Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Front Line Manufacturing Manager - Upstream Bulk Drug Substance - Days

Amgen SA

Front Line Manufacturing Manager - Upstream Bulk Drug Substance - Days Amgen is seeking a Manager Manufacturing Upstream to provide frontline leadership supporting the facility expansion program and facility startup. This essential role will lead a team responsible for manufacturing cell culture operations including seed train, SUBs, Perfusion, RTF, Stainless Steel BRXs, Depth Filtration and Centrifugation, while partnering across functions to ensure successful operational readiness, technology transfer, and ramp‑up of manufacturing operations within the new facility. The Manager will play a critical role supporting the design, build, startup, and operational phases of the facility expansion. The position will initially focus on facility startup and operational readiness activities, transitioning to manufacturing leadership as the facility becomes operational. During this phase of the startup, you will be expected to work a Monday – Friday schedule from 8am – 5pm. This role may require work outside standard business hours, including non‑standard shifts, as needed to support startup, commissioning, and qualification (C&Q), and engineering execution. As the business moves from C&Q to manufacturing operations, this essential position will work on a 12‑hour 2‑2‑3 schedule from 5:45 am to 6:15 pm supporting our critical 24/7 manufacturing operations. As Amgen relies upon the regular attendance of all staff members to meet legitimate business needs, the Manager must be able to work assigned 12‑hour shift, including during inclement weather, some holidays and requested overtime in support of our operations. Responsibilities Frontline Leadership: Lead, develop, and coach a manufacturing team; set clear performance expectations; foster a strong culture of safety, quality, and accountability. Facility Startup & Operational Readiness: Support design, build, commissioning, qualification (C&Q), staffing, training, and readiness milestones for a new manufacturing facility. Manufacturing Operations: Ensure safe, cGMP‑compliant execution; drive performance across safety, quality, schedule, and cost; resolve deviations and operational issues. Technology Transfer & Process Implementation: Support transfer and implementation of manufacturing processes; ensure manufacturability, troubleshooting, and continuous improvement. Cross‑Functional Collaboration: Partner with Quality, Engineering, NPI, Supply Chain, Validation, and Site Leadership to enable successful startup and ramp‑up. Compliance & Inspection Readiness: Maintain inspection readiness and adherence to regulatory and Amgen quality standards. Continuous Improvement: Identify and drive efficiency, reliability, and scalability improvements as operations mature. Shift Support: Work non‑standard hours as required, transitioning to a 12‑hour 2‑2‑3 day shift supporting 24/7 operations. What we expect from you We seek a biotechnology professional who can serve patients and who meets the following qualifications. Basic Qualifications Doctorate degree OR Master’s degree and 3 years of Manufacturing or Operations experience OR Bachelor’s degree and 5 years of Manufacturing or Operations experience OR Associate’s degree and 10 years of Manufacturing or Operations experience OR High school diploma / GED and 12 years of Manufacturing or Operations experience AND previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing allocation of resources Preferred Qualifications Bachelor’s degree in Life Sciences or Engineering Experience with facility startup, commissioning, or operational readiness Biologics / drug substance manufacturing experience (Upstream) cGMP manufacturing experience (5+ years preferred) Experience with technology transfer and process implementation Prior Area Lead / Specialist / Manager experience Strong leadership, performance management, and conflict‑resolution skills Solid understanding of regulatory requirements Proficiency with MES/EBR, DeltaV, Maximo, Veeva, LIMS, and electronic quality systems What you can expect of us Our Total Rewards Plan includes a comprehensive benefits package: retirement and savings plan, medical, dental, and vision coverage, life and disability insurance, flexible spending accounts, discretionary annual bonus, stock‑based long‑term incentives, time‑off plans, and flexible work models including remote arrangements where possible. #J-18808-Ljbffr Amgen SA

Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the Front Line Manufacturing Manager - Upstream Bulk Drug Substance - Days in Holly Springs, NC vacancy
  •  ...these vital and dynamic roles you will be an on-shift front line manager in manufacturing. As a manufacturing leader you will oversee teams of manufacturing...  ...who will be responsible for the manufacture of GMP drug substances. Through structured on the floor presence, you will... 
    Suggested
    Worldwide
    Flexible hours
    Shift work
    Night shift

    Amgen Inc. (IR)

    Holly Springs, NC
    2 days ago
  • Amgen Inc. (IR) in Holly Springs, North Carolina is looking for a Front Line Manufacturing Manager to oversee the expansion of their drug substance manufacturing facility. You will lead a team responsible for crucial operations from startup to ongoing production, ensuring... 
    Suggested
    Shift work

    Amgen Inc. (IR)

    Holly Springs, NC
    4 days ago
  •  ...Title Job Title: Engineer Principal - Drug Substance Manufacturing Process Optimization & Tech Transfer REMOTE...  ...for technical troubleshooting Day to Day Responsibilities Lead optimization...  ...conference interview with hiring manager. Contact Information We invite qualified... 
    Suggested
    Remote job
    Permanent employment
    Contract work
    Local area
    Day shift
    Afternoon shift

    3key Consulting, Inc.

