Senior Manager Drug Product Development And Manufacturing

Job Description

Job Description

Description

•Lead tech transfer activities for late-phase and commercial manufacturing of sterile liquid and lyophilized biologics drug products at CMOs.•Design process development and characterization studies, and perform or oversee study execution.•Conduct developability and manufacturability studies for early-phase lead candidates and collaborate with the Discovery team to support drug candidate selection.•Author and review study protocols and reports and other CMC documentation.•Summarize and communicate project updates, risks, and recommendations to stakeholders.•Manage external partners (CROs/CMOs) to advance project milestones.

Skills

tech transfer, Cmc, CMO, process development and characterization studies, formulation development, fill finish, lyophilizers, vendor management, biologics, antibodies

Top Skills Details

tech transfer,Cmc,CMO,process development and characterization studies,formulation development,fill finish

Additional Skills & Qualifications

•PhD or MS or BS in pharmaceutical sciences, biochemistry, bioengineering, chemistry, or a related discipline, with 5+ years (PhD/MS) or 10+ years (BS) of hands-on experience in biologics formulation development and drug product process development.•Experience with monoclonal antibodies or other biologic drug products, including sterile liquid and/or lyophilized products.•Demonstrated experience managing CMOs for sterile biologic drug product technology transfer, process development, and sterile fill/finish manufacturing.

Experience Level

Expert Level

Job Type & Location

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

Pay and Benefits

The pay range for this position is $75.00 - $90.00/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 fully onsite position in Lexington,MA.

Application Deadline

This position is anticipated to close on Sep 3, 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 withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email View email address on us.fitly.work for other accommodation options.

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

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall 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 applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.