The Sr. Director, Process Sciences will build and lead the company's CMC capability across drug substance process development, scale-up, analytical sciences, and GLP/GMP readiness. The role owns the path from bench-scale synthesis of small-molecule payloads, linkers, and dendrimer conjugates to robust, transferable processes that supply GLP toxicology and clinical studies. This leader will be a hands-on scientific authority and a strategic member of the executive team, translating chemistry and engineering decisions into timelines, budgets, and regulatory filings.
The ideal candidate is a PhD chemical engineer with deep command of organic chemistry, a track record of scaling small-molecule manufacturing processes, expertise in analytical method development and validation, and practical fluency in GLP and cGMP requirements gained by moving programs into the clinic.
Key Responsibilities Process Development and Scale-Up - Lead route scouting, process chemistry, and process engineering for small-molecule payloads, linker intermediates, and dendrimer-drug conjugates, from gram to multi-kilogram scale.
- Apply chemical engineering principles-reaction kinetics, thermodynamics, heat and mass transfer, mixing, crystallization, and separations-to design safe, scalable, and economical processes.
- Drive Quality by Design (QbD): define critical quality attributes and critical process parameters, run risk assessments (FMEA), and use design of experiments (DoE) to establish proven acceptable ranges and control strategies.
- Develop purification, isolation, and drying strategies (chromatography, tangential flow filtration, precipitation, crystallization) appropriate to both small molecules and macromolecular conjugates.
- Oversee process safety assessment (reaction calorimetry, thermal hazard evaluation) and impurity fate-and-purge studies, including mutagenic impurity assessment under ICH M7.
Analytical Sciences - Build the analytical strategy for drug substance and drug product, including identity, assay, purity, residual solvents, elemental impurities, conjugation ratio or payload loading, and molecular-weight distribution.
- Direct method development, qualification, and validation per ICH Q2(R2) and Q14 using HPLC/UPLC, LC-MS, GC, NMR, SEC, ion chromatography, and other orthogonal techniques.
- Set phase-appropriate specifications, reference-standard programs, and ICH Q1A-compliant stability studies; author justifications of specifications.
- Ensure analytical methods are fit for the matrices and formulations used in each program and are transferred successfully to contract laboratories.
GLP/GMP Compliance and Regulatory CMC - Ensure that GLP toxicology batches and clinical supply are manufactured, tested, and released in compliance with 21 CFR Part 58, 21 CFR Parts 210/211, and ICH Q7, in partnership with Quality Assurance.
- Author and review CMC sections (Module 3 / IMPD) for INDs, CTAs, and amendments; lead CMC interactions with FDA and other health authorities, including pre-IND and end-of-phase meetings.
- Establish phase-appropriate documentation: batch records, process descriptions, development reports, deviation and CAPA management, change control, and technology transfer packages.
- Prepare the organization for regulatory inspections and CDMO audits; ensure data integrity (ALCOA+) across internal and external work.
Leadership and Strategy - In addition to relevant, deep scientific expertise the successful candidate must will also be expected to have strong business acumen and organizational/people leadership
- Has demonstrated the ability to perform a talent gap analysis, uses the information to develop a workforce plan which supports the business needs of the organization. Translates business needs into job design for individual positions.
- Maximizes the potential of employees through real-time coaching, regular career development discussions, partnering with employees to support career aspirations.
- Set scientific standards and a culture of rigor and accountability.
- Understands and can articulate the business model and strategic objectives of the company. Translates the corporate objectives into actionable business plan for the functional areas.
- Has the financial acumen and owns the development, execution and tracking of a comprehensive budget. Leads the development of RFP's, vendor selection, contract negotiation and management of outside resources.
- Performs proactive risk analysis and develops back up plans to ensure business objectives are accomplished.
- Able to analyze/ quantify the effectiveness of plans and articulate ROI balancing quality, speed & cost.
- Own the integrated timelines, and risk register; communicate trade-offs clearly to the CEO, Board, and partners.
- Represent CMC in investor, partner, and business-development due diligence; contribute to platform IP through invention disclosures and process patents.
- Partner closely with discovery chemistry, pharmacology, toxicology, formulation, clinical, and regulatory functions to ensure CMC readiness never gates program progress.
First-Year Objectives - Lock scalable, documented processes for lead drug substance(s) and deliver GLP toxicology material on schedule.
- Establish a phase-appropriate analytical control strategy, with qualified methods and stability programs in place for IND submission.
- Author the CMC sections of the first IND and support a successful regulatory review.
- Qualify primary CDMO and testing partners, and deliver the first GMP clinical supply campaign.
- Recruit the core Process Sciences team and implement a CMC risk and budget framework reported regularly to the executive team and Board.
Qualifications Required - PhD in Chemical Engineering; strong foundation in organic and physical chemistry.
- 12+ years of pharmaceutical or biotechnology industry experience in process development and scale-up of small-molecule drug substances, including 5+ years leading teams.
- Demonstrated success moving at least one program from preclinical development through IND and into clinical manufacturing.
- Deep expertise in analytical chemistry, including chromatographic and spectroscopic methods, method validation, specifications, and stability.
- Thorough working knowledge of GLP and cGMP regulations and ICH guidelines (Q1, Q2, Q3A/B/C/D, Q7, Q8-Q11, Q14, M7).
- Hands-on experience authoring CMC regulatory submissions and leading CDMO relationships, including international partners.
- Exceptional written and verbal communication; able to explain complex technical risk to non-specialist executives, Board members, and investors.
- Strong business acumen and demonstrated experience in organizational and people leadership.
Preferred - Experience with polymer, dendrimer, nanoparticle, antibody-drug conjugate, or other macromolecular conjugate chemistries.
- Background in continuous processing, process analytical technology (PAT), or process modeling.
- Familiarity with radiopharmaceutical precursors or oral solid dosage form development.
- Experience in a startup or small-company setting where CMC leadership is both strategic and hands-on.
- Track record of process patents and peer-reviewed publications.
Leadership Attributes - Rigorous and pragmatic - balances scientific depth with pragmatic, phase-appropriate decisions.
- Accountable - takes ownership of outcomes, delivers on commitments, and escalates risk early.
- Collaborative - works seamlessly across disciplines, cultures, and external partners.
- Entrepreneurial - comfortable with ambiguity and able to build systems from first principles.
Compensation and BenefitsThe anticipated base salary range for this role is $250,000-$290,000, plus an annual performance bonus target of 20% of base and a meaningful equity grant. Actual pay will be determined by experience, qualifications and level of competency compared to the position criteria. We believe in providing the best health care alternatives for you and your family. Employees may select from a variety of medical, dental, and vision plans where 100% of the premiums are paid for by the company for you and your family. We also offer a 401(k) plan, flexible paid time off and up to 11 paid holidays per year.
