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  • Sr. Research Scientist, Principal Research…

    Cambrex High Point (Longmont, CO)



    Apply Now

    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

     

    Cambrex is seeking to fill multiple openings at various levels (including Sr. Research Scientist, Principal Research Scientist, Sr. Principal Research Scientist, and Research Investigator) with highly motivated individuals for the Process Chemistry department. Individuals in these position perform routine and complex organic synthesis, purification, and analytical evaluation of materials as part of a process chemistry research and development team. The chemists will optimize synthetic routes to active pharmaceutical ingredients for purity, reproducibility, scalability, and yield. Experience in process chemistry research and development is desirable. Individuals in these positions will design and propose new synthetic routes to drug substances and may be asked to lead process chemistry portion of customer projects and potentially a group of process chemists. They will frequently present work internally and externally to clients or regulatory agencies.

    Responsibilities

    + Perform multistep organic syntheses, isolation, and purification of targeted products independently. Contribute to the strategic approach used to optimize reactions, isolations, and purifications.

    + Proficiently conduct analysis of starting materials, reaction mixtures, intermediates and products using appropriate instrumentation.

    + Work closely with other chemistry and analytical laboratory staff to coordinate project activities and resource usage.

    + Routinely generate summaries and reports on completed experimental work for internal and external use. Routine presentation of experimental work for internal meetings and teleconferences with customers.

    + Work to ensure that teamwork and cooperation exists within the group at all times.

    + Conduct laboratory operations in a safe manner. Maintain familiarity with the company’s chemical hygiene plan. Exhibit safety awareness and safe work practices.

    + Follow responsible actions regarding chemical disposal. Maintain compliance with all regulations at the federal, state, and local levels.

    + Address routine administrative requirements in a timely fashion.

    + Demonstrate effective communication skills (both written and oral). Participate in project team meetings with customers.

    + Work closely with manufacturing and GMP operations to coordinate project-related equipment and activities. Assist in the transfer of processes to the manufacturing team.

    + Independently designs and proposes new synthetic processes to produce the drug substance.

    + May act as process chemistry lead for customer projects. Identify critical questions to be answered and set priorities for the process chemistry team.

    + Maintain familiarity with applicable literature including organic chemistry and techniques.

    + Participate in setting strategy and timing needed for customer proposal requests.

    + Work closely with other chemistry and analytical laboratory staff to coordinate project activities and resource usage.

    + Routinely generate summaries and reports on completed experimental work for internal and external use. Oral and written presentation of experimental work for internal meetings and teleconferences with customers

    + Performs other related duties as assigned.

    Qualifications/Skills

    Senior Research Scientist - Specific Skill & Competency Requirements

     

    + Has advanced knowledge in synthetic chemistry transformations, reaction mechanisms and retrosynthetic analysis skill.

    + Has growing knowledge of principles and practices of other relevant scientific disciplines.

    + Developing intermediate to moderate knowledge of process chemistry principles and practices.

    + Developing knowledge of GMP requirements and ICH guidelines in support of client project needs.

    + Demonstrates sound experimental design skill towards process chemistry development and project goals and regularly contributes internal chemistry discussion with innovative and useful ideas.

    + Works on multiple sub-tasks and experiments in parallel.

    + Advanced use of scientific literature to support own research.

    + Demonstrates good safety practices and participates in safety discussions and contributes to safety investigations and continuous improvement initiatives. Collects safety data to support chemical process evaluations and particpates in overall evaluation.

    + Recognized as a technical expert and significant scientific contributor.

    + Promotes the use of novel experimental approaches within discipline/project; routinely investigates/creates innovative processes, hypotheses and methodologies.

    + A published contributor or co-author to scientific manuscript/poster/presentation. Expected to present externally at conference.

     

    Principal Research Scientist - Specific Skill & Competency Requirements

    In addition to the requirements of the Senior Research Scientist role, qualified candidates must possess/demonstrate the following:

    + Has leading edge knowledge in advanced synthetic, mechanistic and retrosynthetic analysis skill.

    + Developing strong knowledge in principles of process chemistry and drug substance manufacturing requirements.

    + Developing experience in GMP/CMC/ICH guidelines, documentation and execution of batch records in a GMP environment.

    + Developing extensive knowledge of principles, concepts, and practices of other relevant disciplines.

    + Applies technical and functional knowledge to design and independently exectue experiments/ projects, contributing to the overall direction of project.

    + Advanced use of scientific literature to support client project and solve complex pharmaceutical development problems.

    + Demonstrates good safety practices. Identifies safety risks and performs chemical safety evaluations of chemical and manufacturing processes.

    + Recognized as an outstanding scientist and acts as a scientific resource within own discipline and at the site level.

     

    Develops novel experimental approaches; routinely investigates / creates innovative processes, hypotheses, methodologies, and technology.

     

    Expected to be author/co-author to scientific manuscript/poster/presentation. Actively seeks opportunities for publication and presentation.

     

    Senior Principal Research Scientist - Specific Skill & Competency Requirements

    In addition to the requirements of the Senior Research Scientist, Principal Research Scientist, and Senior Principal Research Scientist roles, qualified candidates must possess/demonstrate the following:

    + Has expert knowledge in advanced synthetic chemistry principles and practices. Has principal knowledge in process chemistry and drug substance manufacturing requirements.

