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Sr. Associate, Manufacturing

The Associate/Sr. Associate is responsible for working on a shift with 6 – 10 peers with responsibilities of preparing large scale solutions (buffers and media), managing raw material inventory, and operating process equipment in Upstream or Downstream areas while supporting daily operations.  Additional responsibilities include ensuring compliance with current Good Manufacturing Practice regulations (cGMP), Standard Operating Procedures (SOPs), product licenses, corporate policies, and safety practices. The position will require shift work including weekends, off hours and holidays.
RESPONSIBILITIES 
  • Operate large scale bioprocess equipment for the Cell Culture, Purification, or Buffer and Media processing 
  • Perform all aspects of processing with a broad understanding of science, compliance, and technical aspect 
  • Display competency with process equipment and automated control systems 
  • Perform cleaning and sterilization of parts and equipment used with manufacturing process 
  • Knowledge of biotech manufacturing process and equipment including cell culture, depth and tangential flow filtration, column chromatography, protein purification and formulation and/or buffer and media operations. 
  • Ability to understand, apply, and evaluate basic chemistry, biology, and scientific principles as appropriate for the position 
  • Proficiency with compliance; adherence to standard operating procedures, batch record, good documentation practices and data capturing 
SKILLS
  • Strong communication skills—verbal and write
  • Ability to work in a team environment which includes good conflict resolution and collaboration
  • Displays good initiative to identify areas for improvement and implement solutions
EDUCATION 
  • Bachelor’s degree in science related area or engineering or associate degree in science related area or Biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry 
WORK ENVIRONMENT/PHYSICAL DEMANDS 
  • Consists of strenuous, repetitive work. The following list of physical movements maybe used daily: bending, reaching, climbing stairs and ladders, kneeling and making numerous equipment connections using hands and tools. 
  • Independently can regularly lift, dispense, push and/or pull items with an average weight of 25 pounds. 
  • May require work around loud equipment. 
  • The use of personal protective equipment will be required. 
  • Requires various shift based work and off hours 
EXPERIENCE
2 years of industry experience.
 
EDUCATION
4 years of college or 2 years of biotechnology program.
 
EQUIPMENT 
Autoclave, lab washer, bioreactors. Automated CIP Skids, Bio Welders, Ultra sonic baths, Stainless Steel Vessels and Analytical Benchtop equipment.
 
CONTACTS 
Teammates on shift and Upstream Process Team and Personnel from support departments.
 
SHIFT DETAILS 
Rotating 13hr shift. Hours: 6:00am – 7:00pm / Days: Thursdays-Saturdays with alternating Wednesdays. (Back Half of the week)
 
ONSITE, REMOTE, OR FLEXIBLE 
Onsite Only
 
TRAVEL REQUIRED 
No Travel required.


We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
BioMarin’s Novato commercial manufacturing operations produce recombinant enzyme replacement proteins using perfusion/fermentation-based mammalian cell culture processes and multiple column purification systems. Under direction of the Supervisor, the Manufacturing Associate/Sr. Associate will be responsible for job functions that support activities for commercial manufacturing.

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What You Should Know About Sr. Associate, Manufacturing, BioMarin Pharmaceutical Inc.

At BioMarin, we're dedicated to making significant advancements in therapeutics for patients battling serious genetic diseases. As a Sr. Associate in Manufacturing, you'll be part of a dynamic team working in a fast-paced environment alongside 6 to 10 peers. Your responsibilities will mainly revolve around preparing large-scale solutions, managing raw materials, and operating process equipment in both Upstream and Downstream operations. You’ll have the opportunity to dive into the bioprocessing field, ensuring compliance with current Good Manufacturing Practice (cGMP) regulations and corporate policies while supporting daily operations. While the job does require shift work, including weekends and holidays, the experience you gain here is truly invaluable. You’re expected to handle bioprocess equipment ranging from cell culture to protein purification systems, along with performing regular cleans and sterilizations of machinery used in manufacturing processes. Your strong communication skills and teamwork mindset will be pivotal in navigating challenges and improving processes. A Bachelor’s degree in a science-related area or engineering, along with 2 years of biotech manufacturing experience is preferred. If you enjoy a hands-on, technically engaging role that directly impacts patient lives, come be a part of our mission at BioMarin!

