What are the responsibilities and job description for the Director of CMC, and Process Development position at CAMP4 Therapeutics?
Position Title: Director of CMC, and Process Development
Location: Cambridge, MA
Reports To: SVP of Technical Operations
Join the Adventure!
We are seeking an experienced and dynamic Director of CMC, Process Development, and Analytics to join our biotech company based in Cambridge, MA. We are developing a new class of RNA medicines to increase targeted gene expression using antisense oligonucleotides. This role is critical to the successful execution of our clinical development programs and will be responsible for overseeing all aspects of Chemistry, Manufacturing, and Controls (CMC), process, and analytical methods development.
Key Responsibilities
CAMP4 is developing disease-modifying treatments for a broad range of genetic diseases where amplifying healthy protein may offer therapeutic benefits. Our approach amplifies mRNA by harnessing a fundamental mechanism of how genes are controlled. To amplify mRNA, our therapeutic ASO drug candidates target regulatory RNAs (regRNAs), which act locally on transcription factors and are the master regulators of gene expression. CAMP4’s proprietary RAPTM Platform enables the mapping of regRNAs and design of optimal chemistry to generate potent therapeutic candidates to address hundreds of genetic diseases across multiple tissues. Learn more about us at www.camp4tx.com and follow us @CAMP4tx.
Location: Cambridge, MA
Reports To: SVP of Technical Operations
Join the Adventure!
We are seeking an experienced and dynamic Director of CMC, Process Development, and Analytics to join our biotech company based in Cambridge, MA. We are developing a new class of RNA medicines to increase targeted gene expression using antisense oligonucleotides. This role is critical to the successful execution of our clinical development programs and will be responsible for overseeing all aspects of Chemistry, Manufacturing, and Controls (CMC), process, and analytical methods development.
Key Responsibilities
- Manage process development, and analytical development functions; scale-up, tech transfer, author technical development protocols and reports responsible for direction and oversight for all related activities.
- Develop and implement Oligonucleotide CMC strategies, ensuring alignment with US and ex-US regulatory requirements and company objectives.
- Oversee the planning, initiation, and execution of drug substance and drug product process development, formulations, fill-finish processes, and stability studies.
- Collaborate with cross-functional teams, including pre-clinical, toxicology, regulatory affairs, clinical operations, and quality assurance, to ensure the successful execution of clinical programs.
- Manage relationships with external partners, Contract Manufacturing Organizations (CMOs), analytical labs, and CMC advisors.
- Monitor process development progress, identify and mitigate risks, and ensure timely and accurate reporting of data.
- Develop and manage CMC budgets, ensuring efficient use of resources.
- Minimum of 10 years of experience in CMC, process development, and analytics within the biotech or pharmaceutical industry. Expertise in antisense, siRNA oligonucleotide processes is a plus.
- Proven track record of successfully supporting clinical trials through early- or late-stage development.
- Strong knowledge of GMP, ICH guidelines, and regulatory requirements for CMC.
- Experience with process characterization, scale-up, and technology transfer.
- Excellent communication, analytical, and organizational skills.
- Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.
- Ability to travel domestic and internationally to support CMC, clinical and regulatory interactions in US, ex-US.
- Experience with Oligonucleotides, small molecules and, or other advanced therapeutic modalities.
- Proficiency in statistical analysis and data interpretation.
- Familiarity with regulatory submissions and interactions with health authorities.
- Strong project management skills with the ability to manage multiple priorities and deadlines.
- Demonstrated ability to lead cross-functional teams and drive complex projects to successful completion.
- Innovative mindset with a focus on continuous improvement and problem-solving.
CAMP4 is developing disease-modifying treatments for a broad range of genetic diseases where amplifying healthy protein may offer therapeutic benefits. Our approach amplifies mRNA by harnessing a fundamental mechanism of how genes are controlled. To amplify mRNA, our therapeutic ASO drug candidates target regulatory RNAs (regRNAs), which act locally on transcription factors and are the master regulators of gene expression. CAMP4’s proprietary RAPTM Platform enables the mapping of regRNAs and design of optimal chemistry to generate potent therapeutic candidates to address hundreds of genetic diseases across multiple tissues. Learn more about us at www.camp4tx.com and follow us @CAMP4tx.