Director / Senior Director / VP, Head of CMC

Real Staffing Group; Boston (MA); Sur place; USD 180 000 - 240 000; Plein temps

Résumé du poste

Real Staffing Group is seeking an experienced CMC leader to drive cross-functional development from preclinical through early clinical stages. The role will lead strategy across drug substance and product, overseeing external CDMOs and partners while collaborating with Regulatory, Quality, Nonclinical, and Clinical teams.

Qualified candidates will have significant biotech/pharma CMC experience and a track record advancing programs from preclinical to early clinical development.

Qualifications

• BS, MS, or PhD in a relevant scientific discipline.
• Significant biotechnology/pharma industry experience in CMC development.
• Experience with modalities including oligonucleotides, siRNA, ASO, peptides, biologics, or related platforms.
• Strong track record managing external partners and global development activities.
• Experience advancing programs from preclinical through early clinical development.
• Excellent leadership, communication, and cross-functional collaboration skills.

Responsabilités

• Lead CMC strategy and execution across drug substance and drug product development.
• Manage external CDMOs, manufacturing, analytical, and process development partners.
• Partner with Regulatory, Quality, Nonclinical, and Clinical teams to achieve milestones.
• Drive project timelines, budgets, risk management, and operational execution across multiple programs.
• Support IND-enabling activities and early-stage clinical development.

Connaissances

Leadership

Cross-functional collaboration

Project management

Strategic CMC planning

External partner management

Regulatory interaction

Formation

BS/MS/PhD in a relevant scientific discipline

Outils

External CDMOs management

Description du poste

An emerging biotechnology company developing next-generation therapeutics is seeking an experienced CMC leader to drive cross-functional development activities from preclinical through early clinical stages.

Key Responsibilities

• Lead CMC strategy and execution across drug substance and drug product development
• Manage external CDMOs, manufacturing, analytical, and process development partners
• Partner closely with Regulatory, Quality, Nonclinical, and Clinical teams to achieve key development milestones
• Drive project timelines, budgets, risk management, and operational execution across multiple programs
• Support IND-enabling activities and early-stage clinical development

Qualifications

• BS, MS, or PhD in a relevant scientific discipline
• Significant biotechnology or pharmaceutical industry experience in CMC development
• Experience supporting complex therapeutic modalities, including oligonucleotides, siRNA, ASO, peptides, biologics, or related platforms
• Strong track record managing external partners and global development activities
• Experience advancing programs from preclinical through early clinical development
• Excellent leadership, communication, and cross-functional collaboration skills

Additional Details

• Location: Greater Boston or California preferred; exceptional candidates elsewhere may be considered
• Travel: Ability and willingness to travel internationally, including frequent travel to China
• Title and compensation: Flexible and commensurate with experience (Director through VP level)

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.