Analytical Development Senior Scientist II

Cambrex Corp.; Charles City (IA); On-site; USD 90,000 - 120,000; Full time

Job summary

Cambrex Corp. is seeking a Senior Scientist II to provide technical support across project teams, evaluating analytical results and developing/validating methods for APIs and intermediates in a GMP setting.

The role requires strong analytical chemistry knowledge, experience with instruments like HPLC and GC, and ability to write technical documentation while maintaining strict regulatory compliance.

Qualifications

• Ph.D. in Chemistry or related field with minimum 2 years of experience or M.S. in Chemistry or related field with minimum 6 years of experience or B.S. in Chemistry with 10 years in lab environment.
• Excellent verbal and written communication/interpersonal skills, organizational skills, and ability to work in a diverse team environment.

Responsibilities

• Safely develop, establish, and validate analytical testing methodologies for materials and final products.
• Participate in teams to investigate analytical issues within Analytical Development, Chemical Development, Process Support and Quality Control.
• Perform analytical chemistry assays using new or existing methods.
• Operate analytical instrumentation (HPLC, GC, FTIR, Titrator, P3D or similar) and support method transfers.
• Write technical reports documenting analytical methods and maintain lab notebooks.
• Ensure GMP SOPs and DEA regulations are followed.
• Transfer analytical methods to QC and Process Support groups.
• Set up new/existing methods for compound ID, purity, potency testing.
• Coordinate off-site testing as needed.
• Conduct testing for Chemical Development as required.
• Qualify reference materials and support OE initiatives.
• May perform other duties as required.

Skills

Analytical Chemistry

Cross Discipline

GMP/Regulatory Knowledge

Instrumentation

Communication

Problem Solving

Time Management

Leadership

Technical Documentation

External Influence

Industry Credibility

Operational Excellence

Change Orientation

Education

Ph.D. in Chemistry

M.S. in Chemistry

B.S. in Chemistry

Tools

HPLC

GC

FTIR

Titrator

Particle Size Analyzer

Mass Spectrometry (MS)

Job description

Company Information

You Matter to Cambrex.

Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services.

With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs.

Your Work Matters.

At Cambrex, we strive to build a culture where all colleagues have the opportunity to:

• engage in work that matters to our customers and the patients they serve
• learn new skills and enjoy new experiences in an engaging and safe environment
• strengthen connections with coworkers and the community

We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more!

Your Future Matters.

Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world.

Job Overview

The Senior Scientist II 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, 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/Skills

Analytical Chemistry Knowledge: Strong understanding of the fundamentals of Analytical Chemistry, good laboratory experience.

Cross Discipline Knowledge: Good understanding of the principles of cross-functional departments, including organic chemistry and engineering.

GMP/Regulatory Knowledge: Demonstrated understanding of GMP as it relates to current work; with less manager input, can help advise clients on key regulatory strategies.

Instrumentation: Demonstrated ability to use, train, investigate root cause issues with HPLC, GC, good understanding of MS.

Communication: Good written and oral communication skills, ability to handle client requests with manager review.

Problem Solving: Able to solve problems in the workplace and helps to lead investigations with manager support.

Time Management: Good understanding of time management and can self-organize with or without supervision.

Leadership: Strong demonstration of sharing key ideas across the group.

Technical Documentation and Review: Ability to write technical documents with minimal RFT errors.

External Influence: Actively participates in regular internal project team meetings, including submission of key technical reports; organizes group level initiatives within the larger scientific team.

Industry Credibility and Rapport: Known as a solid scientific contributor within the site.

Operational Excellence: Able to support key OE initiatives.

Change Orientation: Locally supports changes associated with larger Cambrex initiatives.

Education, Experience & Licensing Requirements

Ph.D. in Chemistry or related field with minimum 2 years of experience or M.S. in Chemistry or related field with minimum 6 years of experience or B.S. degree in Chemistry or related field with 10 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.

Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration.

All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affi­rmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.

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