Manufacturing Associate (Backhalf Day)

Company Name

BioMarin Pharmaceutical Inc.

Found Description

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 written
• 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 may be 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

This position is for the Back half Day shift alternating Wed/Thurs-Sat 6am-7pm.

Onsite, Remote, or Flexible

Onsite Only.

Travel Required

No Travel required.

Key Responsibilities

• PROCESS KNOWLEDGE:
• Understanding of process theory and equipment operation
• Ability to learn and operate in biopharmaceutical manufacturing processes including cell culture, cell production and protein harvest, depth filtration, tangential flow filtration, column chromatography, protein purification and formulation of bulk drug substance; and perform all aspects with a broad understanding of scientific, compliance, and technical components
• Support initiatives for process optimization
• Identify and elevate processing issues and support solutions
• Demonstrated experience with automation systems (LIMS, MES, PI, etc.)
• TECHNICAL DOCUMENTATION:
• Provide feedback and/or suggested changes to operational procedures
• Assist in the incorporation of new technologies, practices and standards into procedures
• Capable of writing and reviewing process documents
• QUALITY AND COMPLIANCE:
• Understanding of cGMPs as related to Clinical and/or Commercial Operations
• Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.)
• BUSINESS:
• Ability to participate on projects and contribute to outcomes
• Capability to learn and support new business systems (Track wise, ERP, etc.)
• Support trending of defined department metrics
• Other duties as assigned.

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.