C-Suite Safety Officer

Andre Lowe...

860-***-**** • Branford, CT • ******@***.*** • www.linkedin.com/in/andredlowe/

Senior Operations Leader who brings a high-impact combination of strategic leadership, operations management, and research skills to the development of programs for the scientific and healthcare sectors. Excels at building and integrating EHS programs across multiple sites while driving improvements in operations, workflows, and compliance. Strategic thinker with exceptional communications and interpersonal skills utilized to collaborate across levels and functions to gain buy-in and drive execution. C-suite influencer who held roles as Biosafety Officer and Chief Safety Officer in leading organizations.

Building Environmental, Health, and Safety Programs (EHS): Built comprehensive EHS programs from the ground up in multiple companies, introducing best practices across research operations to ensure safety, avoid exposure, and minimize risk for staff and the public while driving regulatory compliance.

Contributing to Scientific Discoveries: Leveraged expertise in the process of drug discovery, from inception through clinical trials and market launch, coupled with technical skills as bench scientist, to contribute to scientific discoveries that aided in the understanding and treatment of various diseases.

Executing Large Projects Cost Savings: Realized ~$3M in cost savings, delivering fully compliant BSL-2 lab five months ahead of schedule and $600K under budget and eliminating costly GSK worldwide real estate services by directly overseeing construction projects.

Ensuring Business Continuity: Avoided >$1M in losses by anticipating COVID-driven shortages in consumables and supplies, working with vendors and creating a strategic plan focused on storage capability and business continuity. Efforts were critical to successful launch of new drug projected to deliver $50M in annual revenue.

Positioning R&D Staff for Success: Developed competency-based EHS educational programs that ensured staff had the training, certifications, equipment, and resources required to perform. Built talent bench strength through coaching, mentoring, and a servant leadership style that empowered and drove retention and optimized operations. Leadership Strengths to Drive Improvements and Achieve Results

Strategic Planning

P&L Performance

Forecasting Budgeting

Capital Equipment

KPI Development

Environmental, Health, and Safety Programs: Biosafety, Chemical Safety, Site Security

Risk Management Occupational Health and Safety

Project Management Process Development

Operations Management Functional Leadership

C-Suite Relationships

Team Leadership

Diversity Advocate

Vendor Management

R&D Investments

Career Experience Strengthening Operations

and Programs in the Scientific and Healthcare Sectors VIIV HEALTHCARE ǀ GSK, Branford, CT 2019 – Present HEAD OF SITE OPERATIONS

Provide leadership to operations within the global specialist company in HIV care and subsidiary that generates ~45% of total revenue for the GlaxoSmithKline pharmaceutical enterprise. Broad role working directly with C-suite leaders on strategy and collaborating cross-functionally in overseeing multiple sites (labs and offices). Fiscal accountability includes P&L performance, forecasting, budgeting and $1M – $2M for capital equipment and project management. Onboard, train, and develop staff, ensuring sites have the talent required to maintain operations and that team members

(~60) have the skills and certifications required to effectively perform. EHS lead, emergency responder, and member of the IBC and Radiation Safety Committees. Member of the GSK Emerging Leaders Program.

Fortified operations, optimized workflows, and both enhanced and integrated EHS programs across multiple sites, driving efficiencies and improved safety performance.

Introduced a stringent competency-based training program for the BSL-2 enhanced lab that ensured staff was prepared to work independently and that reduced risk and resulted in zero occupational injuries and exposure.

Served as project manager for construction of new BSL-2 lab delivered ahead of schedule and $600,000 below budget.

Maintained ongoing operations and business continuity by implementing all COVID requirements, resulting in zero exposure. Recognized by C-suite for enabling continued work on HIV preventive medicine with double the number of candidates selected for clinical trials.

ADVANCING ORGANIZATIONAL MISSION THROUGH

STRATEGY DEVELOPMENT AND EXCELLENCE IN EXECUTION

Andre Lowe Page 2

Introduced management monitoring process that ensured compliance with requirements, including training, and compliance with SDS inventory, controlled substance, chemical inventory, lab inspections, and CAPA.

