Specialist Contract Development & Manufacturing

BioSpace; Thousand Oaks (CA); On-site; USD 80,000 - 120,000; Full time

Benefits offered by this job

Competitive benefits package

Retirement and Savings Plan

Flexible work models

Stock-based long-term incentives

Job summary

A leading biotech firm seeks a Specialist in Contract Development & Manufacturing to oversee manufacturing operations, ensuring compliance with regulations while managing projects. The ideal candidate will have a Bachelor's degree related to business or science and strong skills in project management, collaboration, and financial knowledge. This role offers opportunities for professional growth within a transformative healthcare environment.

Qualifications

• Collaborate across teams to manage projects effectively.
• Conduct performance monitoring and identify improvement opportunities.
• Ensure compliance with cGMP and FDA regulations.

Responsibilities

• Manage manufacturing operations and ensure data accuracy.
• Monitor site performance and coordinate with internal teams.
• Oversee project management activities from conception to close-out.

Skills

Project management

Collaboration

Problem-solving

Financial knowledge

cGMP knowledge

Education

Bachelor's degree in Business Administration, Engineering, or Science-related field

Job description

Join Amgen's Mission of Serving Patients

At Amgen, if you feel like you are part of something bigger, it's because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's 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, you'll 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, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Specialist Contract Development & Manufacturing

What You Will Do

Lets do this! Lets change the world!

• Manufacturing operations: Ensure accuracy and completion of data entries and/or tasks for budget development, monitoring, and reporting; inputs to contracts, confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc. Own NC Class II/III records, CAPA, CAPA EV, and more complex change control records.
• Site performance monitoring: Report contract site performance metrics to site lead; identify improvement opportunities for site performance; daily duties will include coordination, issuance, and review of meeting minutes, conclusions from analysis of data and metrics, continuous improvement and standardization of performance tools used by the Work Center Teams (WCT), oversight and reporting of procurement/payment of invoices, and active participation in WCT meetings with the contract site as well as internal site team.
• Project Management and Technology transfers: Follow‑up and track activities in a department‑wide project from conception to implementation and close‑out. Manage timeline and highlight risks of transfer team activities; coordinate risk management activities as part of transfer; provide escalation to the right level.

What We Expect Of You

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a collaborator with these qualifications.

Basic Qualifications

• High school diploma / GED and 10 years of Manufacturing experience OR
• Associates degree and 8 years of Manufacturing experience OR
• Bachelors degree and 4 years of Manufacturing experience OR
• Masters degree and 2 years of Manufacturing experience OR
• Doctorate degree

Preferred Qualifications

• Bachelors in Business Administration, Engineering, or Science‑related field.
• 5+ years of experience in protein, API, DS, DP, or packaging manufacturing environment.
• 5+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles.
• 2+ years of project management experience leading multi‑functional and/or multi‑location team.
• 1+ year of experience working with external parties and/or leading cross‑functional teams for clinical and/or commercial products.
• Manufacturing and cGMP knowledge / experience.
• Financial knowledge and business acumen.
• Budget management, including purchase orders, financial forecasting, and adhering to financial targets and systems.
• Demonstrated matrix management and influencing skills.
• Demonstrated negotiation skills.
• Operational Excellence proficiency and ability to drive continuous improvement.
• Proficient project management skills.
• Problem‑solving and critical thinking.
• Understanding of contractual requirements.
• Technical writing and multi‑level communication skills.
• Demonstrated ability to lead effectively in collaborative/team environment.
• Demonstrated ability to take initiative, drive action, and work under minimum supervision.

What You Can Expect From 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 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.

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.

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.