Ahmad Khodabocus
Glen Allen,USA
Summary
Professional with 20+ years’ experience in the drug substance CMC space. Expertise ranging from route scouting to process validation and commercial manufacturing.
Overview
22
22
years of professional experience
1
1
Certification
Work History
Director, Process Chemistry
Phlow Corp.
05.2021 - 06.2024
- Manage R&D development partners to ensure a scalable, cost-competitive manufacturing process is developed on time, on budget and ready for technology transfer to manufacturing partners
- Manage manufacturing partners to ensure that manufacturing processes are successfully validated, and product manufactured on time and on budget
- Review, author and approve manufacturing process documentation such as process development protocols and reports, batch records, validation protocols and reports, specifications, etc
- Contribute to the timely and accurate preparation of regulatory submissions
- Developed high-performing teams by providing mentorship, guidance, and opportunities for professional growth.
- Assisted in recruiting, hiring and training of team members.
- Facilitated cross-functional collaboration for improved decision-making processes within the organization.
- Strengthened internal controls by reviewing existing policies and procedures, ensuring compliance with regulatory requirements.
Senior Research and Development Chemist/Engineer
AdvanSix Inc.
12.2019 - 05.2021
- Development of scalable routes for high value fine chemicals
- Technical assessment of fertilizer products as needed
- Process improvement of AdvanSix products
Process Development Manager / Principal Scientist
AstaGreen/TCG Chem.
05.2018 - 11.2019
- Development of scalable flow process for the manufacture of life-saving HIV drugs
- Tech Transfers for scale up
Associate Director of Process Research and Development
AMPAC Fine Chemicals
03.2017 - 02.2018
- Managed the complete setup of a process development lab
- Developed a coherent strategy for starting up the AMPAC VA site in collaboration with other team members
- Evaluated technology transfers to ensure proper fit into the site capability
- Performed process development activities for external customers: developed scalable processes to the manufacture of a nutritional supplement
- Provided technical support for production and performed troubleshooting work as needed
- Participated in the timely closure of investigations as needed
- Mentored one direct report associate
Senior Research Scientist II (Associate Director)
Gilead Alberta ULC
12.2013 - 03.2017
- Developed/optimized chemical processes for the commercial manufacturing of drug substances
- Managed CMO compliance through supporting site visits/oversight
- Provided technical oversight to commercial API production activities at GAU and CMOs Ensured analytical results are trended and reviewed, and all deviations/OOTs’/OOSs’ are investigated promptly and properly
- Managed a process engineering group mandated with the task of developing sound approach to the understanding of process issues
- Led cross functional investigation teams as needed
- Participated in hiring process and brought the best talent available on board
- Provided project updates to senior management as needed
- Led a team tasked with developing a framework for and the implementation of Continuous Process Verification (CPV) for all commercial APIs
Process Chemist / Production Engineer III
Boehringer Ingelheim Chemicals
11.2004 - 06.2013
- Provided technical support for routine production and introduction of new products
- Investigated deviations (process deviations, product out of specifications, etc.)
- Generated and assisted in completion of corrective and preventive actions (CAPAs)
- Monitored key performance indicators such as quality, yield and cycle times and use statistical tools for the purpose of data trending with a view to tracking product quality and increasing yields and improving cycle times
- Initiated, followed up and closed change controls for various tech transfer projects, as well as small projects to improve yield and/or reduce manufacturing costs
- Wrote and revised production documents such as SOPs, batch records, set ups and investigation reports as needed
- Managed tech transfers and fitted new processes into production equipment as needed
- Trained operations personnel on new procedures/revisions
- Participated in process hazard analysis and address safety issues
- Analyzed data trends from daily operations reports, identifying areas where efficiencies could be improved upon.
- Performed root cause analysis and implemented corrective actions.
- Streamlined workflows to reduce bottlenecks and improve overall productivity rates.
- Proven ability to learn quickly and adapt to new situations.
- Worked well in a team setting, providing support and guidance.
- Used critical thinking to break down problems, evaluate solutions and make decisions.
- Developed and maintained courteous and effective working relationships.
