Production Specialist III CCTC

7 days ago

Berkeley, California, United States Bayer (Schweiz) AG Full time

At Bayer were visionaries, driven to solve the worlds toughest challenges and striving for a world where 'Health for all Hunger for none is no longer a dream, but a real possibility. Were doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining impossible. There are so many reasons to join us. If youre hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, theres only one choice.

Production Specialist III CCTC

Production Specialist III CCTC Berkeley, CA

PURPOSE

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.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role are to:

  • Responsible for all aspects of clinical manufacturing in the following areas: Cell Expansion, Cell Culture, Purification, Solution Preparation and Weigh/Dispense. Employee will work seamlessly across all areas and will be an SME for NLT one area;
  • Participates in new products introductions (NPIs) into CCTC with support from BD and MSAT. Ensures all activities are performed to schedule. Acts as delegate to Sr. Production specialist;
  • Collaborates with BD and MSAT to ensure cross functional alignment with platform process, equipment, raw materials and/or automation for NLT one area;
  • 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;
  • Handles and troubleshoots single use technology (SUT) from end to end in manufacturing process;
  • Monitors and controls processes using data trending and / or statistical process control. Works cross functionally to ensure process is controlled and issues are escalated and investigated;
  • Authors, redlines and reviews controlled documents for various equipment/processes. Ensures alignment with platform philosophy for CCTC. Assesses documentation impact of proposed changes in materials, equipment and provides decision making recommendations for changes;
  • Effectively employs all methods of communication (oral, written, presentation) to ensure knowledge and information transfer across shifts, to management, and cross functionally;
  • Creates, owns, and drives business processes of moderate complexity in CCTC. Owns and drives to ensure operational readiness and manufacturing of products efficiently;
  • Raises and supports investigation of deviations. Partners cross functionally to determine product impact and root cause;
  • Implements and executes manufacturing tasks in alignment with effective corrective actions to prevent re-occurrence;
  • Participates in regulatory and internal audits. Leads internal audit walkthroughs;
  • Performs commissioning and IOPQ of CCTC equipment and executes C&Q documentation;
  • Participates in safety investigations for CCTC and promotes safe behaviors at all times. Partners cross functionally to identify and implement corrective actions;
  • Supports development of training curricula and generates training materials for CCTC team. Delivers training as SME. Ensures own training is always in compliance;
  • Actively looks for opportunities to improve, proposes solutions, and encourages same of others. Drives continuous improvements. Challenges the status quo and embraces change.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

REQUIRED QUALIFICATIONS

  • BS in science related field with 4+ Years of industry experience, or MS or PhD in science related field with no prior industry experience;
  • Transferable skills will be considered; or an equivalent combination of education and experience;
  • 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;
  • Clearly articulates decision making process;
  • Works with highest level of flexibility;
  • Responds easily to last minute changes to production schedule;
  • Must be able to change shift schedule based on business and process needs;
  • Must provide off-hour (night and weekend) coverage to meet business requirements on short notice;
  • Understands functionality of multiple types of equipment such that can troubleshoot and resolve equipment and process related issues independently;
  • Self-motivated. Drives own development, sets goals, teaches and encourages others;
  • Provides formal and informal feedback;
  • Experienced with data integrity, regulatory, and cGMP requirements for pharmaceutical manufacturing;
  • Experienced with Lean manufacturing principles;
  • Experienced with business IT systems;
  • Experienced with Microsoft Office;
  • Excellent computer skills;
  • Acts as a change agent of equipment with moderate complexity and processes;
  • Applies effective change management;
  • Ability to lift 45 lb.

PREFERRED QUALIFICATIONS

  • Previous experience in technology transfers or New Product Introduction is beneficial;
  • Experience in downstream process (DSP) such as ProA, AEX, CEX, Viral Filtration, and TFF, Delta V, Single use.

Employees can expect to be paid a wage between $86,568.00 and $123, Additional compensation may include a bonus or commission (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc.. This wage range is merely an estimate and may vary based on an applicants location, market data/ranges, an applicants skills and prior relevant experience, certain degrees and certifications, and other relevant factors.

This posting will be open for applications until at least

YOUR APPLICATION

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer.
To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

Bayer is an Equal Opportunity Employer/Disabled/Veterans

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

Bayer is an E-Verify Employer. Location: United States : California : Berkeley Division: Pharmaceuticals Reference Code: Contact Us Email:
#J-18808-Ljbffr

  • Project Specialist

    7 days ago

    Berkeley, California, United States Fiserv Full time

    You deserve to do what you love, and love what you do – a career that works as hard for you as you do. At Fiserv, we are more than 40,000 #FiservProud innovators delivering superior value for our clients through leading technology, targeted innovation and excellence in everything we do. You have choices – if you strive to be a part of a team driven to...

