senior specialist international fill finish (temp - 12 months) in BASEL

posted
contact
Lucie Nasshan, Basel Professionals Health Care & Life Sciences
job type
temporary
apply now

job details

posted
location
basel, basel-stadt
sector
life sciences
job type
temporary
reference number
16525
contact
lucie nasshan, basel professionals health care & life sciences
phone
058 201 55 50

job description

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 Finish

Location: Basel

Contract duration: to start asap for 12 months

Here’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 CMOs

  • Write 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