Partnered with Head of R&D in directly connecting adherence to safety guidelines to annual reviews and bonuses, reducing sharps injuries to nearly zero.

MEMORIAL SLOAN KETTERING, New York, NY 2018 – 2019 BIOSAFETY OFFICER ǀ EHS MANAGER

Joined the worldwide leader in cancer research to leverage extensive experience and create a world-class EHS program for BSL-1 and BSL-2 operations. Led, coached, and developed team of 12 and collaborated with facilities and scientific staff in ensuring biosafety and biosecurity regulations were met. Participated in emergency response drills.

Strengthened the EHS program, working closely with medical/technical professionals in creating protocols for chemical safety, radiation safety, and biosafety, and developing competency-based training to ensure compliance with all regulatory guidelines.

Expanded EHS coverage for the institution and hospital from 8 hours a day to 24/7 with introduction of second shift to enable emergency response (i.e., fire, life, or safety incidents) and business continuity.

Created an institution-wide biosafety program based on root cause analysis of lab and hospital inspection data that led to a 3X reduction in biological exposures and sharps injuries.

Collaborated with HR in development of a career ladder that clarified steps for progression within EHS and served as an incentive for retention.

As voting Biosafety Member of IACUC and IBC (performs safety assessment of research/clinical protocols and preregistration inspections) instituted program that ties private investigator’s research registration to lab inspections.

Recognized with the EHS Employee of the Year Award (2018). BOSTON UNIVERSITY, Boston, MA 2017

CHIEF SAFETY OFFICER, NATIONAL EMERGING INFECTIOUS DISEASES LABORATORIES (NEIDL) Recruited as Director of Research Safety and later selected as CSO to improve safety programs and reduce risk for the leading private research institution. Led, developed, and trained EH&S staff while overseeing multiple areas within the facility (BSL-2, BSL-3, BSL-4), representing organization during federal and city audits, and performing emergency responses drills. Served as Alternate Response Official (AR) and moderator for NTAC meetings for BSL-4 laboratory, participated in IACUC and IBC activities, and educated external entities and the public on NEIDL’s mission.

Instrumental to NEIDL attaining the Boston Public Health Commission (BPHC) BSL-4 permit pursued for 10 years, overcoming resistance, gaining local authority and Boston Public Official buy-in, and enabling lab to do research.

Created a more robust EHS program that demonstrated the ability to prevent exposure and release of biological agents and critical to positioning institution for successful independent risk assessment. Program included biosafety processes, SOPs, training, and QA standards for BSL-4 laboratory.

Built internal capability and drove retention by providing training, finding resources, collaborating with HR on updating role requirements, and positioning staff to complete NSF certifications.

Introduced protocols for surveillance to ensure public safety and prevent incidents and unlawful site entry. JACKSON LABORATORY, Farmington, CT 2016 – 2017

LAB MANAGER RESEARCH ASSISTANT

Hired to oversee operations, including biosafety, inventory management, and training, and to institute best practices for a newly created R&D cardiology lab within the independent, nonprofit biomedical research company.

Established laboratory research and safety workflows, creating S&OP, implementing technology, and contributing to scientific discoveries for the treatment of muscular hypertrophic cardiomyopathy.

Developed and implemented QA standards ensuring compliance with requirements and consistent results.

Bench work included iPS cell culture and differentiation for cardiomyocytes to assess genetic markers of muscular hypertrophic cardiomyopathy; molecular assays performed for protein solubilization via RIPA, Western Blotting for protein expression, RNA Seq for transcriptome analysis, and loss and gain of function via CRISPR. US Department of Agriculture (USDA), Orient Point, NY 2011 – 2016 MICROBIOLOGIST

Served in the capacity of Biosafety Officer for the federal agency’s BSL-3 lab with a focus on reagent production for serology and molecular biology assays, assay development, animal handling, and inoculation. Operations role that included inventory optimization, project management, and initiatives to raise awareness of foreign animal disease. Andre Lowe Page 3

Quickly became a subject matter expert on the propagation of CSF (classical swine fever), creating a testing method for detecting flu/fever for the industry and materials to train veterinarians in identifying infected animals.

