Senior R&D Chemist

Hiring for Senior & Principal Chemist roles!

Description

Provides analytical and technical support to new product development. Completes method development, validations, USP/PF method verification, and various laboratory support functions. Participates in new technology evaluation and application. Provide coaching and mentoring to junior chemists.

Responsible for development and validation of assigned analytical methods such as assay and impurities/degradation products, residual solvents, content/blend uniformity and dissolutions. Author method development reports, method validation protocols/reports. Execute method validation testing.

Develops robust methods that are time tested in a routine quality control environment. Leads method troubleshooting and rectifies challenges effectively using a variety of techniques including advanced principles and concepts

Reads understands and follows the current USP/NF, laboratory SOPs, analytical methods and study protocols. Applies applicable ICH and FDA guidelines to analytical method development and validations.

Assists with establishing specifications for APIs, excipients and drug products. Develops justification of these specifications to be included in regulatory submissions.

Documents equipment usages and analytical results in a manner that is consistent with cGMP, in-house SOPs, and can be readily followed by reviewers

Is able to describe a testing challenge and present supporting data effectively in either a 1:1 or a small group setting.

Reviews raw data timely and ensures it meets cGMPs and in-house SOPs, is scientifically sound and can be readily followed by auditors

Shows expertise with analytical instruments such as HPLCs, GCs, dissolution apparatus, and other analytical equipment. Actively solves instrumentation issues and assists others with instrumentation startup and troubleshooting

Serves as instrument owner. Perform requirement function including reviews and audits instrument calibrations. Performs routine instrument maintenance, and calibrations if needed. Oversees the qualification of new instruments and software when needed.

Maintains personal and shared work space in an organized manner. Cleans laboratory glassware and actively participates in lab-wide routine clean up and inspection activities.

Identifies potential training, efficiency, compliance and and/or safety concerns and brings solutions to management. Actively participates in and leads the implementation of continuous improvement efforts associated with laboratory operation

Ensures that analytical laboratory functions (e.g. methods and validations) of the CMC submission are completed according to ICH/FDA guidelines. Coordinates the gathering of necessary documents and assists with writing portions of the CMC submission document.

Qualifications

Senior :

Bachelor's degree in chemistry or related field and 5+ years of analytical chemistry experience

OR master's degree with 3+ years of experience

OR phd with 1+ year of experience in analytical method development in pharmaceutical industry

Principal:

Bachelor's degree in chemistry or related field and 10+ years of analytical chemistry experience

OR master's degree with 6+ years of experience

OR phd with 3+ years of experience in analytical method development in pharmaceutical industry

Preferred-

Analytical experience including HPLC, GC, dissolution

Method development experience

Method validation experience

Pharmaceutical or Medical Device experience

Pay and Benefits

The pay range for this position is $35.00 - $60.00/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 fully onsite position in Plymouth,MN.

Application Deadline

This position is anticipated to close on Sep 3, 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.

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 due to a disability, please email ... for other accommodation options.