Associate Director CMC Technical Development

Job Title: Associate Director, CMC Technical Development

The position is part-time at approximately 20 hours per week, with typical working hours in the morning aligned to Eastern Time to facilitate collaboration with development, quality, regulatory, and manufacturing partners.

The Associate Director, CMC Technical Development provides technical leadership and comprehensive program oversight for oligonucleotide-based therapeutic programs, with a focus on PMO and siRNA platforms. This role drives CMC execution across drug substance and drug product development, manufacturing, scale-up, and commercialization readiness, while coordinating and managing external CDMOs and CMOs and ensuring robust technology transfer between internal teams and manufacturing partners. The position plays a key role in establishing high-quality, compliant processes and documentation to support early-phase GMP manufacturing, process development initiatives, and overall CMC strategy for oligonucleotide modalities.

Responsibilities

• Provide technical leadership for oligonucleotide-based therapeutic programs, with emphasis on PMO and siRNA platforms.
• Lead CMC technical development activities across the full drug substance and drug product development lifecycle.
• Coordinate and manage external CDMOs and CMOs supporting development, manufacturing, and scale-up activities.
• Drive CMC execution from early-phase development through commercialization readiness initiatives.
• Lead and support technology transfer activities between internal development teams and external manufacturing partners.
• Review manufacturing batch records and associated GMP documentation to ensure accuracy, completeness, and compliance.
• Oversee development timelines, risks, and deliverables, maintaining clear cross-functional communication and alignment.
• Ensure quality systems and manufacturing processes adhere to GMP regulations and industry best practices.
• Support early-phase GMP manufacturing activities and related process development initiatives for oligonucleotide therapeutics.
• Collaborate closely with analytical development, formulation development, product development, quality, regulatory, and manufacturing stakeholders to align CMC strategies and execution.
• Identify and implement process improvements to enhance robustness, efficiency, and scalability of manufacturing processes.
• Proactively identify, assess, and mitigate technical and operational risks across development and manufacturing programs.
• Provide PMO-style program leadership across development and manufacturing initiatives, ensuring effective governance, tracking, and reporting.
• Manage relationships with CDMOs and CMOs, including performance oversight and resolution of technical development and manufacturing issues.
• Contribute to the development, review, and continuous improvement of quality systems, including deviations, investigations, CAPAs, and change control.
• Operate independently in a consulting-oriented environment, taking ownership of projects and delivering high-quality outcomes.
• Run and oversee the CMC function, serving as a key technical and strategic partner for tech transfer and manufacturing scale-up activities.

Essential Skills

• Bachelor"s, Master"s, or PhD in Chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or a related scientific discipline.
• 10+ years of experience in the pharmaceutical or biotechnology industry.
• Direct experience supporting oligonucleotide therapeutics, including PMOs, siRNA, ASOs, or related nucleic acid modalities.
• Strong CMC development experience in drug substance and/or drug product development.
• Demonstrated experience with technology transfer activities from development to manufacturing environments.
• Proven experience managing external CDMO and CMO relationships for development and GMP manufacturing.
• Experience in manufacturing scale-up for oligonucleotide or related modalities.
• Strong understanding of GMP regulations and quality systems, including deviations, investigations, CAPAs, and change control.
• Hands-on experience reviewing batch records and manufacturing documentation for GMP compliance.
• Demonstrated PMO or program leadership experience across development and manufacturing organizations.
• Ability to operate independently and effectively in a consulting environment.
• Expertise in CMC technical development for oligonucleotides and related platforms.
• Experience with manufacturing oversight in GMP environments.

Additional Skills & Qualifications

• Experience with phosphorodiamidate morpholino oligomer (PMO) development.
• Experience in early-phase development of oligonucleotide therapeutics.
• Familiarity with siRNA and other oligonucleotide platforms in a technical development context.
• Experience in scale-up activities for oligonucleotide manufacturing processes.
• Knowledge of industry best practices for quality systems and GMP manufacturing in the biotech and pharmaceutical sectors.
• Strong program management skills, including the ability to oversee timelines, risks, and deliverables.
• Excellent communication skills to support effective cross-functional collaboration.
• Ability to build and maintain effective working relationships with internal stakeholders and external partners.
• Comfort working in a remote, consulting-style role with a high degree of autonomy and responsibility.

Work Environment

This role operates in a 100% remote work environment, with flexibility to work from an office if preferred. The work is conducted in a consulting-style setting that emphasizes autonomy, accountability, and close virtual collaboration across cross-functional teams, using standard digital communication and project management tools to support CMC and technical development activities.

Job Type & Location

This is a Contract position based out of Waltham, MA.

Pay and Benefits

The pay range for this position is $110.00 - $120.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a hybrid position in Waltham,MA.

Application Deadline

This position is anticipated to close on Sep 18, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.