Senior Director, External Manufacturing
Syndax Pharmaceuticals · New York, NY · 1 mo ago
RemoteRemoteManagement$270k–$290k/yrFull-time
We need to output HTML fragment with sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. We must not repeat job title. Must not include Job ID etc. Must remove boilerplate like EEO, navigation, etc. Must preserve all substantive info.
We need to parse the posting.
Content:
- Intro: "Syndax Pharmaceuticals is looking for a Senior Director, External Manufacturing At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies."
- "The Role: Reporting to the Senior Vice President, Pharmaceutical Development and Manufacturing, the Senior Director, External Manufacturing will lead business relationship management and ongoing operational oversight of Syndax’s global contract development and manufacturing organization network. Working across modalities, this role will ensure reliable, compliant, and cost-effective drug substance and drug product manufacturing for clinical and commercial programs. The role will partner closely with Chemistry, Manufacturing and Controls (CMC) technical leads on technology transfer, validation, and continued process verification, and Quality to support quality-system oversight, investigations, and corrective and preventive action follow-up."
- "Key Responsibilities:" then bullet list (actually sentences separated by periods). We need to convert to
- .
List items:
- Own the operating relationship with contract development and manufacturing organizations (CDMOs), including governance, business reviews, performance management, issue escalation, and executive engagement.
- Provide ongoing day-to-day operational oversight of external drug substance and drug product manufacturing for all clinical and commercial programs.
- Lead identification, evaluation, selection, onboarding, and business integration of manufacturing partners in collaboration with CMC technical, Quality, Supply Chain, Regulatory, and Finance functions.
- Partner with Drug Substance, Drug Product, and Analytical technical leads to ensure successful process development, technology transfer, validation, and continued process verification.
- Drive CDMO contract development and manufacturing organization readiness, coordination, commitment, and performance across the network.
- Partner with Quality to ensure manufacturing operations are performed in accordance with cGMP requirements.
- Monitor manufacturing plans and campaigns for schedule adherence, capacity, yield, cost, and supply performance, and drive timely resolution of operational risks.
- Establish clear performance measures and accountability for quality, delivery, technical execution, cost, service, and continuous improvement.
- Coordinate across Supply Chain and technical teams to align production plans, materials, capacity, inventory, and business continuity strategies.
- Identify and mitigate external manufacturing risks through alternate sourcing, capacity planning, scenario planning, and supplier improvement plans.
- Support regulatory filings, inspections, agency responses, commercial launches, and lifecycle activities by ensuring manufacturing partner readiness and execution.
- Support CDMO contract negotiations and development of budgets, forecasts, long-range network plans, and continuous improvement goals.
- Communicate manufacturing performance, risks, decisions, and recovery plans clearly to senior leadership and cross-functional teams.
- Build and develop a high-performing external manufacturing team as organizational needs grow.
- Represent the broader CMC/Pharmaceutical Development & Manufacturing Organization on cross functional program/asset teams as required.
- Travel internationally and domestically to manufacturing sites, suppliers, partners, and company offices as required.
- "Desired Experience/Education and Personal Attributes:" then list.
We need to map to sections: Requirements, Qualifications, Skills, Benefits, Pay, Schedule.
We have:
- Education: Bachelor’s degree in chemistry, chemical engineering, biochemistry, pharmaceutical sciences, or a related discipline required; advanced technical degree and/or MBA preferred.
- Experience: 15+ years of progressive pharmaceutical or biotechnology manufacturing experience, including substantial leadership of outsourced manufacturing and global external partners. Executive Director candidates should demonstrate broader network strategy, organizational leadership, and commercial accountability.
- Deep experience with small molecule API and oral solid dose manufacturing is required.
- Experience with biologics drug substance and sterile drug product fill and finish is strongly preferred.
- Experience launching new commercial products in the U.S. and international markets.
- Experience managing multiple international CDMOs across multiple regions and time zones is required.
- Demonstrated success managing external partner governance and driving operating performance improvements.
- Experience supporting technology transfer, process validation, continued process verification, regulatory filings, commercial launch, and ongoing commercial supply.
- Strong understanding of global good manufacturing practice requirements, quality systems, and inspection readiness, with the ability to work effectively within clear technical and Quality accountabilities.
- Sound technical and operational judgment, with experience resolving complex manufacturing and supply issues through cross-functional leadership.
- Ability to integrate manufacturing execution with supply, quality, regulatory, financial, and program priorities.
- Excellent leadership, communication, executive presence, and cross-functional influence in a fast-paced, matrixed, and geographically dispersed organization.
- Strategic and pragmatic leader who drives execution, makes timely decisions, and holds internal and external teams accountable.
- Ability to lead highly capable and technical site management teams through complex situations in a time constrained environment with confidence and poise to ensure successful outcomes for patients and for the business.
- Location: Syndax’s corporate office is in New York, NY.
