Process Development Associate - Microbiology

Initial Therapeutics, Inc.; Thousand Oaks (CA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Stock-based long-term incentives

Health, dental, vision coverage

Flexible work models where possible

Job summary

Amgen is seeking a Process Development Associate in Microbiology to join a collaborative team focused on microbiological method development, optimization and troubleshooting. The role emphasizes laboratory execution, data analysis, and preparation of protocols and summaries.

You will interface with QC Microbiology and cross-functional partners, contributing to scientific discussions and advancing regulatory-compliant microbiological testing methods.

Qualifications

• Bachelor's degree or higher in microbiology or related science field.
• 4 years microbiology-related experience with Associate degree.
• 6 years microbiology-related experience with high school/GED.

Responsibilities

• Execute microbiological method development, optimization, and troubleshooting studies.
• Analyze and interpret data; summarize results; assist in drafting protocols and reports.
• Maintain knowledge of USP, Ph. Eur., JP and regulatory guidance for microbiology testing.
• Collaborate with QC Microbiology, Process Development, Manufacturing, Quality and other functions.
• Represent Process Microbiology in cross-functional meetings; communicate study progress and results.
• Support day-to-day laboratory operations and ensure material availability.

Skills

Hands-on microbiology

Aseptic techniques

Microbiology lab experience

Documentation and technical writing

Cross-functional collaboration

Project/data organization tools

Communication skills

Education

Bachelor's degree in Microbiology or related field

Associate degree + 4 years microbiology experience

High school diploma/GED + 6 years microbiology experience

Tools

SharePoint

Smartsheet

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 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. 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.

Process Development Associate - Microbiology

What you will do

Lets do this. Lets change the world. In this vital role you will work collaboratively with a team of scientists to execute studies supporting microbiological method development, optimization, and troubleshooting. The role will primarily focus on laboratory execution while also contributing to study design, data analysis, as well as support scientists in drafting protocols/summary reports. Activities also include the evaluation of new technologies/rapid microbiology methods (RMM).

The successful candidate will perform studies independently and collaborate with scientists on study execution, support team on data analysis and drafting of protocols/summary reports. In addition, the PD Associate will interface with Amgen QC and other cross-functional partners and represent the Process Microbiology team in scientific and technical discussions.

• Execute laboratory studies supporting microbiological method development, optimization, troubleshooting, validation including (but not limited to):

  • Endotoxin method/low endotoxin recovery (LER) studies

  • Microbial Challenge/Hold time studies

  • Bacterial Retention Testing/Sterile Filtration Studies

  • Advancement of existing methods and implementation of alternative technologies, such as recombinant reagents for endotoxin testing and Monocyte Activation Test (MAT) for pyrogen testing

  • Evaluation of RMMs

• Analyze and interpret experimental data, summarize study results, and assist with the preparation of protocols, technical assessments, reports

• Maintain knowledge of current compendial and regulatory requirements applicable to microbiological testing and microbial control, including USP, Ph. Eur., JP, and relevant regulatory guidance (Annex 1, CFRs, etc.)

• Collaborate with QC Microbiology, Process Development, Manufacturing, Quality and other functions to support the Amgen network

• Participate in and represent Process Microbiology in scientific and cross-functional meetings, including communicating study progress, study results, and technical findings

• Communicate effectively and efficiently with cross-functional team members, clients, and partner organizations

• Support day-to-day laboratory operations, including maintaining laboratory supplies and inventory, coordinating ordering of materials, and ensuring appropriate supplies are available to support study execution

What we expect of you

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:

Requirement 1 Bachelors degree
OR
Associates degree and 4 years of Microbiology, related biological science experience
OR
High school diploma / GED and 6 years of Microbiology, related biological science experience

Preferred Qualifications:

• Hands-on experience in microbiology and aseptic techniques.

• Prior experience in Microbiological Quality Lab or similar microbiology laboratory environment

• Demonstrate the ability to understand, apply, and evaluate microbiological principles

• Experience with compendial microbiological methods, including bioburden, bacterial endotoxins, and/or sterility testing

• Detail-oriented with strong laboratory documentation and technical writing skills.

• Ability to independently organize and execute laboratory studies while effectively managing multiple priorities and timelines

• Effective written and verbal communication skills with the ability to work independently as well as collaboratively in cross-functional teams

• Proficiency with tools used to organize and manage projects and data, such as SharePoint and Smartsheet

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.