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Manufacturing Supervisor Fill – Whiptail

EMD Serono

This is a Full-time position in Carlsbad, CA posted December 22, 2021.

A career with MilliporeSigma is an ongoing journey of discovery: our 58,000 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.

MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.

US employees must be fully vaccinated against COVID-19 prior to your start date unless an accommodation is granted by The Company.

The Company uses the definition of fully vaccinated assigned by the Centers for Disease Control & Prevention for purposes of considering satisfaction of this requirement which is a condition of employment.

Your Role:

The Fill/Finish Manufacturing Supervisor will demonstrate a high level of competency and knowhow related to all aspects of technical cGMP biopharmaceutical manufacturing.

This position will have direct supervisory responsibility of employees and overall responsibility for the Projects they are assigned to.

This role is also responsible for motivating, coaching, and training the manufacturing team.

The Fill/Finish Manufacturing Supervisor will oversee and facilitate the fill/finish process and lead the manufacturing team through all phases and facets of drug product formulation, fill, visual inspection, and labeling.

The Fill/Finish Manufacturing Supervisor will:

  • Guide projects and team leaders to ensure production projects are efficient, accurate, compliant, and the associated operators have the skill levels that match the related work
  • Be responsible for leading the manufacturing staff working in the facility to meet corporate production goals, as well as influencing related, cross-functional groups to meet these objectives
  • Ensure the facility and equipment is maintained and operates in a cGMP compliant state and ready for use
  • Perform very complex tasks with attention to detail. 
  • Maintain operations within contracted guidelines to successfully produce high quality finished products
  • Build and maintain a staff that is both technically qualified and well trained in cGMP manufacturing, while providing a motivating environment and opportunities for their professional advancement in a safety conscious environment 
  • Define, implement and optimize the manufacturing schedules
  • Ensure consistent product quality through appropriate manufacturing programs and by working with other groups such as Quality Control and Quality Assurance
  • Lead process trouble-shooting efforts
  • Develop, implement and update all production SOPs, Batch Records and other documentation needed for GMP production projects
  • Ensure that deviation reports are written accurately and appropriately as they occur.

    Track and implement corrective actions

  • Provide a safe working environment for employees
  • Evaluate employee efficiency and productivity
  • Spend 50% or more of time on work directly and closely related to carrying out exempt functions
  • Spends approximately 25% or more of time working in the facility, training and assisting the Technicians and Biologists
  • Demonstrate well-honed priority and time management skills 

Who You Are:

Minimum Qualifications:

  • Bachelor’s Degree in a related Science discipline
  • 8+ years’ experience in Manufacturing Fill/Finish or Upstream/Downstream cGMP Production
  • 4+ years of team leadership experience in a GMP environment 
  • 4+ years’ experience in and with aseptic manufacturing processes 

Preferred Qualifications:

  • Experience with filling vials with an automated filling machine inside an isolator
  • Lean Six Sigma methodologies experience
  • Excellent written and verbal communication skills 
  • Experience with automated labeling
  • Experience with drug product production (Fill/Finish operations)
  • Experience with single use mixing and fluid transfer operations
  • Experience in Bulk Drug UF/DF Formulation and sterile Filtration

RSRMS

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!

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.