Sr Associate Mfg - Nights

BioSpace; West Greenwich (RI); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Shift differential

Sunday premium pay

Job summary

Amgen in the United States is seeking a Senior Associate Manufacturing - Nights to lead production activities in the Inoc/Seeds area. You will execute operations under SOPs, participate in validation, draft and revise documents, and support a culture of safety and continuous improvement.

The role emphasizes quality, compliance, and collaboration with Quality, Engineering, Process Development, and Regulatory teams.

Qualifications

• High school diploma / GED with 4 years of Manufacturing or Operations experience.
• Associates degree with 2 years of Manufacturing or Operations experience.
• Bachelors degree with 6 months of Manufacturing or Operations experience OR Masters degree.
• Knowledge of GMP/CFR regulations and basic statistical methods.
• Ability to interpret and write SOPs, MP documents and technical reports.

Responsibilities

• Lead manufacturing operations on the production floor.
• Ensure safety and compliance procedures are followed at all times.
• Support equipment qualification, validation, and issue resolution.
• Provide troubleshooting and technical support for equipment, automation, and processes.
• Write, revise, and own SOPs and manufacturing documentation.
• Collaborate with Quality, Engineering, and Regulatory staff on manufacturing events.

Skills

Manufacturing experience

Troubleshooting

GMP knowledge

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in manufacturing or related field

Associate's degree

Master's degree

Tools

Delta V

R&D/Development systems (RDs)

LIMS

Process equipment

Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared mission to serve patients living with serious illnesses drives all that we do.

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared mission to serve patients living with serious illnesses drives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Associate Manufacturing - Nights

What You Will Do

Lets do this. Lets 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/CAPAs 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 as receiving 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
• Associates degree and 2 years of Manufacturing or Operations experience OR
• Bachelors degree and 6 months of Manufacturing or Operations experience OR
• Masters 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, RDs
• 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, well 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.

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.

Application deadline

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

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.