Top 11 Senior scientist, quality cmc Jobs in Crown Point, In

Senior Scientist, Quality CMC
Aquestive Therapeutics Inc. —Portage, IN
- Background check
- Bachelor of Science
- Pass drug screening
Quick Apply
Senior Chemist
Nippon Paint Automotive Americas, Inc. —Lansing, IL
- $57,428.27 - $117,978.40 a year
- Microsoft Word
- Computer literacy
- Ability to lift 50 pounds
- Paid holidays
- Health insurance
Quick Apply
Meteorologist Senior
Amentum —South Pole, IL
- Full-time
- Background check
- Management
- Heavy lifting
Part-Time Optometrist | Outpatient Clinic Setting
Comprehensive Mobile Care —Crown Point, IN
- $900 a day
- Part-time
- Mid-level
- Outpatient experience
- Clinic
Quick Apply
Part-Time Dentist | Outpatient Clinic Setting
Comprehensive Mobile Care —Hammond, IN
- $800 a week
- Part-time
- Mid-level
- Outpatient experience
- Clinic
Quick Apply
Dental Assistant | Part Time
Comprehensive Mobile Care —Hammond, IN
- $26 an hour
- Part-time
- Background check
- Dental office
- OSHA
Quick Apply

Related jobs to explore

Based on your search for senior scientist, quality cmc

Chemical Research and Development Specialist
Cedar Concepts Corporation —Chicago, IL
Maintain and enhance product quality in a production environment through internal audits, investigation of customer complaints, and multi-functional…
$70,000 - $85,000 a year
Quick Apply
11d
Sterile Processing Department Supervisor-( Night Shift)
CMC Sterilization —Chicago, IL
Do you have valid CBSPD or CRCST certification? Respond to calls from the Operating Room (OR) and other departments during and after regular business hours, as…
$68,000 - $80,000 a year
Quick Apply

Show more related jobs

Explore jobs in cities nearby

Check out jobs in cities near your current location, Columbus

Senior Director, Research Security
The Ohio State University —Columbus, OH
The Senior Director oversees the Office’s interactions with the Office of Sponsored Programs, Office of Research Compliance, Office of Academic Affairs, Office…
$140,000 - $183,000 a year
The Ohio State University – Enterprise for Research, Innovation and Knowledge – Senior Director, Research Security
Columbus, OH
The Senior Director oversees the Office’s interactions with the Office of Sponsored Programs, Office of Research Compliance, Office of Academic Affairs, Office…
$140,000 - $183,000 a year

Show more jobs in cities nearby

I want to receive the latest job alert for senior scientist, quality cmc in crown point, in

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

senior scientist, quality cmc jobs near crown point, in

Senior Scientist, Quality CMC

Aquestive Therapeutics Inc.
Portage, IN

Quick Apply

Job Details

Qualifications

Incident investigation techniques for hazard identification
Stability testing
Defect resolution root cause analysis
Stability studies in drug product development
GMP
Internal investigations
Collaboration with product development teams
ICH guidelines
Bachelor's degree
Pharmaceutical company experience
Pharmaceutical analysis
Chemistry, manufacturing & controls
Quality control experience within pharmaceutical industry
Research findings presentation
Cross-functional communication
Failure analysis
Pharmaceutical manufacturing facility experience

Full Job Description

Job Summary:

The Senior Scientist, CMC Quality, bridges analytical science and product performance, providing scientific leadership to distinguish analytical artifacts from true product, process, or manufacturing risks. This role drives complex investigations, informs quality-critical decisions, and partners cross-functionally to ensure sound, risk-based outcomes throughout the product lifecycle.

Responsibilities:

Serve as QC’s primary interface to AR&D and Engineering, connecting analytical findings to process variability, formulation behavior, manufacturing deviations.
Support PQR/APQR product quality narratives, stability trend interpretation.

Lead and provide scientific oversight for complex OOS, OOT, deviation, and product quality investigations, determining whether observations arise from analytical, sampling, product, or manufacturing-related factors.
Lead the development and review of technically complex investigations, risk assessments, scientific rationales, and regulatory support documentation.
Provide independent, evidence-based scientific recommendations to support Quality decision-making and governance.

Understand method capability vs. product behavior.
Identify when method limitations drive variability, specifications may not reflect true capability, escalating systemic or recurring issues (i.e., lifecycle management).

Lead or support analytical and CMC quality improvement projects, as assigned.

Provide scientific assessment of stability trends, out of trend (OOT results), and potential impact to product quality.
Partner with Quality, AR&D and Regulatory to support IND/NDA/MAA submissions, post-approval commitments and annual updates.

Develop hypothesis-driven investigation strategies grounded in product behavior or formulation/process knowledge.

Drive root cause analysis and scientifically sound CAPAs.
Mentor junior scientists and provide technical guidance during investigations and problem-solving activities.

Qualifications:

BS in Chemistry, Pharmaceutical Sciences, or related field required.
Minimum of 8 years in pharmaceutical/biotech Quality Control, Chemistry, Manufacturing Controls (CMC), or Analytical Sciences
Demonstrated ownership of complex OOS, OOT, and deviation investigations, including: developing investigation strategies, performing root cause analysis, defending conclusions and CAPAs
Significant experience in: Cross-functional investigations involving QC, Manufacturing, QA, and AR&D
Significant experience in interpreting analytical data in the context of product quality and process performance
Significant experience in stability programs, trend analysis, and product performance evaluation
Significant experience in analytical method capability, variability, and limitations
Strong understanding of: CMC development and commercialization, GMP and global regulatory expectations (FDA, EMA, ICH), OOS/OOT investigation frameworks and industry best practices
Demonstrated ability to: influence cross-functional teams without authority, articulate and defend scientific positions in QA and leadership forums
Strong business and product acumen, with understanding of: impact of quality decisions on supply, regulatory risk, and product lifecycle
Experience supporting regulatory submissions (IND/NDA/MAA), inspections, or audits preferred
Experience with instrumental techniques such as GC, HPLC, Dissolution.
Some travel required

The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary.

As part of Aquestive’s employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place.

Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.

Quick Apply

Refine Your Search

senior scientist, quality cmc jobs in crown point, in

Senior Scientist, Quality CMC

Senior Chemist

Meteorologist Senior

Part-Time Optometrist | Outpatient Clinic Setting

Part-Time Dentist | Outpatient Clinic Setting

Dental Assistant | Part Time

Related jobs to explore

Explore jobs in cities nearby

I want to receive the latest job alert for senior scientist, quality cmc in crown point, in

Explore jobs in more locations

Responsibilities:

Job Seeker Tools

Employer Tools

Browse

Stay Connected