Top 23 Senior bridge Jobs in Crown Point, In

Senior Scientist, Quality CMC
Aquestive Therapeutics Inc. —Portage, IN
- Background check
- Bachelor of Science
- Pass drug screening
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Lead DevSecOps Systems Engineer
General Dynamics Information Technology —Indiana
- $212,500 - $287,500 a year
- Bachelor of Science
- 8 years
- AWS
- Paid holidays
- Dental insurance
Sr Oracle Fusion Functional Analyst
Wright Technical Services —Indiana
- Full-time
- Remote
- Oracle
- Analysis skills
- Bachelor's degree
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Operations Controller
ITW Automotive —Frankfort, IL
- $135,000 - $150,000 a year
- Full-time
- 6 years
- CPA
- Bachelor of Science
- Health insurance
- Dental insurance
Senior Engineer, Bridge Testing
Canadian National Railway —Homewood, IL
- $104,500 - $137,000 a year
- Microsoft Excel
- Up to 50% travel
- Office
- Paid training
Assistant Dean of Students for Residential Life
Valparaiso University —Valparaiso, IN
- Full-time
- Background check
- 5 years
- Residential
Tool and Die Maker - $41/Hour
Autokiniton —Chicago, IL
- $41 an hour
- Full-time
- 5 years
- Senior level
- Communication skills
- Paid holidays
- Health insurance
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MRO Tool Crib Coordinator
Autokiniton —Chicago, IL
- Full-time
- High school diploma or GED
- Entry level
- Paid holidays
- Health insurance
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Memory Care Program Assistant
Brookdale Senior Living Inc. —Valparaiso, IN
- Part-time
- Sales
- Word processing
- Computer literacy
- Health savings account
- Paid holidays
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Medical Equipment Delivery Driver
AdaptHealth, LLC —Oak Forest, IL
- $19 - $23 an hour
- On call
- Background check
- Customer service
- Military
- Paid parental leave
- Health savings account
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Controls Engineer Sr.
Autokiniton —Chicago, IL
- Full-time
- Basic math
- English
- Mid-level
- Paid holidays
- Health insurance
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D365 F&O Functional Consultant
BlueAngle, LLC —United States
- $90,000 - $110,000 a year
- Full-time
- Background check
- Azure
- CPA
- Health insurance
- Paid time off
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Senior Scientist, Quality CMC

Aquestive Therapeutics Inc.
Portage, IN

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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.

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senior bridge jobs in crown point, in

Senior Scientist, Quality CMC

Lead DevSecOps Systems Engineer

Sr Oracle Fusion Functional Analyst

Operations Controller

Senior Engineer, Bridge Testing

Assistant Dean of Students for Residential Life

Tool and Die Maker - $41/Hour

MRO Tool Crib Coordinator

Memory Care Program Assistant

Medical Equipment Delivery Driver

Controls Engineer Sr.

D365 F&O Functional Consultant

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