Senior Associate Manufacturing - Nights

What you will do

Let’s do this. Let’s change the world. In this vital role you will perform operations in the Manufacturing area, specifically Inoc/Seeds. Operations will be performed according to Standard Operating Procedures (SOPs). Senior Associate will perform and monitor critical processes, execute routine validation protocols, and regularly draft and revise documents such as Manufacturing Procedures, SOPs, and technical reports. Senior Associate will also perform basic troubleshooting and assist in the review of documentation for assigned functions. May participate on cross-functional teams and represent the Inoc/Seeds group. Senior Associate may also have the responsibility of owning NC/CAPA’s and Change Control records. In addition, Senior Associate may identify, recommend, and implement improvements related to routine function.

In this role, you will be expected to work a 12-hour shift (7PM-7AM) on a rotating schedule (D Shift). This includes extra benefits such asreceiving an added 15% shift differential, and also getting premium pay for any Sundays worked.The schedule during the initial on-boarding phase for this role (2-6 weeks) will be administrative (Monday through Friday, approximately 8am to 5pm).

Job Responsibilities:

• Lead manufacturing operations on the production floor.

• Ensure all safety and compliance procedures are followed at all times.

• Participate in the development, implementation, and issue resolution associated with process equipment Commissioning, Qualification, and Validation.

• Provide troubleshooting, technical support, and resolution of equipment, automation, and process issues on the manufacturing floor.

• Write, revise, and own controlled documentation (SOPs, Manufacturing Procedures (MPs), Forms, Technical Reports, etc.)

• Serve as SME for functional area operations.

• Provide training to manufacturing staff on process and equipment.

• Own deviations and Corrective and Preventive Actions (CAPA)

• Champion Lean Transformation and OE initiatives; facilitate the drive towards continuous improvement in all Manufacturing areas.

• Collaborate with Quality, Engineering, Process Development, Validation, and Operations to resolve manufacturing events in a timely manner.

• Assure appropriate escalation to different levels of management when personnel and environmental safety, equipment functionality, product supply, or quality are at risk.

• Collaborate with Quality, Manufacturing Managers, Plant Engineering, Process Development, and Regulatory Compliance staff in multi-functional teams.

• Participate in the design, development, and implementation of processes in support of the manufacturing floor.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a self-starter with these qualifications.

Basic Qualifications:

• High school diploma / GED and 4 years of Manufacturing or Operations experience OR

• Associate’s degree and 2 years of Manufacturing or Operations experience OR

• Bachelor’s degree and 6 months of Manufacturing or Operations experience OR

• Master’s degree

Preferred Qualifications:

• Knowledge of small-scale bioreactors, wave bioreactors, and aseptic processing.

• CFR and Regulatory knowledge

• Mechanical ability/expertise

• Knowledge of WIP lab equipment and computers, with LIMS access

• Basic statistical mathematical skills

• Ability to interpret and apply GMP knowledge

• Understanding of analytical methods for the manufacturing area

• Ability to demonstrate technical writing capability with Trackwise access

• Able to demonstrate project management skills and presentation skills

• Independently collaborate with outside resources

• Ability to understand, apply and evaluate basic chemistry, biology and physical principles

• Basic troubleshooting skills on bioreactors

• Experience with Delta V, RD’s

• Experience with lab equipment/testing

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans

• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship for this role is not guaranteed.

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Salary Range