Premkumar Jangam
Sykesville,MD
Summary
Results-driven Supply Chain Leader experienced in Clinical Trial Management and Clinical Operations. Enhanced pharmaceutical supply chain logistics through process streamlining, achieving a 6% improvement in On-Time In-Full (OTIF) delivery and a 14% reduction in cost per shipment across a $300 million transportation network. Directed a team of over 65 logistics professionals, strengthening cross-border operations between U.S. and Canada and reducing customs delays by 30%.
Overview
26
26
years of professional experience
Work History
Senior Manager, Clinical supply operations Lead
CenExel Clinical Research
Gaithersburg, Maryland
01.2023 - Current
- Directed clinical trial operations, ensuring adherence to regulatory standards and enhancing overall compliance.
- Oversaw budget management and resource allocation for multiple clinical studies.
- Managed team of 10+ employees, providing guidance, setting goals, delegating tasks, and monitoring performance to drive project success.
- Collaborated with cross-functional teams to streamline project workflows and timelines.
- Managed annual budgeting process, including forecasting and financial analysis to optimize resources.
- Streamlined daily operations in clinical trial workflows, improving process efficiency and effectiveness.
- Oversaw inventory management and supply chain logistics for studies.
Director of supply Chain operations (CMC)
Foresee Pharmaceuticals
Delaware City, Delaware
11.2021 - 11.2022
- Engineered supply chain strategies to boost operational efficiency.
- Established logistics solutions that enhanced distribution channels.
- Collaborated with vendors to uphold quality standards and ensure compliance requirements.
- Facilitated team meetings to address supply chain challenges and propose actionable solutions.
- Negotiated contracts with third party providers such as freight forwarders or customs brokers.
- established KPIs to evaluate effectiveness of the organization's supply chain operations.
- Directed logistics operations, including warehousing and transportation, to enhance distribution efficiency.
- Managed cross-border logistics, ensuring customs compliance and adhering to international shipping regulations.
Senior Manager, Clinical Operations
Headlands Research
Houston, Texas
08.2020 - 11.2021
- Utilized Interactive Response Technology (IRT) systems for randomization of clinical trials, specifically with Signiant Health, to enhance trial efficiency.
- Successfully led complex projects focusing on clinical studies, ensuring they met budget, timeline, and quality expectations
- Created and updated Standard Operating Procedures (SOPs) for clinical supplies, ensuring compliance and consistency in operations.
- Ensured compliance with relevant policies, procedures, and international regulations, such as those from FDA, WHO, and ICH.
- Built strong relationships with clients and stakeholders, ensuring effective communication and collaboration.
- Established distribution network for investigational drug products across Headland’s research sites, facilitating timely access to materials.
Director of Global Distribution
Takeda Pharmaceuticals
Frederick, Maryland
01.2011 - 08.2019
- Led team to meet project timelines, ensuring timely completion of deliverables for investigational drug products.
- Oversaw global supply operations for clinical studies, managing team of over 10 to facilitate successful drug product distribution in North America, Latin America, and Europe.
- Extensive experience in Cold chain management and handling 3P logistics
- Directed daily operations, ensuring compliance with laws and regulations.
- Developed policies and procedures to ensure compliance with corporate standards.
- Managed budgeting and financial planning processes for the organization.
- Negotiated agreements with external partners such as contractors or consultants.
Director of Investigational Drug Repository
EMINENT Bio Services Corporation
Frederick, Maryland
11.2006 - 12.2010
- Oversaw a 30,000 sq. ft repository and 300 million dollars inventory for investigational and commercial drug products for over 25 clients, ensuring efficient operation and distribution to both domestic and international sites.
- Advised on shipping requirements and system tracking, resolving challenges for management and study staff.
- Supported inspection teams during regulatory agency inspections for FDA, EMA, and ANVISA.
- Coordinated forecasting and distribution of clinical drug products globally, optimizing inventory management across North America and EU regional depots.
- Clinical Study Design and Execution: Participated in the design and execution of clinical studies across all phases (I-IV) to manage projects through various stages.
- Executed bulk drug pallet shipments with envirotainers, ensuring compliance with shipping regulations.
- Handled Cold chain logistics for investigational drug products across continents
Manufacturing Lead
Royal DSM
Pimpri, Maharastra, India
06.2000 - 08.2006
- Led teams in daily manufacturing operations, ensuring adherence to safety protocols.
- Led team in implementing new processes to reduce waste and increase efficiency.
- Implemented process improvements to streamline production and reduce waste.
- Developed and maintained production schedules to ensure on-time project delivery.
- Developed and maintained production schedule to ensure timely delivery of products.
- Oversaw machinery and equipment maintenance to support continuous manufacturing operations.
- Coordinated cross-functional collaboration between departments for seamless workflow.
- Gained experience in fermentation plant operations, utilizing various bio reactors ranging from 2 KL to 80 KL capacities.
Education
Ph.D. - Pharmaceutical Sciences
Andhra University
Vishakapatnam, India05.2004
Master of Science - Fermentation Technology
Andhra University
Vishakhapatnam, India09.1990
Bachelor of Pharmacy - Pharmaceutical Sciences
Andhra University
Visakhapatnam, India08.1988
Skills
- Clinical operations
- Pharmaceutical logistics
- Cold chain logistics
- Controlled temperature distribution
- Time sensitive shipping
- Compliance regulations
- Supply chain logistics
- Operations logistics management
- Project management
- Budget management
- Budget administration
- Process improvement
- Troubleshooting and problem resolution
- Operations management
- Logistics support services
- Work Planning and Prioritization
- Time management abilities
- Teamwork and collaboration
- Customer relations
Languages
English
Professional
Hindi
Professional
Telugu
Professional
Timeline
Senior Manager, Clinical supply operations Lead
CenExel Clinical Research
01.2023 - Current
Director of supply Chain operations (CMC)
Foresee Pharmaceuticals
11.2021 - 11.2022
Senior Manager, Clinical Operations
Headlands Research
08.2020 - 11.2021
Director of Global Distribution
Takeda Pharmaceuticals
01.2011 - 08.2019
Director of Investigational Drug Repository
EMINENT Bio Services Corporation
11.2006 - 12.2010
Manufacturing Lead
Royal DSM
06.2000 - 08.2006
Ph.D. - Pharmaceutical Sciences
Andhra University
Master of Science - Fermentation Technology
Andhra University
Bachelor of Pharmacy - Pharmaceutical Sciences
Andhra University