Christian Ruiz
Derwood,Md
Summary
Formulation development expert proficient in managing drug product operations with exceptional team supervision, project coordination, innovative thinking and analytical problem-solving skills. Optimizes resource use to achieve challenging targets. Diplomatic in resolving disputes and coordinating diverse teams.
Personable and results-driven professional with strong aptitude for strategic planning and organizational management. Knowledge of biological products, including lyophilized, spray-dried, liquid, coated micro-needles, frozen, liquid nanoparticles, and more. Experienced with various types of pharmaceutical product modalities such as recombinant proteins, vaccines, antibodies and small molecules. Extensive experience in executing and managing tech transfers across drug development stages, from early stage to commercialization. Successfully managed high-risk, high-value projects that require collaboration with external stakeholders such as CROs and CMOs as well as internal company functions. Eager to continue to make a positive impact in a new role.
Overview
18
18
years of professional experience
Work History
Director of Operations, Drug Product
Emergent BioSolutions
08.2023 - 07.2024
- Oversaw daily operations across multiple departments, ensuring seamless coordination and efficient execution of tasks.
- Monitored budget and utilized operational resources.
- Collaborated with senior management to develop and execute long-term corporate goals and objectives.
- Mentored and coached team members to foster productive and engaging work environment.
- Established strong partnerships with vendors, suppliers, and key stakeholders to improve collaboration and ensure alignment with business requirements.
- Contributed to talent acquisition efforts by participating in recruitment activities, identifying top candidates and facilitating smooth onboarding processes for over 10 hired employees.
- Designed GMP-amenable processes and documentation for drug product manufacturing for technical development plans to support various CDMO projects.
- Purchased, set up, managed and maintain processing equipment (mixers, lyophilizers, homogenizers, LNP processing equipment and more) and characterization equipment (particle size analyzers, thermal characterization instruments and more).
- Managed a $2M year long lab renovation project to improve operational flow: building two formulation processing labs, three characterization labs and one visual inspection lab
- Lead tech transfer operations to Emergent manufacturing sites: review batch records, serve as person-in-plant, communicate risks/gaps, oversaw implementation of revised processes, from compounding, sterile filtration, and fill/finish processing, and summarize results.
- Develop scale-down lab to support GMP manufacturing processes which saved millions of dollars by ensuring manufacturing suites were maximized for GMP activities.
- Lead two key projects to improve NARCAN Nasal Spray manufacturing process to improve product yield by saving >1 million doses per year.
- Developed and tested new formulations for NARCAN Nasal Spray to increase solubility/dosage (market potential to duplicate sales).
Senior Manager, Drug Product Development
Emergent BioSolutions
01.2017 - 08.2023
- Operations lead for drug product development team, overseeing technical plans, team schedule, work distribution, infrastructure development (building processing lab, bringing in new technology/equipment, implementing 6S into laboratories, and more).
- Technical lead for over 5 CDMO projects overseeing and managing the execution of process and product development activities for internal tech transfer into Emergent manufacturing sites.
- Lead the operational excellence team to streamline tech transfer processes representing the CDMO business unit (decreased tech transfer time by 50%).
- Lead the technical proposals for CDMO projects in formulation development work (biologics, small molecules, peptides, oncolytic virus, and other types of products).
- Principal Engineer (MS&T), May 2022- Dec 2022
- Brought in to introduce new product into facility (lipid nanoparticle, peptide mixture suspension using extruder).
- Championed interdisciplinary collaboration across departments, fostering innovation and creative problem-solving among colleagues.
- Successfully lead project from new equipment FAT, SAT, set-up in GMP manufacturing suite to completing engineering run and cleaning validation.
- In this role, worked independently and with teams to develop and trouble-shoot process issues, facilitating batch release and process improvements.
- Established best practices in design methodology, resulting in increased efficiency and consistency across projects.
- Evaluated vendor proposals for equipment procurement, selecting optimal options based on cost-effectiveness and performance criteria.
- Coordinated with multiple departments to effectively manage resources, schedules, and budgets during project execution.
- Mentored junior engineers in best practices for problem-solving, fostering professional growth and development within the team.
- Developed and executed the first CDMO drug product development project from proposal to closure stages which lead to more work requested from client, including Phase III GMP manufacturing bringing in over $5M in revenue.
- Trained in conflict resolution, decision making processes, talent management and improving team dynamics.
- Hired and trained 10 scientists with little to no industry experience to execute formulation development work as well as to manage projects.
- Oversaw the development, tech transfer and GMP manufacture of a frozen reference vaccine project for a Phase III vaccine (decreased failure rates of release testing by >20%).
- Provided strong leadership to enhance team productivity and morale.
- Led cross-functional teams to achieve project milestones and deliver high-quality results.
- Improved team performance by providing comprehensive training and fostering a collaborative work environment.
- Conducted performance evaluations, compensations and hiring to maintain appropriate staffing requirements.
- Consistently met or exceeded annual performance targets set by senior leadership.
Manager, Drug Product Development
Emergent BioSolutions
01.2016 - 01.2017
- Served as work package manager for various government contracts that required understanding of earned value management: budgeting, forecasting resources, developing project timelines, and timeline management.
- Performed and supervised technology transfers of small-scale vaccine manufacturing to CMOs for large scale production and fill-finish, which included leading weekly teleconferences.
- Managed and motivated employees to be productive and engaged in work.
- Wrote and reviewed reports, SOPs, and technical documentation for both internal and external quality systems.
- Established an operational and efficient formulation laboratory (from equipment set up, documentation and material control infrastructure that was compliant with both company SOPs and compliance policies).