    Holly Springs, NC
    3 days ago
  • Job Title: Engineer Senior, Biotech GMP Drug Substance manufacturing, tech transfer - Remote (JP14709)...  ...Proficient in Drug Substance processes Day to Day Responsibilities Provides expertise...  ...process Phone interview with hiring manager We invite qualified candidates to... 
    Suggested
    Remote job
    Permanent employment
    Contract work
    Local area

    3key Consulting, Inc.

    Holly Springs, NC
    20 hours ago
  • Overview Job Title: Engineer - Biologics Drug Substance PPQ support (JP14922) Location: Holly...  ...- $38/hour W2 Notes: Hybrid onsite 3-5 days onsite. Standard hours 3 Key Consulting...  ...validation floor support as needed for sample management verification. Assist in developing... 
    Suggested
    Permanent employment
    Contract work

    3key Consulting, Inc.

    Holly Springs, NC
    1 day ago
  • Amgen is seeking a Front Line Manufacturing Manager in Holly Springs, North Carolina. This role involves leading a team in manufacturing operations for cell culture processes, ensuring compliance with regulatory standards, and supporting facility startup. Ideal candidates... 
    Flexible hours

    Initial Therapeutics, Inc.

    Holly Springs, NC
    3 days ago
  •  ...achieve together—researching, manufacturing, and delivering ever-better...  ...’s newest and most advanced drug substance manufacturing plant. When...  ...solving techniques, project management, lifecycle management and Operational...  ...runs as applicable. Manage day‑to‑day operational support... 
    Remote job
    Worldwide
    Monday to Friday
    Flexible hours
    Afternoon shift

    Amgen SA

    Holly Springs, NC
    20 hours ago
  • Responsibilities As an upstream supervisor, you’ll lead and inspire a team of manufacturing associates, supporting the start up...  ...manufacturing facility, offering drug substance production, fill-finish, and...  ...onboarding, and materials management Responsible for building and... 
    Relocation package
    Shift work
    Day shift

    FUJIFILM Biotechnologies

    Holly Springs, NC
    1 day ago
  • A consulting firm in biotechnology is seeking an Engineer for biologics drug substance process validation support. This role involves assisting senior staff with project initiation, design, and delivery, particularly in the area of process validation. Candidates should... 
    Contract work

    3key Consulting, Inc.

    Holly Springs, NC
    1 day ago
  • $34 - $38 per hour

     ...Springs, NC. This position involves supporting biologics technology transfer and ensuring safety and compliance in a commercial drug substance facility. Candidates with a Master's degree or relevant experience are welcome to apply. The role offers a pay rate of $34-$38/... 
    Permanent employment
    Contract work

    3key Consulting, Inc.

    Holly Springs, NC
    4 days ago
  • $45 - $50 per hour

    A leading consulting firm is seeking a Senior Engineer for a remote role focusing on GMP Drug Substance manufacturing and tech transfer. The ideal candidate must have strong expertise in GMP processes and experience in technical problem-solving. This position requires... 
    Remote job

    3key Consulting, Inc.

    Holly Springs, NC
    1 day ago
  • Overview Job Title: Engineer Associate Director - Start-Up Lead New Drug Substance Facility (JP14556) Location: Holly Springs, NC. 27540 (REMOTE with up to 25% travel to Holly Springs, NC) Employment Type: Contract Business Unit: DST Business Operations Duration: 9+ months... 
    Permanent employment
    Contract work
    Remote work

    3key Consulting, Inc.

    Holly Springs, NC
    4 days ago
  •  ...patients as we research, manufacture, and deliver...  ...newest and most advanced drug substance manufacturing plant. When...  ...company by 2027. Senior Manager Manufacturing System...  ...departmental SOPs. Manage day‑to‑day automation...  ...production facility processes (Upstream: Seed train,... 
    Local area
    Flexible hours

    Amgen SA

    Holly Springs, NC
    2 days ago
  • A leading biopharmaceutical company in Holly Springs is seeking a Manufacturing Systems Engineer specializing in Automation to enhance its drug substance manufacturing facility. The ideal candidate will possess extensive experience in process control systems, specifically... 

    Amgen SA

    Holly Springs, NC
    20 hours ago
  • Initial Therapeutics, Inc. in Holly Springs, North Carolina is seeking a Manufacturing Systems Engineer to develop and maintain automation solutions for GMP Drug Substance Plant operations. The role necessitates a strong engineering background, with responsibilities including... 

    Initial Therapeutics, Inc.

