id: NDkxODQxNSA3

reference: 4918415

documentId: 4918415

connectionPointId: 7

lastModificationDate: 1544787967863

stillingsbetegnelse: Manufacturing Support Supervisor

jobbeskrivelse:

Job Description

In the Manufacturing Documentation & Support department we are 35 persons divided into three teams. We develop and maintain the manufacturing documentation packages, drive and execute improvement projects, both site-wide and cross-sites, and provide on-floor manufacturing support.

In this role you will supervise Manufacturing Documentation Associates, schedule tasks, and ensure that GMP is adhered in all procedures. You recruit staff for the assigned team and coordinate Mfg. Documentation relevant activities with other departments. You act as the key person and expert in assigned area and represents Mfg. Documentation in cross-functional teams. You are responsible for supervising, coaching, goal setting and developing the assigned team as well as taking an active part in day to day work.

You are a part of the Mfg. Documentation and Support management team and part of the LSM Management Supervisor team. You will report to Large Scale Manufacturing Senior Management.

Taks:
• Supervise the assigned Mfg. Documentation team in LSM to support production of drug substance according to schedule and GMP compliance. You will have Mfg. Documentation associates in direct reference and you will be responsible for training, coaching and supervision of this group in order to ensure the compliance level in the area.
• Ensuring compliance towards internal Biogen procedures, national and international regulatory requirements, GMP requirements including but not limited to EU GMP II: Basic Requirements for Active Substances used as Starting Materials and Annex II: Manufacture of Biological Active substance and medicinal products for Human use. Ensure audit readiness.
• Work in close cooperation with all our stakeholders (QA, Engineering, Manufacturing Sciences, Validation, etc.) to ensure reliable execution.

*LI-DEN2

Qualifications

You have min. 5-8 years of relevant work experience in a GMP enviroment (e.g. Biotech, pharmceutical industry).

You are able to work under consultative direction in creating goals and objectives of the Function. Assignments are often self-initiated. Virtually self-supervisory. Decisions are made independently with a high degree of initiative.
Supervision of staff, making decisions, setting direction and ensuring development of Mfg. Documentation associates as well as LSM staff in general with regards to cGMP.

Knowledge & skills
• A successful track record in documentation and project processes
• Data driven decision making
• Successful experience with change management
• Possesses a working knowledge of databases, tools and systems (deviations, CAPAs, document change control, Excel etc.)
• Thorough understanding and ability to execute against regulatory compliance parameters and solid and in-depth experience with GMP
• Excellent English skills verbally and in writing and excellent oral and written communication skills – must be able to lead departments and / or cross-functional meetings
• Decision making, Discretion and Latitude

Education

Your minimum educational background is preferably a Bachelor/master in Engineering, Pharmacy or equivalent.

Please apply for this position as soon as possible. We will screen candidates on an ongoing basis and close the job advertisement when we have found the right candidate for the position.

Employment Category: Full-Time Regular

Experience Level: Mid-Senior Level

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2141

abstractJV_contact_0: Please apply using one of the specified channels

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: BIOGEN (DENMARK) NEW MANUFACTURINGApS

source: DK-STAR