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Adc Cmc Jobs (NOW HIRING)

Ideayabio

Director, ADC & MSAT

South San Francisco, CA · On-site

This role will be an integral part of a team built to execute the CMC strategy required to advance ADC programs through clinical development and successfully enable global commercial launch and post ...

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Director, Regulatory Affairs - CMC

Blue Bell, PA · Remote

$143K - $189K/yr

... ADC & Vaccines), Peptides and Radiopharmaceuticals in particular with CMC experience. Responsibilities * Serve as a technical expert in development, testing and manufacturing of Biologics and ...

ICON

Director, Regulatory Affairs - CMC

Blue Bell, PA · On-site

$143K - $189K/yr

... ADC & Vaccines), Peptides and Radiopharmaceuticals in particular with CMC experience. Responsibilities * Serve as a technical expert in development, testing and manufacturing of Biologics and ...

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Adc Cmc information

What are the key skills and qualifications needed to thrive as an ADC CMC professional, and why are they important?

To thrive as an ADC CMC (Antibody-Drug Conjugate Chemistry, Manufacturing, and Controls) professional, you need a solid background in biochemistry, pharmaceutical sciences, or chemical engineering, often supported by an advanced degree (MS/PhD). Familiarity with analytical techniques (HPLC, LC-MS), regulatory guidelines (ICH, FDA), and documentation systems is essential. Strong project management, problem-solving abilities, and cross-functional communication are valuable soft skills in this role. These competencies ensure the development, quality, and regulatory compliance of ADC therapeutics, which are critical for patient safety and successful product approval.

What are some typical challenges faced by professionals in ADC CMC roles, and how can they be addressed?

Professionals in ADC CMC (Antibody-Drug Conjugate Chemistry, Manufacturing, and Controls) roles often face challenges such as ensuring the stability and consistency of complex biologic-drug conjugates, meeting stringent regulatory requirements, and coordinating cross-functional teams. Addressing these challenges involves staying current with evolving regulatory guidelines, implementing robust quality control processes, and fostering strong communication between analytical, process development, and regulatory teams. Proactively managing timelines and risks is also key to successful ADC CMC project execution.

What are ADC CMC roles?

ADC CMC stands for Antibody-Drug Conjugates Chemistry, Manufacturing, and Controls. Professionals in ADC CMC roles are responsible for overseeing the development, manufacturing, and regulatory compliance of ADCs, ensuring product quality, safety, and efficacy throughout the drug lifecycle. Their work includes process development, scale-up, analytical testing, and documentation necessary for regulatory submissions. They collaborate closely with cross-functional teams in research, manufacturing, and quality assurance to bring ADC drugs from the lab to the market.

What is the difference between Adc Cmc vs Pharmaceutical Manufacturing Technician?

AspectAdc CmcPharmaceutical Manufacturing Technician
CredentialsOften requires a degree in chemistry, pharmacy, or related field; certifications in GMP are commonTypically requires a high school diploma or associate degree; GMP training may be provided
Work EnvironmentLaboratories, quality control labs, and manufacturing facilitiesProduction lines, manufacturing plants, and packaging areas
Industry UsageUsed in pharmaceutical development, formulation, and regulatory complianceInvolved in the actual manufacturing and assembly of pharmaceutical products

Adc Cmc professionals focus on drug development, formulation, and regulatory aspects, often working in labs. In contrast, Pharmaceutical Manufacturing Technicians are primarily involved in the production process, operating equipment and ensuring product quality on the manufacturing floor.

Infographic showing various Adc Cmc job openings in the United States as of May 2026, with employment types broken down into 1% Locum Tenens, 3% As Needed, 80% Full Time, 13% Part Time, 2% Contract, and 1% Nights. Highlights an 92% Physical, 4% Hybrid, and 4% Remote job distribution.

Executive Director, CMC

InduPro Therapeutics

Seattle, WA

Full-time

Posted 25 days ago

Job description

About InduPro
InduPro, Inc. is bringing life-changing therapies to patients through novel cell-surface platform technologies. We are defining and manipulating protein interactions beyond natural signaling paradigms. InduPro platforms integrate inherent protein proximity at the cell surface with the ability to manipulate protein pairings via induced protein proximity to create novel signaling pathways and logic gates. Our culture fosters innovation at every level.