    Holly Springs, NC
    20 hours ago
  •  ...Overview The Supervisor, Drug Product Filling supports start...  ...team and is responsible for the manufacturing process and facility which...  ...manufacturing facility, offering drug substance production, fill-finish, and...  ...(PQ), travel as needed Manages and develops direct reports... 
    Shift work
    Afternoon shift

    FUJIFILM Corporation

    Holly Springs, NC
    2 days ago
  •  ...automated Visual inspection operations for Drug Product in a Good Manufacturing Practices (GMP) regulated...  ...manufacturing facility, offering drug substance production, fill‑finish, and...  ...experience leading, supervising, or managing others Preferred Requirements Bachelor... 
    Shift work

    FUJIFILM Holdings America Corporation

    Holly Springs, NC
    3 days ago
  • $163.29k - $220.92k

     ...of patients as we research, manufacture, and deliver innovative medicines...  ...'s newest and most advanced drug substance manufacturing plant. When...  ...by 2027. Senior Manager Manufacturing Systems Engineering...  ...in providing 24x7 day-to-day operational support,... 
    Bank staff
    Work at office
    Remote work
    Flexible hours

    Amgen

    Holly Springs, NC
    2 days ago
  • Position Overview The Automation Engineer 3, DSM Upstream, will provide support to the Drug Substance Manufacturing (DSM) facility using DeltaV. This includes implementing changes to the Automation systems, updating design documents, executing tests, troubleshooting events... 

    FUJIFILM Holdings America Corporation

    Holly Springs, NC
    20 hours ago
  •  ...Overview This role leads a shift team and is responsible for manufacturing bulk drug substance. The manufacturing facility operates 24/7, and the...  ...document review/approval, team onboarding, and materials management Supervises manufacturing associates on technical and operational... 
    Shift work
    Day shift

    Merck & Co.

    Holly Springs, NC
    4 days ago
  • $16.5 per hour

     ...Front Desk Supervisor Pet Paradise is looking for "pet people"...  ...training for the next steps in management with Supervisor and Assistant...  ...Groomer! ~ Complimentary Pet Day Camp Bring your dog with you...  ...United States. WE ARE A DRUG-FREE, SMOKE-FREE, EQUAL OPPORTUNITY... 
    Full time
    Part time
    Night shift

    Pet Paradise

    Apex, NC
    3 days ago
  • $107.8k - $168.01k

     ...are committed to making an impact every day. Company Culture Guidelines & Values:...  ...collective expertise We are seeking an Upstream Principal CQV Engineer is responsible...  ...approaches ~ Experience in biologics manufacturing or monoclonal antibody production... 
    Temporary work
    Work experience placement

    Verista, Inc.

    Holly Springs, NC
    9 days ago
  •  ...sustainment of digital manufacturing systems (e.g., MES,...  ...unit operation family (Upstream, Downstream, or Solutions...  ...facility, offering drug substance production, fill‑finish...  ...measures. Coordinates and manages integrations with...  ...communications; provides day‑to‑day user support... 

    Merck & Co.

    Holly Springs, NC
    20 hours ago
  •  ...lives of patients as we research, manufacture, and deliver innovative medicines...  ...equipment and systems needed for drug substance production. This role will develop...  ...rotational on‑call support and ensure 24×7 day‑to‑day reliability of Upstream and Downstream systems for plant... 
    Work experience placement
    Monday to Friday
    Flexible hours
    Shift work
    Afternoon shift

    Amgen SA

    Holly Springs, NC
    3 days ago
  •  ...organizational goals, and managing the employeelifecycle....  ...end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish,...  ...Anatomy to make decisions in line with P&C strategy...  ...Springs Posted Date 6 days ago (5/22/2026 1:17 PM)... 
    Work at office
    Local area

    FUJIFILM Corporation

    Holly Springs, NC
    3 days ago
  • Manufacturing Systems Engineer: Automation You will work with a group...  ...platforms that support the GMP Drug Substance Plant operations....  ...and sustainability. Support day‑to‑day operations, including...  ...installation, and lifecycle management of automation and field instrumentation... 
    Remote job
    Flexible hours

    Amgen SA

    Holly Springs, NC
    10 hours ago
  •  ...relevant experience. Key responsibilities include gathering process validation criteria and assisting in documentation reviews. A hybrid work model allows 3-5 days onsite weekly, offering a collaborative environment in drug substance biologics. #J-18808-Ljbffr Planet Pharma

    Planet Pharma

    Holly Springs, NC
    20 hours ago
  • Amgen SA seeks a Senior Manager Manufacturing System Engineer in Holly Springs, NC, to oversee automation engineering efforts at its advanced drug substance manufacturing facility. The successful candidate will lead the Automation Engineering team, support 24/7 operations... 

    Amgen SA

    Holly Springs, NC
    4 days ago
  • Initial Therapeutics, Inc. is seeking a Senior Manager for Manufacturing Systems Engineering - Automation in Holly Springs, North Carolina....  ...Engineers and ensure compliance with regulatory standards in drug substance manufacturing. This role involves managing automation... 
    Remote job

    Initial Therapeutics, Inc.

    Holly Springs, NC
    3 days ago
  •  ...daily manual and automated Visual inspection operations for Drug Product in a Good Manufacturing Practices (GMP) regulated environment. This role ensures...  ...projects Previous experience leading, supervising, or managing others Preferred Requirements Bachelor's degree in... 
    Shift work

    Merck & Co.

    Holly Springs, NC
    20 hours ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Front Line Manufacturing Manager - Upstream Bulk Drug Substance - Days. Be the first to apply!