Position Summary:
This individual will participate in the development and implementation of scientific/CMC/regulatory strategies for commercial and investigational products. This individual will also coordinate all aspects of CMC regulatory submissions relevant to their assigned projects and serve as the regulatory CMC representative on relevant project teams. The individual will also be responsible for the direct management of activities carried out by contract manufacturers and external laboratories for assigned products.
Essential Functions:
- Author eCTD sections and manage regulatory submissions relevant to the assigned projects;
- Serve as the regulatory CMC representative on project teams;
- Participate in the development and implementation of regulatory strategies;
- Review and provide comments on SOPs, method development reports, validation protocols and reports, stability protocols, product specifications, comparability protocols and reports, quality agreements, and other related documents;
- Serve as the main point of contact and provide direct management and regulatory guidance to contract manufacturing organizations (CMOs) and/or consultants for assigned projects;
- Provide technical and scientific support for ongoing manufacturing operations at CMOs;
- Manage technology transfers and ensure timely, appropriate communication to regulatory authorities;
- Apply expertise in chemistry and/or biotechnology to resolve manufacturing and control problems for active pharmaceutical ingredient (API) and drug products of small molecules and biologics;
- Collect scientific, technical, and CMC data on drug products (commercial and investigational ones), analyze and interpret them using mathematical tools (i.e.: performing statistical and trend analyses) to resolve OOS, OOT, stability, and manufacturing issues;
- Keep up-to-date on regulatory environment, proposing regulatory initiatives and changes to comply with Federal Register and FDA and ICH guidelines;
Daily Responsibilities:
- Author, co-author, and review CMC sections of regulatory submissions in CTD structure;
- Prepare, collect, review, and assemble technical documentation required for writing annual reports, and CMC sections of IND, NDA, SNDA, and BLA;
- Review Batch Records, Certificates of Analysis (CoA), and CMC reports including analytical, validation, stability, technical change, out of specification, deviation, investigation, corrective and preventive action reports;
- Review change control requests and provide regulatory assessments, regulatory guidance, and submission strategy prior to final implementations;
- Manage technical product inquiries;
- Assist in conducting on-site technical audits to contract manufacturing facilities;
- Review supplier and quality agreements from contract manufactures;
- Assist in due diligence activities for product acquisition reviewing technical documentation related to product manufacturing;
- Monitor Federal Register regarding CMC requirements which may impact pharmaceutical drug development and commercial drug products of the company;
- Participate in project teams as a CMC expert;
- Other duties as assigned.
Specific Job Knowledge, Skill And Ability:
- 5 years of experience in pharmaceutical industry with 2 years of experience in regulatory
- MS or PhD in Chemistry, Biochemistry or other relevant field
- Proficient with MS Office; experience with statistical analysis software (JMP)
- Experience with preparing documents in CTD/eCTD
- Strong analytical and problem solving skills. Effective problem solver with a bias towards proactive behavior.
- Ability to multi-task
- Demonstrated leader with the ability to work effectively in a collaborative work environment
- Strong verbal and written communication skills
- Knowledge of GMP and GCP compliance, FDA guidelines and federal regulations regarding CMC (21CFR part 210 and 211)
- Knowledge/experience with processes of manufacturing of active pharmaceutical ingredient (API) and drug product for chemical and biological substances preferred
- Prior experience in pre- and post-approval CMC changes and strategies preferred
Travel requirements: Must be able to travel 10-20% of the time.
Leadiant Biosciences, Inc. is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, national origin, disability, veteran status, and other legally protected characteristics. The EEO is the Law poster is available here:https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf.
If you need a reasonable accommodation because of a disability for any part of the employment process, please send an e-mail to Jobs@leadiant.com and let us know the nature of your request and your contact information.