- Syndax offers a total compensation and rewards package that is among the most competitive in the industry. Base pay is just one element of our package and is determined within a range based on several factors including market data, experience, qualifications, demonstrated skills, relevant education or training, travel requirements and internal equity. Our overall package also includes an equity offering, annual target bonuses, and an outstanding benefits program. The anticipated annualized salary range for this role is $270,000 - $290,000.
- About Syndax: description.
We need sections: About the role (maybe intro + The Role paragraph). Responsibilities (list). Requirements (maybe education + experience?). Qualifications (maybe desired experience/education?). Skills (maybe leadership, communication etc). Benefits (total compensation, equity, bonuses, benefits program). Pay (salary range). Schedule (maybe travel? Not explicit schedule; but we have travel internationally and domestically as required. That could be schedule? Not exactly schedule like full-time/part-time. There's no explicit schedule like "full-time". So we should not create Schedule section unless posting actually states schedule. It does not. So omit Schedule.
We must not include sections with filler like "commensurate with experience". We have real content for Pay (salary range). Benefits: we have total compensation package, equity offering, annual target bonuses, outstanding benefits program. That's substantive.
We need to decide which headings to use: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay. Possibly also "Location" but not in list; we could fold location into About the role or maybe not needed. The instructions: use headings for those specific section names. We should not add extra headings not in list. So we can include About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay.
We need to decide what goes where.
About the role: likely the introductory paragraph(s) describing the role, reporting line, purpose. Could include: "Syndax Pharmaceuticals is looking for a Senior Director, External Manufacturing At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies." plus "The Role: Reporting to the Senior Vice President, Pharmaceutical Development and Manufacturing, the Senior Director, External Manufacturing will lead business relationship management and ongoing operational oversight of Syndax’s global contract development and manufacturing organization network. Working across modalities, this role will ensure reliable, compliant, and cost-effective drug substance and drug product manufacturing for clinical and commercial programs. The role will partner closely with Chemistry, Manufacturing and Controls (CMC) technical leads on technology transfer, validation, and continued process verification, and Quality to support quality-system oversight, investigations, and corrective and preventive action follow-up."
That seems appropriate.
Responsibilities: the bullet list under Key Responsibilities.
Requirements: maybe education and basic experience requirements (Bachelor's degree required, 15+ years experience, small molecule API experience required, managing multiple international CDMOs required, etc). Could also include "Executive Director candidates should demonstrate broader network strategy..." but that's more for higher level. We'll put core requirements.
Qualifications: maybe preferred qualifications: advanced degree/MBA preferred, biologics experience strongly preferred, experience launching new commercial products, experience supporting technology transfer etc. Could also include "Demonstrated success managing external partner governance..." but that's maybe skill. We'll split.
Skills: leadership, communication, executive presence, cross-functional influence, strategic/pragmatic leader, ability to lead technical teams, sound technical judgment, ability to integrate manufacturing execution with supply etc.
Benefits: total compensation package, equity offering, annual target bonuses, outstanding benefits program.
Pay: anticipated annualized salary range $270,000 - $290,000.
We must not include boilerplate like EEO, About Syndax (maybe we could include as part of About the role? But About Syndax is separate description of company; could be considered "About the company" but not in allowed headings. We could fold into About the role? Might be okay but not required. The instruction: "Prefer a few substantive sections over many thin ones." We could include About Syndax as part of About the role? But it's about company not role. Might be better to omit because not required heading. However we must preserve ALL substantive information; we cannot omit company description. But we could include it under About the role as a paragraph? The heading is About the role, not About the company. But we could still include company description there; it's still substantive. The instruction: "use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." It doesn't forbid adding other content under those headings. So we can put company description under About the role. We must not include duplicated lines. Ensure we don't repeat. Now produce HTML fragment. Structure:
About the role
... (intro + role description + company overview)
Responsibilities
- ... ...
Requirements
- Bachelor’s degree in chemistry, chemical engineering, biochemistry, pharmaceutical sciences, or a related discipline required.
- Advanced technical degree and/or MBA preferred.
- 15+ years of progressive pharmaceutical or biotechnology manufacturing experience, including substantial leadership of outsourced manufacturing and global external partners.
- Deep experience with small molecule API and oral solid dose manufacturing is required.
- Experience managing multiple international CDMOs across multiple regions and time zones is required.
Qualifications
- Experience with biologics drug substance and sterile drug product fill and finish is strongly preferred.
- Experience launching new commercial products in the U.S. and international markets.
- Experience supporting technology transfer, process validation, continued process verification, regulatory filings, commercial launch, and ongoing commercial supply.
- Demonstrated success managing external partner governance and driving operating performance improvements.
- Strong understanding of global good manufacturing practice requirements, quality systems, and inspection readiness, with the ability to work effectively within clear technical and Quality accountabilities.
- Sound technical and operational judgment, with experience resolving complex manufacturing and supply issues through cross-functional leadership.
- Ability to integrate manufacturing execution with supply, quality, regulatory, financial, and program priorities.