Job description

EDUCATION:

• Master degree & 3 years of directly related experience
• Bachelor degree & 5 years of directly related experience

• Materials Science / Engineering / Chemistry / Physics

QUALIFICATIONS:

The Process Development Sr. Associated Scientist provides technical expertise for the Process Development Drug Product Laboratory Operations area. Monitors field of expertise, including literature and technology development, and communicates relevant observations. Understands and interprets primary components defects, specifications, and methods. Demonstrates knowledge regarding primary container defects classifications and components materials behavior. Performs Primary Packaging Evaluations and container defects identification and classification. Introduces advanced scientific methods. Develops and implements new and novel protocols to address specific issues. Initiates productive collaborations within and outside of the Process Development Department and Amgen Network. Advises or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies. Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents. Assumes lead role in department-wide support efforts such as safety, OE and other committees. Develops and follows timelines for completing project teamwork.

SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

• Perform experiments, organize data and analyze results under minimal supervision.
• With minimal supervision, plans, conducts or monitors experiments, records and organizes data, analyses results.
• Generates robust and reliable data in compliance with the respective protocol, methods, or SOPs.
• Identify container defects and provide solutions related to possible technical problems of moderate scope and complexity.
• Perform Container Defects and Primary Packaging Evaluations
• Evaluate and interpret results using imaging acquisition equipment’s.
• Monitors or follows established experimental design and protocols and performs routine tasks and studies to obtain reproducible and reliable results with limited supervision.
• Under general supervision evaluate, select, and apply standard techniques and procedures in a laboratory environment.
• Perform assignments that have clear and specific objectives and require investigation of limited number of variables.
• Initiate and complete laboratory routine technical tasks.
• Prompt and regular attendance to workplace.
• Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.
• Monitor and maintain inventory of supplies and samples.
• Coordinate and review work with peers on an ongoing basis.
• Support a safe working environment by complying with all pertinent environmental health/safety practice, rules, and regulations.
• Must be independent, self-motivated, organized, able to multi-task in laboratory environments, and skilled in communication, facilitation, and collaboration.
• Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
• Apply knowledge and practices outside of area of discipline expertise to broad variety of assignments in related fields.
• Generates robust and reliable data in compliance with the respective protocol or SOPs.

PREFERRED QUALIFICATIONS

• Educational background in Engineering or Sciences (Chemistry or Physics)
• Knowledge in Material Sciences (glass/polymers)
• Familiarity with Biopharmaceutical Environment
• Knowledge in Primary Packaging Components (vials, syringes, cartridges, etc.)
• Advanced scientific analysis and troubleshooting skills
• Able to work in a laboratory environment
• Advanced laboratory work skills
• Experience using stereomicroscopes, calipers, X-Ray/CT Scan equipment, Instrons Machines, optical comparators, etc.
• Ability to motivate and/or supervise the activities of others
• Must be well organized, have multi-task project experience, and be able to communicate and work well with other departments
• Ability to interpret and apply GMPs
• Adheres to company policies and procedures to ensure a continuous state of compliance
• Familiarity with documentation in a highly regulated environment
• Ability to handle multiple tasks/priorities simultaneously at one time
• Able to interact effectively with variety of communications and working styles
• Must have demonstrated skills and competencies in the following areas:

o Verbal communication in English and Spanish
o Written communication in English and Spanish including technical writing skills, negotiation, and conflict resolution
o Analytical problem-solving
o Project management
o Ability to be flexible and manage change
o Computer literacy (Windows environment: Word, Excel, Power Point).
o Skills requiring the application of scientific method
o Creative skills in the design and performance of scientific experiments and interpretation of results
o Strong knowledge of cGMP’s
o Details oriented
o Good teamwork skills
o Time management
o Flexible schedule
o Sense of urgency
o Completion and follow-up
o Fully bilingual (English/Spanish)
o Familiarized with electronic laboratory notebook systems

Job Types: Full-time, Contract

Salary: $35.00 - $40.00 per hour

Schedule:

• 8 hour shift

Application Question(s):

• Available for work in Juncos, PR?

Education:

• Bachelor's (Required)

Language:

• Fully Bilingual (Englis & Spanish) (Required)

Work Location: In person

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