Front Line Manufacturing Manager (Bulk Drug Substance - Downstream) - Night Shift
Initial Therapeutics, Inc.
HOW MIGHT YOU DEFY IMAGINATION? Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience, and passion to work toward your goals? At Amgen, our shared mission to serve patients drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. Manager Manufacturing (Downstream) - Night Shift What you will do 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 based on a day or night shift (12‑hour) rotation. The essential position, which supports our critical 24/7 manufacturing operations, works a 12‑hour 2‑2‑3 schedule from 5:45 pm to 6:15 am. As a manufacturing leader you will oversee teams of manufacturing associates with differing levels of experience who will be responsible for the manufacture of GMP drug substances. Through structured on‑floor presence, you will champion a safe and compliant production environment. As an active participant and role model in a Lean and continuous improvement culture, the manager will embed these principles onto the manufacturing floor. Through your leadership, you will oversee teams in technical, on‑floor operations in a biotechnology production operation. In addition, you will support the development of your staff through coaching, hiring, and mentorship. Font‑line Manager will assist in defining area objectives, identifying improvement opportunities, and leading change efforts; effectively directing the team and delivering short‑ and long‑term Amgen operational goals. Compliance Ensure safe working environment Ensure Amgen policies are followed, including cGMP and CFR compliance of assigned areas Evaluate current operating procedures and recommend changes to management to optimize production Assure all corporate change control procedures are followed, and Regulatory and QA are notified prior to the changes Interact with regulatory agencies as needed Assure proper gowning and aseptic techniques are followed Staff Supervision Engage staff and build relationships of trust and respect while driving team performance and continuous improvement Recruit, train, evaluate, coach and develop staff Mentor and coach staff members to live by the Amgen Values Develop and implement training plans and programs, to ensure staff are prepared and compliant Ensure adherence to production schedule and maintenance activities Interact with management in optimizing organizational structure and responsibilities Ensure plant safety through auditing, evaluations, and cross‑functional walks Ensure gowning and aseptic techniques training programs are maintained Process / Equipment / Facilities Demonstrate technical mastery of manufacturing processes Collaborate with cross‑functional teams (i.e., QA/QC, F&E, PPIC, Mfg, PD, Regulatory, etc.) in completing production activities Develop, implement and assess CAPAs and solutions to complex problems Responsible for elevating and resolving problems during daily operations Oversee set up, execution and completion of critical manufacturing processes/tasks Administrative Interact with management in planning, developing and maintaining budget Assist in developing and maintaining department goals What we expect from you We are all different, yet we all use our unique contributions to serve patients. The biotechnology professional we seek is a manager with these qualifications. Basic Qualifications Doctorate degree OR Masters degree and 3 years of Manufacturing or Operations experience OR Bachelors degree and 5 years of Manufacturing or Operations experience OR Associates 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 leading teams, projects, programs or directing the allocation of resources Preferred Qualifications Bachelors degree in Life Sciences or Engineering Demonstrated strong leadership skills and technical understanding of biotechnology production operations Experience in biotechnology or pharmaceutical plant start up Understanding of downstream purification operation (Column Chromatography, TFF, Viral Filtration, Viral Inactivation) Previous knowledge and experience within a cGMP environment 5+ years process experience in a cGMP manufacturing facility 3+ years of experience in a production Area Lead, Specialist or Manager role Strong leadership and team‑building skills (coaching, mentoring, counseling) Experience with performance management including performance reviews Conflict Resolution, analytical problem solving, and project management skills Thorough understanding of regulatory requirements Excellent verbal and written communication (technical) skills Excellent computer skills with Microsoft, EBR/MES, Delta V, Electronic quality systems What you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well‑being. 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 including: 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
