Senior Manager Drug Product Development And Manufacturing

Actalent • Burlington, MA • 6h ago

Sr Scientist, Drug Product Development

Location: Burlington, MA

About the Opportunity

Our client is seeking an experienced Sr Scientist, Drug Product Development to lead formulation, process development, and technology transfer activities for biologic drug products. This individual will play a key role in advancing both late-stage clinical and commercial programs, working closely with cross-functional teams and external manufacturing partners to ensure successful development and scale-up of sterile biologic therapies.

Key Responsibilities

Lead technology transfer activities for late-stage and commercial manufacturing of sterile liquid and lyophilized biologic drug products at contract manufacturing organizations (CMOs).

Design and oversee process development, optimization, and characterization studies to support product development and manufacturing readiness.

Evaluate the developability and manufacturability of early-stage biologic candidates and collaborate with discovery teams to support candidate selection.

Author, review, and maintain technical reports, study protocols, regulatory documentation, and other CMC-related materials.

Monitor project timelines, communicate progress updates, and proactively identify and mitigate development risks.

Serve as a primary technical liaison with CMOs, CROs, and other external partners to ensure project milestones are achieved.

Support sterile fill-finish process development and manufacturing activities for clinical and commercial products.

Collaborate cross-functionally with Development, Manufacturing, Quality, Regulatory, and Technical Operations teams.

Qualifications

PhD, MS, or BS in Pharmaceutical Sciences, Biochemistry, Bioengineering, Chemistry, or a related scientific discipline.

Minimum of:

5+ years of industry experience for candidates with a PhD or MS, or

10+ years of industry experience for candidates with a BS.

Proven experience in biologics formulation development and drug product process development.

Hands-on experience supporting monoclonal antibodies and/or other biologic therapeutic products.

Strong experience in sterile liquid and/or lyophilized drug product development.

Demonstrated success managing external CMOs for technology transfer, process development, and sterile fill-finish manufacturing activities.

Preferred Experience

CMC strategy and documentation

Process characterization and process validation

Technology transfer and scale-up activities

Lyophilization process development

Sterile manufacturing and fill-finish operations

Vendor and external partner management

Commercial biologics manufacturing

If interested please reach out directly to Lindsee Allienello at lallienello @ actalentservices.com.

Job Type & Location

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

Application Deadline

This position is anticipated to close on Sep 23, 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.

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