Senior Director, Drug Substance Development & Manufacturing

Agios Pharmaceuticals Inc.

United States

Remote

USD 230,000 - 344,000

Full time

13 days ago

Get a reply from this employer

Your resume and cover letter, tailored to exactly what they’re hiring for.

Get past ATS filters

Benefits offered by this job

Deliberate Development
Flexible work
Premium benefits
Competitive compensation

Job summary

Agios Pharmaceuticals is seeking a Senior Director, Chemical Development & Manufacturing to lead our CMC and Technical Operations agenda. This role will define drug substance development, scale-up, technology transfer, external manufacturing, and lifecycle activities from candidate selection through commercialization.

The ideal candidate will bring deep small-molecule API expertise, with experience in nucleic acid therapeutics, and a proven ability to build high-performing teams in a fast-paced,

Qualifications

  • Ph.D. in organic chemistry or related discipline is required or equivalent experience.
  • Deep expertise in small-molecule drug substance development and manufacturing.
  • Experience with oligonucleotide and siRNA development and manufacturing is desired.
  • Proven leadership in cross-functional teams and external partnerships.

Responsibilities

  • Lead small-molecule drug substance strategy from candidate selection through commercial lifecycle.
  • Deliver robust API processes and improve manufacturability, yield, and supply reliability.
  • Own technical ownership for physicochemical, impurity, and process understanding.
  • Direct external development and manufacturing with CROs/CDMOs and tech transfer.
  • Lead regulatory CMC delivery and support inspections and responses.
  • Build talent and organizational depth within the team.
  • Develop operating plans, budgets, and portfolio priorities.

Skills

Small-molecule API expertise
Leadership & mentoring
Cross-functional collaboration
Strategic planning
Regulatory CMC knowledge
Oligonucleotide & siRNA experience
External CRO/CDMO management
Technical communication

Education

Ph.D. in organic chemistry or related discipline

Job description

Agios Pharmaceuticals is seeking a Senior Director, Chemical Development & Manufacturing to lead our CMC and Technical Operations agenda. This role will define drug substance development, scale-up, technology transfer, external manufacturing, and lifecycle activities from candidate selection through commercialization.

The ideal candidate will bring deep small-molecule API expertise, with experience in nucleic acid therapeutics, and a proven ability to build high-performing teams in a fast-paced,

Get your free, confidential resume review.

or drag and drop your file here.

Similar jobs

Similar jobs worth comparing

Senior Director, CMC: Small Molecules & Oligos
Senior Director, CMC: Small Molecules & Oligos

Agios Pharmaceuticals Inc. • Cambridge (MA)

Hybrid
USD 230,000 - 344,000
Senior Director, Chemical Development & Manufacturing, CMC
Senior Director, Chemical Development & Manufacturing, CMC

Agios Pharmaceuticals Inc. • Cambridge (MA)

On-site
USD 230,000 - 344,000
Senior Director, Chemical Development & Manufacturing, CMC
Senior Director, Chemical Development & Manufacturing, CMC

Agios Pharmaceuticals Inc. • United States

Remote
USD 230,000 - 344,000
Deliberate Development
Flexible work
Premium benefits
+1
Drug Substance Process Development Lead
Drug Substance Process Development Lead

Seaport Therapeutics • Boston (MA)

Hybrid
USD 180,000 - 205,000
Director, Small-Molecule CMC & AI-Driven Development
Director, Small-Molecule CMC & AI-Driven Development

Pathos • New York (NY)

Hybrid
USD 210,000 - 250,000
Senior Process Development & Manufacturing Leader
Senior Process Development & Manufacturing Leader

Assembly Biosciences, Inc. • South San Francisco (CA)

Hybrid
USD 199,000 - 204,000
Senior Director, Drug Substance Process Development
Senior Director, Drug Substance Process Development

Innoviva Specialty Therapeutics, Inc. • Waltham (MA)

On-site
USD 250,000 - 350,000
Associate Director, Technical Operations
Associate Director, Technical Operations

Travere Therapeutics • United States

On-site
USD 180,000 - 260,000
Senior CMC Director: Small Molecule Development
Senior CMC Director: Small Molecule Development

Genesis Molecular AI • San Diego (CA)

On-site
USD 250,000 - 400,000
Competitive Pay
Stock Option Eligibility
401(k) Plan
+4
Associate Director, Drug Substance Eng. & Materials
Associate Director, Drug Substance Eng. & Materials

Vertex Pharmaceuticals LLC • Boston (MA)

On-site
USD 180,000 - 240,000