$106.15k - $143.61k
...Career Category Manufacturing Job Description... ...newest and most advanced drug substance manufacturing plant. When... ...by 2027. Front Line Manufacturing Manager - Downstream Bulk Drug Substance - Days... ...including non-standard shifts, as needed to support...SuggestedRemote workWorldwideMonday to FridayFlexible hoursShift workDay shift$106.15k - $143.61k
...Front Line Manufacturing Manager – Downstream Bulk Drug Substance – Days Front-line leadership for a new manufacturing facility, focusing initially on startup and... ...as required, transitioning to a 12‑hour 2‑2‑3 day shift supporting 24/7 operations. Qualifications Basic...SuggestedRemote workFlexible hoursDay shift$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... ...hours as required; transition to a 12‑hour 2‑2‑3 day shift schedule for 24/7 operations. Qualifications Basic Qualifications...SuggestedFlexible hoursDay shift- Senior Associate Manufacturing-Bulk Drug Substance Downstream-Nights What You Will Do In this dynamic role, you will be a Senior Associate in the manufacturing... .... Maintain proper gowning and aseptic techniques. Manage downstream purification operations such as Column...Night shiftWork at officeFlexible hours
- ...meaningful role. Senior Associate Manufacturing-Bulk Drug Substance Downstream - Nights Live What you will do In this... ...be able to work assigned 12‑hour shifts, including during inclement weather... ...in all operations, and assist the manager in escalating concerns as needed...Night shiftWork at officeRemote workWorldwideFlexible hoursShift work
- ...newest and most advanced drug substance manufacturing plant. The Amgen FleX Batch... ...carbon-neutral by 2027. Senior Manager: Manufacturing Live What... ...operations in downstream purification. In this vital... ...and developing Downstream Front-Line Managers who oversee staff...Work experience placementWorldwideFlexible hours
- ...Amgen Inc. (IR) in Holly Springs is seeking a Front Line Manufacturing Manager to lead a new manufacturing facility, focusing on startup and operational readiness. Responsibilities include managing a team, ensuring compliance, and driving performance improvements. The...
$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...- ...Manufacturing Role This role will lead and execute... ...working hours and shift rotation. Upon... ...transition to a day or night shift that will be... ..., offering drug substance production, fill-finish... ...related to bulk drug substance manufacturing... ...cycle counts and manage materials for the...Night shiftWork at officeFlexible hoursShift workWeekend workDay shift
- Position Overview This role as manufacturing Associate 4 will execute... ...on a 2-2-3 schedule for Night Shift- 6P-6A. Company Overview FUJIFILM... ...facility, offering drug substance production, fill‑finish, and... .../or leads cycle counts and manages materials for the assigned...Night shiftWork at officeShift workWeekend work
- 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
- ...role will lead and execute manufacturing processing steps, associated... ...on a 2-2-3 schedule for Night Shift- 6P-6A. Company Overview FUJIFILM... ...facility, offering drug substance production, fill‑finish, and... ...cycle counts and materials management. Other duties as assigned....Night shiftWork at officeShift workWeekend work
- ...Overview The manufacturing associate in Drug Product Manufacturing... ...of filling line including all tasks... ...working hours or shift rotation. Company... ..., offering drug substance production, fill-... ...related to bulk drug product manufacturing... ...potential for nights) Perform other...Night shiftFull timeWork at officeFlexible hoursShift workWeekend workDay shift
- ...looking for a Senior Associate for their manufacturing team in Holly Springs, North Carolina.... ...support 24/7 operations, engaging in downstream manufacturing processes and ensuring compliance... ...able to work flexible hours, including nights and weekends. Amgen offers competitive...Night shiftFlexible hours
- ...patients as we research, manufacture, and deliver... ...QUALITY ASSURANCE - PQA - NIGHT SHIFT What you will do... ...groups for on-going bulk drug substance manufacturing and... ...procedures. Alert senior management of quality,... ...of upstream and/or downstream manufacturing within...Night shiftWork experience placementWork at officeFlexible hoursShift work
