iBio, Inc.
CMC and Nonclinical Development Lead
iBio, Inc., San Diego, California, United States, 92189
About iBio
iBio is an AI-driven innovator that develops next-generation biopharmaceuticals using computational biology and 3D-modeling of subdominant and conformational epitopes, prospectively enabling the discovery of new antibody treatments for obesity, cardiometabolic, hard-to-target cancers, and other diseases. iBio’s mission is to decrease drug failures, shorten drug development timelines, and open up new frontiers against the most promising targets. iBio is based in San Diego, CA. For more information, visit www.ibioinc.com.
Join Our Growing Team as a CMC and Nonclinical Development Lead!
We are seeking an exceptional candidate to oversee all Chemistry, Manufacturing, and Controls (CMC) activities and nonclinical toxicology studies, and play a crucial part in our regulatory submissions.
We're looking for someone who thrives in a dynamic environment and excels at fostering cross-functional collaboration across departments. You will take the lead in advancing our innovative drug development programs, guiding them from discovery all the way to IND clearance and clinical testing.
If you're passionate about making a meaningful impact in the biotech industry and want to be part of a team that's shaping the future of medicine, we want to hear from you!
This role is preferably located in San Diego, CA., but open to remote.
What You’ll Do
Manage Outsourced CMC Activities
- Coordinate and oversee all aspects of outsourced CMC development with CDMOs. Ensure alignment with project timelines, budget, and quality standards.
Lead Nonclinical Study Planning and Toxicology
- Work with internal stakeholders and external contract research organizations (CROs) to plan and manage nonclinical toxicology studies. Ensure that all studies meet regulatory requirements and support IND/CTA filings.
Vendor and Consultant Management:
Act as the primary point of contact for external consultants and vendors supporting CMC, nonclinical, and regulatory activities. Ensure clear communication and seamless integration of external work with internal program goals.
Regulatory Documentation and Submissions
- Support the preparation of regulatory filings (e.g., INDs, IMPDs, CTAs) by coordinating contributions from external consultants and internal teams.
Regulatory Compliance and Quality Oversight
- Ensure that all outsourced work complies with regulatory guidelines and quality standards (e.g., cGMP, GLP). Support regulatory agency interactions as needed.
Requirements:
Bachelor’s degree
in a scientific discipline (e.g., Biology, Toxicology, Biotechnology, or similar) is required. An advanced degree is a plus.
Project management certification is preferred but not required.
Minimum of 4 years of experience
in drug development within the biotech industry, preferably across CMC, regulatory, toxicology, or clinical development functions.
Experience working with contract development and manufacturing organizations
(CDMOs) and contract research organizations (CROs) to manage external collaborations for CMC development, nonclinical studies, and/or early clinical programs.
Familiarity with toxicology and nonclinical study design , including GLP studies and regulatory toxicology requirements for IND submissions.
Basic knowledge of regulatory guidelines
(e.g., FDA, EMA) and experience supporting regulatory filings such as INDs, IMPDs, and CTA submissions.
Direct experience in a small biotech
environment leading or supporting the advancement of programs from discovery through IND is highly valued.
Cross-Functional Collaboration
- Work closely with internal R&D, BD, and leadership teams to ensure that CMC and toxicology activities are integrated into broader program development plans.
Early Clinical Planning
- Support early clinical development strategy by ensuring that all CMC and toxicology activities align with clinical goals and timelines. Contribute to early clinical planning and design.
Support Early R&D Program Management:
Provide project management support to early-stage R&D programs, ensuring smooth transition from discovery through to preclinical.
California Base Salary Range
The expected annual base salary for this position ranges from $95,625.00 to $178,250.00, plus bonus, equity, and comprehensive benefits. The base salary range reflects the target range for this position, but individual pay will be determined by various factors, including the qualifications of the individual applicant for the position, years of relevant experience, job-related skills, relevant education attained, work location, and organizational needs. This range may be modified in the future. A discretionary annual bonus may be available based on individual and Company performance.
All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identify, national origin, disability, veteran status or other protected classes.
What do we offer?
We provide competitive and comprehensive benefits to our employees. Below are some highlights of our benefits:
Medical, Dental, and Vision Insurance Options
Flexible Time Off
Our company observes seven designated holidays each calendar year.
401(k) with Company Match as described in plan documents.
