Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

Manager Cell Culture Technology Center Production

Your tasks and responsibilities

The primary responsibilities of this role, Manager Cell Culture Technology Center Production, are to: 

 

  • Project Support:
  • Provide technical expertise as an SME to the project team;
  • Execute the project to plan;
  • Closely work with all functional areas to ensure timelines are met safely and compliantly;
  • Challenge assumptions appropriately;
  • Review and Approve project documentation (URS, FS, FAT, SAT, IOQ protocols etc) to meet required timelines;
  • Author, review or approve manufacturing documentation required for the project (SOP, BPR, Process descriptions, Risk assessments);
  • Ensure adherence to platform process but with strong focus on flexibility and adaptability;
  • Build high performing team;
  • Ensure timely onboarding of personnel to maximize training opportunities and to support all process and / or facility validation requirements (FAT, SAT, IOQ, PQ);
  • Build team culture that is strictly aligned to LIFE values;
  • Work with the site team to establish robust processes for integration of CCTC with existing site systems;
  • Support tech transfer of new product(s) in parallel with project and ensure GMP readiness to manufacture on time;
  • Post Project:
  • Manage daily manufacturing activities to meet production plan;
  • Coordinate and, if needed, perform manufacturing activities to meet the Production schedule;
  • Adhere to clinical and launch supply chain targets – meeting or exceeding monthly and annual production output demand;
  • Demonstrate commitment to safety by driving a safety culture and engaging in all safety initiatives;
  • Write or review JSAs;
  • Lead safety inspections and investigations;
  • Establish and meet departmental metrics for area (weekly, monthly, and annually);
  • Support release process and cycle time targets;
  • Ensure timely review of manufacturing documentation (BPRs) with focus on GDP and compliance; 
  • Encourage an environment of continuous process improvement and take action accordingly;
  • Work cross functionally to develop an efficient and compliant process for area change over and, if needed, multi-product manufacturing in a single use facility;
  • Support validation in commissioning and IOPQ of new equipment when needed (e.g. tech transfers);
  • Actively manage department cost center by reviewing monthly costs; look for opportunities to reduce costs and to operate more efficiently;
  • Prepare and adhere to production output and operating budgets for department; 
  • Exert proper control and managing of expenses and use of resources, scraps, invoices etc.;
  • Provide off-hour technical support and on-call emergency response when required;
  • Must be able to work an off shift schedule as needed, including weekend cover;
  • Compliance:
  • Ensure Production areas and processes are maintained in excellent cGMP conditions at all times;
  • Ensure that all compliance commitments are met;
  • Ensure the plant, processes and personnel are inspection ready at all times and prepare the plant for inspection by external authorities and internal audits;
  • Drive Quality mindset through ownership and self-assessments;
  • Seek opportunities for improving overall compliance and discrepancies;
  • Track deviation generation in the department and ensure that adverse trends are addressed quickly and effectively; 
  • Lead and / or participate in investigations to resolve deviations;
  • Partner with Quality unit and engineering representatives to determine root causes of discrepancies and write-offs and implement effective corrective actions to minimize reoccurrence;
  • Author, review, approve or revise controlled documents;
  • Assess process impact of proposed changes in materials, equipment and provide decision making recommendations for changes;
  • Personnel:
  • Provide effective leadership including: individual goal setting/performance reviews, training, coaching, and managing the development of employees; ensure appropriate staffing levels are met; effectively manage employee performance issues and corrective actions, recognizing and appreciating employee contributions, mitigating conflict and communication problem; planning and facilitating team activities; selecting personnel and motivating members of the functional area; supporting workforce diversity, quality and safety and supporting supervisors in the management of their employees/department which support achievement of individual/department/business objectives;
  • Create and maintain the structure for staff meetings, daily meetings and floor shift huddles;
  • Ensure standardized agenda, flow or relevant information/ data from one level of meeting to the next;
  • Develop and adhere to standard work practices to improve operational efficiency and communication;
  • Technology Transfer:
  • Lead all manufacturing aspects of Tech Transfer including, but not limited to (1) assessment of new product requirements against platform process (2) generation of product specific documentation (3) supporting the introduction of new equipment, raw materials and / or consumables (4) determine safety implications if any & (5) training of personnel;
  • Develop processes for efficient introduction of new products to CCTC. Develop metrics to track efficiency.

     

Who you are

Your success will be driven by your demonstration of our LIFE values.  More specifically related to this position, Bayer seeks an incumbent who possesses the following:

 

Required Qualifications:

 

  • B.S. with eight or more years of industry experience OR M.S. with two or more years of industry experience OR PhD with no prior industry experience OR Equivalent combination of education and experience;
  • 1 -2  years of line management experience;
  • Broad knowledge & expertise in some or all of the following manufacturing areas: Cell Expansion, Cell Culture, Purification, Media & Solution Preparation and Weigh/Dispense;
  • Ability to monitor and control processes using data trending and / or statistical process control;
  • Proven ability to trouble shoot issues and resolve issues;
  • Solid understanding of manufacturing related instrumentation such as conductivity meters, pH meters, osmometers, Filter Integrity testers, Cedex, YSI, NovaFlex, welders, sealers, microscopes, centrifuges, pipettes etc. Familiar with use of Biological safety cabinets & down flow booths;
  • Experience with single use technology;
  • Experience with regulatory and cGMP requirements for pharmaceutical manufacturing;
  • Solid knowledge of pre and post-viral segregation requirements;
  • Knowledge of applicable agency regulation (FDA, EMA etc) to ensure inspection readiness of department;
  • Previous experience in technology transfers or New Product Introduction desired;
  • Thorough understanding of department & business processes; 
  • Ability to write or follow written standard operating procedures, good manufacturing practices, safety regulations, and corporate policies;
  • Must be able to work in an independent manner and drive the work of others;
  • Experienced with business systems such as SAP, LMS, MES, ITS (DR/CAPA System), Valgenesis etc. Experienced with Microsoft Office, Outlook, Visio, Microsoft project, and web search engines. Excellent computer skills;
  • Effectively employ all methods of communication (oral, written, presentation) to provide ongoing communication to employees or teams;
  • Act as a mentor and provides leadership for direct reports; 
  • Ability to develop appropriate people skills to motivate, teach, and encourage staff; 
  • Recognize the strengths and development needs of others, provides formal and informal feedback, and creates development opportunities for direct reports;
  • Act as a change agent and applies effective change management;
  • Assist in providing leadership, strategic direction, and goal setting for all department activities;
  • Act as delegate to CCTC Plant Production Lead if needed.

Your application

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. 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.

 

Country: United States
Location: CA-Berkeley
Functional Area: [sap_fa_1]
Entry Level: 5