- Maintained detailed documentation on experimental procedures, results, and observations for accurate record-keeping and future reference.
- Collaborated with cross-functional teams to solve process-related issues, ensuring timely resolution and minimal production downtime.
- Optimized chemical processes by designing and executing experiments to improve product quality and efficiency.
- Utilized analytical instruments such as HPLC, GC-MS, and NMR spectroscopy in the characterization of reaction products to ensure purity and consistency across batches.
- Led scale-up efforts from lab trials to full-scale production, ensuring seamless transitions while maintaining product integrity.
- Mentored junior chemists, providing guidance on industry best practices and career development opportunities.
Postdoctoral Associate
Boehringer Ingelheim Pharmaceuticals
04.2002 - 11.2004
- Developed a scalable process for a low temperature boronation and Suzuki cross coupling
- Developed an alternative high temperature boronation potentially scalable process for above
- Created a robust process for the preparation of a key quinolone fragment of API
- Scouted and developed a new scalable route to Nucleoside intermediate
- Developed a scalable new route to key API intermediate involving ligandless Heck coupling
Education
B.Sc. - Chemistry (First Class Honors)
University of Manchester
Ph.D. - Organic Chemistry: Thesis entitled ‘Synthetic approaches to the AB rings of Forskolin’.
University of Manchester
Skills
- Strategic Planning
- Verbal and written communication
- People Management
- Operations Management
Affiliations
American Chemical Society, 2003
Valueproposition
- Route scouting and optimization of med chem route.
- Route development by QbD approach, identification of CPPs by FMEA, establishment of PARs and NORs.
- Development of control strategy for impurity profile.
- Proper specification setting based on fate and purge studies.
- Scale up from lab to plant.
- CGMP, Compliance and ICH guidelines expertise.
- Technology transfer from lab to plant; technology transfer between manufacturing sites.
- Deviation investigations and root cause analysis.
- CAPAs implementation and effectiveness check.
- Crystallization and filtration expertise: optimization of crystallization parameters to optimize filtration.
- Particle size engineering by process and engineering control.
- Process validation: validation protocol to validation report.
Publicationsandpatents
Several peer reviewed papers and patents.
Scholarshipsandawards
- Commonwealth Scholarship.
- Woodiwis Scholarship (Best student of the year).
- Duncan Campbell post graduate Research Scholarship.
- ORS Award (Ministry of Overseas Development; UK).
References
Available upon request.
Personal Information
Citizenship: USA
Accomplishments
- Supervised team of 3-6 staff members at Boehringer Ingelheim Chemicals and Gilead.
- Led a team of three in the development of Continuous Process Verification at Gilead.
- Addressed a production issue through effectively helping with driving a robust solution through a QbD approach.
- Successfully led a complex technology transfer and completed on time and budget.
- Led the development of a robust process to control PSD for a new API.
- Successfully developed a team of chemists and engineers tasked with process development.
Certification
- Six Sigma Green Belt, Boehringer Ingelheim Chemicals, June, 2010
Languages
French
Full Professional
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Work Preference
Work Type
Full TimeWork Location
RemoteHybridImportant To Me
Work-life balanceCompany CultureWork from home optionTimeline
Director, Process Chemistry
Phlow Corp.
05.2021 - 06.2024
Senior Research and Development Chemist/Engineer
AdvanSix Inc.
12.2019 - 05.2021
Process Development Manager / Principal Scientist
AstaGreen/TCG Chem.
05.2018 - 11.2019
Associate Director of Process Research and Development
AMPAC Fine Chemicals
03.2017 - 02.2018
Senior Research Scientist II (Associate Director)
Gilead Alberta ULC
12.2013 - 03.2017
Process Chemist / Production Engineer III
Boehringer Ingelheim Chemicals
11.2004 - 06.2013
Postdoctoral Associate
Boehringer Ingelheim Pharmaceuticals
04.2002 - 11.2004
Ph.D. - Organic Chemistry: Thesis entitled ‘Synthetic approaches to the AB rings of Forskolin’.
University of Manchester
B.Sc. - Chemistry (First Class Honors)
University of Manchester
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