BioSpace
Specialist Manufacturing: NPI, Upstream Process Owner
BioSpace, Holly Springs, North Carolina, United States, 27540
Specialist Manufacturing: NPI, Upstream Process Owner
Join to apply for the
Specialist Manufacturing: NPI, Upstream Process Owner
role at
BioSpace .
Join Amgen's Mission of Serving Patients
At Amgen, if you feel like you're 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.
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 lie within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless‑steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in‑class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon‑neutral company by 2027.
What You Will Do
New Product Introduction (NPI) lead coordinating with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, as well as Quality to introduce new Drug Substance products and/or advanced technologies into the plant using project management tools (e.g., Smartsheet).
Upstream biologics drug substance technical expert who leads or participates in projects, including aiding in commissioning and qualification and training staff on equipment and processes.
Support Manufacturing in troubleshooting, problem solving and RCAs. Support CAPA development to prevent error recurrence.
Owns New Product Introduction Change Controls and collaborates with stakeholders to drive on‑time completion. Responds to regulatory questions and/or audit findings.
Ensures that manufacturing production documents (e.g., Standard Operating Procedures) are accurate and up to date.
What We Expect Of You We are all different, yet we all use our unique contributions to serve patients. The manufacturing professional we seek has a biologics Drug Substance Upstream manufacturing background with strong cross‑functional project management and communication skills as well as the below qualifications.
Basic Qualifications
High school diploma / GED & 10 years of biotechnology operations experience OR
Associates degree & 8 years of biotechnology operations experience OR
Bachelors degree and 4 years of biotechnology operations experience OR
Masters degree in chemistry, biology, or engineering & 2 years of biotechnology operations experience OR
Doctorate degree
Preferred Qualifications
Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry
Excellent cross‑functional project management, meeting facilitation, and technical writing skills
Experience in Upstream GMP manufacturing operations
Strong technical knowledge of Upstream drug substance processing (media preparation, cell culture, harvest) and a broad understanding of related disciplinary areas in bioprocessing.
Ability to organize, analyze and interpret technical data through trend analysis, forecasting, modeling, etc.
Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
Ability to coach, mentor and/or cross train colleagues within core technical areas
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, we will support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now and make a lasting impact with the Amgen team. careers.amgen.com
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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Specialist Manufacturing: NPI, Upstream Process Owner
role at
BioSpace .
Join Amgen's Mission of Serving Patients
At Amgen, if you feel like you're 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.
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 lie within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless‑steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in‑class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon‑neutral company by 2027.
What You Will Do
New Product Introduction (NPI) lead coordinating with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, as well as Quality to introduce new Drug Substance products and/or advanced technologies into the plant using project management tools (e.g., Smartsheet).
Upstream biologics drug substance technical expert who leads or participates in projects, including aiding in commissioning and qualification and training staff on equipment and processes.
Support Manufacturing in troubleshooting, problem solving and RCAs. Support CAPA development to prevent error recurrence.
Owns New Product Introduction Change Controls and collaborates with stakeholders to drive on‑time completion. Responds to regulatory questions and/or audit findings.
Ensures that manufacturing production documents (e.g., Standard Operating Procedures) are accurate and up to date.
What We Expect Of You We are all different, yet we all use our unique contributions to serve patients. The manufacturing professional we seek has a biologics Drug Substance Upstream manufacturing background with strong cross‑functional project management and communication skills as well as the below qualifications.
Basic Qualifications
High school diploma / GED & 10 years of biotechnology operations experience OR
Associates degree & 8 years of biotechnology operations experience OR
Bachelors degree and 4 years of biotechnology operations experience OR
Masters degree in chemistry, biology, or engineering & 2 years of biotechnology operations experience OR
Doctorate degree
Preferred Qualifications
Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry
Excellent cross‑functional project management, meeting facilitation, and technical writing skills
Experience in Upstream GMP manufacturing operations
Strong technical knowledge of Upstream drug substance processing (media preparation, cell culture, harvest) and a broad understanding of related disciplinary areas in bioprocessing.
Ability to organize, analyze and interpret technical data through trend analysis, forecasting, modeling, etc.
Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
Ability to coach, mentor and/or cross train colleagues within core technical areas
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, we will support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now and make a lasting impact with the Amgen team. careers.amgen.com
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.
#J-18808-Ljbffr