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Manager Analytical Operations

Brookfield

Qualifications
Education
Benefits
Special Commitments

CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.

With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions.

We are committed to creating a diverse and inclusive workplace environment. An environment where colleagues can fulfill their career aspirations, realize their potential, and use their unique perspectives and experiences to make a difference in a world that needs solutions to rare and serious disease.

The Role

Could you be our next Manager of Analytical Operations ? This position is located in our Pasadena California office. You will report to the Associate Director, Gene Therapy Bioanalytical Sciences.

The Manager of Analytical Operations position grows analytical systems and compliant processes to support conduct of Phase 1/2 clinical trials and Research & Development. This is a visible and dynamic position requiring and facilitation skills to in a matrix/team-based organization.

You will be responsible for management of analytical operations within the Gene Therapy Bioanalytical Sciences group. You will maintain laboratory testing capabilities and establish analytical processes and logistics suitable for Release Testing and Characterization of Cell and Gene Therapy products.

You will be the department's point person in collaboration with multiple onsite functions. You will adapt global LIMS systems and oversee incorporation into established laboratory workflows. You will work with Quality Assurance to ensure adherence to GXP and company policies. You will coordinate with scientists, Validation, and Technical/Engineering Operations to maintain laboratory operations. The ability to establish and implement procedures, to coordinate personnel, and to build risk mitigation strategies into analytical operations is necessary.

Your skills and experience

Develop and implement systems to support sample/consumable management and routine testing. Establish electronic inventory management and barcoding systems.

Support GXP compliance and audit readiness. Partner with Quality Assurance. Conduct lab investigations, OOS/OOE studies and deviations, implement CAPA and initiate and review change control documentation and other QC investigations.

Maintain laboratory functionality. Coordinate with Technical/Engineering Operations, Validation, and Information & Technology. Oversee instrument procurement, installation, validation, and maintenance.

The expected base salary range for this position at hiring is $110,000 - $150,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity. 

REQUIREMENT

BS. in a Biomedical discipline

At least 5 years' experience in a regulated testing laboratory at an Academic Research Institution or Biotechnology company.

Experience developing procedures for analytical testing, sample management, assay performance tracking, and equipment usage.

Experience authoring SOPs and work instructions.

Working knowledge of GMP/GLP and quality control principles.

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

We want CSL to reflect the world around us

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

Do work that matters at CSL Behring!

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Confirmed 21 hours ago. Posted 30+ days ago.

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