  • Student Support Specialist

    3 weeks ago

    Berkeley, California, United States College Internship Program Inc Full time

    STUDENT SUPPORT SPECIALISTA Day in the Life:The Student Support Specialist collaborates with students in helping them to become well-rounded, informed citizens who can live independent and self-sufficient lives as well as navigate the community. The specialist may work simultaneously in multiple functional areas depending upon center requirements and...

  • Student Support Specialist

    1 week ago

    Berkeley, California, United States College Internship Program Inc Full time

    Job DescriptionSTUDENT SUPPORT SPECIALISTA Day in the Life:The Student Support Specialist collaborates with students in helping them to become well-rounded, informed citizens who can live independent and self-sufficient lives as well as navigate the community. The specialist may work simultaneously in multiple functional areas depending upon center...

  • Student Support Specialist

    7 days ago

    Berkeley, California, United States College Internship Program Inc Full time

    STUDENT SUPPORT SPECIALISTA Day in the Life:The Student Support Specialist collaborates with students in helping them to become well-rounded, informed citizens who can live independent and self-sufficient lives as well as navigate the community. The specialist may work simultaneously in multiple functional areas depending upon center requirements and...

  • IT Support Specialist

    7 days ago

    Berkeley, California, United States Intertrust Full time

    Intertrust's mission is to make every Internet transaction trustworthy. Our family of integrated media, security, and data management products allows small businesses and leading global corporations to expand their reach by delivering rights-managed services, secure apps, and private data sets for various verticals, including energy, entertainment, fintech,...

  • LIMS Master Data Specialist

    3 weeks ago

    Berkeley, California, United States Randstad USA Full time

    job summary: As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We...

  • LIMS Master Data Specialist

    1 month ago

    Berkeley, California, United States Randstad USA Full time

    job summary: As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We...

  • Storage System Administrator

    1 week ago

    Berkeley, California, United States Collins Consulting Full time

    Must be a US Citizen or Green Card holder. This is a hybrid position. Statement of Work:GBS requires the services of a Storage System Administrator III to provide labor services to support the DOE National Energy Research Scientific Computing Center (NERSC) Storage Systems Group (SSG) Team's hardware and software environment at the Lawrence Berkeley National...

  • Associate Non-Destructive Test

    1 month ago

    Berkeley, California, United States Boeing Full time

    Job DescriptionAt Boeing, we innovate and collaborate to make the world a better place. From the seabed to outer space, you can contribute to work that matters with a company where diversity, equity and inclusion are shared values. We're committed to fostering an environment for every teammate that's welcoming, respectful and inclusive, with great...

  • Associate Non-Destructive Test

    3 weeks ago

    Berkeley, California, United States Boeing Full time

    Job DescriptionAt Boeing, we innovate and collaborate to make the world a better place. From the seabed to outer space, you can contribute to work that matters with a company where diversity, equity and inclusion are shared values. We're committed to fostering an environment for every teammate that's welcoming, respectful and inclusive, with great...

  • Production Specialist III CCTC

    4 weeks ago

    Berkeley, United States Bayer Full time

    At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and...

  • Production Specialist III CCTC

    4 weeks ago

    Berkeley, United States Bayer Full time

    At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and...

  • Biopharmaceutical Manufacturing Production Specialist

    2 months ago

    Berkeley, United States Randstad Life Sciences Us Full time

    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...

  • Biopharmaceutical Manufacturing Production Specialist

    3 weeks ago

    Berkeley, United States Randstad Life Sciences US Full time

    Job Title: Manufacturing Production SpecialistLocation: Berkeley, CA 94710Schedule: 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 extensionMultiple openings for five (5) Manufacturing Production Specialists to work with a multinational, biopharmaceutical...

  • Biopharmaceutical Manufacturing Production Specialist

    2 months ago

    Berkeley, United States Randstad Life Sciences US Full time

    Job Title: Manufacturing Production SpecialistLocation: Berkeley, CA 94710Schedule: 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 extensionMultiple openings for five (5) Manufacturing Production Specialists to work with a multinational, biopharmaceutical...

  • Materials Specialist

    3 weeks ago

    Berkeley, United States Rose International Full time

    Date Posted: 05/31/2024 Hiring Organization: Rose International Position Number: 465074 Job Title: Materials Specialist Job Location: Berkeley, CA, USA, 94710 Work Model: Onsite Shift: Starts at 7AM, Monday- Friday. Occasional Saturday and Sunday shift, but rare. Employment Type: Temporary Estimated Duration (In months): 6 Min Hourly Rate...

  • Rb Chem Analyst Iii

    1 week ago

    Berkeley, United States Bayer Full time

    **At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...

  • Specialist

    6 days ago

    Berkeley, United States ICANN, LLC Full time

    **Overview**: A Specialist’s main responsibility is providing superior customer service, facilitating efficient sales transactions and general maintenance of the sales floor. Maintaining our standard of superior customer service with each interaction. Educating customers, listening with empathy, showing compassion, and understanding while facilitating a...

