Mfg Technologies Sr Manager

BioSpace

$130K — $160K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Doctorate with 2 years of manufacturing support experience, or
  • Master's with 4 years of manufacturing support experience, or
  • Bachelor's with 6 years of manufacturing support experience, or
  • Associate's with 10 years of manufacturing support experience, or
  • High school/GED with 12 years of manufacturing support experience.

Responsibilities

  • Lead cross-functional forums to drive decision-making for Amgen's best interests.
  • Oversee and review global Manufacturing Execution Systems (MES) standard operating procedures (SOPs).
  • Develop an application roadmap in collaboration with IT for forthcoming MES functionalities.
  • Maintain system-related controlled documents including SOPs and training content.
  • Approve validation documents and conduct testing for MES and some ERP systems.

Benefits

  • Comprehensive employee benefits package including medical, dental, and vision coverage.
  • Generous Retirement and Savings Plan contributions.
  • Discretionary annual bonus program.
  • Stock-based long-term incentives.
  • Award-winning time-off plans with flexible work models.
Full Job Description
Job Details

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.

Mfg Technologies Sr Manager
What you will do
Lets do this. Lets change the world. In this vital role you will manage a defined set of Manufacturing Execution Systems (MES) objects, such as GMBRs (electronic batch records) and equipment management objects (ESPs, state diagrams), that are utilized across all applicable manufacturing sites.
Responsibilities:
  • Collaborate, communicate be accountable for leading forums with multi-functional areas and make the appropriate decisions for the best interest of Amgen.
  • May include ownership of global MES SOPs in addition of provide input and review of related global training materials.
  • Strategize with DTI on application roadmap and accommodating new offered functionality.
  • Own system related controlled documents such as data integrity assessment report, operational SOPs, and training content (backup).
  • Lead and approve validation documents and records such as validation plan, OQ protocol, configuration specifications, requirements specs, validation summary (backup) report, test scripts, test sets, and test runs mostly for MES but also some for ERP.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Manufacturing Technologies Sr. Manager professional we seek is a collaborative individual contributor leader with these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of Manufacturing support experience
Or
Masters degree and 4 years of Manufacturing support experience
Or
Bachelors degree and 6 years of Manufacturing support experience
Or
Associates degree and 10 years of Manufacturing support experience
Or
High school diploma / GED and 12 years of Manufacturing support experience

Preferred Qualifications:
  • Academic background in Life Science, and/or Engineering.
  • Leadership experience managing contractors and indirect reports.
  • Background in Finish Drug Product (FDP) and/or Drug Product.
  • MES technology knowledge with experience modifying batch records.
  • Proficient communication skills in English.
  • Experience with MBR design in Koerbers PAS|X (or another vendor).
  • MES system experience in biological manufacturing floor operations.
  • Regulated environment work experience with cross-functional collaboration, working in teams.
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, including remote and hybrid work arrangements, where possible
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.

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.

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