About the Company
Following successful Phase 1 results and Series A financing raise, this clinical stage company is expanding their CMC capabilities and is seeking a Manager, CMC Operations, to report to the Chief Scientific Officer.
The ideal candidate will be a diligent and detailed individual with a strong technical background and having industry experience. This is a small virtual company – individuals should be keen to work in an entrepreneurial environment, in a team that manages broad responsibilities.
The Manager, CMC Operations, will be responsible for hands-on operational execution, management and oversight of variety of CMC-focused activities supporting product development. Major components of the work will include API and formulation development; the review and interpretation of technical documentation such as data, batch records, protocols, study reports; tracking timelines and budgets; and supporting the preparation of regulatory documentation.
- Manage and coordinate with external parties performing outsourced CMC activities including but not limited to contract manufacturing organizations, testing laboratories, and consultant subject matter experts, working closely and managing relationships with these parties.
- Review of documents, such as technical reports, batch records, protocols, change controls, and other documents related to drug supply chain in support of clinical development.
- Contribute to the writing, compiling and review of CMC sections of regulatory documents, including but not limited to submissions and updates to FDA, EMA and Health Canada.
- Take an active role in SOP maintenance, deviation investigations, change control activities, batch record review, site visits and vendor audits in partnership with QA and Regulatory Affairs.
- As required, ensure studies and activities are aligned with current Good Manufacturing Practices (GMP).
- Develop projects timelines and study plans, manage and coordinate assigned activities from start up to completion.
- Proactively identify potential risks to timelines, deliverables and budgets and implement effective risk management plans and mitigation strategies.
- Provide accurate and timely project status reports to company management.
- Advanced Degree (MSc, PhD) is required in Chemistry, Pharmaceutics, or related technical discipline.
- Minimum of 5 years in a pharmaceutical or biotechnology industry setting with emphasis on hands-on management and technical execution of CMC activities; small biotech experience is strongly preferred.
- Excellent knowledge and hands-on experience of drug manufacturing and quality control processes with exposure to different scientific/technical areas such as formulation and process development, analytical development, manufacturing, stability.
- Experience with oral and parenteral formulations is preferred, including the production of sterile dosage forms.
- Knowledgeable and experienced in both early and late-stage clinical programs, Phase 3 experience is an asset.
- Excellent understanding of GMPs, regulatory guidelines and other CMC-related regulations.
- Hands-on experience with regulatory filings for peptide and small molecule therapeutics, NDA experience is an asset.
- Exceptional technical writing and documentation skills with CMC regulatory dossier experience considered a plus.
- Exemplary ability to manage complex technical projects in collaboration with external parties including planning scope, allocating resources, defining timelines and tracking budgets.
- Strong values-driven individual able to function in a diverse, cross-functional and multi-disciplinary team.
- A desire to be “hands-on”, and thrive in a collaborative, fast-paced, and dynamic business environment.
- Flexible and adaptable, able to provide leadership in core areas of expertise and provide a support role in adjacent technical areas.
- Keen attention to detail and demonstrated ability to multitask.
- Critical thinker, able to proactively identify issues and mitigate risks.
- Willingness and ability to travel, including internationally, up to 20% of the time
To apply, please submit your resume using the Apply Now button.
Please note that only applicants being considered for an interview will be contacted.