TALENT PIPELINE - Sr. Scientist I (ARD)
Cambrex, Durham, NC, United States
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You Matter to Cambrex.
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 more than 40 years of experience and a growing team of over 2,400 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.
Job Overview
Execute analytical methods and provide general analytical support, such as release and stability testing of drug substances and drug products. Able to organize routine work independently and to evaluate, troubleshoot and interpret generated data. Demonstrated understanding of method development and qualification / validation principles. Routinely and effectively interacts with clients to discuss data and methods. Works on problems of moderate and sometimes advance scope in which analysis of situation or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action.
Responsibilities
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
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 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 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, methods, qualification protocols and other standard documents as directed
With guidance, prepares well written and organized development reports
Performs other related duties as assigned
Qualifications / Skills
Working knowledge of experimental design, including chemistry supporting method development
Working knowledge of analytical techniques and instrumentation such as NMR, IR, MS and HPLC
Working exposure to cross functional techniques including organic chemistry
Understands the chemical properties relating to method development, qualification /validation and troubleshooting
Able to comply to SOPs and basic 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
Basic computer skills
Ability to operate laboratory equipment and computers
Good problem-solving skills
Good attention to details
Can repeat and follow detailed scientific procedures with supervision
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
Education, Experience & Licensing Requirements
S/B.A. Chemistry with 6+ years of experience in related industry or MS with 2+ years related experience
Cambrex is an Equal Opportunity / Affinitive 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.
Travel: Not applicable
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.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Pharmaceutical Manufacturing
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Get AI-powered advice on this job and more exclusive features.
You Matter to Cambrex.
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 more than 40 years of experience and a growing team of over 2,400 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.
Job Overview
Execute analytical methods and provide general analytical support, such as release and stability testing of drug substances and drug products. Able to organize routine work independently and to evaluate, troubleshoot and interpret generated data. Demonstrated understanding of method development and qualification / validation principles. Routinely and effectively interacts with clients to discuss data and methods. Works on problems of moderate and sometimes advance scope in which analysis of situation or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action.
Responsibilities
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
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 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 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, methods, qualification protocols and other standard documents as directed
With guidance, prepares well written and organized development reports
Performs other related duties as assigned
Qualifications / Skills
Working knowledge of experimental design, including chemistry supporting method development
Working knowledge of analytical techniques and instrumentation such as NMR, IR, MS and HPLC
Working exposure to cross functional techniques including organic chemistry
Understands the chemical properties relating to method development, qualification /validation and troubleshooting
Able to comply to SOPs and basic 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
Basic computer skills
Ability to operate laboratory equipment and computers
Good problem-solving skills
Good attention to details
Can repeat and follow detailed scientific procedures with supervision
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
Education, Experience & Licensing Requirements
S/B.A. Chemistry with 6+ years of experience in related industry or MS with 2+ years related experience
Cambrex is an Equal Opportunity / Affinitive 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.
Travel: Not applicable
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.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Cambrex by 2x
Get notified about new Senior Scientist jobs in Durham, NC.
#J-18808-Ljbffr