CTMOD Quality Ops Functional Lead (Berkeley) Job at Bayer, Berkeley, CA

VmdkMDE1MUNoZ1pEbGZoSHlOQWpadm9Cd0E9PQ==
  • Bayer
  • Berkeley, CA

Job Description

Join to apply for the CTMOD Quality Ops Functional Lead role at Bayer

2 days ago Be among the first 25 applicants

Join to apply for the CTMOD Quality Ops Functional Lead role at Bayer

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.

CTMOD Quality Ops Functional Lead

CTMOD Quality Operations Functional Lead Berkeley, CA

PURPOSE

The CTMOD Quality Operations Functional Lead provides QA expertise & oversight for CT Activities (Com, Clinical, Dev, current focus on DA01) @ CTMOD (B69) and @ CTlab when required. Quality representative in the assigned DA01WorkStream and related missions teams.

Supports the implementation and maintenance of the quality assurance processes and procedures for CTMOD & CTLAB Facilities, through close collaborations with Biologics Q Capability Pool personnel.

Provides functional leadership for managing the scheduling, resource planning and execution work required to implement and maintain these QA processes and procedures. Utilizes and provides expert knowledge in developing, implementing and maintaining quality assurance processes, standards and procedures.

Supports and manages the planning and coordination of QA activities related to new and modified existing facilities, systems and equipment.

Your Tasks And Responsibilities

Operational:

  • Member of CGT Quality Assurance Team;
  • Participate in Biologics QULT PSS and Staff Meetings;
  • Supports CTMOD & CTLab teams for CT manufacturing activities (routine and launch activities and works with site to execute project milestones and deliverables in a compliance manner, Accountable for shopfloor QA oversight, prioritization, and coordination of tasks, Primary contact with CTMOD &CTLab Operations team;
  • Responsible for back up activities for CGT QA SMEs. Accountable for ensuring CGT Q Head is informed of operational QA activities, progress to milestones, and escalations;

DA01 Strategy:

  • For the DA01 Works Streams and related missions teams, develops and owns product quality strategy and co-creates the control strategy (incl. critical quality attributes, release criteria, in process controls, stability) together with the different partners;

Operational / CAPEX Project related responsibilities:

  • Executes / Support Quality tasks for CTMOD, including but not limited to:
    • Quality systems and processes establishment needed to enable compliant operations, maintenance, and works with site teams to integrate with and influence revisions, where applicable, of existing site systems;
    • Inputs, reviews and approves process descriptions, process control strategies and recipes (automation);
    • Inputs, reviews and approves qualification strategy & documentation and supports execution;
    • Inputs, reviews & approves project/equipment/ facility related documents;
    • Reviews and approves Production documents for operation of equipment and area, such as SOPs, BPRs, Sample tables etc.;
    • In collaboration with QA Batch release team, support/conduct QA Batch Record Review, in collaboration with QADCM team lead/ support trouble shooting activities related CT products (i.e Support/ Lead root cause investigation and or approve Deviation Report);
    • Provides support for inspections / audits and support the review corrective actions.
Who You Are

Bayer seeks an incumbent who possesses the following:

Required Qualifications

  • Bachelor of Science in Engineering, Biology, Chemistry, Biochemistry or related field;
  • 10 or more years of Pharmaceutical and/or Biotechnology, with Cell Therapy Technology experience;
  • Understanding of IPSCs manufacturing;
  • 5-10 years of experience working in a cGMP environment in the pharmaceutical or biotech industry (with Aseptic Operations including shopfloor activities) or an equivalent combination of education and experience;
  • Experience in cGMP for cell therapy products, particularly with IPSCs;
  • Experience in Aseptic Operations, with significant QA Oversight experience;
  • Advanced working knowledge of Good Manufacturing Practice (cGMP) including ISO Standards for the development, manufacture and commercialization of biologics and Cell Therapy (preferred) products;
  • Ability to influence, to work independently and to self-motivate;
  • Ability to multitask and support changing priorities;
  • Ability to solve complex problems requiring in-depth technical, scientific and engineering knowledge, in a compliant manner and under pressure of timelines.

