Contract Manufacturing Professional

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Søborg

Are you passionate about working with contract manufacturing and thrive in a dynamic, international environment with many stakeholders? Are you ready to be involved in support activities to enable the aseptic manufacturing of drug products at CMOs and operate within a GMP environment? If this sounds like you, we are looking forward to welcoming you in our Drug Product Manufacturing Science and Technology (DP MSAT) Support team within Global Contract Manufacturing (GCM). Apply now! The position As Professional in GCM DP MSAT Support, your overall objective is to provide support to the GCM DP department. Some of your key activities include:
  • Handling deviations by performing Systematic Problem Solving to identify solutions to newly discovered challenges
  • Coordinating and preparing change control cases in accordance with [xxxxx] procedures
  • Overseeing and/or leading cross-functional activities to enable successful and GMP compliant change controls, including updating Standard Operations Procedures
  • Writing and reviewing regulatory documentation related to manufacturing processes of drug products
  • Cooperating closely with colleagues from manufacturing development areas, quality control, quality assurance, contract manufacturing organizations, and regulatory affairs
    • The seniority level depends on candidate experience, and whether you possess a wealth of experience or aspire to continue building your career with us, we want to hear from you. Qualifications To be successful in this role, we believe you:
  • Hold an academic degree in Science within Pharmacy, Chemistry, Engineering, or a similar field
  • Possess excellent skills in planning and coordinating writing tasks in line with an ambitious submission strategy
  • Demonstrate the ability to create comprehensive overviews and prioritizing tasks effectively, even under tight deadlines
  • Show proficiency in change management and stakeholder engagement at different organizational levels
  • Display fluency in both spoken and written English
    • It would be considered as a strong advantage if you have experience in the pharmaceutical industry, regulatory areas, or health authorities, particularly in writing or reviewing regulatory documents. As a person, you thrive in a dynamic everyday life where your ability to make sustainable decisions is absolutely essential. You have a proactive approach to work and see opportunities rather than limitations, adeptly completing your tasks and quickly adapting when priorities change. You are quality-conscious, appreciating and understanding the importance of thorough documentation. You have a sense of humour and foster a good working environment for yourself and your colleagues, contributing with your open and productive attitude. About the department GCM is part of [xxxxx]’s Product Supply organization. We are responsible for all [xxxxx] contracts and license manufacturing of Active Pharmaceutical Ingredients, intermediates, semi-finished, and finished drug products to global markets. GCM is physically located in Søborg, Denmark. The primary role of GCM is to monitor and control the production handled by external Contract Manufacturing Organizations (CMOs), ensuring delivery of products from the CMOs to our respective customers. Our CMOs are located in Europe and North America. The position is in a production support department, GCM Support, a team of highly experienced professionals and specialists with a well-documented history in pharmaceutical sciences. You will join a team of experts within the field and become a part of a well-functioning team where we work and solve problems in collaboration. Several of the CMOs we currently work with are in project phases where extra focus is needed from a set of skilled specialists. The every-day work in GCM can shift in many directions and therefore it is good if you can approach new situations with an open mind. Working at [xxxxx] At [xxxxx], we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact For further information, please contact Karina Ayala on +[xxxxx]or [xxxxx] Deadline 26 May 2024. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At [xxxxx] we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.


    Information og data

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

    Arbejdsstedet er beliggende i Søborg.

    Jobbet er oprettet på vores service den 9.5.2024, men kan have været deaktiveret og genaktiveret igen.

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

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