Frequently Asked Questions (FAQs) for Sr. Associate, Manufacturing Role at BioMarin Pharmaceutical Inc.
What are the main responsibilities of a Sr. Associate in Manufacturing at BioMarin?

As a Sr. Associate in Manufacturing at BioMarin, you'll operate large-scale bioprocess equipment for various processes, manage raw material inventories, and support daily operations while ensuring compliance with good manufacturing practices. You'll also perform cleaning and sterilization of parts and equipment.

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What qualifications are necessary for the Sr. Associate position at BioMarin?

To qualify for the Sr. Associate position at BioMarin, you should have a Bachelor’s degree in a science-related field or engineering, or an associate degree with a minimum of 2 years of biotech manufacturing experience. Familiarity with machinery and compliance with regulatory standards is crucial.

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What does the work environment look like for a Sr. Associate in Manufacturing at BioMarin?

The work environment for a Sr. Associate at BioMarin is dynamic and involves strenuous, repetitive tasks. You will need to engage in physical activities like bending, lifting, and using tools, all while adhering to safety protocols.

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Is shift work required for the Sr. Associate role at BioMarin?

Yes, the Sr. Associate role at BioMarin involves shift work, which may include weekends, holidays, and off hours. The shifts are typically 13 hours long, covering days from Thursday to Saturday, with rotating schedules.

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What kind of equipment will a Sr. Associate in Manufacturing operate at BioMarin?

In the Sr. Associate role at BioMarin, you'll operate various bioprocess equipment like bioreactors, automated CIP skids, and analytical benchtop equipment, showcasing your technical skills within the biotech manufacturing environment.

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Common Interview Questions for Sr. Associate, Manufacturing
Can you describe your experience with bioprocess equipment?

Discuss any relevant experience you have with operating bioprocess equipment, highlighting specific equipment types you've worked with, the processes you were involved in, and any compliance measures you implemented.

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How do you ensure compliance with Good Manufacturing Practices?

Explain your understanding of cGMP and offer examples of how you ensured compliance in previous roles, focusing on attention to detail, adherence to SOPs, and effective documentation practices.

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What steps do you take when faced with a manufacturing challenge?

Share a specific example of a challenge you encountered and the process you used to resolve it. Emphasize teamwork, communication, and your willingness to identify improvements.

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How do you prioritize tasks during a shift?

Discuss your planning and organization strategies that help you manage tasks effectively at BioMarin. Mention setting priorities based on production schedules and compliance requirements.

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What safety protocols have you implemented in your previous roles?

Describe your experience with workplace safety, including how you adhered to protocols and trained others, ensuring a safe environment for all staff in the manufacturing area.

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How do you keep abreast of industry trends and regulations?

Talk about your methods for staying informed, such as attending workshops, reading industry publications, or participating in networking events to stay updated on regulatory changes.

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Can you describe your teamwork experience in manufacturing operations?

Provide an example that showcases your collaboration and conflict resolution skills within a team, highlighting how you cooperated to achieve manufacturing goals.

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How do you handle repetitive tasks while maintaining accuracy?

Discuss methods you employ to remain engaged and attentive to detail during repetitive tasks, like taking breaks or employing mindfulness techniques to keep your focus sharp.

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What biotechnological concepts do you feel most comfortable with?

Express your understanding and comfort level with biotech concepts like cell culture, protein purification, or filtration processes, and how this knowledge aids your performance in manufacturing.

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Why do you want to join BioMarin as a Sr. Associate in Manufacturing?

Share your passion for biotechnology and patient care, linking it to BioMarin’s mission and how your skills and experiences align with their goals for manufacturing excellence.

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BioMarin, founded in 1997 and headquartered in San Rafael, California, is a biotechnology company specializing in manufacturing pharmaceuticals.

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Full-time, on-site
DATE POSTED
March 24, 2025

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