Associate Scientist, Manufacturing - #1397245

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 healthcare, life insurance, planning for retirement, 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

The Associate Scientist, Manufacturing will work within a team to perform kilogram scale organic synthesis of pharmaceutical drug substance. The Associate Scientist will operate chemical manufacturing equipment and execute detailed written instructions from a batch record under Good Manufacturing Practice (cGMP) conditions. In addition, the Associate Scientist is responsible for maintaining the manufacturing suites for activities by properly setting up, breaking down, operating, and cleaning production equipment for both GMP and non-GMP drug substance manufacturing operations. An Associate Scientist in manufacturing will operate under and develop subject matter expertise in cGMP practices and Good Documentation practices (GDP) within the Quality Management System.

Responsibilities

• Performs basic to intermediate scale-up chemical synthesis and manufacturing operations of drug substance with manager supervision.
• May contribute and support process development in the R&D labs as needed with supervision.
• Properly sets up, operates, breaks down and cleans production equipment per written procedures.
• Maintains cGMP suites to be tour/audit ready and prepared for manufacturing activities.
• Understands and follows detailed written procedures.
• Consistently, clearly, and accurately documents activities in production records and laboratory notebooks in accordance with Good Documentation Practices (GDP).
• Performs routine equipment maintenance/preventative maintenance activities.
• Identify, stock and requisition equipment/parts as needed for manufacturing processes.
• Works with or around hazardous chemicals and waste in the chemical manufacturing environment.
• May perform other duties as assigned.
  
  

Qualifications/Skills

• Basic understanding of undergraduate chemistry, mathematics and the scientific method. Undergraduate organic chemistry experience is considered a plus.
• Basic understanding of cGMP and GDP requirements for drug substance manufacturing. Some experience operating in a GMP environment is considered a plus.
• Good aptitude for setting up and operating chemical reaction and manufacturing equipment. Knowledge of equipment and facility maintenance for the GMP and non-GMP production is a plus.
• Good chemical processing skills, including chemical weighing, basic to intermediate calculations, detailed record keeping, vacuum/pressure pumps, filtration techniques, distillation principles, etc.
• Ability to wear respirators and various types of PPE while promoting a safe work environment.
• Willingness to handle and work with hazardous chemicals and chemical waste in a safe environment.
• Able to read and comprehend detailed written instructions. Provides input to ensure instructions are accurate and can be performed as written.
• Must adhere to the Cambrex attendance policy. Employee should be punctual, reliable, and willing to work outside of normal working hours as requested.
• Effectively communicates both verbally and in writing.
• Able to work independently or within a team environment with supervision.
• Shows initiative and does tasks without being asked. Provides input on potential roadblocks.
  
  

Education, Experience & Licensing Requirements

• BS in chemistry or related field with 0-3+ years relevant experience, or equivalent combination of education and experience.
  
  

The hiring range in Colorado for this position is $31.83/hour - $35.65/hour; however, 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 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.

Supervision Received: Direct

Works under direct supervision. Relies on experience and judgment to plan and accomplish goals within defined procedures and practices. Seeks management direction for problems of diverse scope.

Travel: 0%

Physical And Environmental Demands

Physical Demands

While performing the duties of this position, the employee must regularly stand and bend, and climb; and is frequently required to sit and walk, crawl, stoop. Employee must frequently use hands to handle or feel objects, tools or controls. Must be able to communicate verbally and read written instructions.

Employee must frequently lift and/or move up to 75 pounds and able to move drums or pallets of up to 2,400 pounds with use of a pallet jack. Specific vision ability required by this job includes close vision, distance vision, depth perception, and the ability to adjust focus, and observe color changes.

Must be able to work in a production setting with the ability to wear PPE. Such personal protective equipment may include, but not limited to: Safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc. The noise level is moderate to loud. Exposure to airborne particles and chemical fumes possible.

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.

The noise level is moderate to noisy. Occasionally, employee may be exposed to airborne particles and fumes. Occasionally, employee may be exposed to chemicals. Must be able to wear PPE as required. Employee occasionally may be exposed to moving mechanical parts and vibration.