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R&D Operations Manager

Thousand Oaks, CA
Top 3 Must Have Skill Sets:    

Scientific training in large molecule and ADA (Anti-Drug Antibodies) analysis
Supplier management experience. shows oversight of supplier
Excellent Communication and Problem solving skills.

Description:

Expectation 100% remote.

***Ideal candidate PHD and MBA with scientific background. REally needs to have Strong knowledge of ADA (Anti-Drug Antibodies) and Large Molecule bioanalysis and have previous experience with CRO management.

The Manager, R&D Supplier Performance Management is responsible for oversight of outsourced work related to anti-drug antibodies and large molecule bioanalysis. The successful candidate will work as part of a cross-functional team to evaluate, qualify, onboard, and manage Contract Research Organizations conducting research on behalf. This role will help plan and coordinate method transfers, clinical study sample analysis, and manage the associated contracting and budget analytics across multiple programs & studies. The Manager will work as part of a cross-functional team that includes internal scientists, contract operations support staff, and budget leads. He/she will participate in team meetings, ensure correct collection and reporting of KPIs/metrics, manage escalations, and provide forecasting to ensure our ability to support the pipeline. The Manager will assist in developing & executing efficient supplier and expense management strategies while finding opportunities to align, improve and re-design processes and tools. In addition, they will participate in R&D-wide strategic initiatives to improve operational efficiency and enable the organizational vision to be achieved.
The successful candidate will have strong working knowledge of ADA and Large Molecule bioanalysis and have previous experience with CRO management.
As a creative problem solver who can deliver meaningful results, this role will focus on:
• Developing strong collaborative relationships with internal partners to support and proactively respond to business needs.
• Maintaining oversight of a global pool of suppliers and finding innovative solutions that provide the right mix of quality, agility, and value.
• Elevating the strategic values of supplier relationships by optimizing the mix, volume, and type of work packages.
• Executing fit for purpose portfolio and expense management strategies to support planning, tracking and reporting.
• Leading supplier evaluation, qualification, & remediation teams
• Assist in replying to RTQs from regulatory agencies
• Ensure regulatory inspection readiness and participate in audits
• Collaborating cross-functionally to develop and track appropriate supplier performance metrics
• Managing supplier contract deliverables within the categories assigned.
• Collaborating with Global Strategic Sourcing on outsourcing and contract terms development, and the financial management of contracts throughout the life cycle of the study.
• Developing and maintaining data visualization tools to ensure transparency of budget and timelines
• Participating in establishing departmental and cross-functional policies and procedures.
• Assisting functional stakeholders in resolving issues relating to contract negotiation or management.
• Managing study level supplier relationships in conjunction with other corporate functions.
• Working with internal customers in supplier scope of work development (request for proposal creation and analysis, depending on thresholds)
• Leading contract life cycle management process related to various supplier agreements

Basic Qualifications
Doctorate degree and 2 years of biotech/pharma-related business operations/supplier management experience
OR
Master’s degree and 4 years of biotech/pharma-related business operations/supplier management experience
OR
Bachelor’s degree and 6 years of biotech/pharma-related business operations/supplier management experience
AND
2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources


Preferred Qualifications
· Degree in biology, life sciences, health, medical or clinical sciences along with additional education in finance or business.
· Strong background in ADA and/or Bioanalysis
· Experience in outsourcing, CRO management, and clinical study support
· Experienced “integrator” role across multiple organizations, teams and processes with proven ability to advance strategic imperatives.
· Familiarity with procurement compliance requirements (Sunshine Act, SOX, etc).
· Familiarity with multiple sourcing models (Fee-for-service, dedicated resource, functional service provider).
· Finance and budget management experience including cost analysis and reporting.
· Proven ability to effectively implement strategies and deliver results.
· Proven experience as a change agent and managing through organizational transformation.
· Exceptional interpersonal, organizational, critical thinking and verbal/written communication skills.
· Proven ability to develop collaborative internal and external relationships and navigating matrixed organizations.
· Being able to adapt work and communication styles to meet organization needs.
· Strong planning and project management skills with the demonstrated ability to work effectively in a fast-paced environment with multiple high priority projects.
· Strong data analytics skills with experience in analytics software, (eg. Spotfire, Tableau, Smartsheet) as well as experience with document management applications (eg. Veeva), and portfolio planning tools and financial systems (eg. Planisware, SAP, MS Projects)


"This posting is for Contingent Worker, not an FTE"
 

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