Sr. Manufacturing Manager

Posted 23 Feb 2022

Carlsbad, California - United States

Req Id 242019

Details

 

A career with MilliporeSigma 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. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.


 

Your Role:

Leadership of Manufacturing activities at the Carlsbad Viral Vector Manufacturing site. You will be responsible for ensuring the successful GMP manufacture and release of products, promoting a culture of quality and compliance, and continuous improvement. You will be involved in leading a multi-product manufacturing department, the supervision of approximately 40 staff member manufacturing team responsible for manufacturing Biologic Products. The position reports to the Head of Manufacturing.

 

Who you are:

Minimum Qualifications:

  • Bachelor's degree required, in a science related field
  • At least 10 years of leading a GMP manufacturing team involving the scheduling and coordination of staff, materials, and manufacturing operations
  • Ability to drive continuous improvement, leveraging data and technology to impact quality, maintain innovative thinking habits and actively seeking to partner with Quality teams to ensure highest quality manufacturing and operational success
  • In-depth knowledge of FDA, EMA, GMP regulatory requirements
  • Knowledge of Quality Systems as they relate to GMP production operations and process optimization
  • Capable of motivating others, creating a positive work climate where interdepartmental collaboration, coaching and performance feedback are continuous.
  • Capable of clearly assigning objectives, clearing setting, measuring, & monitoring progress, marshaling resources and handling opposing priorities
  • Knowledgeable and aligned with all pertinent safety policies, rules, and regulations.

 

Preferred Qualifications:

  • Lead buffer preparation, Upstream and Downstream GMP production, and fill/finish teams and activities
  • Identify and mitigate risks in manufacturing that could adversely impact project outcomes and timely delivery of critical treatments to patients
  • Engage in internal process development activities related to technology transfer and scale-up
  • Partner with Failure Investigation group to report, investigate, and resolve deviations during GMP production
  • Establish and maintain training requirements for manufacturing staff
  • Develop, implement, and improve GMP systems and procedures (SOPs, Batch Records, etc.)
  • Support the MFG budget and defined areas within approved budget and contracted scope of work
  • Create and track metrics demonstrating successful manufacturing operations
  • Assist in the preparation of business development presentations, and occasionally assist with site tours and visits
  • Experience with both adherent and Suspension processes utilizing Single Use technologies.

 


 

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.emdgroup.com/en/company/press-positions.html

 

If you are a resident of NYC, Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

 

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.

 

As an employee of the Company, you will be required to comply with all of the Company’s COVID-19 safety protocols and policies. The organization has currently suspended enforcement of its COVID-19 Vaccination Policy, but that policy may be reinstated by the Company in its discretion.

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