Offers “Merckgroup”

42 days agoMerckgroup

GMP生产负责人

  • 浦东新区, 浦东新区
  • Teaching

Job description

A career at our company is an ongoing journey of discovery: our 57,000 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.

 

This position will manage the Production department: upstream unit (USP) and downstream unit (DSP). Supervise all activities concerning the production of Intermediate Drug Substance or Purified Drug Substance for Preclinical and Clinical trials purpose in line with agreed objectives (described process, timeline, and budget) and respecting the requirements of cGMP when needed.

 

Your role:

Team Management

Establish and manage production Upstream and Downstream team. Hire, supervise and train staff on procedures and processes.

To be the guarantor of the proper implementation of HR processes.

Promote the culture of continuous improvement within its teams (processes, tools, standards, etc.).

Contribute to the motivation, performance, and development of the team through setting objectives, coaching employees, appropriate action planning, appraisal of performance and determination of reward outcomes.

Drive performance culture by giving clear performance-based feedback, managing high and low performance, applying high-impact solutions, and implementing new business opportunities.

Ensure team members' activities are completed efficiently and in a timely manner, if needed, develop and/or implement adequate procedures and tools.

Continually enhance the technical and knowledge level of the team by defining adequate training programs, prepare the yearly training plan and encourage the technical sharing.

Encourage team members to collaborate within their team and the other teams of Process Development, QA & Reg, Technical leaders & project managers, other Biodevelopment teams worldwide and across departments.

Drive quality culture within the team.

 

Technical Management

To be the guarantor that all the documentation associated with the various areas of the production are up to date: technical documentation, regulations, and quality

Participate to Tech Transfer activities between Development and Production departments (supervision if needed and documentation review)

Ensure consistency of the process through accurate documentation of the process

Prepare production protocols, write batch campaign reports and participate to release of clinical batches

Ensure that procedures, work instructions and batch-records are appropriate to collect accurate and reliable data.

Analyze problems, identify, and ensure implementation solutions across the production activities together with the relevant departments

Review qualification documentation for implementation of new equipment

Anticipate and prevent potential Out of specification and Out of trend

Maintain and monitor a production plan to ensure product supply according to the general plan defined with the General Management.

 

Production Area Management

Ownership of areas to ensure that they are kept clean and appropriately maintained

Ensure that the equipment is calibrated, validated and maintained according to the established procedures and timelines

Provide resources to support the activities of calibration, validation, and maintenance of production equipment.

Manage safety and security of the production units.

Participate to continuous improvement and efficiencies programs

Coordinate and support Site production activities.

Create an environment that promotes, supports, and encourages delivering, on time, of high-quality DS batches.

Establish the department CAPEX and OPEX budget and manage within the financial constraints agreed. Minimize and optimize the production cost.

 

Quality and Compliance Responsibilities

The owner of the function to ensure the strict application of quality rules defined in the quality Manual of the site

Implement corrective and preventive actions necessary for quality risk prevention on products manufactured on the site

Participate to environmental review of the production area.

Always ensure inspection readiness

Ensure that all documentation associated with manufacture of products for clinical trials are authorized by QA and are implemented in the departments.

Ensure that in case of deviation, proper documentation and investigation are carried out in coordination with QA, and implement corrective actions within timelines

Ensure that all production staff has appropriate cGMP training for the tasks assigned to them

Guarantee data integrity

 

EHS

Respect and follow EHS rules

Ensure the strict application of EHS rules and have the responsibility to alert the hierarchy about any health or security risk, for himself as well as for the other, or for the environment.

Ensure the information and training of newcomers under his responsibility on risks and environmental impact of their positions.

Put in place correctives and preventives actions necessary to prevent risks for people, assets and environment of the site.

 

Autonomy and Substitution

Autonomy:

Autonomy in the daily quality management within the framework of specific regulations and procedures.

Autonomy in motivate, promote, and coach the production department staff.

Autonomy in analyze problems, identify, and ensure implementation solutions across the production activities together with the relevant departments

 

Who you are:

Bachelor’s degree or above

Major in Pharmacy, Biotechnology, Engineering, Life science or related backgrounds

Strong working experiences in GMP environment

Solid knowledge of cGMP, FDA, EMEA, and other quality regulations.

Rich experience of pharmaceutical operation and on-site management; State of the art and best practices for production of recombinant proteins at large scale

Excellent presentation and communication skills

Team spirit and respectful behavior

Strong sense of responsibility and professionalism

Good competencies in budget establishment, cost control and optimization.

Fluent English speaking, reading, and writing

Good technical writing skills in English is a plus.

 

HR: 89829

Functional Area: Manufacturing 

 

What we offer:  With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

 

Curious? Apply and find more information at https://jobs.vibrantm.com

 

Job Requisition ID:  219348

Location:  Shanghai

Career Level:  D - Professional (4-9 years)

Working time model:  full-time .buttontextf748fab0b60d052d a{ border: 1px solid transparent; } .buttontextf748fab0b60d052d a:focus{ border: 1px dashed #eb3c96 !important; outline: none !important; }

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

Job Segment: Biotech, Pharmacy, Quality Manager, Pharmaceutical, Environmental Health & Safety, Science, Healthcare, Quality

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