Senior Laboratory Scientist
4300 Hacienda Dr Pleasanton, CA 94588
Bayside Solutions is seeking a Senior Laboratory Scientist to be part of our client’ s team in the Tri Valley. 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
Sr. Lab Scientist
- 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:
- Oversees the laboratory services and management operations of designated laboratory areas, including lab user orientations, authorization of use, access, general supply replenishment, equipment, cleaning, & maintenance, regulatory compliance (documentation, managing non-conformances) and support of lab safety policies.
- This role serves as a key contact person for information and inquiries regarding lab areas, including during internal and external audits from regulatory agencies
- Trains and documents orientations for new lab users on laboratory organization, workflows, quality system compliance, and safety requirements.
- Manages lab documentation to ensure quality, safety and departmental compliance.
- Addresses laboratory organization/waste/cleanliness issues with laboratory users to ensure compliance.
- Enforces safety and other required laboratory practices with professionalism. Has independent authority to deny lab users room access, impose re-orientation, and contact the user' s supervisor as necessary.
- Conducts quarterly internal lab audit-preparedness inspections.
- Responsible for conducting investigations and problem solving for CAPAs, Non-conformance, and audit observations based on experience, knowledge, and good judgement
- Responsible for the overall management of departmental laboratory equipment/instrumentation requiring calibration, maintenance and/or validation.
- Responsible for freezer alarm response and impact investigations, and related inputs into electronic data systems.
- Responsible for conducting investigations, root cause analysis, impact assessments needed for Quality Analysis Reports (QARs).
- Responsible for generating equipment related QARs. Partners directly with Quality, Calibration, and Facilities to resolve these non-conformances.
- Follows and leverages equipment/instrumentation and calibration standard operating procedures (SOPs) to ensure Quality System compliance and resolve problems.
- Partners with owning department scientific staff, and cross-functionally with Subject Matter Experts in the Calibration/Systems Support groups, Facilities, and Validation Department to ensure timely installation and operation of new/existing equipment.
- Coordinates equipment/instrumentation calibration, certification, relocation and repair.
- Serves as the Equipment Owner of non-client branded equipment. Responsible for maintaining data in the asset management system regarding asset induction, relocation, decommission, and disposal of departmental equipment/instrumentation.
- Partners with department scientific staff and cross-functionally with Subject Matter Experts in Calibration/Facilities to ensure minimal impact to Development project teams during installation, calibration and validation of new non-client branded equipment.
- Responsible for maintaining data in the Calibration Management System regarding asset induction, relocation, decommission, and disposal of non-client branded departmental equipment/instrumentation.
- Reviews and ensures equipment/instrumentation documentation (log sheets, chart recorders) is compliant with Good Documentation Practices. Resolves documentation issues with equipment users.
- Interacts with senior or designated personnel from other departments on significant matters requiring coordination between departments/organizations. May represent the department on established cross-functional teams/projects impacting Development (e.g., Quality issues, Facility building construction/remodeling/major upgrades).
- Generate and manage monthly newsletter
- Manage and coordinate Lab training and ensure credit in Cornerstone.
- Lead freezer management program for sequencing reagents and kit storage.
- Includes but not limited to other tasks and duties per business needs.
Summary of Qualifications:
- Minimum: 3-5 years of relevant industry experience. Preferred: 6-8 years of experience working in an IVD GLP/ISO regulated laboratory environment.
- Experience in audits, knowledgeable in requirements and controls for IVD product development lab, (e.g. ISO 13485, GLP, GDP) or similar regulated lab environment
- Understanding of laboratory workflows used in next generation sequencing, proficiency in standard molecular biology techniques, prior hands-on experience as a lab user in these areas desired
- Experience in research, laboratory automation, product development, design quality, quality systems, Core Labs, as an NGS product customer/user, and/or other life science industries also preferred
- Previous lab management / lab supervisor / lab owner experience desired
- Experience in stakeholder management / communications
- Possesses excellent people skills with ability to build effective internal/cross-functional relationships.
- Demonstrated experience in a regulated environment, with diligent attention to detail to ensure laboratory areas meet regulatory, safety and departmental requirements.
- Comfortable using of both Google and Microsoft Office environments for maintaining spreadsheets, creating presentations, writing reports.
- Demonstrated problem solving skills (e.g. root cause analysis, process improvements)
- Demonstrated ability to make independent decisions, and apply good judgement
- Ability to learn and follow routine procedures independently as well as part of a team.
- Comfort and flexibility in a work environment with changing business needs and direction.
- Ability to build and maintain positive working relationships with team members, lab users, and stakeholders
- Demonstrated excellent written communication and public speaking skills, and a professional customer-service oriented mindset.