AdvanCell

Manufactures Lead-212 for targeted alpha therapy

Director CMC - Precursor Development & Manufacturing

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours

Full-timeBoston, MA, USA$170k - $230k /yr

About the Job

Requirements

A Ph.D. in Chemistry, preferably Organic or Process Chemistry, or a related discipline.
Typically, 6 or more years of industry experience in CMC, process development, or technical operations.
Strong expertise in synthetic chemistry, including multi-step synthesis and impurity control.
Working knowledge of analytical development and validation, including high-performance liquid chromatography, liquid chromatography–mass spectrometry, and stability-indicating methods.
Advanced knowledge of good manufacturing practice manufacturing and regulatory expectations.
Strong understanding of International Council for Harmonisation guidelines and global regulatory requirements.
Demonstrated experience selecting and managing contract development and manufacturing organizations and external partners.
Ability to operate independently and effectively in a fast-paced, development-stage environment.
Demonstrated ability to deliver to timelines in high-pressure environments.

Responsibilities

Lead process development, optimization, and scale-up for precursor molecules and reference standards, including small molecules and peptide-based constructs.
Provide subject matter expertise in synthetic organic and process chemistry, including route design, impurity control, and process robustness.
Partner with the Associate Director of Analytical Development to guide analytical development activities and ensure methods are good manufacturing practice-ready, fit for intended use, and capable of supporting manufacturing, release, and stability programs.
Ensure good manufacturing practice-compliant manufacturing of precursor materials at contract development and manufacturing organizations.
Support technology transfer and scale-up activities for clinical and commercial manufacturing.
Ensure chemistry, manufacturing, and controls activities align with International Council for Harmonisation guidelines and global regulatory requirements for drug substance development.
Prepare and review chemistry, manufacturing, and controls documentation for regulatory submissions, including Investigational New Drug, Clinical Trial Application, and Marketing Authorisation Application submissions.
Partner with Quality Assurance on deviations, investigations, change controls, and audit readiness.
Drive continuous improvement in process efficiency, robustness, and cost of goods.
Support material specifications, control strategies, and impurity fate and purge assessments.
Provide technical input to supply chain planning and risk mitigation strategies.
Mentor and develop CMC staff and foster a strong technical culture.
Observe the company’s workplace, health and safety, and regulatory policies and procedures.
Engage and communicate with other company business unit staff to ensure activities are coordinated seamlessly and effectively.
Adhere to the company’s quality management system processes and policies.
Perform other tasks as requested by the Vice President of CMC and Supply Chain.

Desired Qualifications

Experience in radiopharmaceutical or radiochemistry environments.
Familiarity with chelator chemistry and metal complexation.
Experience supporting regulatory submissions, including Investigational New Drug, Clinical Trial Application, New Drug Application, and Marketing Authorisation Application submissions.
Knowledge of chemistry, manufacturing, and controls strategies for early- and late-phase development.

Salary Range: 170000 to 230000 (Currency: USD) (Pay period: per-year-salary)

The Director, CMC – Precursor Development & Manufacturing is responsible for the development, optimization, manufacturing, and lifecycle management of precursor molecules and related reference standards used in the Company’s radiopharmaceutical products. This role provides technical leadership across synthetic chemistry, process development, analytical development, and GMP manufacturing of complex small molecules, including peptide-based and chelator-containing precursors.

The successful candidate will work closely with external contract development and manufacturing organizations (CDMOs) to build process understanding, support analytical method development and validation, and ensure alignment with global regulatory expectations (e.g., ICH, GMP). This work enables the timely delivery of high-quality drug substance and reference standards for clinical and commercial manufacturing. The Director also supports CDMO selection and shipping logistics for precursor materials.

The role also includes leading CMC regulatory writing and documentation to support regulatory submissions for precursors and related reference standards.

Key Responsibilities and Duties

Lead process development, optimization, and scale-up for precursor molecules and reference standards, including small molecules and peptide-based constructs

Provide subject matter expertise in synthetic organic and process chemistry, including route design, impurity control, and process robustness

Partner with the Associate Director of Analytical Development to guide analytical development activities and ensure methods are GMP-ready, fit for intended use, and capable of supporting manufacturing, release, and stability programs.

Ensure GMP-compliant manufacturing of precursor materials at CDMOs

Support technology transfer and scale-up activities for clinical and commercial manufacturing

Ensure CMC activities align with ICH guidelines and global regulatory requirements for drug substance development

Prepare and review CMC documentation for regulatory submissions (e.g., IND/CTA/MAA)

Partner with Quality Assurance on deviations, investigations, change controls, and audit readiness

Drive continuous improvement in process efficiency, robustness, and cost of goods

Support material specifications, control strategies, and impurity fate and purge assessments

Provide technical input to supply chain planning and risk mitigation strategies

Mentor and develop CMC staff and foster a strong technical culture

Other Responsibilities

Observe the Company’s workplace, health and safety, and regulatory policies and procedures

Engage and communicate with other AdvanCell business unit staff to ensure that activities are coordinated seamlessly and effectively

Adhere to the Company’s quality management system processes and policies

Other tasks as requested by the VP, CMC and Supply Chain

Essential Skills, Qualifications, Industry and Educational Requirements

Ph.D. in Chemistry (preferably Organic or Process Chemistry) or related discipline

Significant industry experience (typically 6+ years) in CMC, process development, or technical operations

Strong expertise in synthetic chemistry, including multi-step synthesis and impurity control

Working knowledge of analytical development and validation (e.g., HPLC, LC-MS, stability-indicating methods)

Advanced knowledge of GMP manufacturing and regulatory expectations

Strong understanding of ICH guidelines and global regulatory requirements

Demonstrated experience selecting and managing CDMOs and external partners

Excellent problem-solving, communication, and leadership skills

Ability to operate independently and effectively in a fast-paced, development-stage environment

Demonstrated ability to deliver to timelines in high-pressure environments

Desirable Skills, Qualifications, Industry and Educational Requirements

Experience in radiopharmaceutical or radiochemistry environments

Familiarity with chelator chemistry and metal complexation

Experience supporting regulatory submissions (e.g., IND/CTA/NDA/MAA)

Knowledge of CMC strategies for early- and late-phase development

About the Company

AdvanCell

Manufactures Lead-212 for targeted alpha therapy

AdvanCell develops radiopharmaceuticals for targeted alpha therapy, using Lead-212 and an on-demand Alpha Isotope Generator to produce the isotope daily. Its core product ADVC-001 targets PSMA to treat metastatic castration-resistant prostate cancer, evaluated in the multicenter TheraPb Phase I/II trial, while the company also pipelines other cancer therapies. The approach combines isotope production, drug manufacturing, and clinical development in a vertically integrated model to ensure reliable supply and faster development. Its goal is to speed patient access to radiopharmaceutical treatments by expanding its portfolio through collaborations, including a strategic partnership with Eli Lilly, and advancing clinical trials.

Company size: 51-200
Company stage: Series D
Total funding: $440.8M
Headquarters: Sydney NSW, Australia
Founded: 2019

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