Intra-Group Data Transfer Umbrella Agreement") for transfers of Personal Data between our group companies, which require all group companies to protect Personal Data they process from the EEA in accordance with the GDPR.

We have implemented similar appropriate safeguards with our third party service providers and partners and further details can be provided upon request.

Rights of the interested parties

Within the limits of the GDPR, you have the right to ask us, at any time, to access your personal data, to rectify or cancel them or to oppose their treatment, the limitation of processing and to obtain a structured format, in common use and readable by automatic device data concerning you.

Requests should be sent to the Data Controller using the address indicated in the position description.

In accordance with applicable law, you have, in any case, the right to lodge a complaint with the competent supervisory authority (Personal Data Protection Authority) if you consider that the processing of your personal data is contrary to the law in force.

More information on treatment

Defense in court

Your personal data can be used for the defense by us in court or in the stages of its establishment, in case of abuse in the use of our services.

You declare to be aware that we may be required to disclose the data at the request of the public authorities.

Additional information

You may request more information in relation to the processing of your personal data at any time using the contact information.

Changes to this privacy policy

We reserve the right to make changes to this privacy policy at any time by giving publicity to users.

Current Position *

Current Company *

What are you current salary level? *

Are you a Danish citizen? *

If no, do you have a work VISA? *

Scientific teamlead for Analytical Development Characterization team

Apply for this Job