• Analytical Development Principal Scientist

  • Cambrex
  • Charles City, Iowa
Job Summary
Employment Type
Full Time
Years Experience
10 - 15 years
Bonus/Commission
Yes
Benefit Insights
Health Insurance
Vacation Leave
Sick Leave
401(k)
Holiday Pay
Health Savings Accounts (HSAs)
Life Insurance
Dental Insurance
Vision Insurance
Long-Term Disability
Job Description

Analytical Development Principal Scientist

Job LocationUS-IA-Charles City

 

At Cambrex, it’s our people that set us apart. We work locally and have an impact globally. We’re committed to attracting, nurturing and retaining a passionate and talented team of experts in our fast paced and growing company. You will be valued and recognized. We offer an exceptional benefits package including medical, dental, vision, Life, LTD, generous vacation in your first year, sick time, and retirement savings!

Cambrex is the small molecule company that provides drug substance, drug product and analytical services across the entire drug lifecycle. Known for our scientific and manufacturing excellence and customer focus, we offer a range of career opportunities across our global network of locations. As a team, we share one goal – to improve the quality of life for our customers’ patients across the world.

Overview

The Principal Scientist will provide technical support for multiple project teams. This individual will evaluate and interpret analytical results, develop, validate and transfer analytical methods for APIs, API intermediates and raw materials. Strict compliance with cGMP guidelines is required to perform most job tasks.

Responsibilities

  • Safely and effectively develop, establish, and validate analytical testing methodologies used to control raw materials, production intermediates, and final products
  • Actively participate in teams assembled to investigate and solve analytical technical issues within Analytical Development, Chemical Development, Process Support Group and Quality Control.
  • Perform analytical chemistry assays based on new and existing methodologies
  • Operate analytical instrumentation such as HPLC, GC, GC/MS, FTIR, Titrator, Particle Size Analyzer
  • Write technical reports to document analytical methods
  • Maintain laboratory notebooks documenting work
  • Maintain compliance with GMP SOPs and DEA regulations
  • Transfer documented analytical methods to the QC and Process Support Group departments
  • Set up new or existing analytical methods for compound identification, purity and potency testing.
  • Coordinate off-site testing as necessary
  • Conduct testing of analytical samples for the Chemical Development Department as needed.
  • Qualify reference materials.
  • May also perform other duties as required.

Qualifications

 

Education/knowledge requirements

Ph.D. in Chemistry or related field with minimum 8 years of experience or M.S. in Chemistry or related field with minimum 12 years of experience or B.S. degree in Chemistry or related field with 16 years of experience in lab environment, pharmaceutical experience preferred.

 

Excellent verbal and written communication/interpersonal skills, organizational skills, and the ability to work in a diverse team environment are essential.

 

 

 

 

 

Position COMPETENCIES:

Analytical Chemistry Knowledge: Strong understanding of advances theories in Analytical Chemistry.

Cross Discipline Knowledge: Higher level understanding of other cross-functional technical departments, including organic chemistry and engineering.

GMP/Regulatory Knowledge: Strong understanding of the GMP landscape and fundamental understanding of the industrial regulatory landscape; Good understanding of site SOPS, regulatory CMC concerns and can answer client questions and help them develop their clinical package.

Instrumentation: Advanced knowledge of HPLC, GC, MS, and ability to train and troubleshoot problems with equipment (and help others).

Communication: Excellent oral and written communication, often leading technical calls with clients.

Problem Solving:  Demonstrated ability to perform root cause analysis and solve problems.

Time Management: Very good organizational skills and time management.  Able to work on several key items at once including two or more medium complexity projects at once.

Leadership: Regularly seeks to share ideas and learning across the group/site; pushes new initiatives from the ground up.

Technical Documentation and Review: Strong ability to generate key technical documents with minimal RFT issues and to review documents for others. Basic ability to write new SOP.

External Influence: Strong demonstrated ability to independently steer client or technical teams; ability to redirect and point out scope change; good ability to work with site leadership team and steer local initiatives.

Industry Credibility and Rapport: Demonstrated reputation as a leader within the Cambrex Analytical Community.  Good publication record, where possible, and strong contributions to the Cambrex portfolio.

Operational Excellence: Demonstrate ability to participate and share leadership on local OE initiatives.

Change Orientation: Demonstrated contribution of input and ideas for larger Cambrex system level changes.

This job description is not intended to be all-inclusive. It is understood that the employee will also perform other reasonably related duties to support our company’s mission.

Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

 

Cambrex Charles City offers an extraordinary opportunity, a competitive salary, and an exceptional benefits package including medical, dental, vision care and prescription, life, LTD, STD; 401(k) with employer match; tuition reimbursement; and the ‘Arthur I. Mendolia Scholarship Program.’ Relocation assistance will be offered for this position. 

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