Trained internal and external partners on ABC ELISA, CSF virus propagation, cell culture, virus titration, and monoclonal antibody production, expanding awareness of infectious disease.

Key participant in furthering the advancement, understanding, and treatment of foreign animal diseases, such as ASF, CSF, and FMD infections, by ensuring the quality and timely delivery of products (reagents for assay development, vaccine development, diagnostic testing, and veterinary disease demonstrations).

Increased number of diverse candidates applying for open positions as member of the Diversity Advocacy Committee leading or participating in programs at local high schools, including chemistry demonstrations.

Improved internal customer service by implementing survey and taking action on issues impacting satisfaction. PFIZER PHARMACEUTICALS, Groton, CT 2007 – 2011

SENIOR RESEARCH ASSOCIATE II

Hired as preclinical scientist to help mitigate potential losses from patent exclusivity rights for product generating $15M in revenue for the premier biopharmaceutical company. Role included preclinical research, scientific writing, and collaboration with project teams on analysis and presentation of data.

Preclinical Scientist in the discovery of candidate compounds for diabetes and obesity treatment with little or no side effects, contributing to scientific breakthroughs for the treatment of the disease. The new drug was one of fastest developed in Pfizer history (from inception to market) and resulted in numerous publications and a US Patent.

Revised laboratory protocols to facilitate recreation of experiments and consistency of results.

Scientific bench work included running and optimizing kinetics binding experiments, transport assay using robotics and radioactivity, membrane preparation, and running dose response in vitro assay, sandwich ELISA, cell line development and characterization via cloning, western blotting, and time course studies. Additional Experience

MANNKIND CORPORATION, Danbury, CT: Quality Control (QC) Associate

Established the company’s QC program for microbiology testing on raw materials, authoring SOPs, creating logbooks, and both validating and training team on equipment (i.e., Vitek, Biolog).

Served as Supervisor building lab staff capability through training and ensuring raw materials used for a highly competitive inhalable insulin product with potential financial impact met USP and European standards. CENTER FOR DISEASE CONTROL (CDC), Los Angeles, CA: Molecular Biologist

Performed bioterrorism agent clinical specimen testing in the aftermath of the 9/11 terrorist attack in the US.

Developed a QC testing process to increase confidence in results and reduce notification times in the event of a terrorist attack. Created a protocol for environmental sampling for the molecular biology lab.

Developed an internal monitoring program to minimize cross-contamination and false positive results. Education and Additional Qualifications

MBA, Operations and Executive Leadership

Quantic School of Business and Technology, Washington, DC MS, Biology, New York University, New York, NY

BS, Major: Biology, Minor: Math and Chemistry, cum laude Johnson C. Smith University, Charlotte, NC

Highlights of Professional Affiliations: American Biological Safety Association – ABSA (2017 – Present); Alpha Phi Alpha Fraternity, Inc (1999 – Present); Boston Biosafety Committee (2021); Board Member and Webmaster, New England Biological Safety Association – NEBSA (2021); Alpha Lambda Delta Honor Society, Beta Kappa Chi Honor Society, and Participant in Sigma Xi Research Forum (four years)

Technology and Software: Mattrack, GCManager, Sights, GraphPad Prism literate, Vector NTI, XLDA, Bioloader, RGate, NCBI, UCSC, Vector NTI, Genome Portal, SIGHTS, Microsoft Office, Microsoft ARIBA/CERPs, eLNB, SAP, Microsoft Teams, Zoom, Skype, Biomek, Envision, SpectraMax, IT switches/servers, Thermo Smart-Vue

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