Senior Biotechnologist, Downstream Operations

Posted Yesterday
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Headquarters, AZ, USA
In-Office
Senior level
Biotech • Pharmaceutical • Manufacturing
The Role
Executes downstream biopharmaceutical manufacturing activities in cleanroom environments, including chromatography, viral inactivation, filtration, formulation, bulk filling, and freeze storage. Ensures cGMP, EHS, inspection readiness, and documentation compliance; supports validation, investigations, CAPAs, regulatory inspections, and continuous improvement. Serves as a subject matter expert, authors and reviews GMP documentation, and mentors team members while working rotating shifts.
Summary Generated by Built In

Overview of Role
 

Are you an experienced biotechnology professional with a passion for manufacturing excellence, quality, and continuous improvement? At Alvotech, we are looking for a motivated and solution-oriented Senior Biotechnologist to join our growing Manufacturing team.

This is an exciting opportunity to play a key role in the production of high-quality biologic medicines in a dynamic, international environment. You will work alongside talented colleagues, contribute to innovative projects, and help ensure the reliable manufacture of life-changing therapies for patients worldwide.

Please note: This role requires working rotating day, evening, and night shifts.

Job Description

As a Senior Downstream Biotechnologist, you will be responsible for supporting and executing downstream manufacturing activities while ensuring compliance with cGMP and EHS standards. You will serve as a subject matter expert within your area, contribute to process improvements, support investigations and validation activities, and help maintain a state of inspection readiness across manufacturing operations.

This role offers the opportunity to work with advanced bioprocessing technologies and make a meaningful impact within a fast-paced and collaborative production environment.
 

Key Responsibilities

  • Perform all activities in compliance with cGMP, EHS, and company procedures, maintaining the highest standards of quality and safety.
  • Demonstrate strong ownership and initiative, taking on additional responsibilities with limited supervision.
  • Execute manufacturing activities within Grade CNC, D, and C cleanroom environments.
  • Operate and become fully proficient in downstream processing activities including:

    Protein A chromatography

    Ion exchange chromatography

    Viral inactivation and filtration

    Tangential Flow Filtration (TFF)

    Formulation

    Bulk filling

    Freeze/storage operations through completion of the production process

  • Ensure manufacturing suites, equipment, and work areas remain in a continuous state of inspection readiness.
  • Act as a Subject Matter Expert (SME) by authoring, reviewing, and approving SOPs, batch manufacturing records (BMRs), and other GMP documentation within your area of expertise.
  • Support the execution of technical studies, engineering runs, and validation protocols.
  • Participate in investigations, identify root causes, and contribute to the implementation of effective corrective and preventive actions (CAPAs).
  • Support successful regulatory inspections, Pre-Approval Inspections (PAIs), customer audits, and health authority interactions.
  • Mentor and coach team members, promoting knowledge sharing and operational excellence.
  • Drive continuous improvement initiatives to enhance manufacturing performance and compliance.

Job Requirements

We are seeking a proactive professional who thrives in a manufacturing environment and enjoys working both independently and collaboratively.

Qualifications & Experience:

  • Minimum 3-5 years of experience within biopharmaceutical manufacturing or a related technical field.
  • Hands-on experience operating drug substance manufacturing and processing equipment.
  • Knowledge of downstream bioprocessing operations and GMP manufacturing practices.
  • Understanding of cell culture principles, process scale-up, technology transfer, and process validation activities.
  • Demonstrated experience coaching, training, or mentoring colleagues.
  • Strong problem-solving and analytical skills with a continuous improvement mindset.
  • Excellent communication and interpersonal skills.
  • Ability to work independently, adapt to changing priorities, and contribute positively within a team environment.

What we offer:

  • An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.
  • The chance to be a part of a global and fast-growing company.
  • An international work culture that encourages diversity, collaboration and inclusion.
  • Positive, flexible, and innovative work environment.
  • Support for personal growth and internal career development.
  • Company social events and milestone celebrations.
  • Excellent in-house canteen and coffee house.
  • Exercise and wellbeing support for full-time employees.
  • On-site shower facility.
  • Transportation grant towards eco-friendly modes of travel for full-time employees.
  • Internet at home for full-time employees.
     

Why Alvotech :
 
At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We’re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.

True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let’s create a healthier world together, through affordable biologic medicines.

Skills Required

  • Minimum 3-5 years of experience in biopharmaceutical manufacturing or a related technical field
  • Hands-on experience operating drug substance manufacturing and processing equipment
  • Knowledge of downstream bioprocessing operations and GMP manufacturing practices
  • Understanding of cell culture principles, process scale-up, technology transfer, and process validation activities
  • Experience coaching, training, or mentoring colleagues
  • Strong problem-solving and analytical skills
  • Excellent communication and interpersonal skills
  • Ability to work independently, adapt to changing priorities, and contribute positively within a team environment
  • Ability to work rotating day, evening, and night shifts
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The Company
1,279 Employees
Year Founded: 2013

What We Do

Alvotech is a global biotechnology company focused exclusively on developing and manufacturing biosimilar medicines. Its mission is to improve patients’ lives by expanding access to affordable biologic treatments worldwide. The company operates as a fully integrated specialty biopharmaceutical business, pursuing high-quality biosimilars and building treatment options that can make important biologic therapies more accessible to patients through its research, development, and production capabilities.

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