  • Client Service Specialist- AT&T

    1 month ago

    Berkeley, United States Clear Concepts Management Full time

    If you're ready to embark on a path that fosters growth, learning, and hands-on experience in the world of client relations, we encourage you to explore the opportunity of becoming an Entry Level Client Service Specialist at Clear Concepts Management. In this role, you'll have the chance to build a strong foundation of customer service expertise while...

  • Client Service Specialist- AT&T

    4 weeks ago

    Berkeley, United States Clear Concepts Management Full time

    If you're ready to embark on a path that fosters growth, learning, and hands-on experience in the world of client relations, we encourage you to explore the opportunity of becoming an Entry Level Client Service Specialist at Clear Concepts Management. In this role, you'll have the chance to build a strong foundation of customer service expertise while...

  • Client Service Specialist- AT&T

    4 weeks ago

    Berkeley, United States Clear Concepts Management Full time

    If you're ready to embark on a path that fosters growth, learning, and hands-on experience in the world of client relations, we encourage you to explore the opportunity of becoming an Entry Level Client Service Specialist at Clear Concepts Management. In this role, you'll have the chance to build a strong foundation of customer service expertise while...

  • Client Service Specialist- AT&T

    1 month ago

    Berkeley, United States Clear Concepts Management Full time

    Job DescriptionJob DescriptionIf you're ready to embark on a path that fosters growth, learning, and hands-on experience in the world of client relations, we encourage you to explore the opportunity of becoming an Entry Level Client Service Specialist at Clear Concepts Management. In this role, you'll have the chance to build a strong foundation of...

  • Retail Sales Specialist

    1 month ago

    Berkeley, United States Zwilling J.A. Henckels Full time

    ** Retail Sales Specialist** **Job Category****:** Associates **Requisition Number****:** RETAI001666 Showing 1 location **Job Details** **Description** **OBJECTIVE:** The Retail Sales Specialist will be a self-motivated professional with a culinary passion who will be a brand ambassador of, and selling consultant for, the ZWILLING JA HENCKELS brands;...

  • Project Specialist

    3 weeks ago

    Berkeley, United States Fiserv Full time

    You deserve to do what you love, and love what you do a career that works as hard for you as you do. At Fiserv, we are more than 40,000 #FiservProud innovators delivering superior value for our clients through leading technology, targeted innovation and excellence in everything we do. You have choices if you strive to be a part of a team driven to create...

  • Enrollment Specialist

    2 weeks ago

    Berkeley, United States Eagle Peak Solutions, Inc. Full time

    Are you ready to turn a new leaf this year and fall head first into a new and fulfilling career? When you think about important qualities for your next employer to have, do growth, originality, enthusiasm, and investment in people and infrastructure come to mind? If so, then Experiential is the place for you. If you want to join a team that values integrity,...

  • Student Support Specialist

    7 days ago

    Berkeley, United States College Internship Program Inc Full time

    **STUDENT SUPPORT SPECIALIST** **A Day in the Life**: The Student Support Specialist collaborates with students in helping them to become well-rounded, informed citizens who can live independent and self-sufficient lives as well as navigate the community. The specialist may work simultaneously in multiple functional areas depending upon center requirements...

  • Enrollment Specialist

    2 days ago

    Berkeley, United States Eagle Peak Solutions, Inc. Full time

    Job DescriptionJob DescriptionAre you ready to turn a new leaf this year and fall head first into a new and fulfilling career?When you think about important qualities for your next employer to have, do growth, originality, enthusiasm, and investment in people and infrastructure come to mind? If so, then Experiential is the place for you. If you want to join...

  • Student Support Specialist

    4 weeks ago

    Berkeley, United States College Internship Program Inc Full time

    Job DescriptionJob DescriptionSTUDENT SUPPORT SPECIALISTA Day in the Life:The Student Support Specialist collaborates with students in helping them to become well-rounded, informed citizens who can live independent and self-sufficient lives as well as navigate the community. The specialist may work simultaneously in multiple functional areas depending upon...

  • Student Support Specialist

    2 weeks ago

    Berkeley, United States College Internship Program Full time

    STUDENT SUPPORT SPECIALIST A Day in the Life: The Student Support Specialist collaborates with students in helping them to become well-rounded, informed citizens who can live independent and self-sufficient lives as well as navigate the community. The specialist may work simultaneously in multiple functional areas depending upon center requirements and...

  • Student Support Specialist

    3 weeks ago

    Berkeley, United States College Internship Program Inc Full time

    Job DescriptionJob DescriptionSTUDENT SUPPORT SPECIALISTA Day in the Life:The Student Support Specialist collaborates with students in helping them to become well-rounded, informed citizens who can live independent and self-sufficient lives as well as navigate the community. The specialist may work simultaneously in multiple functional areas depending upon...