Senior Scientist 1 - QC

Company Information 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. Your Work Matters. At Cambrex, we strive to build a culture where all colleagues have the opportunity to: engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes medical, dental, vision, Life, LTD, retirement savings and more! Your Future Matters. Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today! Job Overview Cambrex High Point is seeking a highly motivated, energetic, results-oriented individual to join our Quality Control team of dedicated professionals focused on customer service and quality. We are currently accepting resumes for the position of Senior Scientist 1 - QC. The role performs routine and non-routine analytical testing on raw materials, intermediate, and final products as well as in-process testing; performs data entry; writes deviations, and participates in OOS investigations. Ensures compliance with applicable Company SOPs and regulatory guidance's Responsibilities Perform routine and non-routine testing of raw materials, intermediate, and final products (may include stability). Provide support to the plant by performing in-process testing and analyzing cleaning samples. Maintain laboratory notebook. Ensure equipment is left in good working order after use. Perform laboratory upkeep (wash glassware, reorder supplies, check for expired chemicals). Able to handle heavier workload and multiple priorities without compromise to quality or turn-around time. Write deviations. Lead laboratory investigations. This position works with and handles hazardous materials and wastes in a pharmaceutical laboratory environment. Ability to read, understand, apply and communicate written and verbal information regarding handling and managing hazardous wastes. Responsible for recognizing emergency situations concerning hazardous materials and wastes. Modify and create Analytical Procedures (infrequently) Modify and create SOPs (infrequently)

Qualifications/Skills Analytical Chemistry Knowledge :

Basic understanding of the principles of

Analytical Chemistry or Quality Control Cross Discipline Knowledge:

Workplace exposure to cross functional technical departments, including organic chemistry

GMP/Regulatory Knowledge :

Basic understanding of GMP; With manager assistance, can help to answer client inquires related to SOP or regulatory guidance

Instrumentation:

Basic understanding of key analytical R D equipment and ability to run independently using

SOP Communication:

Good written and oral communication skills, demonstration of successful interdepartmental communication

Problem Solving:

Ability to support laboratory investigations with manager support

Time Management :

Reasonable ability to handle one or more tasks or projects, often with supervision

Leadership:

Shares ideas with peers

Technical Documentation and Review:

Ability to write technical documents with assistance Education, Experience & Licensing Requirements M.S. in Chemistry or related field with 3 years of experience or B.S. degree in Chemistry or related field with 7 years minimum experience, or Technical Degree with 6 years minimum experience, or High School Degree with 8 years minimum experience. Experience with and fundamental understanding of several of the following analytical technologies (

• - most important): HPLC
• FTIR
• Titration Basic wet chemistry

NMR XRPD

cKF Working knowledge of other analytical equipment common to the pharmaceutical industry. ►The daily work is performed is primarily in a laboratory setting. Walking and standing are required regularly. ► Position also requires visual acuity, talking and fingering. ► Involves regular use of basic PPE (personal protective equipment) such as supplied air respirator, negative pressure respirator, gloves, safety glasses, shielding clothing.