CMC Technical Officer, Center for Vaccine Innovation and Access

4 weeks ago

New Delhi, India PATH Full time

PATH is currently recruiting

for a CMC Technical Officer to provide tactical and operational support for the Polio vaccine project.

Responsibilities

Process Development, Scale up, Technology Transfer

Coordinate the technology transfer of viral vaccine manufacturing processes between manufacturers covering process and analytical transfer at full production scale. Work with polio vaccine manufacturing partners in Low- and Middle-Income Countries (LMICs) to conduct manufacturing and analytical data analysis, including translation of results into decisions related to CMC development and manufacturing procedures. Review manufacturing and CMC development data to ensure accuracy, validity, and sufficiency for optimization and scale-up of the manufacturing and analytical processes under Good Manufacturing Practices (GMP). Support regulatory submissions such as eCTD Modules 2.3 and 3, by authoring or coordinating the authorship of CMC content. Participate in process troubleshooting and identify root causes of deviations. Periodically track and trend stability data from manufacturing partners.

Clinical Supply

Accountable for clinical supply readiness and shipment from manufacturing partners to clinical sites. Assess clinical supply availability, formulate strategy and provide oversight for expiry dating, material availability, and supply demand.

Strategy

Participate in the establishment of short- and long-term CMC development and manufacturing strategies, including facilities allocation and release testing. Prepare and review reports for partners and donors including project status, risk identification, and potential mitigation strategies.

Required skills and experience

PhD and a minimum of 5-7 years late-stage process development or manufacturing experience in pharma highly desired; or a Master’s degree and a minimum of 8-10 years late-stage process development or manufacturing experience required. Experience performing CMC manufacturing and compliance activities including gap analysis and risk assessments. Experience with process validation required. Demonstrated current working experience with cGMP. Proven experience with assay development, qualification, and validation. Must be able to review and edit assay validation protocols and reports. Experience with assays for viral vaccines, such as viral culture potency assays, PCR, etc. Next Generation Sequency familiarity preferred. Demonstrated experience with manufacturing process characterization and evaluation, such as design, execution, and analysis of DoEs. Strong communication skills for project reports and funder engagements, including technical reports and slide presentations. Proven experience authoring and reviewing CMC content of regulatory submission technical documentation. Knowledge and exposure of technology transfer to ensure transfers are successful, such as authorship of analytical comparability protocols and tech transfer reports. Experience authoring subcontractor scopes of work with external manufacturers, including budgeting. Experience contracting with CDMOs highly desired. Understanding implications of release criteria on overall program development highly desired. Proficiency in Microsoft Office Suite (Teams, Outlook, Word, PowerPoint). Must have legal authorization to work in the US, Belgium, Switzerland, UK, or India. Fully remote candidates in these locations will be considered.

  • CMC Technical Officer, Center for Vaccine Innovation and Access

    3 days ago

    New Delhi, India PATH Full time

    PATH is currently recruitingfor a CMC Technical Officer to provide tactical and operational support for the Polio vaccine project.ResponsibilitiesProcess Development, Scale up, Technology TransferCoordinate the technology transfer of viral vaccine manufacturing processes between manufacturers covering process and analytical transfer at full production...

  • CMC Technical Officer, Center for Vaccine Innovation and Access

    1 week ago

    new delhi, India PATH Full time

    PATH is currently recruiting for a CMC Technical Officer to provide tactical and operational support for the Polio vaccine project. Responsibilities Process Development, Scale up, Technology Transfer Coordinate the technology transfer of viral vaccine manufacturing processes between manufacturers covering process and analytical transfer...

  • Program Officer

    3 days ago

    Delhi, Delhi, India Clinton Health Access Initiative Full time

    Overview: **Please note: This role is based in Patna, Bihar** The Clinton Health Access Initiative, Inc. (CHAI) is a global health organization committed to our mission of saving lives and reducing the burden of disease in low-and middle-income countries. We work at the invitation of governments to support them and the private sector to create and sustain...

  • Director, CMC, FDA Experience

    2 weeks ago

    delhi, India Allucent Full time

    DescriptionAt Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Director, Chemistry Manufacturing and Controls (CMC) (Director, CMC) to join our A-team (hybrid*/remote). As a...

  • 3 Days Left: Director, CMC, FDA Experience

    4 days ago

    Delhi, India Allucent Full time

    DescriptionAt Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Director, Chemistry Manufacturing and Controls (CMC) (Director, CMC) to join our A-team (hybrid*/remote). As a...

  • Graphic Designer

    5 days ago

    New Delhi, India Clinton Health Access Initiative Full time

    Overview: The Clinton Health Access Initiative, Inc. (CHAI) is a global health organization committed to our mission of saving lives and reducing the burden of disease in low-and middle-income countries. We work at the invitation of governments to support them and the private sector to create and sustain high-quality health systems. CHAI was founded in 2002...

  • Finance Officer, Project Jeet

    4 weeks ago

    New Delhi, India Clinton Health Access Initiative Full time

    Overview: The Clinton Health Access Initiative, Inc. (CHAI) is a global health organization committed to our mission of saving lives and reducing the burden of disease in low-and middle-income countries. We work at the invitation of governments to support them and the private sector to create and sustain high-quality health systems. CHAI was founded in 2002...

