Director, Bioanalytical Operations
Company: Eurofins Scientific
Location: Saint Charles
Posted on: February 25, 2021
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Job Description:
Eurofins Scientific is an international life sciences company,
providing a unique range of analytical testing services to clients
across multiple industries, to make life and our environment safer,
healthier and more sustainable. From the food you eat, to the water
you drink, to the medicines you rely on, Eurofins works with the
biggest companies in the world to ensure the products they supply
are safe, their ingredients are authentic and labelling is
accurate.Eurofins believes it is a global leader in food,
environmental, pharmaceutical and cosmetics products testing and in
agroscience CRO services. It is also one of the global independent
market leaders in certain testing and laboratory services for
genomics, discovery pharmacology, forensics, CDMO, advanced
material sciences and in the support of clinical studies. In over
just 30 years, Eurofins has grown from one laboratory in Nantes,
France to over 47,000 staff across a network of more than 900
independent companies in over 50 countries and operating more than
800 laboratories. Eurofins offers a portfolio of over 200,000
analytical methods to evaluate the safety, identity, composition,
authenticity, origin, traceability and purity of biological
substances and products, as well as providing innovative clinical
diagnostic testing services, as one of the leading global emerging
players in specialised clinical diagnostics testing. --In 2019,
Eurofins generatedtotal revenues of EUR --- 4.56 billion, and has
been among the best performing stocks in Europe over the past 20
years. Job Description Eurofins BioPharma Services Services, US is
searching for a--Director, Bioanalytical Services in St. Charles,
MO. The Director, Bioanalytical Operations is responsible for
ensuring contract services are delivered to clients according to
internal standard operating procedures and current industry
standards. This position is responsible for managing scientific
staff and supporting lab operations while driving scheduling of
Sample Analysis, QC Review, and Technical Writing activities to
meet timelines, revenue and profit plans. Essential Duties and
Responsibilities: Sample & Reagent Management, Sample Analysis, QC
Review, and Report Writing teams to ensure on-time delivery of
services according to internal and external customers program needs
Manages Facilities & Metrology department according internal SOP
and current industry/regulatory standards.-- Manages team to ensure
that service quality is maintained and in line with current SOPs
and regulatory needs, as appropriate Drive schedules that meet
client projects, planned revenue, and profit targets Responsible
for data review, analysis review, and ensuring accuracy and
integrity of data reporting Responsible for critical reagent
oversight, scheduling, inventory, and forecasting Tracks and
reports the following KPIs: Analysis Utilization rates, Sample and
Plate passing rates, Peer review documentation accuracy rates
Provides scientific guidance that supports technical writing
Provides guidance and oversight for compliance and scientific
integrity of the studies to ensure that studies are performed in a
compliant manner Serves as Principal Investigator or Lead Scientist
as needed Responsible for the data developed by the department to
ensure compliance with study requirements, accuracy and consistency
and compliance with the regulatory requirements Plans and
coordinates the daily service operational activities with the
appropriate staff and related operations/activities as needed
ensuring that work is scheduled and completed to deliver data and
reports to clients in a timely manner in compliance with
regulations and the Company's quality system Understands and
follows all procedures and processes required for work performed
under Regulatory Compliance (i.e. GxP, FDA/GLP and GCP, OECD, CLIA,
etc.) and attends annual GLP training Directs investigations of
service operations, such as deviation reports, non-conforming
reports, corrective action reports, etc.; produces documentation
according to established standards Reviews and approves operations
documents to assure consistency with regulatory standards and
requirements. (i.e. SOPs, batch records, training records, etc.)
Develops process improvements to drive efficiency gains while
maintaining highest quality levels Mentors and develops employees
through objectives and performance management Manages team to
ensure provision of a high level of customer and technical service
support for all services Facilitates flexibility within team to
meet shifting business needs Develops new ideas for new services
offerings Contributes to tactical and strategic marketing practices
for site services Implants and nurtures the corporate values within
the department and guarantee commitment to these by all team
members Provides technical input to business development activities
and in support of client relationships, as required Conducts all
activities in a safe and efficient manner Demonstrates and promotes
the company vision Strong understanding and practice of project
management skills Regular attendance and punctuality with ability
to work overtime to accommodate business need High work ethic
Knowledge of laboratory EHS practices and requirements for
biologicals and chemicals Applies GMP/GLP in all areas of
responsibility, as appropriate and understands and follows all
written procedures that apply to the function of the position
Position is full-time, Monday-Friday, 8:30 a.m.-5 p.m., with
overtime as needed. Candidates currently living within a commutable
distance of St. Charles, MO--are encouraged to apply. As a Eurofins
employee, you will become part of a company that has received
national recognition as a great place to work. We offer excellent
full-time benefits including comprehensive medical coverage, life
and disability insurance, 401(k) with company match, paid holidays,
paid time off, and dental and vision options. Master's Degree or
higher, 5 years in lab operations management/supervisory role,
Ligand Binding Assay experience Scientific method development and
validation of large molecules/biologics for pharma drug development
Project management of complex projects Direct client communication
and interaction Contract terms and implications Scientific
personnel and lab management of at least 5 employees Process
excellence Bioanalytical or CMO experience a plus Authorization to
work in the United States indefinitely without restriction or
sponsorship Additional Information Eurofins is a M/F, Disabled, and
Veteran Equal Employment Opportunity and Affirmative Action
employer. Other jobs at Eurofins USA BioPharma Services
Keywords: Eurofins Scientific, Rochester , Director, Bioanalytical Operations, Executive , Saint Charles, Minnesota
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