A career with MilliporeSigma 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. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
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 managing a multi-product manufacturing department, the supervision of approximately 20 staff member manufacturing team responsible for manufacturing Biologic Products. The position reports to the Head of Manufacturing.
Who you are:
- Bachelor's degree in Chemistry, Biology or in a science related field
- 5+ years of experience managing a GMP manufacturing team involving the scheduling and coordination of staff, materials, and manufacturing operations
- 5+ years of experience driving 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
- 5+ years of experience of the FDA, EMA, GMP & ICH regulatory requirements
- Manage 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
- 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 competing priorities
- Knowledgeable and compliant with all pertinent safety policies, rules, and regulations
RSRMSWhat 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
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.
Job Requisition ID: 216215
Career Level: E - Professional (10+ years)
Working time model: full-time