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D. in Chemistry or related field with minimum 8 years of experience or M.S. in Chemistry or related field with minimum 10 years of experience or B.S. degree in Chemistry or related field with 12 years of experience in lab environment, pharmaceutical experience preferred. External Influence: Ability to lead project teams and steer clients to desired outcomes; ability to work with management to develop key local laboratory-based initiatives.

Overview:
The Principal Scientist I 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:
<ul><li style="margin-left:0.25in">Safely and effectively develop, establish, and validate analytical testing methodologies used to control raw materials, production intermediates, and final products</li><li style="margin-left:0.25in">Actively participate in teams assembled to investigate and solve analytical technical issues within Analytical Development, Chemical Development, Process Support Group and Quality Control.</li><li style="margin-left:0.25in">Perform analytical chemistry assays based on new and existing methodologies</li><li style="margin-left:0.25in">Operate analytical instrumentation such as HPLC, GC, GC/MS, FTIR, Titrator, Particle Size Analyzer </li><li style="margin-left:0.25in">Write technical reports to document analytical methods</li><li style="margin-left:0.25in">Maintain laboratory notebooks documenting work</li><li style="margin-left:0.25in">Maintain compliance with GMP SOPs and DEA regulations</li><li style="margin-left:0.25in">Transfer documented analytical methods to the QC and Process Support Group departments</li><li style="margin-left:0.25in">Set up new or existing analytical methods for compound identification, purity and potency testing.</li><li style="margin-left:0.25in">Coordinate off-site testing as necessary</li><li style="margin-left:0.25in">Conduct testing of analytical samples for the Chemical Development Department as needed.</li><li style="margin-left:0.25in">Qualify reference materials.</li><li style="margin-left:0.25in">May also perform other duties as required.</li></ul>

Qualifications / Skills::
Analytical Chemistry Knowledge: Beginning to demonstrate an understanding of advanced theories in Analytical Chemistry and method development.  Cross Discipline Knowledge: Higher level understanding of the principles of cross-functional departments, including organic chemistry and engineering.GMP/Regulatory Knowledge: Demonstrated understanding of industrial GMP and practical application to Cambrex programs; Some ability to provide feedback to clients re: clinical strategy.Instrumentation: Advanced knowledge of HPLC, GC, MS, and ability to train and troubleshoot problems with equipment (and help others).Communication: Good written and oral communication skills, ability to communicate with clients without manager supervision.Problem Solving:  Strong demonstration of problem solving, ability to lead investigations.Time Management: Able to maintain timeline of key activities and use time efficiently; ability to handle projects without supervision though requires regular check in with manager.Leadership: Regularly seeks to share ideas and learning across the group/site; pushes new initiatives from the ground up.Technical Documentation and Review: Ability to author and review key technical documents with minimal RFT errors.  Can write new SOP with manager assistance. External Influence: Ability to lead project teams and steer clients to desired outcomes; ability to work with management to develop key local laboratory-based initiatives.Industry Credibility and Rapport: Recognized scientific leader within the Cambrex organization, locally and possibly beginning to extend to other sites.Operational Excellence: Actively participates in key operational excellence initiatives. Change Orientation: Active participation and support for implementation of Cambrex system level changes/initiatives.

Qualifications:
Ph.D. in Chemistry or related field with minimum 8 years of experience or M.S. in Chemistry or related field with minimum 10 years of experience or B.S. degree in Chemistry or related field with 12 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 innovative life sciences company with a refreshingly human approach. Driven by passion, our pharmaceutical products, expertise and technologies accelerate our customers’ small molecule therapeutics into markets across the world.

With over 35 years of active pharmaceutical ingredient (API) development and manufacturing expertise, a growing team of more than 1,200 experts and a strong presence in the USA and Europe, we are tried and trusted across branded and generic API markets.

Cambrex

Analytical Development, Principal Scientist I

[AW]-iCims

D. in Chemistry or related field with minimum 6 years of experience or M.S. in Chemistry or related field with minimum 10 years of experience or B.S. degree in Chemistry or related field with 14 years of experience in lab environment, pharmaceutical experience preferred. Must demonstrate a proficiency to carry out laboratory syntheses and purification techniques on scales ranging from milligrams to several kilograms, and design and implement process modifications.

Overview:
Position is directed toward optimization of existing chemical routes and development of alternate chemistry toward key synthetic intermediates and APIs.  Carries out multistep chemical synthesis and product isolation/purification operations in the laboratory, independently or as part of an integrated team.  Chemist utilizes modern analytical tools to determine identity and purity of products made during projects.  Communication with clients in regular team meetings; prepares R&D reports at the conclusion of projects.

Responsibilities:
<ul><li>Design and carry out multistep organic syntheses, isolation, and purification of targeted products.</li><li>Must possess a strong understanding of modern organic synthesis methodologies.</li><li>Must have a thorough understanding of modern analytical and spectroscopic techniques and be able to interpret the corresponding data and spectra.</li><li>Ability to conduct literature searches for specific target compounds and be able to use the literature to base a design of alternate routes to these compounds. Requires ongoing professional development to keep abreast of current scientific literature and discuss these findings with colleagues.</li><li>Must demonstrate a proficiency to carry out laboratory syntheses and purification techniques on scales ranging from milligrams to several kilograms, and design and implement process modifications.</li><li>Requires excellent time management with the ability to manage projects on-time without supervision.</li><li>Ability to author and review comprehensive reports at the conclusion of projects for internal and customer use.</li><li>Work closely with other chemistry and analytical laboratory staff to coordinate project activities and resource usage.</li><li>Work to ensure that a spirit of teamwork and cooperation always exists within the group.</li><li>Conduct laboratory operations in a safe manner. Maintain familiarity with the company’s chemical hygiene plan. Exhibit safety awareness and safe work practices.</li><li>Follow responsible actions regarding chemical disposal. Maintain compliance with all regulations at the federal, state, and local levels.</li></ul><ul><li>Must demonstrate effective communication skills (both interpersonal and presentations). Participate in project team meetings with customers.</li><li>Work closely with manufacturing and GMP operations to coordinate project related equipment and activities.</li></ul>

Qualifications / Skills::
Demonstrated ability to scale up pharmaceutical processes.Excellent verbal and written communication/interpersonal skills, organizational skills, and the ability to work in a diverse team environment are essential.

Qualifications:
Ph.D. in Chemistry or related field with minimum 6 years of experience or M.S. in Chemistry or related field with minimum 10 years of experience or B.S. degree in Chemistry or related field with 14 years of experience in lab environment, pharmaceutical experience preferred.

Chemical Development Principal Scientist I

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Analytical Development, Principal Scientist ICambrex

Chemical Development Principal Scientist ICambrex

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