  • Country Manager for India

    1 month ago

    new delhi, India International Potato Center Full time

    The International Potato Center (CIP)is looking for highly motivated and experienced Country Manager to lead CIP’sregional Office in New Delhi, India. The position: The CountryManager is responsible for government, partner and funder relations and representsCIP with these stakeholders in India, working closely with the RegionalDirector for South Asia....

  • Country Manager for India

    4 weeks ago

    New Delhi, India International Potato Center Full time

    The International Potato Center (CIP)is looking for highly motivated and experienced Country Manager to lead CIP’sregional Office in New Delhi, India. The position: The CountryManager is responsible for government, partner and funder relations and representsCIP with these stakeholders in India, working closely with the RegionalDirector for South Asia....

  • Front Office

    4 weeks ago

    New Delhi, India Park Hospital Full time

    Front Office / Hospitality / Call Center Walk-in Interview Fri, Sat & Sun 31 Mar, 1 & 2 Apr 8 AM ONWARDS Venue: PARK HEALING TOUCH HOSPITAL, CHANDIGARH-AMBALA HIGHWAY, AMBALA

  • Office Assistant

    4 weeks ago

    New Delhi, India MNT RUBBER LLP Full time

    REQUIRED FEMALE OFFICE ASSISTANT - Computer Savy - Good Communication Skills - Presentable. - Punctual - Office work knowledge - All office work (daily basis) - Coordination with all department.**Job Types**: Full-time, Regular / Permanent **Salary**: ₹10,000.00 - ₹30,000.00 per month **Benefits**: - Internet reimbursement Schedule: - Day...

  • IRS23161 Chief Engagement Officer

    2 weeks ago

    new delhi, India International Maize and Wheat Improvement Center (CIMMYT) Full time

    CIMMYT is a cutting edge, non-profit, international organization dedicated to solving tomorrow's problems today. It is entrusted with fostering improved quantity, quality, and dependability of production systems and basic cereals such as maize, wheat, triticale, sorghum, millets, and associated crops through applied agricultural science, particularly in the...

  • Accessibility Consultant

    3 weeks ago

    Delhi, India Omm IT Solutions Full time

    Job DescriptionPlease Note:Selected candidate must reside within two (2) hours of the client's Headquarters in Woodlawn, MDSelected candidate must be willing to work on-site at least 2 days a week.Position Description:Advise on defining, standardizing, & implementing accessibility activities across the enterprise and within the Customer Experience (CX) Team...

  • IRS23161 Chief Engagement Officer

    2 weeks ago

    New Delhi, India International Maize and Wheat Improvement Center (CIMMYT) Full time

    CIMMYT is a cutting edge, non-profit, international organization dedicated to solving tomorrow's problems today. It is entrusted with fostering improved quantity, quality, and dependability of production systems and basic cereals such as maize, wheat, triticale, sorghum, millets, and associated crops through applied agricultural science, particularly in the...

  • IRS23161 Chief Engagement Officer

    2 weeks ago

    new delhi, India International Maize and Wheat Improvement Center (CIMMYT) Full time

    CIMMYT is a cutting edge, non-profit, international organization dedicated to solving tomorrow's problems today. It is entrusted with fostering improved quantity, quality, and dependability of production systems and basic cereals such as maize, wheat, triticale, sorghum, millets, and associated crops through applied agricultural science, particularly in the...

  • IRS23161 Chief Engagement Officer

    2 weeks ago

    New Delhi, India International Maize and Wheat Improvement Center (CIMMYT) Full time

    CIMMYT is a cutting edge, non-profit, international organization dedicated to solving tomorrow's problems today. It is entrusted with fostering improved quantity, quality, and dependability of production systems and basic cereals such as maize, wheat, triticale, sorghum, millets, and associated crops through applied agricultural science, particularly in the...

  • Officer

    1 day ago

    New Delhi, India Relaxo Full time

    Position Title: Officer Assembly Department: Production Work Location: Bhiwadi Grade: O1 Travel Required: 10% Reporting to: Administrative: Manager Production Reported by: Workers ...

  • Associate Director

    4 weeks ago

    Delhi, India NTT Global Data Centers and Cloud Infrastructure, India Full time

    EDUCATION & EXPERIENCE1. Bachelor’s degree in related field or equivalent education and/or work experience to meet requisite skills2. 20 years’ progressive data center and/or critical facilities experience with minimum 5 years in a managerial position.3. PG / MBA qualification would be an added advantage.4. Data Center operations management...

  • Research Fellow

    4 weeks ago

    Delhi, India Vidhi Centre for Legal Policy Full time

    **About Vidhi**: Vidhi is an independent think-tank doing legal research to make better laws and improve governance for the public good. Vidhi is committed to producing legal research of the highest standard with the aim of informing public debate and contributing to improved governance. Vidhi works with Ministries of the Government of India and State...

  • IRS23161 Chief Engagement Officer

    2 weeks ago

    New Delhi, India International Maize and Wheat Improvement Center (CIMMYT) Full time

    CIMMYT is a cutting edge, non-profit, international organization dedicated to solving tomorrow's problems today. It is entrusted with fostering improved quantity, quality, and dependability of production systems and basic cereals such as maize, wheat, triticale, sorghum, millets, and associated crops through applied agricultural science, particularly in the...