Senior Scientist, Drug Product Development
Emergent BioSolutions
01.2014 - 12.2015
- Simultaneously managed several complex projects, meeting all pertinent milestones.
- Oversaw the development and subsequent validation of closure. leachables methods and glass vial delamination methods at a CRO.
- Lead project for the screening, selection and procurement of a new container closure system that would be suitable for a Phase III product.
- Lead various assay development and qualification experiments for Phase III product.
- Lead vaccine characterization efforts for IND submission.
- Traveled internationally to support a tech transfer of lyophilized and spray dried products for GMP manufacturing.
Scientist, Drug Product Development
Emergent BioSolutions
11.2012 - 12.2013
- Built infrastructure for formulating spray-dried and lyophilized vaccines at a larger scale (>500 g)
- Developed early phase characterization assays
- Lead a project to implement spray drying, foam drying, and lyophilization technologies in house
- Lead formulation efforts in adjuvant screening studies for drug development
Associate Scientist, Drug Product Development
Emergent BioSolutions
11.2011 - 11.2012
- Established an operational and efficient formulation laboratory
- Worked and patented technology (Temperature stable vaccine formulations, Patent number:10357559) for the stabilization of aluminum based lyophilized vaccine, which led to the company being awarded a $29M NIAID contract
- Maintained a safe and organized laboratory environment by adhering to best practices for chemical handling and waste disposal.
Senior Research Associate, Formulation
Intercell (formerly IOMAI)
06.2006 - 11.2011
- Helped lead efforts in the development of nanoparticle based transdermal vaccine adjuvant and a microneedle, transdermal technology.
- Worked on the development of a traveler’s diarrhea vaccine utilizing trans-cutaneous immunization (patch technology).
- Helped lead formulation and analytical assay development to support a Phase I clinical trial for clostridium difficile, alum- adjuvanted vaccine candidate.
- Leader in company’s Center of Excellence, a group that discovered, developed, and formulated vaccine candidate antigen proteins for trans-dermal delivery.
- Managed multiple projects simultaneously, ensuring timely completion and high-quality deliverables.
Education
Bachelor of Science - Biological Sciences
University of Maryland Baltimore County
Baltimore, MD12.2004
Bachelor of Science - English Literature
University of Maryland Baltimore County
Baltimore, MD12.2004
Skills
- Operational efficiency
- Operations oversight
- Strategic planning and execution
- Process improvement
- Leadership training
- Risk mitigation
- Resource allocation
- Teamwork and collaboration
- Team leadership
- Decision-making
- Employee development
- Hiring and onboarding
- Experienced with MS projects, Visio, MS Word, Excel, PowerPoint and JMP
Timeline
Director of Operations, Drug Product
Emergent BioSolutions
08.2023 - 07.2024
Senior Manager, Drug Product Development
Emergent BioSolutions
01.2017 - 08.2023
Manager, Drug Product Development
Emergent BioSolutions
01.2016 - 01.2017
Senior Scientist, Drug Product Development
Emergent BioSolutions
01.2014 - 12.2015
Scientist, Drug Product Development
Emergent BioSolutions
11.2012 - 12.2013
Associate Scientist, Drug Product Development
Emergent BioSolutions
11.2011 - 11.2012
Senior Research Associate, Formulation
Intercell (formerly IOMAI)
06.2006 - 11.2011
Bachelor of Science - Biological Sciences
University of Maryland Baltimore County
Bachelor of Science - English Literature
University of Maryland Baltimore County
Technical Expertise
Tg, Tcrystallization and other thermal characteristics by DSC (differential scanning calorimetry) for solid/lyophilized samples; Freeze-dry microscopy; Stereo microscopy, troubleshoot and maintenance of lyophilizers (bench-scale to manufacturing scale; Lyophilizer output (product and shelf temperature, pirani and capacitance monometer) data analysis; determination of protein melting point (tm) by DSC; homogenization, analysis and characterization of cell lysate for purification purposes; Extrusion for liquid nano-particle processing; Extractables/Leachables development process & toxicological risk assessment; ICP; GC-MS; LC-MS; Particle Size Analysis (PSD); Malvern Nano-sizer and Mastersizer; SDS-PAGE; Western Blot; Various cell-based assays; pH, conductivity; and more!
Awards
- Emergent BioSolutions’ Team Award-2013, For displaying excellent team player qualities during challenging engineering run series and helping to solve particle issue.
- Emergent BioSolutions’ Individual Excellence Award-2015 (Company’s top award of $15,000) for innovation and problem solving, For setting up dry formulation capabilities at Emergent, which led to various government funded projects (>30M)
- Emergent BioSolutions’ Achievement Award-2016 &2018, In 2016, for launching dry formulation project for key anthrax vaccine, In 2018, for helping to solve formulation issue in product (continuous improvement)
Technical Expertise
Tg, Tcrystallization and other thermal characteristics by DSC (differential scanning calorimetry) for solid/lyophilized samples; Freeze-dry microscopy; Stereo microscopy, troubleshoot and maintenance of lyophilizers (bench-scale to manufacturing scale; Lyophilizer output (product and shelf temperature, pirani and capacitance monometer) data analysis; determination of protein melting point (tm) by DSC; homogenization, analysis and characterization of cell lysate for purification purposes; Extrusion for liquid nano-particle processing; Extractables/Leachables development process & toxicological risk assessment; ICP; GC-MS; LC-MS; Particle Size Analysis (PSD); Malvern Nano-sizer and Mastersizer; SDS-PAGE; Western Blot; Various cell-based assays; pH, conductivity; and more!
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