Front Line Manufacturing Manager - Upstream Bulk Drug Substance - Days
Amgen SA
Front Line Manufacturing Manager – Upstream Bulk Drug Substance – Days What you will do Let’s do this. Let’s change the world. 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. Basic Qualifications Doctorate degree Master’s degree and 3 years of Manufacturing or Operations experience Bachelor’s degree and 5 years of Manufacturing or Operations experience Associate’s degree and 10 years of Manufacturing or Operations experience High school diploma / GED and 12 years of Manufacturing or Operations experience Previous managerial experience directly managing people and/or leading teams, projects, programs, or directing the 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 Benefits The annual base salary range for this opportunity in the U.S. is provided below. In addition to the base salary, Amgen offers a total rewards plan comprising 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. 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 and bi‑annual company‑wide shutdowns Flexible work models, including remote work arrangements, where possible #J-18808-Ljbffr Amgen SA
$106.15k - $143.61k
Front Line Manufacturing Manager - Bulk Drug Substance Services We are seeking a manager to lead frontline manufacturing operations, support the expansion and... ...standard hours as required; transition to a 12‑hour 2‑2‑3 day shift schedule for 24/7 operations. Qualifications...SuggestedFlexible hoursDay shift- Manager Manufacturing(Downstream)- Day Shift Let’s do this. Let’s change the world. In these vital and dynamic roles you will be a non‑shift front line manager in manufacturing. The working schedule is... ...for the manufacture of GMP drug substances. Through structured on‑...SuggestedTemporary workRemote workFlexible hoursShift workNight shiftDay shift
- Manager Manufacturing (Downstream) - Day Shift Lead frontline manufacturing operations for GMP drug substances in a 12‑hour 2‑2‑3 shift schedule (5:45am-6:15pm). Oversee 24/7 production with an emphasis on safety, quality, and continuous improvement. Responsibilities Supervise...SuggestedRemote workFlexible hoursShift workDay shift
$106.15k - $143.61k
Manager Manufacturing (Downstream) - Night Shift Live Key responsibilities include: Oversee and manage manufacturing associates producing GMP drug substances on a 12‑hour night shift. Champion a safe, compliant production environment and uphold cGMP, CFR, and company safety...SuggestedWork at officeRemote workFlexible hoursNight shift- ...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...SuggestedRemote jobPermanent employmentContract workLocal areaDay shiftAfternoon shift
- ...Downstream Bioprocess Engineer - Drug Substance Tech Transfer & Manufacturing Support (Biologics) (JP15... ...in a commercial bulk drug substance facility,... ...Downstream Tech transfer Day to Day Responsibilities:... ..., and product life cycle management Ensure safety and compliance...Permanent employmentContract workFlexible hoursDay shift
- 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...Remote jobPermanent employmentContract workLocal area
- 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...Permanent employmentContract work
$106.15k - $143.61k
Amgen Inc. (IR) in Holly Springs is seeking a Front Line Manufacturing Manager to lead the operations of a new drug substance facility. The role involves managing teams, ensuring safety and quality standards, and supporting production startup. The ideal candidate will possess...- 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 packageShift workDay shift
- 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
$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 employmentContract work$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- 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 employmentContract workRemote work
- 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...
- Position Overview The Supervisor, Drug Product Filling supports... ...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 workAfternoon shift
- Amgen SA is seeking a Manager for Manufacturing in Holly Springs, NC. This vital role involves overseeing teams, ensuring production compliance in a biotechnology environment, and fostering a safe workplace. The successful candidate will manage ongoing operations on a 1...Shift workDay shift
- 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...
- ...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...
- ...Overhead Transmission Line Structural Engineer... ...improvement and change management efforts Engineering... ...at the job site and in front of customer personnel.... ...civil background check, drug screen, and motor vehicle... ...offered after the first 90 days of employment based upon...Work experience placementHome officeFlexible hours
- ...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 workDay shift
- ...of patients as we research, manufacture, and deliver innovative medicines... ...'s newest and most advanced drug substance manufacturing plant. When... ...company by 2027. Senior Manager Manufacturing Systems Engineering... ...in providing 24x7 day-to-day operational support,...Bank staffRemote workFlexible hours
$163.29k - $220.92k
...of patients as we research, manufacture, and deliver innovative medicines... ...'s newest and most advanced drug substance manufacturing plant. When... ...company by2027. Senior Manager Manufacturing Systems Engineering... ...in providing 24×7 day‑to‑day operational support,...Bank staffWork at officeRemote workFlexible hours- ...responsible for providing day to day supervision,... .../STAT testing of manufacturing batch samples, clean utility... ...facility, offering drug substance production, fill-finish... ...their team and first line escalation point in areas... ...Assists senior management with resource planning...Full timeAll shiftsShift workDay shift
- 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 jobFlexible hours
- 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
$108.64k - $146.98k
Career Category Manufacturing Job Description HOW MIGHT YOU DEFY IMAGINATION? If you feel... ...of Amgen's newest and most advanced drug substance manufacturing plant. When completed,... ...carbon‑neutral company by 2027. Utilities Manager - Day Shift What you will do Let’s do this....WorldwideFlexible hoursRotating shiftDay shift- Arcadis is seeking a Process Engineer - Upstream Manufacturing at its Holly Springs facility. This crucial role focuses on optimizing and supporting... ...medical, dental, 401(k), paid parental leave, and 15 days PTO. Arcadis is committed to diversity and inclusion. #J-18...
- ...is seeking a qualified professional to improve biopharmaceutical manufacturing processes through technical leadership and innovation. The ideal candidate will have extensive experience in drug substance manufacturing processes and a strong background in biologics process...
- ...- hours may vary to support manufacturing (early/later shifts, possible... ...needs Familiar with Drug substance process equipment, autoclaves... ...technical support and sample management to cleaning activities associated... ...multiple priorities. Day to Day Responsibilities: Support...Permanent employmentContract workWeekend workAfternoon shiftEarly shift
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!
- manufacturing operations manager Holly Springs, NC
- production control manager Holly Springs, NC
- manufacturing production manager Holly Springs, NC
- director manufacturing Holly Springs, NC
- production planning manager Holly Springs, NC
- industrial production manager Holly Springs, NC
- production manager food manufacturing Holly Springs, NC
- director manufacturing science and technology Holly Springs, NC
- area production manager Holly Springs, NC
- manufacturing manager Holly Springs, NC

