Cmc Project Manager (Manager/Senior Manager)

Building on our founders’ Nobel-prize winning discoveries in RNA interference, Atalanta Therapeutics is developing novel branched siRNA therapeutics to treat severe neurological diseases at the root cause. With two active partnerships with large biopharmaceutical companies plus a robust and growing internal pipeline, Atalanta is poised to make a difference in patients’ lives. Atalanta fosters a culture of integrity, respect, collaboration, opportunity, learning, and fun. We are located in Boston’s vibrant Seaport district near South Station.
POSITION SUMMARY:
Atalanta is seeking a highly skilled and motivated CMC Project Manager to join the Program Management team. Reporting to the SVP of Program and Alliance Management, this individual will be responsible for timely and efficient delivery of CMC projects to support Atalanta’s pipeline focused on the discovery and development of novel siRNAs to treat neurological diseases with significant unmet need. This position represents a unique opportunity for a talented project manager to join a dynamic team and have a significant impact on advancing our science into the clinic and the success of the company.
RESPONSIBILITIES:

• Coordinate the preparation and review of CMC sections for regulatory filings.
• Provide regular updates to leadership on CMC activities and deliverables.
• Establish and lead cross-functional teams in the operational management of CMC activities to support Atalanta’s pipeline.
• Coordinate with internal and external stakeholders to ensure timely and efficient deliveries of manufacturing batches.
• Work in partnership with scientists to proactively identify and mitigate manufacturing risks and promptly resolve CMC issues.
• Create and maintain cohesive CMC project plans, timelines, and budgets that are aligned with project and corporate goals.
• Facilitate CMC project team meetings including setting agendas, distributing minutes, and tracking decisions and action items.
• Provide oversight to CDMOs and serve as the primary point of contact within Atalanta.
• Implement CMC project management best practices that optimize pharmaceutical development and analytical services within Atalanta

QUALIFICATIONS:

• Ability to work independently and implement Project Management tools, methodologies, and best practices.
• Experience with oligonucleotides and/or nucleic acid therapeutics is a plus.
• A minimum of 7-10 years of professional work experience in CMC project management within the Biotechnology or Pharmaceutical field.
• Enthusiasm to help develop novel therapeutics targeting neurological diseases with a high unmet medical need.
• Strong risk analysis, decision making, and contingency planning skills and the ability to resolve complex issues.
• A minimum of a Bachelor’s degree with a focus in Science, Engineering, or related scientific discipline is required; An advanced degree (i.e. MS, PhD, etc.) is preferred.
• Proven track record in developing and managing cross-functional CMC teams including external consultants and CDMOs.
• In-depth knowledge of chemical synthesis, process development, analytical development, and quality control concepts
• Excellent organizational, leadership, and communication skills and attention to detail.
• Understanding of FDA and EMA regulations related to CMC and experience with regulatory filings.

Atalanta is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.