Biosample Operations Specialist IV
150 Clove Rd Little Falls, NJ 07424
Bayside Solutions is seeking a Biosample Operations Specialist IV to be part of our client’ s team in New Jersey, Little Falls. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Biosample Operations Specialist IV
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Drives alignment of study and project level strategies within the overarching therapeutic area strategy for biosamples, through close partnership with the Biosample Therapeutic Area Leaders (BTALs), service providers (including lab vendors) and DTA stakeholders
- Is responsible for the delivery and implementation of the biosample strategy within multiple clinical programmes in accordance with the requirements of quality, ethical and regulatory standards including ICH/GCP/GLP
- Ensures project level consistency for biosampling across studies and is the primary point of contact within Biosample Operations for project, clinical and study teams
- Delivers expert input on strategic direction and operational considerations for Biomarker sampling to project and study teams
- Leads or contributes to innovation and continuous improvement activities in the area of biosample collection, processing and data delivery
- To provide operational expertise to ensure the successful implementation of the biosample strategy for a given molecule or clinical programme? To ensure the appropriate level of sample quality, defining corrective actions if necessary, and acting as a point of escalation for issues at the study and project levels
- To implement the biosample sourcing strategy within given projects through partnership with the BTAL and other key stakeholders involved in project and study delivery
- To be accountable for project level oversight (from feasibility to study close) of laboratories/vendors and associated costs involved in biosampling activities and analyses. Provides input to the laboratory selection process to ensure appropriate vendor selection where applicable
- Leads cross-functional operations team meetings as required to ensure optimal delivery of project biosampling objectives
- To actively promote knowledge sharing within Clinical Operations and across studies within a project by partnering with stakeholders.
- To be accountable for the accurate and timely forecasting and management of individual project and study variable costs related to bio-sampling, in collaboration with key stakeholders
- To provide regular project/study level biosample status updates to key stakeholders as required.
- To act as a subject matter expert within the Clinical Operations for specific business related topics or processes
- To contribute to, and occasionally lead, functional process and system improvements to ensure operational excellence
- Mentor others as required to maximise their capability and contribution to deliver high quality biosamples
- Partner with cross functional parties and external vendors to communicate and train on relevant processes which underpin the laboratory operating model
- To contribute to a positive and motivating work environment that encourages mutual respect, innovation and accountability at all levels through role modelling values of courage, passion and integrity
- Ensures implementation of the ethical and legal framework for biosampling
Summary of Qualifications:
- Life Sciences degree or higher qualification
- Excellent written and spoken English.
- Willingness to travel internationally and work cross-culturally
- Significant experience implementing clinical trials - required
- Extensive experience in leading and managing biosample operational activities on a range of logistically complex multi-centre clinical studies, - preferred
- Demonstrated knowledge of ICH GCP
- Clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples
- Demonstrated leadership skills
- Proven ability to successfully achieve results within a multi-cultural and geographically diverse matrix environment
- Proven ability to influence effectively and confidently within a matrix environment
- Knowledge of legal and regulatory environment related to human specimen collection, analysis and retention
- High Performance Competencies
- Effective communication skills
- Ability to lead and work across a global matrix team and stakeholder environment
- Ability to work independently and manage multiple competing priorities
- Effective strategic agility
- Ability wo work with internal and external partners