What are the responsibilities and job description for the Aseptic Officer position at BioSpace?
Join Amgens Mission of Serving Patients
At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives 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. 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.
Aseptic Officer
What You Will Do
Lets do this. Lets change the world. In this vital role you will provide technical leadership and oversight of aseptic operations within the multi-product drug product manufacturing facility. This role is accountable for maintaining compliance with cGMP requirements through robust execution of the aseptic technique and media fill programs and by supporting contamination control initiatives across operations. You will own theMedia Programfor one of two isolator-based filling lines, lead observation and training efforts to sustain aseptic compliance, and partner cross-functionally with Quality, Validation, and Engineering to ensure sterility assurance standards are consistently met.
Responsibilities
Aseptic Program Leadership
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a go getter with these qualifications.
Basic Qualifications
Doctorate degree
Or
Masters degree and 2 years of operations or quality experience
Or
Bachelors degree and 4 years of operations or quality experience
Or
Associates degree and 8 years of operations or quality experience
Or
High school diploma / GED and 10 years of operations or quality experience
Preferred Qualifications
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
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.
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.
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. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives 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. 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.
Aseptic Officer
What You Will Do
Lets do this. Lets change the world. In this vital role you will provide technical leadership and oversight of aseptic operations within the multi-product drug product manufacturing facility. This role is accountable for maintaining compliance with cGMP requirements through robust execution of the aseptic technique and media fill programs and by supporting contamination control initiatives across operations. You will own theMedia Programfor one of two isolator-based filling lines, lead observation and training efforts to sustain aseptic compliance, and partner cross-functionally with Quality, Validation, and Engineering to ensure sterility assurance standards are consistently met.
Responsibilities
Aseptic Program Leadership
- Lead the Aseptic Technique Program for the suite, including routine observation of critical operations, data trending, and implementation of corrective and preventive actions (CAPAs).
- Provide coaching and mentoring to operations personnel to strengthen aseptic practices and contamination control awareness.
- Author, review, and maintain aseptic-related SOPs, reports, and training materials to ensure alignment with current regulatory expectations and site standards.
- Partner closely with Quality Assurance, Validation, and other site Aseptic Officers to ensure consistent execution and knowledge sharing across functions.
- Represent Manufacturing during internal and external inspections, demonstrating robust understanding and control of aseptic practices.
- Lead the Media Fillssupporting the sites one of two isolator-based filling lines.
- Author and implementmedia fill protocols, complete final reports, and perform data trending and risk analysis.
- Partner with Manufacturing, Quality, and Engineering to ensure execution aligns with aseptic process design, batch records, and contamination control strategy.
- Evaluate results, find opportunities for process or operator improvement, and ensure timely closure of associated investigations and CAPAs.
- Support contamination and cross contamination control initiatives and provide aseptic expertise in investigations, deviations, and change controls.
- Participate in data reviews and trending related to aseptic or microbiological quality indicators (e.g., EM, bioburden, or utility monitoring) as needed.
- Contribute to improvements in facility design, procedures, and behaviors that enhance aseptic performance and sterility assurance.
- Participate in partner and regulatory audits, provide required information, and respond to findings as appropriate.
- Actively participate in Lean Transformation and continuous improvement initiatives (e.g., SQDIP boards, Kaizen events, and Work Center Teams).
- Use problem-solving and root-cause tools (5S, Fishbone, 5 Whys) to identify and implement improvements to aseptic performance and process control.
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a go getter with these qualifications.
Basic Qualifications
Doctorate degree
Or
Masters degree and 2 years of operations or quality experience
Or
Bachelors degree and 4 years of operations or quality experience
Or
Associates degree and 8 years of operations or quality experience
Or
High school diploma / GED and 10 years of operations or quality experience
Preferred Qualifications
- 10 yearsof biopharmaceutical or medical technology experience with increasing responsibility.
- Bachelors or Masters degree inMicrobiology, Life Sciences, or a related field.
- Demonstrated expertise inaseptic processing,isolator operations, andmedia fill program management.
- Experience supporting regulatory inspections and contamination control initiatives in a sterile manufacturing environment.
- In-depth understanding ofcGMPs,aseptic technique, andsterility assurance principles.
- Familiarity with microbiological investigations, environmental monitoring data interpretation, and deviation management.
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, including remote and hybrid work arrangements, where possible
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.
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.
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. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
