Manufacturing Technician

Description

CTG is seeking to fill a Manufacturing Technician opening for our client in Berkeley, CA.

Location: Berkeley, CA

Duration: 8 months

Overview:

Responsible for clinical manufacturing of monoclonal antibodies (mAB) Drug substance within the Cell Culture Technology Center (CCTC). Collaborates closely with biological development (BD) and Manufacturing Science and Technology (MSAT) for new product introductions and ensure platform alignment.

Duties:

• Responsible for all aspects of clinical manufacturing in the following areas: Cell Expansion, Cell Culture, Purification, Solution Preparation and Weigh/Dispense. Including freezing and put away products.

• Employee will move with the process and work seamlessly across all areas.

• Ensures all activities are performed to schedule.

• Manufactures products in various phases of product life cycles from clinical thru launch. Clearly understands, communicates, and manages differences in terms of documentation, sample handling, automation and cGMPs etc. for different phases of product life cycle.

• Provide feedbacks to handles and troubleshoots single use technology (SUT) from end to end in manufacturing process.

• Works cross functionally to ensure process is controlled and issues are escalated and investigated.

• Redlines and reviews controlled documents for various equipment/processes.

• Effectively employs all methods of communication (oral, written, presentation) to ensure knowledge and information transfer across shifts, to management, and cross functionally.

• Raises and supports investigation of deviations.

• Participates in safety investigations for CCTC and promotes safe behaviors at all times.

• Must be able to change shift schedule based on business and process needs.

• Must provide off-hour (night and weekend including holiday) coverage to meet business requirements on short notice.

• Ability to lift 45 lb.

Skill & Competency Requirements:

• Demonstrates strong tendency towards independent thinking and decision making.

• Able to make logical decisions independently for multiple process work streams with limited information or supervision available.

• Works with highest level of flexibility.

• Responds easily to last minute changes to production schedule.

• Must be Experienced in cGMP and GDP requirements for pharmaceutical manufacturing.

Preferences:

• Experienced with data integrity, regulatory, requirements for pharmaceutical manufacturing.

• Experienced in operation of thermo SUM, 200L and 2000 bioreactors, Akta ready XL, Akta ready gradient, and Akta ready Flux XL.

• Experienced with business IT systems (Delta V, Team, outlooks, SAP etc.)

• Experienced with Microsoft Office. Excellent computer skills.

Travel Requirements: (if applicable)

• Not required.

Experience:

• Must have minimum of 2 years' experience.

• Transferable skills will be considered. or an equivalent combination of education and experience.

Education:

• Minimum of BS in science related field is preferred

Excellent verbal and written English communication skills and the ability to interact professionally with a diverse group are required.

CTG does not accept unsolicited resumes from headhunters, recruitment agencies, or fee based recruitment services for this role.

To Apply:

To be considered, please apply directly to this requisition using the link provided. For additional information, please contact Emily Drew at 716-888-3417 or Emily.Drew@ctg.com. Kindly forward this to any other interested parties. Thank you!

About Us

CTG is a leading provider of digital transformation solutions and services that accelerate clients' project momentum and achievement of their desired IT and business outcomes. Our vision is to be an indispensable partner to our clients and the preferred career destination for digital and technology experts. CTG has operations in North America, South America, Western Europe, and India. For more information, visit www.ctg.com.

Our culture is a direct result of the people who work at CTG, the values we hold, and the actions we take. In other words, our people are the culture. It's a living, breathing thing that is renewed every day through the ways we engage with each other, our clients, and our communities. Part of our mission is to cultivate a workplace that attracts and develops the best people, reflected by our recognition as a Great Place to Work-certified company in every country in which we operate.

CTG will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of all applicable local, state, and federal laws.

CTG is an Equal Opportunity and Affirmative Action Employer. CTG will assure equal opportunity and consideration to all applicants and employees in recruitment, selection, placement, training, benefits, compensation, promotion, transfer, and release of individuals without regard to race, creed, religion, color, national origin, sex, sexual orientation, gender identity and gender expression, age, disability, marital or veteran status, citizenship status, or any other discriminatory factors as required by law. Our Affirmative Action program serves to promote occupational equality and diversity through good faith efforts. CTG is fully committed to promoting employment opportunities for members of protected classes.