Director/sr. Director CMC

General Summary

The CMC position will be based in Lexington, MA, and will play a key role in the progression to IND and beyond for Orum’s clinical products. This role requires the candidate to lead the company’s CMC efforts, including a combination of (1) setting the overall direction of the CMC activities and (2) developing functional strategies and driving tactics to accomplish manufacturing goals while meeting regulatory requirements.

Reporting to Head of Research, the ideal candidate will have demonstrated strong functional expertise within biomolecule manufacturing, executing supply chain projects and strategies and optimizing technology and productivity and output increases with excellent compliance levels. Understanding of related process development and analytical activities is also required.

The candidate will have significant leadership experience vetting and managing external development and manufacturing partners (CDMOs), ideally in biologics clinical manufacturing (e.g., ADCs), focusing on the biologics process in R&D and manufacturing and taking a product through the various clinical trial phases.

You will need to assume overall responsibility for managing manufacturing processes, scaling up production, improving processes, and increasing efficiency while maintaining the highest standards. You will also be responsible for all manufacturing operations as well as related process development and analytical activities.

Principle Duties and Responsibilities

• Set a vision and strategy for the CMC organization to include compliant and robust manufacturing and analytical capabilities at CDMOs
• Manage key activities at third-party providers to ensure satisfaction of key quality and delivery performance goals
• Champion the assessment and implementation of innovative approaches to manufacturing with CDMOs
• Work closely with technical consultants to deliver high-quality supply performance to meet key targets of clinical development plan
• Work collaboratively with the research and clinical teams, as well as business development, to meet the current and future needs of the company’s programs
• Deliver on key production performance, financial, compliance, and quality goals
• Establish highly effective technical capability across all operations and teams
• Support regulatory filings

Skills, Abilities & Competencies

• Bachelor’s degree in biochemical engineering, biochemistry, or equivalent
• Minimum of 5 years relevant experience in biomanufacturing (e.g., antibodies and antibody drug conjugates). Previous experience in ADC manufacturing is highly desirable.
• Technical skills in biomolecule process development and related analytics highly desirable–specific knowledge of bioconjugation a plus
• Experience working with CDMOs at multiple remote locations essential
• Strong leadership skills–both in terms of people and science
• Flexible mindset capable of managing change and dealing with ambiguity
• Proven ability to withstand pressure and manage complex projects with flexibility to re-prioritize workload to meet changing timelines; adaptability
• Autonomous, proactive personality, and driven to achieving highest results in shortest timeframe
• Work in a fast-paced, international, biotech setting

*U.S. citizens and those authorized to work in the U.S. (green card) are encouraged to apply. We are unable to sponsor at this time.

*Candidate must be able to pass a background investigation.

*Unable to work with 3rd party candidates or agencies.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above. Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position’s essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Orum Therapeutics is an Equal Opportunity Employer (EOE).