    + Has moderate to deep experience in GMP/CMC/ICH requirements. Increasingly strong experience with GMP practices, documentation and execution of batch records in a GMP environment.

    + Developing experience with the Quality Management System.

    + Has extensive knowledge of principles, concepts, and practices of other relevant disciplines.

    + Applies technical, functional, and industry knowledge to design and independently executes experiments/projects that shape the strategic direction of one or more projects.

    + Independently designs research plans to advance client projects with limited supervision. May contribute scientifically to more than one client project. Developing strong client management skills.

    + Demonstrates good safety practices. Identifies safety risks and performs chemical safety evaluation of chemical and manufacturing processes. Provides leadership and investigation and advisement on safety matters

    + Recognized as an outstanding scientist and acts as a scientific resource within own discipline and at the site level.

    + Works across department to test and advance innovative processes, hypotheses, methodologies and technology; encourages curiosity and challenges the status quo at the department level in order to foster innovation.

    + Expected to be author/co-author to scientific manuscript/poster/presentation. Actively seeks opportunities for annual publication and presentation.

     

    Research Investigator - Specific Skill & Competency Requirements

    In addition to the requirements of the Senior Research Scientist & Principal Research Scientist roles, qualified candidates must possess/demonstrate the following:

    + Has expert knowledge in advanced synthetic chemistry principles and practices. Has expert knowledge in process chemistry and drug substance manufacturing requirements.

    + Substantial experience with GMP practices, CMC principals and ICH guidelines for pharmaceutical development. Has deep knowledge and experience with GMP practices, documentation and execution of batch records in a GMP environment.

    + Developing significant expertise with the Quality Management System including investigations and root cause analysis.

    + Has extensive knowledge of principles, concepts, and practices of other relevant disciplines.

    + Applies technical, functional, and industry knowledge to design and independently executes experiments/projects that shape the strategic direction of one or more projects.

    + Provides department and site leadership on safety practices, root cause investigations and prevention measures.

    + Recognized within department, site and externally as an expert in field.

    + Works across department and site level to test and advance innovative processes, hypotheses, methodologies and technology; encourages curiosity and challenges the status quo at the site level in order to foster innovation.

    + Identifies opportunities to lead author on scientific manuscripts and invited presenter at external scientific events. Identifies opportunities for others to lead author or co-author publishable research.

    Skill, Knowledge, and Ability Requirements for All Levels:

    + Advanced to expert understanding of general chemistry and organic chemistry.

    + Understanding of modern organic synthesis reactions, isolations, and purification procedures.

    + Full understanding of common synthetic organic reaction mechanisms.

    + Understanding and proficient use of all relevant analytical techniques and instrumentation such as NMR, IR, MS and HPLC.

    + Expertise in laboratory glassware and organic chemistry reaction set up, isolation and purification

    + Must demonstrate proficiency in synthesis and purification techniques on scales ranging from milligrams to kilograms.

    + Strong written and verbal communication skills

    + Familiarity with computer software such as ChemDraw, Microsoft Word, PowerPoint, and Excel.

    + Aptitude and willingness to gain more skills & knowledge.

    + Strong attention to detail and good problem-solving skills.

    + Clear and concise communication skills.

    + Effectively presents ideas and concepts.

    + Demonstrates leadership skills.

     

    Education, Experience & Licensing Requirements

     

    Senior Research Scientist - Education & Experience Requirements

     

    + PhD in Organic Chemistry with 0-4+ years of experience in related industry, or MS in Organic Chemistry with 11+ years of experience in related industry, or BS in Organic Chemistry with 13+ years of experience in related industry.

     

    Principal Research Scientist - Education & Experience Requirements

     

    + PhD in Organic Chemistry with 2-8+ years of experience in related industry, or MS in Organic Chemistry with 15+ years of experience in related industry, or BS in Organic Chemistry with 17+ years of experience in related industry.

     

    Senior Principal Research Scientist - Education & Experience Requirements

     

    + PhD in Organic Chemistry with 8-12+ years of experience in related industry, or MS in Organic Chemistry with 18+ years of experience in related industry, or BS in Organic Chemistry with 20+ years of experience in related industry.

     

    Research Investigator - Educatiton & Experience Requirements

     

    + PhD in Organic Chemistry with 12+ years of experience in related industry, or MS in Organic Chemistry with 20+ years of experience in related industry, or BS in Organic Chemistry with 22+ years of experience in related industry.

     

    Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

     

    While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required.

     

    Environment and Protective Equipment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is occasionally exposed to moving mechanical parts and vibration. The noise level in the work environment is usually very quiet.

     

    The hiring range in Colorado for these positions is $100,000/year - $170,000/year depending on level which is determined by experience, education, and competencies. Base pay offered may vary depending on job-related knowledge, education, skills and experience of the applicant, internal equity, and alignment with market data. This hiring range encompasses several levels. This information is provided per the Colorado Equal Pay Act. This position includes a competitive benefits package.

     

    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.

    #LI-SK1



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