1 job found in Basel, Basel-Stadt

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    • basel, basel-stadt
    • temporary
    Do you have good communication skills and strong experience in the bio-pharmaceutical industry?Are you experienced working with partner organizations (CMOs)?In this case you should have a look at this opportunity!To work for our client, a pioneering biotechnology company, we are looking for a: Senior Specialist, International Fill FinishLocation: BaselContract duration: to start asap for 12 monthsHere’s What You’ll Do: Support the (Associate) Director, International Fill Finish in various tasks related to the buildup of GMP production at Fill Finish Contract Manufacturing Organizations (FF CMOs). Act as a counterpart for FF CMOs team members to ensure on-time and in-full deliveries. Partner with Quality, Technical Development, Manufacturing Science and Technology, and Regulatory colleagues on specific aspects of the relationships with the FF CMOs.Ensure operational related activities at the FF CMOs are conducted to meet Company’s requirements (Compliance, Meeting Orders, Dispute resolution, Production Planning, Materials Management, Technology Issues, OpEx). Ensure externally manufactured drug products are produced and stored according to the appropriate documentation in order to obtain the required quality. Ensure that instructions relating to external production operations are strictly implemented by the  CMOs.Ensure in collaboration with quality that the appropriate qualification, maintenance, training and validations are performed to meet the appropriate Company requirements. Support and perform the reviews for process performance at FF CMOs. Monitor Key Performance Indicators of FF CMOs. Support preparation of periodic business and operations review meetings.  Drive for and implement agreed continuous improvements at FF CMOs. Coordinate reviews and approvals of various documentations from FF CMOs. In collaboration with Quality coordinate investigations and troubleshooting efforts at FF CMOsWrite or revise the appropriate GMP documentations. Frequently visit and maintain presence at the external partners’ sites and build strong interdependent relationships with the CMO Counterparts in order to assess the as is state & risks for action-oriented improvement plans. Performs other administrative duties as required. Here’s What You’ll Bring to the Table:Bachelor's Degree with 5-8 years of experience in biopharmaceutical operations or a Master’s Degree with 2-5 years industry experience; Degree in Engineering or Life Sciences is preferred.Proficiency in English required. Spanish and German are a plus. Good communication skills (verbal and written) to collaborate with other CMC team members and managers in a dynamic, cross-functional matrix environment.Ability to work with members of partner organizations (CMOs).Well organized – a natural ability to be organized in how you think, communicate and conduct your work.You drive for results – you set a high bar for yourself and others.Good critical thinker that can anticipate the needed next step and therefore can work independently.A curious mindset that allows you to constantly learn and challenge the status quo.Ability to navigate through ambiguity and rapid growth and adapt to change.  You would like to contribute to a fast-thinking and innovative company, changing the industry ?Apply now! Please note that a valid Swiss work permit or Swiss or EU-25/EFTA citizenship is required for this position
    Do you have good communication skills and strong experience in the bio-pharmaceutical industry?Are you experienced working with partner organizations (CMOs)?In this case you should have a look at this opportunity!To work for our client, a pioneering biotechnology company, we are looking for a: Senior Specialist, International Fill FinishLocation: BaselContract duration: to start asap for 12 monthsHere’s What You’ll Do: Support the (Associate) Director, International Fill Finish in various tasks related to the buildup of GMP production at Fill Finish Contract Manufacturing Organizations (FF CMOs). Act as a counterpart for FF CMOs team members to ensure on-time and in-full deliveries. Partner with Quality, Technical Development, Manufacturing Science and Technology, and Regulatory colleagues on specific aspects of the relationships with the FF CMOs.Ensure operational related activities at the FF CMOs are conducted to meet Company’s requirements (Compliance, Meeting Orders, Dispute resolution, Production Planning, Materials Management, Technology Issues, OpEx). Ensure externally manufactured drug products are produced and stored according to the appropriate documentation in order to obtain the required quality. Ensure that instructions relating to external production operations are strictly implemented by the  CMOs.Ensure in collaboration with quality that the appropriate qualification, maintenance, training and validations are performed to meet the appropriate Company requirements. Support and perform the reviews for process performance at FF CMOs. Monitor Key Performance Indicators of FF CMOs. Support preparation of periodic business and operations review meetings.  Drive for and implement agreed continuous improvements at FF CMOs. Coordinate reviews and approvals of various documentations from FF CMOs. In collaboration with Quality coordinate investigations and troubleshooting efforts at FF CMOsWrite or revise the appropriate GMP documentations. Frequently visit and maintain presence at the external partners’ sites and build strong interdependent relationships with the CMO Counterparts in order to assess the as is state & risks for action-oriented improvement plans. Performs other administrative duties as required. Here’s What You’ll Bring to the Table:Bachelor's Degree with 5-8 years of experience in biopharmaceutical operations or a Master’s Degree with 2-5 years industry experience; Degree in Engineering or Life Sciences is preferred.Proficiency in English required. Spanish and German are a plus. Good communication skills (verbal and written) to collaborate with other CMC team members and managers in a dynamic, cross-functional matrix environment.Ability to work with members of partner organizations (CMOs).Well organized – a natural ability to be organized in how you think, communicate and conduct your work.You drive for results – you set a high bar for yourself and others.Good critical thinker that can anticipate the needed next step and therefore can work independently.A curious mindset that allows you to constantly learn and challenge the status quo.Ability to navigate through ambiguity and rapid growth and adapt to change.  You would like to contribute to a fast-thinking and innovative company, changing the industry ?Apply now! Please note that a valid Swiss work permit or Swiss or EU-25/EFTA citizenship is required for this position

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