Description:

• Provide manufacturing operations support including the formulation and aseptic filling of Cryopreservation media, cell culture media, and cell culture supplements. Executes and maintains documentation relating to manufacturing procedures. compliance with applicable regulations and industry standards (e.g. FDA 21CFR, cGMP, ISO13485).

• Supports all technical writing requirements for manufacturing/operations.

• Author and revise manufacturing batch records, SOPs, work instructions, validation/qualification protocols, forms, logbooks, technical reports, CAPAs, change controls and any other document that may apply.

• Formulate, fill and finish manufactured products, including cryopreservation media, cell culture media, and supplements.

• Perform aseptic processes in a controlled or cleanroom environment.

• Perform in-process testing of products using general laboratory equipment/instrumentation.

• Utilizes formulas, work instructions or equivalent to monitor the production process.

• Perform experiments associated with development, improvement and scaling up or optimization of manufacturing and development processes.

• Troubleshoot problems associated with equipment, process development/production/ including data analysis and internal record keeping.

• Perform Environmental Monitoring activities as required.

• Perform the cleanzone cleaning as required.

• Maintains current knowledge of developments related to product recovery and purification processes.

• Performs duties in accordance with established laboratory standards.

• Evaluate, troubleshoot and solve routine problems. Interprets data based on knowledge and experience.

• Perform process validation and equipment qualification as required.

• Perform general equipment preventive maintenance. Contribute to maintaining lab and equipment cleanliness.

• Support and coordinate deviation investigations and implementation of change controls or robust corrective and preventative actions.

• Support finished product labeling, raw material aliquoting and, re-labeling requirements when necessary.

Skills & Qualifications:

• 2 years minimum relevant experience in a lab / biotech environment.

• Detailed oriented with good time management and organizational skills.

• Ability to work well under pressure and prioritize assignments in a multi-task position.

• Motivated and able to work independently.

• Excellent verbal communication skills and people/customer service oriented.

• Basic knowledge of Outlook, Word, Excel, and Software Programs.

• Requires a strong adherence to cGMPs, regulatory compliance and safety requirements, SOPs and other related documents such as SDS and manuals.

• BS or MS in Biology, Chemistry, Bioengineering or a related field + 2 years minimum experience working in a life science manufacturing role

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.