Senior Manager Analytical Development

Actalent

United States

Hybrid

USD 110,000 - 131,000

Full time

10 days ago
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Benefits offered by this job

Medical benefits
Dental and vision
401(k) retirement plan
Life insurance
Disability insurance
Health Savings Account
Transportation benefits
Employee Assistance Program
Paid time off

Job summary

Actalent seeks an expert to lead analytical strategy for PMO and conjugated oligonucleotide development programs. You will design and oversee analytics method development, optimization, and qualification, and support characterization of drug substances, intermediates, impurities, and degradants.

The role requires 8+ years in analytical development, experience with oligonucleotide therapeutics, and collaboration with CRO/CDMO partners. Hybrid-based in Waltham, MA with contract engagement.

Qualifications

  • Bachelor's degree required in a related field.
  • 8+ years of experience in analytical development.
  • Experience supporting oligonucleotide therapeutics.
  • Experience with PMO or related oligonucleotide modalities.
  • Experience supporting IND, CTA, BLA, or NDA submissions.
  • Experience with drug substance conjugates.
  • Leadership experience in biotech/pharma environments.
  • Experience managing external CRO/CDMO analytical activities.

Responsibilities

  • Lead analytical strategy for PMO and conjugated oligonucleotide programs.
  • Design, develop, optimize, and qualify analytical methods.
  • Support characterization of drug substances, intermediates, impurities, and degradants.
  • Provide technical oversight of external labs and CDMOs.
  • Review analytical protocols, reports, investigations, and development documentation.
  • Support specification setting and lifecycle management; contribute to regulatory filings.

Skills

Oligonucleotide therapeutics knowledge
PMO chemistry
Analytical strategy leadership

Education

Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline

Job description

Description

Lead analytical strategy for Phosphorodiamidate Morpholino Oligomer and conjugated oligonucleotide development programs

Design and oversee analytical method development, optimization, and qualification activities

Support characterization of drug substance, intermediates, impurities, and degradation products

Provide technical oversight of external analytical laboratories and CDMO partners

Review analytical protocols, reports, investigations, and development documentation

Support specification setting and lifecycle management activities

Contribute to regulatory filings and health authority responses

Partner with process development teams to support manufacturing scale-up and technology transfer

Evaluate analytical risks and recommend mitigation strategies

Drive technical decision making and provide subject matter expertise across CMC functions

Additional Skills & Qualifications

Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline

8+ years industry experience within analytical development

Prior experience supporting oligonucleotide therapeutics

Experience with PMO or related oligonucleotide modalities

Experience supporting IND, CTA, BLA, or NDA submissions

Experience with drug substance conjugates

Previous biotech or pharmaceutical leadership experience

Experience managing external CRO/CDMO analytical activities

Experience Level

Expert Level

Job Type & Location

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

Pay and Benefits

The pay range for this position is $80.00 - $95.00/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 jobclassification and length of employment. Benefits are subject to change and may besubject 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 25, 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 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 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.

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