Manufacturing Associate

Description:

POSITION SUMMARY:

The incumbent is responsible for supporting the operations in our cGMP clinical manufacturing site producing plasmids, viral vectors, and autologous cell therapies. This role is responsible for performing day to day operations. Shift Schedule: Wednesday-Saturday (4x10's): Will either be early morning start time or more of a swing shift starting at 12 pm.

KEY ROLE AND RESPONSIBILITIES:

Execute the Day-to-Day Manufacturing Processing

• Execute manufacturing operations safely, as scheduled, and right the first time for delivery of treatment to patients.
• Adhere to the current Good Manufacturing Practices (cGMP) and standard operating procedures (SOPs).
• Escalate manufacturing operations issues to management and quality assurance in a timely manner.
• Maintain production facilities at a high standard of cleanliness and organization.
• Perform equipment maintenance and calibrations as required.
• Complete and review GMP documentation in a timely manner.
• Maintain appropriate level of training for assigned responsibilities.
• Assist with inventory management of supplies in the manufacturing facility.
• Assist with daily tasks and support manufacturing.

Collaborate Effectively

• Be a team player, offer assistance, and respond well to requests for help from team members.
• Use strong communication and build relationships.
• Demonstrate technical acumen, operational understanding, and GMP compliance.
• Support operational excellence initiatives.
• Support a culture of safety and GMP compliance.
• Identify opportunities for continuous improvement.

Additional Skills & Qualifications:

PREFERRED EDUCATION & EXPERIENCE:

• BSc degree in a relevant field (eg biochemistry, chemical engineering, bioengineering, or related scientific field) with 0 - 2+ years of experience in GMP biopharmaceutical operations, or a high school diploma with 4-6+ years of industry experience.
• Experience with quality management systems (e.g. Deviations, CAPAs, Change Management).
• Experience with electronic systems such as MES and ERP.

KNOWLEDGE, SKILLS AND ABILITIES:

• Familiar with regulations for GMP manufacturing of drug substance, drug products, cellular and gene therapies, and viral vectors for clinical phase therapies.
• Proven track record in cGMP manufacturing operations, including producing therapies safely and right the first time.
• Fast learner, adaptable, and excellent cross-collaboration and inter-personal skills.
• The desire and ability to work in a fast-paced, start-up environment.

PHYSICAL REQUIREMENTS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. While performing their duties, the employee must be able to do the following:

• Confirm visual information in the environment such as batch record and SOP steps were completed properly, parameters on equipment and computer screens, status of materials and equipment, and perform visual inspection of materials and product. A vision test may be required. Use of corrective lenses is acceptable.
• Stand and step over a gowning bench (12-24”) and aseptically don head-to-toe non-sterile and sterile gowns.

SHIFT WORK, WEEKEND WORK AND HOLIDAY COVERAGE:

Due to the nature of our autologous cell therapies and the need to deliver life-saving treatments to our patients as timely as possible, shift work, weekend work, and holiday work will be required. We are looking for passionate team members to join our team that are willing to learn, grow, and evolve with us. Part of this evolution will be to work together

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 for other accommodation options.