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Supervisor, Downstream Manufacturing, Bern

Letztes Update 2024-02-27
Läuft ab 2024-03-27
ID #2002232043
125 CHF
Supervisor, Downstream Manufacturing, Bern
Switzerland, Bern, Bern,
Geändert January 21, 2024

Beschreibung

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locations

Switzerland - Plan-les-Ouates

time type

Full time

posted on

Posted Yesterday

job requisition id

R00005554

JOB SUMMARY
The downstream manufacturing supervisor will lead associates during the startup and production in the purification areas for a new clinical GMP biopharmaceutical facility. The supervisor will coach associates during the commissioning, qualification, and production activities while safeguarding work environments and ensuring c GMP compliant behaviors.
Downstream supervisors will assign and supervise daily tasks of team members and maintain strict accordance with production batch records, SOPs and Good Manufacturing Practices. This proven and qualified candidate will use their past experiences, depth and knowledge of purification fundamentals in chromatography, filtration, viral inactivation and bulk fill operations to teach, troubleshoot and continuously improve the daily operations of downstream manufacturing.

The supervisor should have in depth knowledge of mixing vessels, chromatography equipment filtration equipment, protein concentration analytical measurement equipment, and other general biotechnology auxiliary equipment such as balances, pumps, sterile tubing welders, tubing sealers, p H meters, filter integrity testers and conductivity meters. Experience using single use equipment is desired. The ideal candidate will be both technically sound as well as an experienced team motivator and coach.

The supervisor will review and understand manufacturing procedures and apply their fundamental knowledge combined with production batch records to train manufacturing personnel ensuring manufacturing operations are conducted accurately, safely and compliantly. The supervisor will maintain a sense of ownership of the production processes, manufacturing environment and facility. Following task execution, the supervisor will review the executed production batch records, and ERP orders to ensure a comprehensive and accurate set of actions have occurred. It is management’s expectation that any deviations/events are documented and escalated to the Management and Quality system according to KBI internal notification processes.

The ideal candidate can demonstrate that they have learning agility, are action oriented, drive for results, are excellent team workers, have a strong attention to detail, and have superior integrity and accountability. The incumbent will lead manufacturing planning and operations with a drive to ensure ‘Right the First time’ execution.

JOB RESPONSIBILITIES
Plan, schedule, and support daily production tasks to ensure schedule adherence while maintaining a successful and GMP compliant execution. Facilitate additional manufacturing activities and process support with other manufacturing groups, MS&T and PD, QA, Maintenance and Engineering, and AFS and Microbiology.
Ensure timely execution and review of batch documentation and logbooks, initiation of deviations, and execution and completion of ERP orders. Ensure timely corrections to batch documentation and logbooks.
Supervise, coach, mentor and train team members to maintain educated, qualified and motivated employees. Ensure staff maintain a high level of compliance to procedures and quality expectations.
Ensure equipment and manufacturing facilities remain in working order by overseeing production technician maintenance, cleaning, and ensuring timely submission of work orders for facility and equipment maintenance and repair.
JOB MINIMUM REQUIREMENTS
B. S. in a Life Sciences or Master/Engineering degree and 7+ years relevant experience or equivalent education and experience.
Demonstrated knowledge of purification unit operations is

preferred. Experience in single-use platform technology is

preferred.
Prior experience in a lead/leadership roll is

preferred.
Excellent written and verbal communication skills are

required.
Energetic, motivated and dynamic individual.
Must be organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.
Fluent in French, with technical English language both reading and writing.
Computer Skills:

MS Office, ERP, EDMS, production equipment software, other
The job requires working on shifts which may include working overnight as well as week-end or “on duty” working periods.
Please note that due to the position's location, we can only consider candidates with European passports or Swiss working permits/citizenship.
KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.
I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.
About Us

At KBI, we are constantly seeking to improve our team with accomplished individuals who share in our commitment to serve our clients as they seek to advance important medicines to the patients who need them.

We offer our employees a challenging, rewarding and fast-paced environment along with the opportunity for career advancement through the development of one’s technical skills. At KBI, employees work in a collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged.

If you do not see a position that matches your background, we invite you to return to our site often as positions are updated frequently.
Please Note: To 3rd Party Search Firms/Employment Agencies:

All inquiries must be directed to

staffinginquiry@kbibiopharma.com

. Please do not call or email any KBI Biopharma employee about current or future job openings. All resumes submitted by search firms or employment agencies to any employee at KBI Biopharma via-email, telephone, social media or other means will be deemed to be the sole property of KBI Biopharma, unless the firm submitting the resume has

previously entered into a written agreement with KBI Biopharma regarding recruitment services and has been approved by Human Resources to work on an open position

. KBI Biopharma will not pay any fee or remuneration with respect to candidates without complying with this requirement.

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Jobdetails

Auftragstyp: Vollzeit
Vertragstyp: Dauerhaft
Gehaltsart: Täglich
Besetzung: Supervisor, downstream manufacturing
Mindest. Gehalt: 100

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