Demo

CMC Manager

Actalent
Watertown, MA Full Time
POSTED ON 3/6/2025
AVAILABLE BEFORE 6/5/2025

Job Title : CMC Project ManagerJob Description

We are seeking a highly skilled CMC Project Manager to join our team. This individual will partner with CMC teams to build project timelines, milestones, risk registers, and mitigation plans supporting CMC development and manufacturing activities related to our clinical pipeline. The role involves proactive collaboration with Process and Analytical Science, Quality, Manufacturing, and Supply Chain teams to ensure alignment of CMC activities with overall project goals.

Responsibilities

Partner with CMC teams to build project timelines, milestones, risk registers, and mitigation plans.

Ensure CMC activities align with overall project goals in collaboration with Process and Analytical Science, Quality, Manufacturing, and Supply Chain teams.

Track and ensure CMC milestones are delivered on-time, in-full, and within budget.

Maintain compliance and high-quality standards throughout project execution.

Identify and escalate issues as appropriate through governance bodies, taking full ownership to drive issue resolution.

Essential Skills

CMC development and product development experience.

CMC project management and program management expertise.

Experience in cell therapy development.

Understanding of regulatory CMC requirements and cGMP compliance.

Advanced degree (BS / MS or PhD) in Life Sciences.

At least 5-10 years of technical operations experience within the biopharmaceutical industry.

Additional Skills & Qualifications

Strong leadership and people skills.

Experience managing cross-functional teams responsible for the development and manufacturing of cellular drug products.

Work Environment

You will work first shift Monday to Friday from 9 : 00 am to 5 : 00 pm on a hybrid schedule, with a minimum of 3 days per week in the office, although more is preferred. The work environment is business casual, and the company culture is strong, featuring regular outings, game nights, and free snacks for all employees.

Pay and Benefits

The pay range for this position is $70.00 - $85.00 / hr.

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 Mar 10, 2025.

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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through :

Hiring diverse talent

Maintaining an inclusive environment through persistent self-reflection

Building a culture of care, engagement, and recognition with clear outcomes

Ensuring growth opportunities for our people

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 ( actalentaccommodation@actalentservices.com) for other accommodation options.

Salary : $70 - $85

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