TALENT PIPELINE - Analytical R&D - Future Opportunities in High Point, North Carolina

Cambrex-posted 7 months ago

Mid Level

High Point, NC

1,001-5,000 employees

Chemical Manufacturing

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Thank you for considering a future opportunity with Cambrex! If you are interested in joining our team but don't see a current role that fits your background, please submit your resume here. If we have future opportunities that match your skillset, we will contact you. While we are not currently hiring for a role linked to this specific posting, we would love to connect with talented individuals who are interested in potential future positions. By joining this talent pipeline, you will be the first to be notified when suitable opportunities arise within our Analytical R&D function. Cambrex's Analytical R&D positions will be on-site at one of our 14 locations. Locations include: Agawam, Massachusetts, Charles City, Iowa, Durham, North Carolina, East Rutherford, New Jersey (HQ), Edinburgh, UK, High Point, North Carolina, Karlskoga, Sweden, Liege, Belgium, Longmont, Colorado, Paullo, Milan, Italy, Tallinn, Estonia, Waltham, Massachusetts, Waterford, Ireland, and Wiesbaden, Germany.

Execute analytical methods for in-process control, release testing and stability monitoring of bulk drug substances and drug products under cGMP guidelines
Independently develop and evaluate methodologies, design and implement experiments
Participates in experimental design, including development of methods and testing requirements to demonstrate method suitability
Maintains compliant records with little or no supervision
Able to write technical documents with assistance
Strong understanding and proficiency in use and maintenance of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks
Perform assigned tasks carefully, safely and on schedule according to SOPs and supervisor instructions
Sets up various instrumentation for testing according to written test methods and with little to no supervision
As needed, troubleshoots laboratory instrumentation
Leads a sample project with assistance
May participate in client level meetings, with approval
May lead and develop other team members
May advise clients on site procedures
May act as a team/project lead supporting scheduling of project tasks and deliverables
Responsible for ensuring compliance with cGMP and other regulatory guidelines
Analyze information for technical correctness and accuracy
Compile, maintain, interpret and extrapolate data on results of analysis and communicate these results to supervisor
Perform routine laboratory procedures in a timely and efficient manner
Gain familiarization with analytical techniques
Participate in cGMP activities
Provides input on SOPs and client questions
Maintain laboratory equipment and supplies as directed
May support peer-led laboratory investigations process with assistance
Maintain a clean and safe work-space
Maintain laboratory notebook and/or computer files (i.e. LIMS) according to standard, accepted practices
Participate in group and project meetings as required
Enter project hours promptly and update project status on appropriate tracking and/or timekeeping systems
Attend seminars as required
Participate in and comply with all current safety, health and environmental programs
Shows initiative and interest in learning new techniques and tests
Participates in technical discussions and brainstorming sessions
Communicates issues or challenges to senior staff and/or management
May review test data acquired by others and witness others' notebooks
Assists with writing technical documentation such as OOS, atypical investigations, deviations and CAPAs
Assists with writings standard operating procedures (SOPs), methods, qualification protocols and other standard documents as directed
Provides input on SOPs and client questions
Effectively and routinely provides training
With guidance, prepares well written and organized development reports
Performs other related duties as assigned

B.S./B.A. Chemistry with 8+ years of experience in related industry or MS with 4+ years related experience or PhD with 0+ years related experience
Working knowledge of experimental design, including chemistry supporting method development
Working knowledge of advanced laboratory techniques
Working exposure to cross functional techniques including organic chemistry
Subject matter expert in one or more instruments (i.e. GC, LC, dissolution, TGA/DSC)
Able to comply to SOPs and have understanding of regulatory compliance
Working knowledge of scientific concepts, principles and procedures
Actively and positively engages with team and supports process improvements
Ability to read and execute compendial methodologies
Strong understanding of current FDA and cGMP regulations
General knowledge of chemistry and scientific calculations
Hands on experience in analytical techniques such as HPLC, GC, etc
Strong computer skills
Ability to operate laboratory equipment and computers
Ability to take direction from experienced scientists and contributes in a team Environment
Ability to effectively train and mentor others
Good problem-solving skills
Good attention to details
Can repeat and follow detailed scientific procedures
Able to clearly present results verbally in group meetings and in written progress reports
Routinely and effectively presenting findings to clients
Good interpersonal skills and is willing to ask questions about procedures and concepts
Aptitude and willingness to gain more skills and knowledge in support of GMP regulations
Good written and verbal communication skills
Familiarity with computer software such as Empower, ChemDraw, Microsoft Word, PowerPoint, and Excel

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TALENT PIPELINE - Analytical R&D - Future Opportunities in High Point, North Carolina

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