Analytical Development, Senior Principal Scientist

Company: Cambrex
Location: Charles City
Posted on: May 29, 2023

Job Description:

Company Information




Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With over 40 years of experience and a growing team of over 2,200 experts servicing global clients from North America and European sites, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.

At Cambrex, our people set us apart. We're committed to attracting, nurturing, and retaining a passionate and talented team of valued experts in our fast-paced and growing company. We offer an exceptional benefits package including medical, dental, vision, Life, LTD, generous vacation in your first year, sick time, and retirement savings!

Known for our scientific and manufacturing excellence, as well as our strong customer focus, we offer a range of career 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 Principal Scientist will provide technical support and leadership to 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.


--- - - - 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 necessary.


--- - - - Qualify reference materials.


--- - - - May also perform other duties as required.



Qualifications/Skills


Analytical Chemistry Knowledge: Higher level understanding of advances theories in Analytical Chemistry and Method Development.
Cross Discipline Knowledge: Strong understanding of other cross-functional technical departments, including organic chemistry and engineering.
GMP/Regulatory Knowledge: High level demonstration of GMP controls and understanding of regulatory requirements; Solid understanding of site SOPS, industrial CMC requirements, and demonstrates an ability to steer clients toward best outcome.
Instrumentation: Very high level understanding of front-line technology in the field (HPLC, GC, NMR, MS, ICP, etc), strong ability to train others and advanced troubleshooting ability.
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.
Education, Experience & Licensing Requirements

-
Ph.D. in Chemistry or related field with minimum 10 years of experience or M.S. in Chemistry or related field with minimum 14 years of experience or B.S. degree in Chemistry or related field with 18 years of experience in lab environment, pharmaceutical experience preferred.

Demonstrated ability to transfer processes to commercial scale manufacturing. -
Excellent verbal and written communication/interpersonal skills, organizational skills, and the ability to work in a diverse team environment are essential. -


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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Keywords: Cambrex, Rochester , Analytical Development, Senior Principal Scientist, Other , Charles City, Minnesota