生物安全检测经理

Posté 24 mai 2022

Shanghai, Shanghai - China

Demander un identifiant 247887

Détails

 

A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

 


Your role:

The Biosafety Testing Manager is responsible for day to day management of a GLP/GMP (GxP) operations and drives on-time delivery of Lot Release Testing Assays and Cell Line Characterization testing in the BioSafety Testing Laboratory. Responsibilities include direct management of a team working in the BioSafety Testing laboratory.

 The role will ensure the smooth running of the laboratory to support the conduct of contract GMP regulatory testing including scheduling of laboratory work, organizing employee’s training and development and ensuring equipment and facilities are maintained to the highest standards. The ability to maintain effective working relationships with study management, global Quality, Global PSS testing laboratory functions and facilities personnel are critical for success in the role.

  • Plans, organises and overseeing the activities to make sure resources are utilised efficiently and effectively to achieve organisational goals.
  • Deliver technical knowledge and analytical ability to develop, perform, analyze and report results of departmental studies.
  • Own responsibility for overall lab performance ensuring equipment, instrumentation and computer systems are kept in a validated state at all times.
  • Collates and communicates Key Performance Indicators (KPIs) by lab and rectify KPIs scorecard to meeting the yearly target. Take action when adverse trends or other issues arise.
  • Responsible for compliance of studies and act as QC responsible person for the release of test results in a GMP.
  • Provide financial stewardship for the department; specifically ensuring expense budgets are met (or maintained in line with revenue).  Drive necessary cost control and process improvement actions to ensure budget expectations are met / exceeded.
  • Manage deviations, implement effective Corrective and Preventative Actions (CAPAs) and change control records in a timely manner
  • Performs routine housekeeping checks on a daily, weekly and monthly basis, to ensure high standards of regulatory compliance and cleanliness of the laboratory
  • Co-ordinates the procurement of consumables, reagents and materials and takes responsibility for ensuring effective stock control
  • Conduct regular Go-See and ensure process improvements within the laboratory are coordinated and implemented on time to improve quality and performance
  • Ensure a safe and healthy work environment by ensuring that all employees adhere to and actively embrace health and safety policies and procedures
  • Ensure employees are sufficiently trained to execute tasks and supporting activities.
  • Maintains employee work schedules including assignments, job rotation, shift assignment, training (including training records), holiday and paid time off, cover for absence, and in-lieu off time scheduling.
  • Coaches, mentors, and develops staff, including overseeing new employee on-boarding and supporting ongoing career development, promoting a positive working environment.
  • Complete performance reviews fairly and on-time; conduct regular one-on-one discussions with employees; interview and hire job candidates; ensure development plans are in place for all key staff members.
  • Demonstrate consistent good communication, engagement and interpersonal skills with employees, management and other stakeholders.
  • Actively develops and builds a collaborative team through regular communication and feedback both to the group and on an individual basis
  • Represent the department during internal and external audits, client meetings and communications.  Respond to audit observations, complaints and CAPAs.
  • Ensure the department delivers a high level of client satisfaction
  • Promote a culture of continuous improvement and act as champion on initiatives and / or projects to drive improvement in quality and / or client service
  • Review client proposal, studies, projects and advice costing to commercial
  • Acts as point of contact for routine study and commercial sales enquires
  • May perform other related duties as required and / or assigned.

Who you are:

Education:

  • Master’s degree in Biological Sciences or higher degree in relevant scientific subject

Experience:

  • Minimum 5 years of laboratory supervisory or manager experience, ideally in a contract or QC testing laboratory environment
  • Previous experience working in a regulated environment (GLP/GMP) would be advantageous
  • Demonstrable scientific understanding of Virology, Microbiology, Sterility, Molecular and Mycoplasma would be advantageous

 

Additional Skills                                                        

  • Approachable always with good listening skills
  • Can communicate clearly, establishing clear direction and setting objectives
  • Ability to manage conflict effectively and ensure staff are treated equally
  • Ability to motivate others and build effective teams
  • Knowledge & understanding of working in a highly regulated environment.

Knowledge & Skills:

  • Computer literacy and entry of data into databases (LIMS, ELN, SAP, etc.)
  • Ability to complete documentation (both handwritten and electronic) neatly and accurately
  • Operating skills
  • Puts safety first by adhering to health and safety procedures and actively takes necessary action when encountering unsafe situations
  • Has strong organization skills with the ability to use available resources effectively
  • Drives a quality culture by role modeling and overseeing compliance to site SOPs and protocols.
  • Provides the information people need to know to do their jobs through effective communication
  • Plans workload by assigning tasks appropriately depending on length and difficulty of task

 

  • Problem solving and drive
  • Uses logic to solve problems with effective solutions
  • Action-oriented and determined to provide best-in-class service
  • Is self-motivated and pursues everything with energy, drive and the need to finish, especially in the face of resistance or setbacks
  • Seizes opportunities to realize process improvements and establishes processes to drive team efficiency and effectiveness
  • Can be counted on to achieve goals, constantly and consistently, even under adversity

 

  • Personal and interpersonal skills
  • Relates well to all kinds of people in the organization, builds constructive and effective relationships using diplomacy and tact
  • Is seen as a team player, cooperative and encourages collaboration
  • Can maintain effective working relationships with study management, facilities, and other lab functions
  • Communicates effectively with others and handles conflict effectively

ADDITIONAL LOCAL NEEDS

  • Ability to work overtime or flexible shifts from time to time to cover testing requirements

Core competencies:  

  • Be purposeful: Improve lives, act ethically, ensure quality and create customer value
  • Future oriented: Anticipate opportunities, be entrepreneurial, go digital and apply technology
  • Innovative: Be open minded, work with agility, unlock creativity and implement change
  • Results driven: Give feedback, drive performance, be efficient, take responsibility 
  • Collaborative: Include others, build networks, teamwork and think global
  • Empowering: Develop talents, foster potential, give vision and share emotions 

 

HR: 89829

Functional Area: Research & Development


 

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!

 

Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com

 

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.merckgroup.com/en/company/press-positions.html

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