Supervisor Cell Banking

Profile

A career with MilliporeSigma is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of **MEMBERS ONLY**SIGN UP NOW***., Darmstadt, Germany.
US employees must be fully vaccinated against COVID-19 prior to your start date unless an accommodation is granted by The Company. The Company uses the definition of fully vaccinated assigned by the Centers for Disease Control & Prevention for purposes of considering satisfaction of this requirement which is a condition of employment.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role:
The Cell Banking Supervisor is responsible for advising and leading cGMP Cell Banking manufacturing operations as supervising Associate Scientists and Technicians. The Cell Banking Supervisor will develop technical specifications from input from clients and lead activities, to manufacture cGMP cell banking for clients aligned with cGMP regulations and guidelines.
Responsibilities will include but are not limited to:
Oversees the development, implementation and maintenance of quality control systems and activities at the site
Ensure the tasks are defined, implemented and completed in accordance with regulations and approved quality standards and procedures
Performs tasks in accordance with SOPs and regulations (cGMP and GLP)
Reviews and revises manufacturing methods, SOPs, equipment IQ/OQ/PQ, and investigation reports
Adheres to client expectations and service level agreements
Maintain close communication and interaction with the existing management, staff and clients to ensure timely detailed analysis, interpretation and reliable data
Interacts with regulatory agencies to present applicable data, explain incidents, trends and reports as needed
Performs management responsibilities such as the development and management of the area budget
Provides varying levels of general and specific work instruction and guidance to team members depending on their level of experience
Provides direct supervision to personnel. Meet with team members to set goals, conduct regular one-on-one discussions with employees, ensure development plans are in place for all employees, address personnel issues promptly, interview and hire new candidates and complete performance reviews fairly and timely
Responds to changing needs by reallocating equipment and / or staff resources accordingly
Coordinates documentation of manufacturing deviations, incidents and investigations
Provides effective conflict and change management, good presentation, meeting management and project management skills
Who You Are:
Minimum Qualifications:
Bachelor's degree in a scientific field (i.e., Biology, Chemistry, etc.) with 3 years working experience in cGMP manufacturing
1 years leadership experience in a high-level technical or project lead role
Preferred Qualifications:
Cell Bank manufacturing and ISO Clean Room experience
cGMP experience of data evaluation trending and troubleshooting
Ability to work in teams and develop organization into a unified and aligned direction
Knowledge of applicable computer systems (i.e., Excel, Word, PowerPoint, LIMS, BRIQS, etc.)
Excellent oral and written communication skills
Effective at networking and achieving targets
Strong technical writing skills, planning and organizing
Knowledge of fundamental business principals, including accounting concepts, budgeting, staffing, and general management
Proven understanding of industry practices, and regulatory trends pertaining to the testing of raw materials, biopharmaceuticals, and pharmaceuticals
Extensive knowledge of fundamentals of raw material, biopharmaceutical or pharmaceutical testing and associated cell culture techniques, methods and regulatory requirements
Solid understanding of manufacturing, applications and management in the biotechnology or biopharmaceutical or pharmaceutical fields
Strong proficiency in investigational skills for root cause analysis
RSRMS
What we offer:
With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Our Benefits -
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If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may **** from 8:00am to 5:30pm ET Monday through Friday, for assistance.
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

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