This is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, this is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On Time.
The Manufacturing Associate performs GMP manufacturing operations safely, reliably and in compliance with stated processes.
Execute unit operations described in standard operating procedures and batch records
Perform bioprocess operations such as filtration, purification, cell culture or recovery
Perform review of GMP documentation
Clean, assemble/disassemble, sterilize and operate primary process equipment
Complete required processing documentation including deviation reports, change control, product change over, etc.
Ensure compliance with company quality systems, safety procedures, and other company policies.
Ensure acceptable quality and quantity of work executed.
Ensure that standard operating procedures are followed and are correct for bioprocess operations and equipment.
Other duties as assigned.
KNOWLEDGE, SKILLS & ABILITIES:
Expertise in relevant math, science and engineering disciplines.
Excellent aseptic technique
Thorough knowledge of GMP regulations (ICH Q7A) as it applies to job function
Thorough understanding equipment and technology as applies to job function.
Ability to exercise independent judgement when applying industry practices and company policies to daily operations.
Working knowledge of business practices used by company
Demonstrated ability to manage time efficiently and effectively.
Ability to interact constructively with peers and support groups
Organizational and communication skills necessary to ensure daily work plan is executed
Must be detail oriented, with the ability to complete written and verbally assigned tasks following specific procedures.
Ability to interact constructively with peers and support groups.
Excellent technical writing skills.
BS in Chemistry, Biology or other relevant discipline
Depending on level, 1-8 years relevant experience, including experience in aseptic processing
Advanced computer skills including Excel and Word.
Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at email@example.com or 844-463-6178.