Life and Disability Insurance
Short-term and long-term disability insurance
EEO Statement
iBio is proud of its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.
iBio is committed to helping individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at iBio, please email ibio_peopleculture@ibioinc.com for further assistance. Please note that this email address is intended only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
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iBio is an AI-driven innovator that develops next-generation biopharmaceuticals using computational biology and 3D-modeling of subdominant and conformational epitopes, prospectively enabling the discovery of new antibody treatments for obesity, cardiometabolic, hard-to-target cancers, and other diseases. iBio’s mission is to decrease drug failures, shorten drug development timelines, and open up new frontiers against the most promising targets. iBio is based in San Diego, CA. For more information, visit www.ibioinc.com.
Join Our Growing Team as a CMC and Nonclinical Development Lead!
We are seeking an exceptional candidate to oversee all Chemistry, Manufacturing, and Controls (CMC) activities and nonclinical toxicology studies, and play a crucial part in our regulatory submissions.
We're looking for someone who thrives in a dynamic environment and excels at fostering cross-functional collaboration across departments. You will take the lead in advancing our innovative drug development programs, guiding them from discovery all the way to IND clearance and clinical testing.
If you're passionate about making a meaningful impact in the biotech industry and want to be part of a team that's shaping the future of medicine, we want to hear from you!
This role is preferably located in San Diego, CA., but open to remote.
What You’ll Do
Manage Outsourced CMC Activities
- Coordinate and oversee all aspects of outsourced CMC development with CDMOs. Ensure alignment with project timelines, budget, and quality standards.
Lead Nonclinical Study Planning and Toxicology
- Work with internal stakeholders and external contract research organizations (CROs) to plan and manage nonclinical toxicology studies. Ensure that all studies meet regulatory requirements and support IND/CTA filings.
Vendor and Consultant Management:
Act as the primary point of contact for external consultants and vendors supporting CMC, nonclinical, and regulatory activities. Ensure clear communication and seamless integration of external work with internal program goals.
Regulatory Documentation and Submissions
- Support the preparation of regulatory filings (e.g., INDs, IMPDs, CTAs) by coordinating contributions from external consultants and internal teams.
Regulatory Compliance and Quality Oversight
- Ensure that all outsourced work complies with regulatory guidelines and quality standards (e.g., cGMP, GLP). Support regulatory agency interactions as needed.
Requirements:
Bachelor’s degree
in a scientific discipline (e.g., Biology, Toxicology, Biotechnology, or similar) is required. An advanced degree is a plus.
Project management certification is preferred but not required.
Minimum of 4 years of experience
in drug development within the biotech industry, preferably across CMC, regulatory, toxicology, or clinical development functions.
Experience working with contract development and manufacturing organizations
(CDMOs) and contract research organizations (CROs) to manage external collaborations for CMC development, nonclinical studies, and/or early clinical programs.
Familiarity with toxicology and nonclinical study design , including GLP studies and regulatory toxicology requirements for IND submissions.
Basic knowledge of regulatory guidelines
(e.g., FDA, EMA) and experience supporting regulatory filings such as INDs, IMPDs, and CTA submissions.
Direct experience in a small biotech
environment leading or supporting the advancement of programs from discovery through IND is highly valued.
Cross-Functional Collaboration
- Work closely with internal R&D, BD, and leadership teams to ensure that CMC and toxicology activities are integrated into broader program development plans.
Early Clinical Planning
- Support early clinical development strategy by ensuring that all CMC and toxicology activities align with clinical goals and timelines. Contribute to early clinical planning and design.
Support Early R&D Program Management:
Provide project management support to early-stage R&D programs, ensuring smooth transition from discovery through to preclinical.
California Base Salary Range
The expected annual base salary for this position ranges from $95,625.00 to $178,250.00, plus bonus, equity, and comprehensive benefits. The base salary range reflects the target range for this position, but individual pay will be determined by various factors, including the qualifications of the individual applicant for the position, years of relevant experience, job-related skills, relevant education attained, work location, and organizational needs. This range may be modified in the future. A discretionary annual bonus may be available based on individual and Company performance.
All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identify, national origin, disability, veteran status or other protected classes.
What do we offer?
We provide competitive and comprehensive benefits to our employees. Below are some highlights of our benefits:
Medical, Dental, and Vision Insurance Options
Flexible Time Off
Our company observes seven designated holidays each calendar year.
401(k) with Company Match as described in plan documents.
Life and Disability Insurance
Short-term and long-term disability insurance
EEO Statement
iBio is proud of its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.
iBio is committed to helping individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at iBio, please email ibio_peopleculture@ibioinc.com for further assistance. Please note that this email address is intended only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
#J-18808-Ljbffr