- ..., North Carolina is looking for a Senior Associate for their Manufacturing team. In this role, you will support 24/7 operations on a 12-... ...ensuring adherence to cGMP practices and quality standards in downstream manufacturing. The position requires a strong communicator...Night shiftFlexible hours
- Note: Fully Onsite, Shift Work Schedule (... ...weekends, and possibly nights) Once shift is determined... .... Must have: Manufacturing and PQA background... ...groups for on-going bulk drug substance manufacturing and new... ...procedures. • Alert senior management of quality,...Night shiftShift work
$70.99k - $96.04k
Career Category Manufacturing Job Description HOW MIGHT YOU DEFY IMAGINATION... ...newest and most advanced drug substance manufacturing plant. When... ...Associate Manufacturing - Downstream - Nights (Multiple Positions) Live... ...to work assigned 12-hour shift, including during...Night shiftFull timeWork at officeRemote workWorldwideFlexible hoursShift work- ...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 work
$16.5 per hour
...service experience to fill our open Front Desk Supervisor position.... ...train for that next step in management with opportunities across the... ...schedule needs including days, night, weekends, holidays, and peak... ...in the United States. WE ARE A DRUG-FREE, SMOKE-FREE, EQUAL OPPORTUNITY...Night shiftFull timePart time- ...of patients as we research, manufacture, and deliver innovative medicines... ...technologically advanced drug substance manufacturing plant. The... ...libraries, and system lifecycle management in alignment with Operations... ..., preferably both in Bulk API and Formulation/Fill/Finish...Contract workRemote workFlexible hours
- ...Overview We have opportunities for Manufacturing Associates at several levels within our Drug Substance production teams who are willing and able to work on a NIGHT SHIFT (Approximately 6:00PM-6:00AM).... ...related to Weigh and Dispense, bulk Drug Substance or Drug Product manufacturing...Night shiftWork at officeShift workWeekend work
- Amgen Inc. (IR) is seeking a Senior Manager in Manufacturing Systems Engineering in Holly Springs, North Carolina. The role involves providing... ...administration and maintenance of automation systems for Drug Substance manufacturing. Key responsibilities include leading teams...Remote jobFlexible hours
- ...Initial Therapeutics, Inc. is seeking a Manager for its Manufacturing team in Holly Springs, NC. This role involves leading production teams in a biopharmaceutical environment, ensuring adherence to compliance and safety standards while fostering staff development. The...Night shift
- The Manufacturing Associate 3 in Drug product is responsible for Component... ...Formulation of Drug Substance, Sterile Filling and... ...with working hours and shift rotation. What You’... ...cycle counts and manages materials for the assigned... ...and potential for nights) Performs other...Night shiftShift workWeekend workDay shift
$22 - $24 per hour
Manufacturing Associate - Biologics (Multiple Openings) - NIGHT SHIFT Location: Holly Springs, NC | Salary: $22.00‑$24.00 per hour... .... Join us to help produce drug substances, fill‑finish, and packaging for... ...for weigh‑and‑dispense, bulk drug substance or drug product...Night shiftHourly payFull timeWork at officeShift workWeekend work- ...The Production Scheduler, Drug Product Finished Goods is responsible... ...across drug product manufacturing, filling, inspection, and packaging... ...facility, offering drug substance production, fill-finish, and... ...What You'll Do Develops and manages detailed production schedules...
- Merck & Co. is seeking an experienced individual to lead and execute manufacturing processes in Holly Springs, North Carolina. The role demands adherence to safety protocols and compliance with cGMP regulations. Candidates must have significant experience in life sciences...Night shift
- A biopharmaceutical manufacturing company in Holly Springs, North Carolina is seeking a highly experienced professional to lead manufacturing... ...guidelines. The role demands flexibility in working hours, including nights and weekends. #J-18808-Ljbffr FUJIFILM BiotechnologiesNight shift
- ...leading biopharmaceutical company is seeking an experienced manufacturing associate in Holly Springs, North Carolina. The role involves... ...manufacturing and a relevant degree. The position operates on a Night Shift schedule. Join us in shaping the future of healthcare and...Night shift
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