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Job ID :
55383BR
Location :
US - California - Fremont
:
Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Position Summary:
The Antibody Production Value Stream Manager is responsible for all aspects of Antibody manufacturing which includes cell banking activities, mammalian cell/tissue culture processes, fermentation for antibodies and purification. The Value Stream Manager will work closely with Planning to prioritize production schedules in order to achieve product availability objectives while maintaining high degrees of cGMP and GLP standards. This position requires close partnership with Quality Assurance to ensure the manufacturing team maintains a high degree of compliance with company and regulatory requirements. This position also requires close partnership with Engineering, Technical Operations and other internal teams in order to realize productivity and delivery objectives. As a people manager, the Value Stream Manager will use effective allocation of resources within the department as well as guide the development of future leaders, scientists, and associates.

Key Responsibilities:

  • Manage Antibody Production team to ensure adequate levels of ascites, monoclonal, and polyclonal antibody inventory to satisfy commercial sales needs as well as in-process bulk manufacturing needs.
  • Champion the entire antibody production process; from immunogen preparation, immunization, injection schedules, hybridoma creation, collection, screening and titering, purification, and to raw materials QC release.
  • Identify opportunities within the Antibody Production value stream, without compromising the customer’s experience, to improve gross margin, improve product availability, improve efficiency, and reduce leakage.
  • Train new employees in Antibody production, as needed.
  • Complete timely performance reviews, counsel and mentor team as needed.
  • Develop aggressive goals and champion the use of appropriate metrics to monitor and drive business progress and make data driven decisions.
  • Participate on CAPA and NCAR investigations as needed and champion the reduction of GMP/GLP related issues.
  • Be customer centric and represent the Antibody Operations Department during customer visits, Agency and Government audits, and support customer inquiries as needed.
  • Continually help to improve the company culture by practice and example to the 4”I” values of Thermo Fisher Scientific – Integrity, Intensity, Innovation and Involvement
  • Identify opportunities for material and labor productivity and adequately resource projects to realize hard savings from key opportunities.
  • Partner with Planning/Supply Chain to ensure effective prioritization and schedule adherence.
  • Partner with Quality to ensure high state of compliance
  • Partner with R&D and Technical Operations during new product introductions and product transfers.
  • Partner with Customer Service and Supply Chain to ensure adherence to schedule and product delivery to meet customer needs.
  • Partner with Engineering and Manufacturing Services to ensure efficiency and increased productivity and quality with improvement ideas.
  • Partner with Product Management to ensure full product viability and perform periodic review of product offering.
  • Complete all company required training programs.
  • Provide updates or presentations to Senior Leadership Team (SLT) regarding status of projects or programs.

Requirements/Qualifications:

  • Bachelor’s degree, preferably in Biology, Biochemistry or Chemistry.
  • Minimum 1.5 years’ experience in Supervisory role or people management experience with leadership capacity.
  • 7+ years of industry related experience in cGMP/GLP regulated environment and knowledge of FDA and ISO regulations are essential.
  • Knowledge of fermentation systems, purification, and basic tissue culture processes preferred.
  • Superior organizational skills with ability to multi-task and balance high complex and technical work activities.
  • Ability to lead cross-functional teams and deliver desired results on projects.
  • Display an understanding of required levels of business acumen.
  • Advanced interpersonal and communication skills, both written and verbal, with the ability to work as a team player and team builder.
  • Excellent communication skills for group presentations and intercompany written and verbal communications.
  • Experience building robust processes in a highly cross functional environment.
  • Change management ability preferred with ability to drive change in process, facility, and culture.
  • Solid skills using MS Office, Outlook, and MRP/ERP Systems.

At Thermo Fisher Scientific, each one of our 55,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Apply today http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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