The OpportunityWe are seeking a highly-motivated and collaborative Executive Director with strong leadership and technical skills to oversee CMC activities for our ADC programs including: cell line, drug substance, drug product, process development, analytical development, cGMP manufacturing and stability studies, and clinical packaging labeling and distribution. This role will serve as the main point of contact with CDMOs and work within a cross-functional team, including representatives from research, translational, operations, clinical, and finance departments to successful advance programs through the clinic. This is an exciting, high visibility role for a seasoned individual looking to make an impact in a startup company.
Key Responsibilities:
  • Establish, manage and lead CMC strategy and execution for assigned programs for drug substances and drug products from pre-clinical through commercial development with close attention to timelines and budget.
  • Select third-party vendors, negotiate effective supply/technical agreements. Identify contract analytical laboratory sites required to guide and support third party manufacturing relationships.
  • Direct/oversee contract manufacturing, testing, packaging and labeling operations for the company’s drug substances and drug products. Act as primary liaison with contractor(s) on assigned projects. Guide external operations through tech transfer, process and method development, optimization, qualification and validation of the activities related to all manufacturing operations in compliance with GMP.
  • Participate in product development project teams as CMC functional area representative.
  • Support the creation of SOPs and guidelines related to the production, planning, disposition and management, materials, etc. in compliance with GMP.
  • Work with consultants for Regulatory and QA, alongside Senior Management to ensure that all company policies are adhered to and all external manufacturing activities comply with relevant regulations.
  • Maintain knowledge of current best practices of biological manufacturing. Identify emerging trends and technologies and lead implementation/feasibility assessment, as appropriate.
  • Design and execute the CMC development plan to support global submissions.
  • Prepare CMC regulatory filing sections (domestic and international) including Module 3 and review of supporting documentation.
  • Review and approve master and executed batch records from all manufacturing activities; analytical release testing, stability studies and investigations, as required.
  • Develop production plans to support preclinical, clinical, and commercial development and adjust plans as appropriate to meet corporate objectives.
  • Provide comprehensive project analysis to senior management as required in the form of reports or presentations as needed.
Education & Experience:
  • BS/MS or PhD in a relevant discipline.
  • A minimum of 10 years of experience in CMC project management, development, scale-up and clinical/commercial development and manufacturing of biologic products in the biotechnology or pharmaceutical industry. At least 5 years of experience in a leadership role.
  • Experience in leading and direct management of research, process development, and manufacturing.
  • Extensive experience in leading biological process and analytical development.
  • Previous experience leading cross-functional project teams, and familiarity with the drug development process, including transitions from pre-clinical to clinical development.
  • Experience managing contract development and manufacturing (CDMO) partnerships strongly preferred.
  • ADC experience strongly preferred.
  • Hands on experience in more than one of the following CMC functions; drug substance, drug product, analytical development, process development, and stability, or program management.
  • Experience developing and manufacturing aseptic biologic products.
  • Experience authoring successful IND and IMPD CMC regulatory submissions.
  • Familiarity with small start-up environments is strongly preferred.
  • Team player that is able to think creatively and integrate perspectives from different functional areas.
  • Strong leadership skills with demonstrated track record of success.
  • Excellent oral and written communication skills.
  • Able to effectively balance technical program requirements with business needs.
Physical Work Requirements:
  • Prolonged periods sitting at a desk and working on a computer
Travel Requirements:

This position does not generally require travel.

Physical presence at the InduPro worksite, or in the field, is required for this role. At InduPro we believe that physical presence helps enhance collaboration, innovation, productivity, employee well-being, employee engagement, and Company culture.

Benefits
At InduPro we believe that being face to face helps enhance collaboration, innovation, productivity, employee well-being, employee engagement, and Company culture.

Every member of the InduPro team plays a role in shaping our science and our culture in a dynamic startup environment. We offer a competitive total compensation package, including stock options, participation in an annual performance bonus incentive program, a comprehensive benefits package, paid time off, and exciting opportunities for professional development.

Benefits include medical, dental, and vision coverage; company-paid life and disability insurance; supplemental life and disability insurance; voluntary accident, critical illness, and hospital indemnity insurance; a 401(k) plan with employer matching contributions; flexible spending accounts; an employee assistance program; flexible paid time off; 10 paid company holidays; and employee access to voluntary auto, home, legal, and pet insurance.

InduPro, Inc. is an equal opportunity employer. All qualified applicants will be considered for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability, or any other status protected by federal, state, or local law.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.