Prefered Qualifications

  • 15 years of Pharmaceutical and/or Biotechnology, with Cell Therapy Technology experience.

Employees can expect to be paid a salary between $171,480.00 to $257,220.00. Additional compensation may include a bonus or incentive compensation (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc..

This salary 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 available for application until at least 8-4-2025.

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.

Bayer is an E-Verify Employer.

Location: United States : California : Berkeley

Division: Pharmaceuticals

Reference Code: 850522

Contact Us

Email: hrop_usa@bayer.com

Seniority level

  • Seniority level

    Mid-Senior level

Employment type

  • Employment type

    Full-time

Job function

  • Job function

    Management and Manufacturing
  • Industries

    Chemical Manufacturing, Pharmaceutical Manufacturing, and Biotechnology Research

Referrals increase your chances of interviewing at Bayer by 2x

Sign in to set job alerts for Operations Lead roles.

Sr. Operations Manager - Distribution Centers

San Francisco, CA $160,000.00-$175,000.00 2 weeks ago

Hayward, CA $100,000.00-$135,000.00 2 weeks ago

San Francisco, CA $125,000.00-$200,000.00 2 weeks ago

Richmond, CA $81,900.00-$150,100.00 2 days ago

San Francisco, CA $80,000.00-$120,000.00 1 month ago

San Francisco, CA $65,000.00-$74,000.00 1 day ago

San Francisco, CA $150,000.00-$165,000.00 2 months ago

San Mateo, CA $217,000.00-$301,000.00 2 weeks ago

Manager / Senior Manager, Remote Operations

Foster City, CA $153,000.00-$200,000.00 1 week ago

San Francisco, CA $120,000.00-$140,000.00 5 months ago

Senior Manager, D&I Programs and Operations

San Francisco, CA $132,900.00-$177,200.00 2 days ago

Executive Business Operations Lead, Infra Data Centers

San Francisco, CA $174,000.00-$242,000.00 2 weeks ago

San Francisco, CA $246,000.00-$279,000.00 4 hours ago

Sr. Manager Growth Strategy & Operations

San Francisco, CA $67,000.00-$100,000.00 1 month ago

San Francisco, CA $165,000.00-$200,000.00 2 days ago

Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr

Job Tags

Full time, Remote work,

Similar Jobs

Waterway Carwash

Store Manager in Training Job at Waterway Carwash

 ...Waterway is hiring for its renowned Manager Training and Development Program in the...  ...mentor! Be the role model! Be the boss! Target Compensation (based on 45 hours per week)...  ...variety of responsibilities running the store: Provide excellent customer service:... 

Farm Job Search

Farm Worker Job at Farm Job Search

 ...Farm Worker (6305) Location: Moscow, Idaho JobNumber: 6305 Esser Farms is a mid-size family-owned and operated farm in the Palouse Region of Idaho. We are focused on improving soil health and finding innovative farm practices in collaboration with our agricultural... 

Montgomery Independent School District

Class C Auxiliary Driver Job at Montgomery Independent School District

 ...Position Type: Transportation Date Posted: 10/3/2024 Location: Transportation Department Primary Purpose: A Class C Auxiliary Driver is responsible for safely driving students to and from school using district vehicles not requiring a commercial driver... 

Reliant Rehabilitation

Speech Language Pathologist Job at Reliant Rehabilitation

 ...Masters Degree, or equivalent, in Speech Language Pathology Computer Skills: Computer...  ...and Licenses: Valid Speech-Language Pathologist state license (where appropriate) Please...  ...Provide Speech-Language Pathology (SLP) Therapy and related services for patients... 

Good Samaritan

Certified Nursing Assistant - Miller - FT - Day Job at Good Samaritan

 ...Facility: GSS SD Miller Prairie Ctr Location: Miller, SD Address: 421 E 4th St, Miller, SD 57362, USA Shift: 8 Hours - Day Shifts Job Schedule: Full time Weekly Hours: 32.00 Salary Range: $17.00 - $24.00 Pay Info: $10,000 Sign on Bonus!...