- 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.
- BS in science related field is preferred. MS or PhD in science related field with no prior industry experience.
- Must have min. of two (2) years' experience.
- Transferable skills will be considered. or an equivalent combination of education and experience.
- 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.
- 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.
- Experienced with data integrity, regulatory, and cGMP 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.
-
Stellar Enterprises Oakland, United StatesAre you interested in a job at our location in Lüneburg as: · Production specialist and/or · Chemical technician (m/f/d) · in a 3-shift system · and would like to bring your expertise to a challenging work environment, work with a high level of responsibility, and support our s ...
-
Randstad Life Sciences US Berkeley, United StatesJob Title: · Manufacturing Production Specialist · Location: · Berkeley, CA 94710 · Schedule: · 1st shift (6am-3pm), 2nd shift (1-10pm), 3rd shift (9:30pm-6:30am) · Tue.-Sat. or Sun.-Thurs. · Position Type: · 5 mos. contract through Q3; potential for extension · Multiple ope ...
-
Retail Product Specialist
1 day ago
Skechers U.S.A. El Cerrito, United StatesSKECHERS - JobID: JR102672 [Retail Sales / Store Associate / Team Member] As a Retail Product Specialist at Skechers, you'll: Engage customers the first time and every time; Greet, meet and get to know the customer in order to meet their needs; Treats shoes and accessories with l ...
-
IT Product Specialist, Senior
4 days ago
PG&E Corporation OAKLAND, United StatesRequisition ID # · Job Category: Information Technology · Job Level: Individual Contributor · Business Unit: Information Technology · Work Type: Hybrid · Job Location: Oakland · Department Overview · Information Systems Technology Services is a unified organization comprised of ...
-
IT- Product Specialist, Expert
6 days ago
Sunrise Systems, Inc. Oakland, CA, United States***Local Preferred · If not available, then we will go for non-local · Hybrid · 2 days a week working from onsite.**** · TOP THINGS: Extensive ELK Administration · Data ingestion & enrichment from various sources, webhooks, and REST APIs with JSON/YAML/XML payloads & testing POST ...
-
Therapeutic Specialist East Bay Ca
4 days ago
Insmed Incorporated Berkeley, United StatesCompany Description: · Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicate ...
-
Product Intake Specialist
19 hours ago
KIVA Confections™ Alameda, United StatesProduct Intake Specialist - Northern California (8am to 4:30pm) · Kiva Confections ) is a world-class cannabis-infused edibles company in California, the largest cannabis market in the world. Kiva's line includes Kiva Chocolate Bars, Terra Bites, Petra Mints, Lost Farms Gummies ...
-
Product Intake Specialist
1 week ago
KIVA Confections™ Alameda, United StatesKiva Confections ) is a world-class cannabis-infused edibles company in California, the largest cannabis market in the world. Kiva's line includes Kiva Chocolate Bars, Terra Bites, Petra Mints, Lost Farms Gummies & Chews, and Camino Gummies. Our products are crafted from premium ...
-
Production Specialist
1 week ago
FLEX Inc West Valley City, United StatesTo support our extraordinary teams who build great products and contribute to our growth, were looking to add a Production Specialist located in Salt Lake City, UT Reporting to the Production Supervisor the Production Specialist is responsible for a Production Specialist, Product ...
-
Product Specialist
1 day ago
Parabola San Francisco, United States Full timeAbout us: · Parabola is transforming the way companies operate by empowering non-technical teams to automate complex data processes with ease. · Our mission is to provide non-technical teams ("operators") with the same type of leverage as their technical counterparts. We do thi ...
-
Product Specialist
1 week ago
Parabola Labs San Francisco, United StatesAbout us: · Parabola is transforming the way companies operate by empowering non-technical teams to automate complex data processes with ease. · Our mission is to provide non-technical teams ("operators") with the same type of leverage as their technical counterparts. We do thi ...
-
ServiceNow System Administrator
2 days ago
Aurora Technologies Berkeley, United StatesAs one of the largest IT service providers and digitalization partners in Europe, we are driving the digital transformation within the Sparkassen-Finanzgruppe. With over 4,000 employees at 3 locations, we make digital banking of today powerful and develop smart financial services ...
-
Maintenance Technician
3 days ago
ZephyrTech Berkeley, United StatesMaintenance Technician / Electrician (m/f/d) for our location in Jülich near Aachen Gissler & Pass In its 4th generation, Gissler & Pass is a specialist in the corrugated cardboard and packaging industry and a strong partner for international brand manufacturers and private label ...
-
Production Specialist
1 week ago
PDS Defense, Inc. West Valley City, United StatesPDS Defense, Inc. is seeking a Fabrication Specialist A, in Salt Lake City, Utah. · Job Description: · Regular and predictable attendance is required. Performs routine production assembly operations on structural and mechanical assemblies, subassemblies and aircraft systems, eq ...
-
Production specialist
1 day ago
Flextronics West Valley City, United StatesJob Posting Start Date Job Posting End Date Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world.We believe in the power of diversity and inclusion and cultivate a workplace c ...
-
Human Resources Specialist
2 days ago
National Mortgage Insurance Corporation Emeryville, United States(Position is hybrid) · The role of the Human Resources Specialist is to provide coordination and support for all HR programs and processes with a focus on payroll and benefits and a mindset towards continuous process and systems improvement. This position will serve as an interna ...
-
Project Management Employee
1 day ago
Skyline Solutions Emeryville, United States· The VHV Group / is a well-established conglomerate of specialists in insurance, retirement, and wealth. With its brands VHV Versicherungen and Hannoversche, it is a competent and future-oriented partner for policyholders and intermediaries. For our success, we rely on the str ...
-
Product Specialist
1 week ago
Atlas AC Repair LLC Burlingame, United StatesProduct Specialist Are you a dynamic and results-oriented People person with an interest in the HVAC industry? Weare seeking a highly motivated HVAC Product Specialist. You will be responsible for executingthe Atlas AC Repair Culture, by creating product solutions, working with v ...
-
Middle School Education Specialist
3 days ago
Invictus Academy of Richmond El Cerrito, United States**Job Title**:Middle School Education Specialist · **Work Year**: 10.5 months · **Employment Type**:Exempt · **Salary Range**: $60,375-$95,126 · **Supervisor**:Principal or Designee · **____________________** · **OUR MISSION** · Invictus Academy of Richmond prepares 100% of stude ...
-
Education Specialist
2 days ago
Invictus Academy of Richmond El Cerrito, United States**Job Title**:Education Specialist · **Work Year**: 10.5 months · **Employment Type**:Exempt · **Salary Range**: $60,375-$95,126 · **Supervisor**:Principal or Designee · **____________________** · **OUR MISSION** · Invictus Academy of Richmond prepares 100% of students in grades ...
Biopharmaceutical Manufacturing Production Specialist - Berkeley, United States - Randstad Life Sciences US
Description
Job Title: Manufacturing Production Specialist
Location: Berkeley, CA 94710
Schedule: 1st shift (6am-3pm), 2nd shift (1-10pm), 3rd shift (9:30pm-6:30am)
Tue.-Sat. or Sun.-Thurs.
Position Type: 5 mos. contract through Q3; potential for extension
Multiple openings for five (5) Manufacturing Production Specialists to work with a multinational, biopharmaceutical company on their 46 acre biologics manufacturing campus in Berkeley, CA. This role is supporting new CDMO business as well as internal new product pipelines and will perform cell culture/expansion and purification operations.
Position Summary: 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.
Essential Duties and Responsibilities:
Qualifications:
Preferences:
